[Federal Register Volume 86, Number 201 (Thursday, October 21, 2021)]
[Rules and Regulations]
[Pages 58398-58431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22787]



[[Page 58397]]

Vol. 86

Thursday,

No. 201

October 21, 2021

Part II





Postal Service





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39 CFR Parts 111 and 211





Treatment of E-Cigarettes in the Mail; Final Rule

Federal Register / Vol. 86 , No. 201 / Thursday, October 21, 2021 / 
Rules and Regulations

[[Page 58398]]


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POSTAL SERVICE

39 CFR Parts 111 and 211


Treatment of E-Cigarettes in the Mail

AGENCY: Postal ServiceTM.

ACTION: Final rule.

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SUMMARY: The Postal Service revises its regulations in Publication 52, 
Hazardous, Restricted, and Perishable Mail, to incorporate new 
statutory restrictions on the mailing of electronic nicotine delivery 
systems. Like cigarettes and smokeless tobacco, such items are 
generally nonmailable, subject to certain exceptions.

DATES: This rule is effective October 21, 2021.

FOR FURTHER INFORMATION CONTACT: Dale E. Kennedy, Director, Product 
Classification, at 202-268-6592.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Summary of Final Rule
III. Response to Comments
    A. Lack of Policy Discretion
    1. Extra-Statutory Expansion of Mailability
    2. Extra-Statutory Restriction of Mailability
    3. Effective Date
    B. Constitutionality
    C. Relation to Other Laws
    1. FDA Regulation of Certain ENDS as ``Tobacco Products''
    2. Laws Regarding Marijuana, Hemp, and Hemp Derivatives
    3. Other Issues
    D. Scope of Covered ENDS Products
    1. Non-Nicotine-Related ENDS Products Generally
    i. Relation to Nicotine and Flavor
    ii. Relation to Listed Devices
    iii. Legislative History of the POSECCA
    2. Products That Aerosolize Non-Solution Solids
    3. Heat-Not-Burn Cigarettes
    4. Products That Release Aerosols Into Ambient Air, Not for 
Direct Inhalation
    5. Natural vs. Synthetic Nicotine
    6. Precursors
    E. Exclusion of Tobacco Cessation and Therapeutic Products
    F. Intra-Alaska and Intra-Hawaii Shipments
    G. Business/Regulatory Purposes Exception
    1. Availability in General
    2. Eligible Parties
    3. Application Process
    4. Documentation of Legally Operating Status
    5. Qualifying Postal Service Products
    6. Methods of Tender
    7. Delivery Requirements
    H. Certain Individuals Exception
    I. Consumer Testing and Public Health Exceptions
    1. Testing by Manufacturers
    2. Testing by Federal Agencies
    3. Testing by Public-Health Researchers
    J. Other Issues
    1. International and Overseas Military/Diplomatic Mail
    2. Reasonable Cause
    3. Terminology
    4. Communications
    5. Enforcement
    6. Availability of Rules' Text
    7. Updates
IV. Explanation of Changes From Proposed Rule

I. Background

    The Postal Service hereby amends Publication 52, Hazardous, 
Restricted, and Perishable Mail, with the provisions set forth herein. 
While not codified in Title 39, Code of Federal Regulations (``CFR''), 
Publication 52 is a regulation of the Postal Service, and changes to it 
may be published in the Federal Register. 39 CFR 211.2(a)(2). Moreover, 
Publication 52 is incorporated by reference into Mailing Standards of 
the United States Postal Service, Domestic Mail Manual (``DMM'') 
section 601.8.1, which is incorporated by reference, in turn, into the 
Code of Federal Regulations. 39 CFR 111.1, 111.3. Publication 52 is 
publicly available, in a read-only format, via the Postal 
Explorer[supreg] website at https://pe.usps.com. In addition, links to 
Postal Explorer are provided on the landing page of USPS.com, the 
Postal Service's primary customer-facing website; and Postal Pro, an 
online informational source available to postal customers.
    On February 19, 2021, the Postal Service published a notice of 
proposed rulemaking (86 FR 10218) to implement the Preventing Online 
Sales of E-Cigarettes to Children Act (``POSECCA''), Public Law 116-
160, div. FF, title VI (2020). Section 602 of the POSECCA adds 
``electronic nicotine delivery systems'' (``ENDS'') to the definition 
of ``cigarettes'' subject to regulation under the Jenkins Act, codified 
at 15 U.S.C. 375 et seq. As a result, ENDS are now subject not only to 
rules and restrictions governing remote sales under the Jenkins Act, 
but also to separate restrictions and exceptions for postal shipments, 
which rely on the same definition. 18 U.S.C. 1716E(a)(1). Section 603 
of the POSECCA requires the Postal Service to promulgate implementing 
regulations and provides that the prohibition on mailing ENDS will 
apply immediately ``on and after'' the date of this final rule.
    The statutory framework into which ENDS must now fit was 
established by the Prevent All Cigarette Trafficking Act of 2009 
(``PACT Act''), Public Law 111-154, sec. 3, 124 Stat. 1087, 1103-1109 
(2010), codified at 18 U.S.C. 1716E. Briefly, the PACT Act allows 
cigarettes and smokeless tobacco to be mailed only in the following 
circumstances:
    Intra-Alaska and Intra-Hawaii Mailings: Intrastate shipments within 
Alaska or Hawaii;
    Business/Regulatory Purposes: Shipments between verified and 
authorized tobacco-industry businesses for business purposes, or 
between such businesses and federal or state agencies for regulatory 
purposes;
    Certain Individuals: Lightweight, noncommercial shipments by adult 
individuals, limited to 10 shipments per 30-day period;
    Consumer Testing: Limited shipments of cigarettes sent by verified 
and authorized manufacturers to adult smokers for consumer testing 
purposes; and
    Public Health: Limited shipments of cigarettes by federal agencies 
for public health purposes under similar rules applied to manufacturers 
conducting consumer testing.

18 U.S.C. 1716E(b)(2)-(6). Outside of these exceptions, the Postal 
Service cannot accept or transmit any package that it knows, or has 
reasonable cause to believe, contains nonmailable smokeless tobacco or 
cigarettes. Id. at (a)(1).
    Nonmailable cigarettes and smokeless tobacco deposited in the mail 
are subject to seizure and forfeiture. 18 U.S.C. 1716E(c). Senders of 
nonmailable cigarettes or smokeless tobacco are subject to criminal 
fines, imprisonment, and civil penalties, in addition to enforcement 
under other Federal, State, local, and Tribal laws. Id. at (d), (e), 
(h).
    In inviting public comment, the notice of proposed rulemaking 
highlighted certain topics on which comments would be especially 
helpful: The definition of ENDS, appropriate ``catch-all'' terminology, 
standards for determining mailability, and the potential applicability 
of the PACT Act's exceptions, particularly the Consumer Testing and 
Public Health exceptions. 86 FR 10219-10220. We received more than 
15,700 comments on these and other topics, most of which appear to be 
electronically generated form letters and general expressions of ENDS 
users' dissatisfaction with the POSECCA.
    In considering the comments, and in view of Congress's abrogation 
of the standard 30-day notice period for a final rule under the 
Administrative Procedure Act (``APA''), see id. at 10220, the Postal 
Service determined that additional guidance might assist the industry 
in preparing for the final rule. On April 19, 2021, the Postal Service 
published a guidance document (``April 2021 Guidance'') (86 FR 20287) 
on two topics. First, the Postal Service informed ENDS industry 
participants that it

[[Page 58399]]

would not accept exception applications until the final rule had been 
issued, but that industry participants might instead use the 
intervening period to compile various types of documentation for 
submission with exception applications following the final rule (should 
such exceptions be made available). Second, the Postal Service reminded 
ENDS industry participants that, regardless of the impending 
applicability of PACT Act restrictions or exceptions, certain ENDS 
products are currently, and will remain, subject to other mailability 
prohibitions and restrictions (e.g., cannabis and other controlled 
substances, drug paraphernalia, lithium batteries, liquids, certain 
chemicals found in ENDS liquids, and certain advertisements and 
promotional materials). Readers of this final rule are encouraged to 
review the April 2021 Guidance and Publication 52 overall for 
additional information on these prohibitions and restrictions, which 
can render even a PACT-Act-exempt item nonmailable.

II. Summary of Final Rule

    ENDS products are generally nonmailable, except as authorized by an 
exception, and then only if all PACT-Act-related and non-PACT-Act-
related conditions of mailability are met. Congress did not grant the 
Postal Service authority to make policy decisions to waive or defer the 
operation of the POSECCA, to create new PACT Act exceptions, or to 
expand, restrict, or modify the scope of existing exceptions, beyond 
the reasonable application of the conditions enumerated in the PACT 
Act.
    ENDS products comprise (1) any electronic device that, through an 
aerosolized solution, delivers nicotine, flavor, or any other substance 
to the user inhaling from the device; and (2) any component, liquid, 
part, or accessory of an ENDS, regardless of whether sold separately 
from the device. This statutory definition resides in the Jenkins Act, 
which is administered by the Bureau of Alcohol, Tobacco, Firearms, and 
Explosives (``ATF''), and inquiries about whether specific products are 
covered should be directed to ATF. Provisionally, however, certain 
aspects of the definition are apparent from the plain statutory 
language, such as that a user must inhale from the device and that a 
covered ENDS product must be, or be capable of use with, a liquid 
solution. At the same time, Congress expressly provided that covered 
ENDS products extend beyond nicotine-related use, as relevant products 
may deliver ``nicotine, flavor, or any other substance.''
    The POSECCA excludes from the mailing ban any ENDS product that is 
approved by the U.S. Food and Drug Administration (``FDA'') for sale as 
tobacco cessation products or for other therapeutic purposes and 
marketed and sold solely for such purposes. At this time, the FDA has 
not approved any such devices or drugs.
    The statutory parameters for the Intra-Alaska/Intra-Hawaii, 
Business/Regulatory Purposes, and Certain Individuals exceptions are 
compatible with and administrable for ENDS products, and so they will 
be made available for such products.
    The preexisting centralized application process for the Business/
Regulatory Purposes exception will be extended to ENDS products, albeit 
with certain modifications to improve administration. Other, 
statutorily-derived requirements relating to acceptance and delivery 
will apply to ENDS products in like manner to cigarettes and smokeless 
tobacco. For example, approved shippers of Business/Regulatory Purposes 
mailings must use specified product combinations that allow for age and 
identity verification at delivery (e.g., Priority Mail with Adult 
Signature service) and must tender items in a face-to-face transaction 
either at a Postal Service retail office or at a Postal Service 
business mail acceptance location. For clarity, product combinations 
that include Adult Signature service can receive normal carrier 
delivery, subject to identity and age verification.
    The Certain Individuals exception will apply to ENDS products, 
subject to all of the same frequency, weight, age-verification, and 
other conditions that apply to other shipments covered by the PACT Act. 
By statute, this exception applies to qualifying shipments by 
individual adult mailers without regard to the nature of the recipient 
entity, expressly including the return of damaged or unacceptable 
products to manufacturers. Among other conditions, however, the statute 
limits the exception to shipments for noncommercial purposes. Thus, the 
compatibility of ENDS manufacturers' recycling programs with this 
exception may depend on whether such programs are structured so as not 
to involve any exchange of commercial value. The final rule also 
clarifies the standard for noncommercial purposes in the context of 
returns of damaged or unacceptable products, to the effect that any 
value provided in exchange for the returned item cannot exceed that 
which would restore the sender to the status quo ante.
    As for the Consumer Testing and Public Health exceptions, it is 
apparent that Congress intended those exceptions to apply only to 
combustible cigarettes, and not to ENDS products or smokeless tobacco. 
First, the Consumer Testing exception is statutorily restricted to 
cigarette manufacturers with a permit under section 5713 of the 
Internal Revenue Code (``IRC''), which does not apply to ENDS 
manufacturers. Second, shipments under the Consumer Testing exception 
(and, by extension, the Public Health exception) are expressly limited 
to specified quantities of ``packs of cigarettes'' containing 20 
cigarettes each. This standardized quantification is meaningful in the 
context of combustible cigarettes, but not in the context of ENDS 
products or smokeless tobacco. Upon consideration of the public 
comments, there does not appear to be a workable standard by which to 
apply this material condition for the Consumer Testing and Public 
Health exceptions to ENDS products, notwithstanding their treatment as 
``cigarettes'' for broader purposes of the PACT Act. Given this 
context-based plain reading of the statute and the narrow construction 
typically due exceptions, the Postal Service concludes that current law 
does not support applying these exceptions to ENDS products.
    Upon original implementation of the PACT Act, the Postal Service 
determined that the PACT Act exceptions cannot feasibly be applied to 
inbound or outbound international mail or to mail to or from the Freely 
Associated States. The Postal Service cannot fulfill the PACT Act's 
verification requirements in locations where it does not interact 
directly with shippers and addressees. Nothing has changed in that 
regard. As such, all cigarettes and smokeless tobacco in such mail will 
continue to be nonmailable, without exception, and the same will be 
true of ENDS products.
    Moreover, consultation with partner agencies regarding the PACT 
Act's requirements and the availability of relevant postal services has 
indicated that the statutory prerequisites for the PACT Act's 
exceptions cannot reliably be fulfilled at overseas U.S. military 
postal addresses. Thus, while shipments from such installations to the 
United States were already ineligible for any PACT Act exceptions, 
shipments from the United States to such installations must likewise be 
ineligible for the exceptions at this time.

III. Response to Comments

    The Postal Service received more than 15,700 responses to the 
notice of

[[Page 58400]]

proposed rulemaking, several of which included comments on multiple 
topics. Commenters included businesses that ship ENDS products; 
individual consumers of ENDS products; organizations representing ENDS 
shippers and/or consumers; organizations representing taxpayer and/or 
business interests generally; a group of state and local attorneys 
general; public-health researchers, research institutions, and advocacy 
organizations; and a number of individual law students. In addition, 
the Postal Service consulted informally with ENDS researchers, industry 
participants, State and local attorneys general, and Federal agencies 
involved in regulating tobacco and ENDS products. Comments and Postal 
Service responses are summarized as follows.

A. Lack of Policy Discretion

1. Extra-Statutory Expansion of Mailability
    A large number of ENDS consumers, ENDS shippers, and some law 
students (collectively, ``pro-ENDS commenters'') urged the Postal 
Service not to subject ENDS products to the PACT Act. As rationales, 
these commenters invoked the purported public benefits associated with 
ENDS products; the impact of a mailing ban on businesses and the Postal 
Service; the possibility of unanticipated and even perverse economic, 
distributive, and public-health effects of a mailing ban; doubts about 
the role that the mails may play in youth access to ENDS products 
(perceived to be the policy motivation for the mailing ban); skepticism 
about enforceability; \1\ perceived hypocrisy in the roster of mailable 
and nonmailable items; \2\ and concerns about restriction of individual 
liberty.
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    \1\ These last two sets of arguments, typically expressed by 
ENDS consumers, are in tension with one another: One holds that 
youth do not tend to get ENDS products through the mails, the other 
that youth will continue to access ENDS products through the mails 
regardless.
    \2\ Some ENDS consumers expressed outrage that ENDS products 
should be nonmailable while alcohol, cigarettes, firearms, gun 
parts, lettuce, marijuana, and other controlled substances 
supposedly remain mailable. In fact, each of these types of items is 
nonmailable in at least some--and, in some cases, most or all--
circumstances. See Publication 52 subchapters 42, 43, 47, 53 & part 
453.
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    A number of ENDS consumers and shippers also proposed that the 
Postal Service implement some alternative method of regulating the 
mailability of ENDS products, in lieu of the PACT Act's ban and 
exceptions. Proposals included the following:
     Permit the mailing of ENDS products with age verification 
of recipients.
     Permit the mailing of ENDS products with warning labels.
     Permit the mailing of ENDS products under the same 
conditions provided for non-postal delivery channels under the Jenkins 
Act (as amended by section 2 of the PACT Act).
     Allow the ENDS industry to regulate itself, subject to a 
requirement to conduct age verification of consumers.
     Limit mailability to ENDS products containing less than a 
specified threshold of nicotine.
     Limit mailability to non-nicotine-containing ENDS 
products.
     Limit mailability to single-use ENDS products.
     Scale mailability restrictions according to a policy-based 
hazard assessment of the product, shipper, and recipient.
    In addition, some public-health-oriented commenters and law 
students, as well as some Federal agency partners with which the Postal 
Service consulted, proposed that the Postal Service ensure that ENDS 
products can be shipped in circumstances not covered by any statutory 
exception, such as between public-health researchers and individual 
test subjects; between governmental actors for enforcement, 
investigative, or testing purposes; and from the government to non-
governmental public-health entities. These commenters invoked the 
interests of promoting public-health research into and effective 
regulation of ENDS products. Many of these stakeholders also urged the 
Postal Service to allow use of the Public Health exception for ENDS 
products on policy grounds and to allow ENDS-industry businesses to 
ship ENDS products to governmental actors for any regulatory purpose, 
without regard to the statutory parameters of the existing PACT Act 
exceptions.
    Finally, a number of commenters of varying orientations--including 
some in the ENDS industry--acknowledged that the POSECCA charges the 
Postal Service merely with incorporating ENDS products into the 
existing PACT Act framework, rather than authorizing it to revisit and 
alter that framework.
    The latter group of commenters is correct: In this context, the 
Postal Service lacks the authority to adopt a regulatory scheme 
different from what Congress has prescribed. In general, the Postal 
Service, as part of the Executive Branch, is bound to faithfully 
execute the laws enacted by Congress and can act only within the scope 
of discretion that Congress has delegated to it. U.S. Constitution 
article I, section 1; id. at article II, section 3; see, e.g., Gundy v. 
United States, __U.S. __, __, 139 S. Ct. 2116, 2123 (2019). The PACT 
Act expressly provides that cigarettes and smokeless tobacco are 
generally nonmailable, that the Postal Service generally may not accept 
them for delivery or transmit them through the mails, and that those 
prohibitions give way only in circumstances defined by a number of 
statutory parameters and conditions. 18 U.S.C. 1716E(a)-(b). The 
POSECCA extends that treatment to ENDS products by including them 
within the term ``cigarette.'' POSECCA section 602(a)(1)(C).
    Neither the PACT Act nor the POSECCA includes any provision 
authorizing the Postal Service to waive the mailing ban for ENDS 
products or any other subcategory of ``cigarettes,'' with or without 
other regulatory conditions devised by the Postal Service (e.g., age 
verification, nicotine limits). In particular, the POSECCA charges the 
Postal Service only with ``clarify[ing] the applicability'' of the PACT 
Act's mailing ban to ENDS products. POSECCA section 603(a). 
Clarification means to make something clear or understandable or to 
dispel confusion, presupposing the pre-establishment of the proposition 
being clarified: A self-evidently modest task that falls far short of 
substantive change to that proposition. See Clarify, Merriam-Webster.com (last visited Oct. 14, 2021). As such, whatever policy 
judgments the Postal Service might reach as to public-health effects, 
commercial impact, the need to facilitate effective regulation, or 
other considerations, those judgments have already been made by 
Congress in legislating that ENDS products cannot be mailed except in 
statutorily prescribed circumstances.
    Congress could have left ENDS products mailable, subjected them to 
alternative restrictions (as section 2 of the PACT Act does for non-
postal delivery carriers), or delegated authority to the Postal Service 
to grant waivers, create new exceptions, or devise some other 
appropriate mailability scheme. Cf. 18 U.S.C. 1716(b)-(e) (authorizing 
the Postal Service to permit or limit the mailing of potentially 
hazardous materials); 39 U.S.C. 3018(b) (giving the Postal Service 
discretion to declare hazardous materials to be nonmailable or to 
restrict the time, place, and manner of their mailing). Yet Congress 
did none of those things. Instead, it chose to bar the Postal Service 
from carrying ENDS products, except pursuant to a limited set of 
specifically delineated statutory exceptions. See

[[Page 58401]]

Treatment of Cigarettes and Smokeless Tobacco as Nonmailable Matter, 75 
FR 29662, 29664 (2010) (notice of final rule); see also Gordon v. 
Holder, 721 F.3d 638, 657 (D.C. Cir. 2013) (declining, on rational 
basis review, to ``second-guess the wisdom of [Congress's] choice'' to 
enact the PACT Act's mailing ban in lieu of some alternative measure).
    In sum, arguments to relax the PACT Act's application to ENDS 
products on policy grounds are misdirected to the Postal Service. 
Whatever the merits of ENDS products generally or the anticipated 
effects of the POSECCA, the forum for that debate is Congress, which 
has declined to delegate, and thus has reserved to itself, policy 
discretion over the pertinent parameters.
2. Extra-Statutory Restriction of Mailability
    Conversely, some public-health-oriented commenters, State and local 
attorneys general, law students, and other individual commenters 
(collectively, ``anti-ENDS commenters'') urged the Postal Service to 
deny or restrict the application of the PACT Act's exceptions to ENDS 
products, due to concerns about hazardous materials, controlled 
substances, public health, youth access, and the purported risk of 
circumventing law enforcement.
    For the reasons discussed in the preceding section, neither the 
PACT Act nor the POSECCA authorizes the Postal Service to make policy 
judgments to narrow or rescind the availability of the statutory 
exceptions. Cf. 18 U.S.C. 1716(d)-(e). The parameters of the exceptions 
are expressly set forth in the statute. Notwithstanding some limited 
interpretive and administrative latitude in implementing the statute, 
the Postal Service cannot repeal, disregard, or amend the statute's 
explicit parameters on policy grounds. Like policy arguments to relax 
the PACT Act for ENDS products, policy arguments to tighten it should 
be directed to Congress, not the Postal Service. See United States v. 
Rodgers, 466 U.S. 475, 484 (1984) (``Resolution of the pros and cons of 
whether a statute should sweep broadly or narrowly is for Congress.'').
    Moreover, the public-health and worker-safety concerns raised by 
certain public-health-oriented commenters are already addressed by 
statutes and regulations independent of the PACT Act. As noted in the 
April 2021 Guidance, ENDS products that constitute controlled 
substances or drug paraphernalia are nonmailable regardless of whether 
the PACT Act would also preclude mailability. 21 U.S.C. 843(b)-(c), 
863; Publication 52 part 453; see 86 FR at 20289.
    Likewise independently of the PACT Act's application, liquids and 
hazardous materials are also nonmailable to the extent that the shipper 
has not observed applicable mailing requirements and restrictions. 18 
U.S.C. 1716(a), (h); 39 U.S.C. 3018; DMM section 601.3.4; Publication 
52 chapter 3 & parts 451, 711-728 & app. A, C; see 86 FR at 20289. The 
hazardous-materials rules already embody determinations by the 
Department of Transportation, the Postal Service, and other relevant 
authorities about how to balance worker safety against commercial 
interests, resulting in, for example, differing levels of restriction 
and mailing requirements for differing concentrations of nicotine.\3\
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    \3\ One public-health-oriented commenter opined that PACT Act 
exceptions should be disallowed for ENDS products because they may 
contain hazardous materials and yet be transported by air, including 
in intrastate shipments pursuant to 18 U.S.C. 1716E(b)(2). But many 
hazardous materials are not categorically barred from air 
transportation; rather, they can be transported by air 
transportation so long as they are properly prepared and labeled 
and/or are packaged in limited quantities. See Publication 52 parts 
327, 331-337, 343, 346, 349. To the extent that these restrictions 
are not observed, then--as was the case prior to this final rule--an 
ENDS shipment is nonmailable under the hazardous-materials rules 
regardless of the PACT Act.
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    That said, the public-health-oriented commenters rightly point out 
that the broad array of covered ENDS products is more likely than 
cigarettes and smokeless tobacco to implicate mailability rules outside 
of the PACT Act. ENDS products include or may contain lithium 
batteries, as well as nicotine and other chemicals that are flammable 
or toxic. See April 2021 Guidance, 86 FR at 20289; Harmful and 
Potentially Harmful Constituents in Tobacco Products; Established List; 
Proposed Additions; Request for Comments, 84 FR 38032, 38033-38034 
(2019). Once again, all mailers, including businesses, individuals, and 
governmental entities that may ship ENDS products pursuant to the PACT 
Act's exceptions, are strongly encouraged to review and comply with all 
pertinent statutes and Postal Service regulations.\4\ ENDS 
manufacturers and distributors are further encouraged to educate ENDS 
consumers about the need to ensure that any further mailing of ENDS 
products conforms to applicable legal requirements regarding controlled 
substances, drug paraphernalia, and potentially hazardous materials, in 
addition to the PACT Act.
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    \4\ As noted in the April 2021 Guidance, advertisements and 
promotional or sales matter regarding controlled substances and 
certain hazardous materials are generally also nonmailable. 18 
U.S.C. 1716(h); 21 U.S.C. 843(b), (c)(1); DMM section 601.9.4.1; 86 
FR at 20289.
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3. Effective Date
    Some pro-ENDS commenters proposed that, if the Postal Service does 
implement the mailing ban, the Postal Service should defer its 
effective date or exercise its enforcement discretion to effectively 
allow the continued mailing of ENDS products for some period (e.g., a 
period long enough to allow some segment of the ENDS industry to apply 
for and receive authorization to use the Business/Regulatory Purposes 
exception). One ENDS consumer urged the Postal Service to stay 
implementation until after the COVID-19 pandemic, and another suggested 
a delay in the general interest of facilitating industry compliance and 
reducing diversion to the black market. A law student suggested that 
the Postal Service could delay implementation in areas where brick-and-
mortar stores do not meet ENDS demand.
    The Postal Service lacks discretion as to the effective date. The 
POSECCA expressly provides that the prohibition will apply to mailings 
of ENDS ``on and after'' the publication date of the final rule. 
POSECCA section 603(b). If anything, it is the effective date of any 
applicable PACT Act exceptions, and not the PACT Act's general mailing 
ban, about which the POSECCA is silent. Whatever transition-related 
challenges that the POSECCA's effective date might pose on the industry 
(despite having had an extended period to prepare for the mailing ban), 
Congress conferred no authority on the Postal Service to derogate from 
the requirement that the final rule have immediate effect.
    As for enforcement discretion, the scope of the Postal Service's 
enforcement discretion under the PACT Act is the subject of ongoing 
litigation. See generally City of New York v. U.S. Postal Serv., No. 
1:19-CV-05934 (E.D.N.Y. filed Oct. 22, 2019). To the extent that the 
Postal Service can exercise discretion as to enforcement of the PACT 
Act, however, the Postal Service declines to exercise it in the manner 
proposed by the commenters here. While law-enforcement discretion can 
encompass decisions not to enforce a law, such decisions are expressly 
and exclusively vested in the relevant Executive Branch entity, which 
must balance policy and resource considerations, and are not amenable 
to judicial review. E.g., Heckler v. Chaney, 470 U.S. 821, 831-32 
(1985). The Postal Service does not regard the commenters' proposal--in 
effect, implementing the POSECCA on paper only while broadly

[[Page 58402]]

maintaining the status quo ante in practice--to be a viable or 
preferable exercise of its law-enforcement discretion.

B. Constitutionality

    A number of pro-ENDS commenters advanced various theories as to the 
supposed unconstitutionality of the POSECCA and the proposed 
implementing regulations: They would impair the rights of adults to 
receive ENDS through the mails; the law is too vague; and the POSECCA 
is overbroad in its impact on adult users of ENDS products, not only 
minors.
    As an initial matter, the constitutionality of the POSECCA has no 
bearing on the Postal Service's obligation to execute it. As discussed 
in section III.A.1, the Constitution requires the Postal Service, as an 
entity within the Executive Branch, to faithfully execute the laws. 
U.S. Constitution article II, section 3. By contrast, ``it is, 
emphatically, the power and duty of the [Judicial Branch], to say what 
the law is.'' Marbury v. Madison, 5 U.S. (1 Cranch) 137, 177 (1803). 
For the Postal Service unilaterally to decide not to execute a duly 
enacted law on constitutional grounds would abdicate its constitutional 
duty and usurp the powers of the Legislative and Judicial Branches. See 
Ameron, Inc. v. U.S. Army Corps of Engineers, 787 F.2d 875, 889 & n.11 
(3d Cir. 1986) (the President can ``veto, criticize, or even refuse to 
defend in court, statutes which he regards as unconstitutional,'' but 
may not refuse to execute them on constitutionality grounds) (citing 
Marbury and other significant Supreme Court opinions to that effect); 
see also Am. Coalition for Competitive Trade v. Clinton, 128 F.3d 761, 
766 n.6 (D.C. Cir. 1997) (``administrative agencies . . . cannot 
resolve constitutional issues''). As such, barring a contrary judicial 
determination, any concerns about the POSECCA's constitutionality are 
no bar to its Congressionally mandated implementation by the Postal 
Service.
    That said, by all indications, the relevant statutes appear to be 
constitutional. Congress has plenary powers to enact laws governing the 
postal system, as well as to regulate interstate commerce and commerce 
with foreign and Tribal nations. U.S. Constitution article I, section 
8, clauses 3, 7. In exercising those powers, Congress's authority to 
ban a class of products from the mails--even those that are legal in 
all States and that are not harmful to Postal Service personnel--is 
well-established: Indeed, Congress has historically done so with a 
number of other such products. U.S. Postal Serv. v. Council of 
Greenburgh Civic Ass'ns, 453 U.S. 114, 126 (1981) (``The validity of 
legislation describing what should be carried has never been 
questioned. The power possessed by Congress embraces the regulation of 
the entire Postal System of the country. The right to designate what 
shall be carried necessarily involves the right to determine what shall 
be excluded.'') (quoting Ex parte Jackson, 96 U.S. 727, 732 (1878)) 
(cleaned up); Gordon, 721 F.3d at 656; Musser's Inc. v. United States, 
1 F. Supp. 3d 308, 318 (E.D. Pa. 2014). The PACT Act's mailing ban in 
particular has been upheld as a rational exercise of Congress's 
constitutional powers. Gordon, 721 F.3d at 657; Musser's, 1 F. Supp. at 
318.
    Given Congress's plenary power over the very existence of the 
postal system, it cannot be said that there is a fundamental right to 
mail any particular item, let alone ENDS products, and shippers or 
users of ENDS products do not constitute a protected class any more 
than shippers or users of cigarettes or smokeless tobacco. See Gordon, 
721 F.3d at 657 (regarding the PACT Act as a ``law that does not 
infringe on a fundamental right or involve a suspect classification''). 
As such, Congress's action is presumptively legitimate as long as any 
rational basis is conceivable. Id. at 656-57 (plaintiff challenging the 
PACT Act must meet a ``high burden to negative every conceivable basis 
which might support'' it) (quoting FCC v. Beach Communs., Inc., 508 
U.S. 307, 315 (1993)).
    It does not require much to conceive of a legislative rationale in 
this case. Although the task is ``by no means restricted to the stated 
reasons for passing a law,'' the statute here expressly offers multiple 
rational bases for a mailing ban on ENDS products. See id. at 657.
    By modifying the PACT Act's definition of ``cigarettes'' to extend 
to ENDS products, the 116th Congress effectively incorporated ENDS 
products into the statement of findings and purposes underlying the 
PACT Act. Public Law 111-154, sec. 1(b)-(c), 124 Stat. 1087-1088. For 
example, the 116th Congress presumably believed that ``the sale of 
illegal cigarettes [now including ENDS products] and smokeless tobacco 
over the internet, and through mail, fax, or phone orders, makes it 
cheaper and easier for children to obtain tobacco products'' and that a 
mailing ban would ``prevent and reduce youth access to inexpensive 
cigarettes [including ENDS products] and smokeless tobacco through 
illegal internet or contraband sales'': Indeed, the title of the 
POSECCA and the relevant House committee report indicate as much. See 
id. at section 1(b)(4)-(5), (c)(6); H. Rept. 116-260 at 3-4 (2019).
    Contrary to the commenters' overbreadth argument, the PACT Act's 
purposes are not limited to youth access. Other stated purposes of the 
PACT Act--combating illegal trafficking, circumvention of state and 
local laws, and unfair competition with law-abiding retailers--
implicate adult as well as youth consumers and can apply as easily to 
ENDS products as to cigarettes and smokeless tobacco. See id. at 
section 1(b)(1)-(3), (b)(6)-(7), (c)(1)-(5); Gordon, 721 F.3d at 657.
    So, too, can Congress's judgment that an outright ban on the 
mailing of ENDS products, notwithstanding the applicability of other, 
more targeted requirements and enforcement opportunities, is necessary 
to address these harms. Gordon, 721 F.3d at 657.
    As discussed in section III.D.1.iii, many pro-ENDS commenters 
questioned the evidence of legislative intent to ban the mailing of 
ENDS products that do not contain nicotine. For purposes of the 
constitutionality discussion here, it is noted that plain language of 
the statute makes that intent clear, and the legislative history does, 
in fact, attest to the framers' public-health concerns in relation to 
non-nicotine-related ENDS products. Even without such expressions of 
intent, however, there would certainly be a rational basis for Congress 
to have specified the POSECCA's breadth as it did. Given operational 
and legal constraints, it is not simple--indeed, it is generally 
impossible--for Postal Service personnel prohibited from accepting or 
transmitting ENDS products to distinguish liquids that contain nicotine 
from those that do not, and it is equally difficult for acceptance 
personnel to distinguish devices intended to be used with nicotine-
containing versus non-nicotine-containing liquids. Even barring any 
more specific motive for banning non-nicotine-related ENDS products 
from the mails, it would be conceivable that Congress intended to 
ensure effective enforcement against nicotine-related ENDS products, 
rather than letting a safe harbor for non-nicotine-related ENDS 
products get in the way of advancing Congress's nicotine-related policy 
concerns.
    Again, however, such speculation is unnecessary, because the youth-
access and public-health concerns underlying the POSECCA were not 
restricted to nicotine. The relevant House committee report cites 
information from the Centers for Disease Control and Prevention (CDC) 
about lung injuries associated with the use of ENDS

[[Page 58403]]

products, which were ultimately--after the committee report but prior 
to floor debate on and passage of the POSECCA--attributed to non-
nicotine constituents of ENDS liquids. H. Rept. 116-260 at 3 & nn.22-23 
(citing CDC, Outbreak of Lung Injury Associated with the Use of E-
Cigarette, or Vaping, Products, https://go.usa.gov/xHd78 (last updated 
Feb. 25, 2020)). There is no indication in the legislative record that 
the POSECCA framers' concern about ENDS-related lung injuries was 
conditional upon or limited to any eventual nexus specific to nicotine-
related ENDS products.
    Turning to the vagueness contention, it is difficult to see what is 
``vague'' about the POSECCA or the PACT Act. The POSECCA makes 
nonmailable (with exceptions) ``any electronic device that, through an 
aerosolized solution, delivers nicotine, flavor, or any other substance 
to the user inhaling from the device,'' as well as ``any component, 
liquid, part, or accessory'' of such a device. 15 U.S.C. 375(7)(A), 
(7)(B)(vii). While certain terms may benefit from interpretation 
pursuant to well-established principles of administrative law, it 
cannot be said that the statute fails to give the public or law-
enforcement agencies reasonable notice about what is prohibited. If 
anything, the POSECCA definition is more prescriptive than some other 
longstanding mailability statutes. Cf. 18 U.S.C. 1716(a) (``hazardous 
materials, inflammable materials, infernal machines, and mechanical, 
chemical, or other devices or compositions which may ignite or explode, 
. . . and all other natural or artificial articles, compositions, or 
material which may kill or injure another, or injure the mails or other 
property''); id. at (j) (``spirituous, vinous, malted, fermented, or 
other intoxicating liquors of any kind''). While the POSECCA definition 
may be broad in a manner that some persons find objectionable, that is 
not the same as being vague.
    For all of these reasons, the Postal Service maintains that it is 
not constitutionally barred from executing the POSECCA.

C. Relation to Other Laws

1. FDA Regulation of Certain ENDS as ``Tobacco Products''
    Multiple pro-ENDS commenters noted the FDA's definition of ENDS as 
noncombustible tobacco products, asserted that the FDA has confined the 
scope of its regulations to devices intended to be used with nicotine-
containing ENDS liquids, and urged us to harmonize the POSECCA's ENDS 
definition with this purported FDA policy. At least one commenter 
pointed to the POSECCA's rule of construction, which provides that the 
POSECCA definition shall not ``be construed to affect or otherwise 
alter any provision of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.), including its implementing regulations.'' POSECCA 
section 602(c). Additionally, some pro-ENDS commenters asserted that 
the FDA excludes ``accessories'' from regulation as ``tobacco 
products'' and urged the Postal Service to follow suit. See 21 CFR 
1100.1-.2.
    As an initial matter, the Federal Food, Drug, and Cosmetic Act 
(``FD&C Act'') and the PACT Act (as modified by the POSECCA) govern 
different subjects. Under the FD&C Act, the FDA regulates the 
manufacturing, marketing, and distribution of tobacco products to 
protect the public health. FDA regulation of tobacco products is not 
necessarily tied to a given distribution method. By contrast, the 
relevant portion of the PACT Act governs whether such products--
following or pending authorization for interstate commerce--may be sent 
through the federally administered postal system, or whether they may 
be transported only through non-postal channels. Indeed, section 2 of 
the PACT Act provides that covered items may be carried through non-
postal delivery channels, so long as carriers and sellers comply with 
various requirements. Although nonmailability may influence the 
practicalities of interstate commerce (e.g., products' costs and 
accessibility), it does not constitute an outright legal bar to 
interstate commerce.\5\
---------------------------------------------------------------------------

    \5\ Of course, it is possible for multiple Federal authorities 
to apply concurrently. FDA authorization of a cigarette for 
introduction or delivery into interstate commerce does not absolve 
an actor from other Federal requirements that govern the manufacture 
and distribution of cigarettes and other covered products: Rather, 
all overlapping requirements must be complied with in order to offer 
the product in interstate commerce.
---------------------------------------------------------------------------

    The FDA's regulation of ENDS emanates from a statutory framework 
regarding tobacco products that is unrelated to and distinct from the 
POSECCA. More specifically, the Family Smoking Prevention and Tobacco 
Control Act (``Tobacco Control Act''), Public Law 111-31, granted the 
FDA the authority to regulate tobacco products by, among other things, 
adding Chapter IX (Tobacco Products) to the FD&C Act, 21 U.S.C. 387a. 
Section 901 of the FD&C Act provides that this chapter applies to 
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless 
tobacco, as well as to any other tobacco products that the Secretary of 
Health and Human Services by regulation deems subject to it. It is 
pursuant to that delegation of ``deeming'' authority that the FDA 
decided to subject certain ENDS products--specifically, those that meet 
the FD&C Act definition of a ``tobacco product''--to tobacco regulation 
under the FD&C Act. 81 FR 28973, 28982 (2016). The FDA's broad 
discretion under the FD&C Act encompasses the ability to define the 
scope of ENDS products that the FDA considers amenable to regulation, 
subject to the FD&C Act's parameters. For example, FDA-regulated 
tobacco products (including ENDS products) must be either made or 
derived from tobacco and intended for human consumption, or else a 
part, component, or accessory of such a product. 21 U.S.C. 321(rr)(1), 
387a(c)(1). Pursuant to its discretion, the FDA decided to regulate 
``components or parts'' of ENDS products but not ``accessories.'' Id. 
at 28,975.
    The context here is different, because the statute itself 
explicitly defines the scope of nonmailable ENDS in a manner that 
departs from the FD&C Act and FDA definitions. Specifically, the 
POSECCA makes nonmailable ``any electronic device that, through an 
aerosolized solution, delivers nicotine, flavor, or any other substance 
to the user inhaling from the device.'' The POSECCA refers to 
``nicotine'' without distinguishing on the basis of origin (tobacco or 
otherwise). Furthermore, the POSECCA definition of ENDS sweeps beyond 
nicotine to include, as standalone triggers, ``flavor[ ] or any other 
substance.'' Clearly, Congress could have phrased the POSECCA to tie to 
or mirror the FD&C Act terminology, or it could have used other 
terminology that aligned with the scope of FDA regulation. Yet Congress 
did not do so; instead, it chose to specify a broader universe of 
nonmailable items than those that are subject to FDA regulation.
    It is apparent that the POSECCA neither alters nor conflicts with 
the FD&C Act, and that it impinges in no way on the FDA's implementing 
regulations. Rather, the two laws apply concurrently, albeit with only 
a partial overlap in scope. This is nothing new. For example, the 
universe of products subject to FDA regulation as ``tobacco products'' 
is itself broader than the scope of ``tobacco products'' subject to 
Treasury Department regulation under IRC chapter 52, which expressly 
does not include ENDS products. See 26 U.S.C. 5702. Among other laws, 
manufacturers of combustible cigarettes must contend with IRC chapter 
52 and FDA tobacco regulation as well as the PACT Act; manufacturers of 
ENDS

[[Page 58404]]

products within the FD&C Act definition of ``tobacco product'' must 
contend with FDA tobacco regulation and now the PACT Act, but not IRC 
chapter 52; and manufacturers of other ENDS products must now contend 
with the PACT Act, but neither IRC chapter 52 nor FDA tobacco 
regulation. There is no conflict of laws here; Congress simply chose to 
subject different products to different layers of regulation.
    It also bears mention that certain commenters mischaracterized the 
FDA's policy on ENDS liquids, suggesting that the FDA has deemed only 
liquid nicotine and nicotine-containing liquid to fall within its 
regulatory purview. This is not necessarily true. Rather, the FDA 
observed that non-nicotine-containing liquids may be FDA-regulated as 
components or parts of ENDS liquids, to the extent that they are 
``intended or reasonably expected to be used with or for the human 
consumption of a tobacco product and do not meet the definition of 
accessory.'' 81 FR at 29041. It therefore may be that the POSECCA's 
coverage of ENDS products that deliver ``flavor[ ] or any other 
substance'' beyond nicotine, as well as non-tobacco-derived nicotine, 
represents less of a step beyond FDA regulation than these commenters 
asserted.
    As for ``accessories'' of ENDS products, it is true that the FDA's 
``deeming'' rule exempted them from regulation under the FD&C Act. Yet 
Congress chose to render them nonmailable under the POSECCA. We note 
that the POSECCA does not define ``accessories,'' and so Congress has 
not spoken to whether the term should be interpreted in a manner 
consistent with the scope of items that the FDA has defined as outside 
of its regulatory framework. As discussed in section III.D, the POSECCA 
definition resides in a statute administered by ATF, and so the Postal 
Service will look to ATF for interpretive guidance about the scope of 
``accessories'' for PACT Act purposes.
2. Laws Regarding Marijuana, Hemp, and Hemp Derivatives
    Numerous pro-ENDS commenters urged that the POSECCA be construed, 
or the Postal Service's implementing regulations be written, to exempt 
ENDS items consisting of, containing, or used with marijuana and 
marijuana- or hemp-derived products. Many of these commenters asserted 
that rendering such items nonmailable would conflict with State and 
local laws decriminalizing or legalizing cannabis for medical or 
recreational purposes. Some claimed that the inclusion of such products 
would conflict with provisions in recent appropriations Acts (including 
that which includes the POSECCA) that bar the Department of Justice 
from using appropriated funds to prevent certain States and Territories 
``from implementing their own laws that authorize the use, 
distribution, possession, or cultivation of medical marijuana.'' E.g., 
Public Law 116-260, div. B, sec. 531. Finally, some argued that 
inclusion of such products would conflict with the removal of hemp and 
hemp derivatives (with not more than 0.3 percent tetrahydrocannabinol 
(``THC'') by dry weight) from the definition of marijuana in the 
Controlled Substances Act (``CSA''). See Agriculture Improvement Act of 
2018, Public Law 115-334, sec. 10113, 12619, 132 Stat. 4490, 4908, 
5018, Public Law 91-513, sec. 102(16)(B), codified at 7 U.S.C. 
1639o(1); 21 U.S.C. 802(16)(B), 812(c)(17).
    As discussed further in section III.D.1.i, notwithstanding 
Congress's use of ``nicotine'' in the term ``electronic nicotine 
delivery systems,'' the plain language of the POSECCA definition makes 
clear that nonmailable ENDS products include those containing or used 
with not only nicotine, but also ``flavor[ ] or any other substance.'' 
It goes without saying that marijuana, hemp, and their derivatives are 
substances. Hence, to the extent that they may be delivered to an 
inhaling user through an aerosolized solution, they and the related 
delivery systems, parts, components, liquids, and accessories clearly 
fall within the POSECCA's scope.
    That said, THC is generally nonmailable for reasons independent of 
the POSECCA and the PACT Act. THC-containing substances remain 
generally prohibited under the CSA, regardless of whether they are 
intended for purportedly medical or recreational purposes or whether 
the shipper or recipient resides in a State or locality that has 
decriminalized either or both such uses. 21 U.S.C. 812(c)(17), 843(b); 
Publication 52 section 453. Devices, parts, components, and accessories 
used with such substances can qualify as drug paraphernalia, which is 
likewise nonmailable. 21 U.S.C. 863; Publication 52 part 453. The only 
exceptions to this mailing ban are for hemp and hemp derivatives that 
contain no more than 0.3 percent THC by dry weight. See Publication 52 
section 453.37.
    Thus, ENDS products containing or used with THC (e.g., THC-
containing liquids, cannabis waxes, dry cannabis herbal matter) are 
already nonmailable under the CSA. Congress's decision to keep such 
items out of the Federal postal network does not bear on whether their 
use or exchange violates State or local law. Nor does it alter whether 
the Department of Justice--a Federal entity independent of the Postal 
Service--may use its appropriated funds to interfere with the operation 
of State or local laws.
    For clarity, even if a shipper could avail itself of a PACT Act 
exemption with respect to ENDS products generally, the shipper is still 
prohibited from mailing ENDS products that contain THC (other than hemp 
derivatives with no more than 0.3 percent THC by dry weight). Nor does 
the lack of civil or criminal sanction under State or local law entitle 
any person to ship THC through the Federal postal network or absolve 
them of penalties under Federal law, so long as the Federal CSA remains 
applicable.
    Conversely, THC-containing substances that are excluded from the 
CSA--that is, hemp and hemp derivatives with no more than 0.3 percent 
THC by dry weight--are not subject to CSA-based mailability 
restrictions, and items used with such substances (and not with 
controlled substances) may fall outside the definition of drug 
paraphernalia. Publication 52 section 453.37. As such, those substances 
continue to be mailable generally, to the extent that they are not 
incorporated into an ENDS product or function as a component of one. To 
the extent that they do comprise or relate to an ENDS product, however, 
then that product is now nonmailable under the PACT Act and POSECCA, 
except pursuant to a PACT Act exception.
    The POSECCA and the Agriculture Improvement Act overlap, but they 
do not conflict. The Agriculture Improvement Act merely excludes 
certain products from the CSA. It does not affirmatively declare hemp 
and hemp derivatives to be mailable in any and all circumstances, 
superseding all other relevant laws (such as the POSECCA). For its 
part, the POSECCA restricts the mailability of only certain hemp-based 
and related products; hemp-based non-ENDS products are unaffected, as 
are ENDS products falling within one of the PACT Act's exceptions. That 
Congress has rendered some subset of a class of goods to be nonmailable 
while leaving the remainder mailable is not some sort of legal 
conflict, but, rather, how mailability regulation typically works.
3. Other Issues
    Certain ENDS industry commenters argued that the PACT Act should 
not apply to non-nicotine-related ENDS

[[Page 58405]]

products to avoid conflicts with State and local law. Specifically, 
commenters asserted that the PACT Act requires manufacturers to 
register and certify tax compliance to State and local authorities, yet 
some States and localities do not specially tax non-nicotine-related 
ENDS products. One cannabis industry coalition also opined that 
requirements to report consumer sales could violate State privacy laws. 
Another complained that statutory labeling requirements regarding 
``nicotine'' and ``tobacco'' are inapt for non-nicotine-related ENDS 
products.
    Whatever their merit, these comments are misdirected. It is true 
that section 2 of the PACT Act amended the Jenkins Act to impose 
various registration, labeling, and tax-compliance requirements on 
remote sales of cigarettes and smokeless tobacco, and that the 
POSECCA's amendment of the ``cigarette'' definition now subjects ENDS 
products to those requirements. See generally 15 U.S.C. 375 et seq. But 
that portion of the PACT Act is not germane here. Section 3 of the PACT 
Act--the portion at issue here--more broadly prohibits consumer sales 
from being effected through the mails (except for intrastate shipments 
within Alaska and Hawaii). Thus, the Jenkins Act requirements bear 
almost entirely on sales through non-postal delivery channels. Whatever 
their application to sales of ENDS products shipped through non-postal 
channels or to intrastate sales within Alaska and Hawaii effected 
through the mails, it should be noted that the Jenkins Act is 
administered by ATF, not by the Postal Service. As such, inquiries 
about the application of the Jenkins Act's requirements to non-nicotine 
ENDS products should be directed to ATF.
    Finally, a Federal agency partner inquired whether the final rule 
would include an analysis pursuant to the Regulatory Flexibility Act 
(RFA). The Postal Service is generally exempt from Federal statutes 
that govern administrative matters. 39 U.S.C. 410(a); see Kuzma v. U.S. 
Postal Serv., 798 F.2d 29, 31-32 (2d Cir. 1986) (exemption from 
Paperwork Reduction Act is consistent with legislative intent to expand 
business discretion and modernize day-to-day managerial operations of 
the postal system); \6\ accord Shane v. Buck, 658 F. Supp. 908, 913-15 
(D. Utah 1985), aff'd, 817 F.2d 87 (10th Cir. 1987).\7\ The RFA is not 
among those statutes that Congress has enumerated as specifically 
applicable, 39 U.S.C. 410(b), nor does the RFA itself expressly include 
the Postal Service as a covered ``agency,'' such as might arguably 
supersede the Postal Service's general exemption. See 5 U.S.C. 601(1). 
Indeed, the RFA's definition of covered ``agencies'' points back to the 
APA, id. (cross-referencing 5 U.S.C. 551(1)), from the ambit of which 
Congress removed the Postal Service. 39 U.S.C. 410(a). Although 
Congress, as a narrow exception, has provided that proceedings 
concerning mailability, such as this one, must be ``conducted in 
accordance with chapters 5 and 7 of title 5'' (that is, the APA), 5 
U.S.C. chapter 6 (the RFA) is conspicuously absent from this 
prescription. 39 U.S.C. 3001(m). Congress's decision to reference two 
sets of provisions but not a third is logically dispositive, e.g., 
Longview Fibre Co. v. Rasmussen, 980 F.2d 1307, 1312-13 (9th Cir. 
1992); accord Friends of the Earth v. EPA, 333 F.3d 184, 189-90 (D.C. 
Cir. 2003), and the contrast is particularly conspicuous here, where 
the non-referenced chapter resides between the two referenced chapters. 
For all of these reasons, the RFA does not apply.
---------------------------------------------------------------------------

    \6\ The Kuzma court noted that the Paperwork Reduction Act was 
passed ten years after the enactment of 39 U.S.C. 410(a); that the 
Paperwork Reduction Act does not mention the Postal Service or 
otherwise expressly indicate Congressional intent that it apply to 
the Postal Service; and that repeals by implication are disfavored. 
Kuzma, 798 F.2d at 32. The same can be said of the RFA, which was 
likewise passed ten years after 39 U.S.C. 410(a), see Public Law 96-
354 (1980), and does not expressly indicate intent to apply to the 
Postal Service.
    \7\ The Shane court noted that the Postal Service's businesslike 
economic operations and financial self-sufficiency framework, in 
contradistinction to typical Federal bureaucracies, give it inherent 
incentives to minimize paperwork for customers. Shane, 658 F. Supp. 
at 915. The same is true with respect to the policy motives for the 
RFA. Unlike most Federal agencies, the Postal Service is supported 
almost entirely by revenues, not appropriations. See generally 39 
U.S.C. 2401. As such, the Postal Service has inherent business 
incentives to minimize burdens for small-business customers and to 
encourage their patronage, to the extent permitted by law. The 
Postal Service is highly mindful of the particular needs of small 
businesses and has designed various services and outreach tools 
especially with such customers in mind. See, e.g., U.S. Postal 
Service, Small Business Solutions, https://www.usps.com/smallbusiness (last visited Oct. 14, 2021).
---------------------------------------------------------------------------

    Even if the RFA did apply, however, the substance of this final 
rule would address all of the elements of a regulatory flexibility 
analysis. Sections I-II state the need for and objectives of the final 
rule: Namely, fulfillment of a specific statutory directive. See 5 
U.S.C. 604(a)(1). This section III states the significant issues raised 
by public comments, the Postal Service's assessment of those issues, 
and any changes to the proposed rule made as a result of the comments. 
See id. at (a)(2). No response is made to comments by the Chief Counsel 
for Advocacy of the Small Business Administration because no such 
comments were filed; nonetheless, the Postal Service consulted 
informally with staff of that office, and issues raised by such staff 
are addressed throughout this section. See id. at (a)(3). Because of 
the breadth and heterogeneity of persons and entities who might send or 
receive ENDS products, there is no available estimate of the number of 
small entities to which the rule will apply. See id. at (a)(4). The 
final rule does not impose reporting or recordkeeping requirements; to 
the extent that the final rule--or, rather, the governing statute--
imposes various types of compliance requirements, the classes of 
entities subject to those requirements should be evident from this 
final rule. See id. at (a)(5). Finally, as explained in section III.A 
and elsewhere, this rulemaking fulfills statutory directives as to 
which the Postal Service was not delegated substantial policy 
discretion. As such, the Postal Service has few, if any, means to 
minimize the economic impact on small entities. See id. at (a)(6). To 
the extent that the Postal Service, in this final rule, does exercise 
some limited administrative authority, such as with respect to the 
precise method for verifying eligibility for the Business/Regulatory 
Purposes exception, the relevant portion of section III will explain 
the legal, policy, and/or factual rationale for the chosen measures and 
why they are superior to alternatives. Thus, despite their 
inapplicability, the substantive requirements of the RFA are fulfilled 
in this instance.

D. Scope of Covered ENDS Products

1. Non-Nicotine-Related ENDS Products Generally
    The POSECCA defines ENDS products in relation to their delivery of 
``nicotine, flavor, or any other substance.'' 15 U.S.C. 375(7)(A). 
Through use of this list and the disjunctive ``or,'' this language is 
clear on its face: Covered ENDS products may be used to deliver 
nicotine, or they may be used to deliver flavor, or they may be used to 
deliver any other substance (with or without nicotine or flavor). For 
this reason, the Postal Service observed in the notice of proposed 
rulemaking that, ``[d]espite the name, an item can qualify as an ENDS 
product without regard to whether it contains or is intended to be used 
to deliver nicotine; liquids that do not actually contain nicotine can 
still qualify as ENDS, as can devices, parts, components, and 
accessories capable of or intended for

[[Page 58406]]

use with non-nicotine-containing liquids.'' 86 FR at 10219.
    Before addressing comments on non-nicotine substances, it must be 
emphasized that ATF is charged with administering the statute in which 
the relevant definitions reside. While the Postal Service consulted 
with ATF in developing the discussion that follows, questions of 
whether a particular product falls within these definitions therefore 
should be directed to ATF.
i. Relation to Nicotine and Flavor
    Two ENDS industry commenters presented multiple legal arguments for 
an alternative construction. First, they invoked the canon of statutory 
construction known as ejusdem generis, which ``instructs that, where 
general words follow specific words in an enumeration describing a 
statute's legal subject, the general words are construed to embrace 
only objects similar in nature to those objects enumerated by the 
preceding specific words.'' Norman & Shambie Singer, 2A Sutherland 
Statutes & Statutory Construction section 47:17 (7th ed. 2020). One of 
the commenters argued that, applied here, ``any other substance'' must 
be interpreted as ``any other substance that mimics nicotine or 
flavor.'' The other argued that ``any other substance'' should be 
``limited to substances related to nicotine and flavor, such as liquid 
nicotine and liquid nicotine combined with colorings, flavorings, or 
other ingredients,'' and posited that Congress may have intended this 
to encompass non-nicotine liquids used with e-cigarettes but not with 
other ENDS devices.
    This argument is unpersuasive. ``Nicotine'' and ``flavor'' do not 
admit of any common characteristic, such as might define a class of 
substances beyond nicotine and flavor. See id. section 47:18 
(application of the canon requires the enumerated things to constitute 
a class that is not exhausted by the enumeration); see, e.g., Yates v. 
United States, 574 U.S. 528, 543-46 (2015) (``tangible object'' means 
``object used to record or preserve information'' when used in 
connection with ``record [or] document''). The commenters do not 
propose any characteristic common to nicotine and flavor. Nor do they 
offer any examples of what things might share characteristics with 
nicotine and flavor besides substances that themselves contain nicotine 
and flavor. The impression left by these comments is that their 
proposals' chief import would be to render the catch-all ``any other 
substance'' a nullity, running headlong into the canon against 
superfluities. See Singer & Singer, 2A Sutherland Statutes section 
46:6; Ali v. Fed. Bureau of Prisons, 552 U.S. 214, 227 (2008).
    Moreover, the ejusdem generis canon readily gives way ``when the 
whole context dictates a different conclusion.'' Norfolk & Western Ry. 
Co. v. Am. Train Dispatchers Ass'n, 499 U.S. 117, 129 (1991); see also 
Ali, 552 U.S. at 227 (``we do not woodenly apply limiting principles 
every time Congress includes a specific example along with a general 
phrase''). Here, Congress's enumeration demonstrates its intent to 
include non-nicotine-containing substances within the scope of 
nonmailable ENDS: The definition includes solutions containing 
``nicotine'' as well as--separately and thus independent of any 
nicotine content--those containing ``flavor.'' Thus, despite the focus 
on nicotine in the shorthand term ``electronic nicotine delivery 
system,'' the explicit listing of ``flavor'' shows that Congress 
intended the scope of covered ENDS products to cover some substances 
that do not contain nicotine. This enumeration strengthens, rather than 
weakens, the ordinary inference that ``any other substance'' extends to 
non-nicotine substances. Cf. Norfolk & Western Ry., 499 U.S. at 129 
(``all other law'' in exemption means that ``[a] carrier is exempt from 
all law,'' with enumeration of antitrust law serving merely to overcome 
presumptions against its inclusion).
    As in Norfolk & Western, the enumeration here, with its lack of any 
reasonably salient shared characteristic among ``nicotine'' and 
``flavor,'' implies that Congress intended covered ENDS products to be 
those used to deliver any substance, with nicotine and flavor indicated 
expressly as examples. The framers may have believed that ``nicotine'' 
was necessary to justify the use of the shorthand term ``electronic 
nicotine delivery systems,'' and/or that listing ``nicotine'' and 
``flavor'' would most clearly evince the aim of combating youth access 
to nicotine products. As discussed in section III.D.1.iii, youth access 
was certainly a major focus of the framers' concern, albeit far from 
their exclusive focus: Hence their expressed intent not to limit the 
statute to ``nicotine or flavor.''
    The statute here is clear on its face: ``any other substance'' 
means ``any other substance,'' limited not by some dubiously inferred 
principle but explicitly by the surrounding text, which confines the 
scope to substances delivered from an electronic device to an inhaling 
user via an aerosolized solution. Given that the enumerated list 
already includes one non-nicotine substance (``flavor,'' as an 
alternative to nicotine), it cannot be said that other non-nicotine 
substances are ``as dissimilar [from the enumerated items] as documents 
and fish.'' See Yates, 574 U.S. at 546; id. at 550 (Alito, J., 
concurring). In effect, the commenters' invocation of the ejusdem 
generis principle is an effort to create ambiguity where none exists, 
and so there is no occasion to resort to it here. See Ali, 552 U.S. at 
227; United States v. Turkette, 452 U.S. 576, 581 (1981).
    Finally, the second commenter's alternative hypothesis that 
Congress may have intended ``any other substance'' to encompass non-
nicotine and non-flavor substances, but only in connection with e-
cigarette devices, finds no support in the statute. The phrase 
``delivers nicotine, flavor, or any other substance'' appears in the 
definition's opening paragraph, which establishes the qualifying 
parameters for all covered ENDS products, without differentiation as to 
any particular species of ENDS device. 15 U.S.C. 375(7)(A). The next 
paragraph offers an illustrative list of various devices that are 
included within the definition, such as an e-cigarette, e-hookah, e-
cigar, or vape pen. Id. at (B). Nothing in either paragraph ties the 
phrase ``any other substance'' exclusively to e-cigarette devices. 
Absent such an indication, a plain reading of the statute indicates 
that any of the listed devices, along with any part, component, liquid, 
or accessory of the device, qualifies as an ENDS if it is used to 
deliver any substance through an aerosolized solution, whether or not 
the substance is or contains nicotine or flavor.
ii. Relation to Listed Devices
    One ENDS industry commenter attempted to enlist a second canon of 
construction: Noscitur a sociis, whereby ``doubtful words in an 
ambiguous statute [are] given more precise content by the neighboring 
words with which [they are] associated.'' Singer & Singer, 2A 
Sutherland Statutes section 47:16. The commenter proposed that ``any 
other substance'' be construed in light of the list of included devices 
in 15 U.S.C. 375(7)(B), which, the commenter claimed, ``can only be 
used with nicotine-based products.'' The commenter further asserted 
that a nicotine-focused construction would be consistent with the FDA 
and CDC's construction of the term ``ENDS.''
    This argument, too, founders for multiple reasons. First, the canon 
overlaps heavily with ejusdem generis and ``does not apply absent 
ambiguity, or to thwart legislative intent, or to make general words 
meaningless.'' Id.; see, e.g., Yates v. United States, 574 U.S.

[[Page 58407]]

528, 564 (2015) (Kagan, J., dissenting) (citing Ali, 552 U.S. at 227). 
As described in the preceding section, a construction of ``any other 
substance'' to mean only substances that contain nicotine, which is 
separately enumerated, would indeed make general words meaningless and 
thwart legislative intent. And there is no ambiguity in the phrase 
``any other substance'': It means what it says, and there is no 
apparent reason to infer a (redundant) nicotine-only construction. See, 
e.g., Graham County Soil & Water Conservation Dist. v. United States ex 
rel. Wilson, 559 U.S. 280, 286-90 (2010) (rejecting noscitur a sociis 
as a basis to construe ``administrative'' to refer exclusively to 
Federal activities, as opposed to those by State and local 
governments).
    Even if there were reason to resort to noscitur a sociis here, it 
would not produce the limiting construction proposed by the commenter. 
Several, and possibly even all, of the statutorily enumerated terms 
(not to mention parts, components, and accessories) are used to refer 
to devices marketed for use with cannabis, for example, without 
concomitant reference to nicotine.\8\ Absent further technical 
specificity in the statute, there is no apparent technological or 
economic reason why such devices would be capable of use only with 
nicotine-containing substances.
---------------------------------------------------------------------------

    \8\ E.g., Jen Bernstein, ``The Best Vape Pens: High Times' Vape 
Pen Buyers' Guide,'' High Times, https://hightimes.com/products/high-times-2015-vape-pen-buyers-guide (last visited Oct. 14, 2021); 
``Marijuana Vaporizers & Vapes,'' Leafly, https://www.leafly.com/products/vaping (last visited Oct. 14, 2021) (vape pens, portable 
vaporizers, batteries, power supplies, and accessories); ``Sherlock 
Vape Pipe,'' WeedGadgets.com, https://www.weedgadgets.com/sherlock-vape-pipe (last visited Oct. 14, 2021) (e-pipe); see also ``Cannabis 
E-Cigarettes: Risks vs. Advantages,'' Way of Leaf (last updated Mar. 
17, 2021) (``An e-cigarette, also known as a vaporizer or a vape 
pen, is an electronic device that heats up your marijuana and 
enables you to consume it in vapor form.'').
---------------------------------------------------------------------------

    Finally, as explained in section III.C.1, the FDA operates under 
statutory authority that explicitly requires a nexus to tobacco. The 
POSECCA does not; instead, it refers to ``any other substance'' in the 
alternative to ``nicotine'' and ``flavor.'' As such, the scope of ENDS 
products made nonmailable by the POSECCA is self-evidently and 
materially broader than the scope of ENDS products regulated as 
``tobacco products'' by the FDA.
iii. Legislative History of the POSECCA
    Some ENDS industry commenters purported that certain floor 
statements by the POSECCA's sponsors evince an exclusive focus on 
nicotine-containing or -delivering ENDS products. From these supposed 
floor statements, the commenters concluded that non-nicotine-related 
ENDS products are beyond the scope of what Congress intended.
    Legislative history ordinarily is useful only for resolving 
ambiguity in a statute, not for superseding or ambiguating already-
plain statutory text. See Singer & Singer, 2A Sutherland Statutes & 
Statutory Construction section 48:1. Here, the statutory text is clear 
in its coverage of ENDS used with ``nicotine, flavor, or any other 
substance [i.e., any substance other than nicotine or flavor].'' Even 
if the legislative history contained only examples of concern relating 
to nicotine substances, that would not be a basis to read out of the 
statute the catch-all that Congress expressly included. In that 
hypothetical instance, absence of evidence of intent as to non-
nicotine-related ENDS products would not equate to evidence of the 
absence of such intent.
    Moreover, the commenters are incorrect: The legislative history of 
the POSECCA actually attests to concerns about non-nicotine-related and 
nicotine-related ENDS products alike. Bill sponsors frequently decried 
an epidemic of youth vaping without specifying the chemical composition 
of the vapors thus inhaled. One Senate sponsor spoke of teens 
``regularly vaping both nicotine and THC products'' and singled out 
``closed systems that deliver only nicotine'' as but one subset of a 
larger universe of devices, all of which his sponsored bill impliedly 
targeted. 165 Cong. Rec. S6,898 (daily ed. Dec. 9, 2019) (statement of 
Senator Cornyn).
    Most tellingly, perhaps, the POSECCA was introduced in the 116th 
Congress during a widely reported health crisis related to vaping 
practices, which led to at least 68 deaths and 2,807 hospitalizations 
across the country from lung damage related to ENDS use. Hassan Z. 
Sheikh, Regulation of Electronic Nicotine Delivery Systems (ENDS): 
Background and Select Policy Issues in the 117th Congress 9 (Cong. 
Research Serv. Sept. 30, 2021). As discussed in section III.B, the 
House committee report on the POSECCA expressly adverted to this crisis 
as a motivating factor, as did floor statements regarding the POSECCA. 
See H. Rept. 116-260 at 3; 166 Cong. Rec. S7,028 (daily ed., Nov. 17, 
2020) (statement of Senator Cornyn); 166 Cong. Rec. S4,174 (daily ed., 
July 2, 2020) (statement of Senator Feinstein); 165 Cong. Rec. H8,491 
(daily ed., Dec. 9, 2019) (statement of Representative Mucarsel-
Powell); 165 Cong. Rec. S6,586 (daily ed., Nov. 14, 2019) (statement of 
Senator Cornyn); 165 Cong. Rec. S5,431 (daily ed., Sept. 11, 2019) 
(statement of Senator Durbin). The CDC ultimately determined--several 
months prior to Congress's passage of the POSECCA, and some of the 
relevant floor statements--that this crisis was related to a chemical 
found in non-nicotine-related (specifically, THC-related) ENDS 
products. CDC, Outbreak of Lung Injury Associated with the Use of E-
Cigarette, or Vaping, Products, https://go.usa.gov/xHd78 (last updated 
Feb. 25, 2020); see also Sheikh, Regulation of Electronic Nicotine 
Delivery Systems at 9 (``Among a subset of hospitalized [e-cigarette or 
vaping use-associated lung injury] patients, 82% reported using THC-
containing products.'').
    It is evident, then, that, while youth nicotine consumption was a 
prominent concern animating this bill, it by no means constituted the 
sole motivating concern. The framers' expressed concerns about the 
dangers of both nicotine-related and non-nicotine-related ENDS use 
underscore the plain import of the POSECCA's inclusion of all such ENDS 
products.
2. Products That Aerosolize Non-Solution Solids
    Some ENDS industry commenters urged the Postal Service to exclude 
personal vaporizers intended for use with waxes or dry herbs, as such 
substances do not take the form of an ``aerosolized solution.'' 
However, one public-health-oriented commenter recommended including 
solid substances and devices that aerosolize them, noting that, 
according to at least one definition, ``solution'' includes solid as 
well as liquid mixtures.
    Once again, ATF is charged with administering the statute in which 
the relevant definitions reside. Questions of whether a particular 
product falls within these definitions therefore should be directed to 
ATF.
    As a further initial matter, we note that many such products are 
already nonmailable regardless of the POSECCA. To the extent that 
personal vaporizers are intended for use with waxes or dry herbs 
containing THC (other than the limited class of hemp and hemp-based 
products under Publication 52 section 453.37), those substances are 
controlled substances and the vaporizers are drug paraphernalia under 
the CSA. Indeed, online marketing, reviews, and blog posts frequently 
tout the suitability of such products for use with controlled 
substances. See Publication 52 section 453.131 (listing such 
circumstances as

[[Page 58408]]

evidence that an item is drug paraphernalia). For further discussion of 
the nonmailability of such products, see section III.C.2.
    The Postal Service recognizes that some personal vaporizers may 
also be used as aromatherapy devices with herbs that do not contain 
controlled substances (e.g., mint or chamomile). Of course, at least 
some of the same products may also be used with controlled substances, 
and some are capable of use with liquid solutions as well as solid 
matter. The remainder of this section will therefore consider 
aerosolizing devices (and their related parts, components, and 
accessories) intended for use with solids other than controlled 
substances (e.g., aromatherapy herbs) and incapable of use with a 
liquid solution.
    Such devices appear to fall outside of the POSECCA definition of a 
generally nonmailable ENDS product (and also would not be nonmailable 
as drug paraphernalia). As discussed in the preceding section, the 
POSECCA defines ENDS by reference to ``an aerosolized solution'' 
containing ``nicotine, flavor, or any other substance.'' Regardless of 
the constituent substance or substances, they must form part of a 
``solution.'' A solution is a mixture of chemical substances that is 
both homogenous (i.e., uniformly mixed) and stable (i.e., not prone to 
separating upon standing or filtration).\9\
---------------------------------------------------------------------------

    \9\ See, e.g., Solution, in Int'l Union of Pure & Applied 
Chemistry, Compendium of Chemical Terminology (2d ed. 1997), https://goldbook.iupac.org/terms/view/S05746 (last edited Feb. 24, 2014); 
Solution (chemistry), Brittanica, https://www.britannica.com/science/solution-chemistry (last edited Dec. 19, 2019); Solution 
(chemistry), Wikipedia, https://en.wikipedia.org/wiki/Solution_(chemistry) (last edited Aug. 26, 2021).
---------------------------------------------------------------------------

    Raw or minimally processed organic matter, such as aromatic herb 
leaves, does not qualify as a ``solution.'' As such, if a device heats 
such matter to produce vapors for the user to inhale, that device does 
not operate ``through an aerosolized solution'' and thus falls outside 
the scope of the POSECCA definition. By the same token, its parts, 
components, and accessories (as well as the herbal matter used in the 
device) likewise fall outside of the POSECCA's scope.\10\
---------------------------------------------------------------------------

    \10\ As the public-health-oriented commenter noted, solutions 
may be typically liquid, but they are not exclusively so. Because 
the matter at issue here is not a solution in any event, it is 
unnecessary to discuss here whether the reference to ``liquid'' in 
the POSECCA's inclusion of ``any component, liquid, part, or 
accessory of [an ENDS] device'' excludes the possibility that 
covered devices may be used with solid solutions.
---------------------------------------------------------------------------

    It is emphasized that this analysis covers only devices used 
exclusively with non-solution matter. If a device can be used to 
aerosolize a solution as well as non-solution matter for delivery to a 
user inhaling from the device, then the POSECCA definition applies 
notwithstanding the device's capability of alternative use with non-
solution matter. Finally, it is emphasized again that a device intended 
for use with controlled substances (e.g., cannabis herbal matter or 
wax) is nonmailable regardless of the POSECCA, irrespective of any dual 
capability of alternative licit use.
3. Heat-Not-Burn Cigarettes
    One public-health-oriented commenter and two Federal agency 
partners inquired whether so-called ``heat-not-burn cigarettes'' are 
nonmailable under the PACT Act, either as ENDS products or as other 
forms of ``cigarettes.''
    Once again, ATF is charged with administering the statutes in which 
the relevant definitions reside. Questions of whether a particular 
product falls within these definitions therefore should be directed to 
ATF.
    To the extent that ``heat-not-burn cigarette'' refers to a product 
that functions by heating tobacco leaf matter just shy of the point of 
combustion, such products vaporize a solid mass of processed tobacco 
leaf, not an aerosolized solution. As discussed in the preceding 
section, it seems likely that such products fall outside the POSECCA's 
definition of ENDS products.
    Nevertheless, many, and perhaps all, such products contain or 
comprise a roll of tobacco wrapped in paper or another substance not 
containing tobacco. As such, these products may already be nonmailable 
under the preexisting definition of ``cigarette'' used for PACT Act 
purposes. 18 U.S.C. 2341(1)(A), referenced in 15 U.S.C. 375(2)(A)(i), 
referenced in 18 U.S.C. 1716E(a)(1). Such products may also be 
nonmailable as ``smokeless tobacco,'' insofar as they contain tobacco 
and are intended to be consumed without being combusted. 15 U.S.C. 
375(13). Parties interested in a definitive opinion are advised to 
contact ATF, as instructed in the new rules.
4. Products That Release Aerosols Into Ambient Air, Not for Direct 
Inhalation
    One ENDS industry commenter expressed concern that the POSECCA 
definition of ENDS would prove so expansive as to encompass air 
fresheners, essential oil misters, portable aromatherapy diffusers, 
electric incense burners, household humidifiers, and other products 
that aerosolize matter for release into ambient air, rather than for 
direct inhalation. The commenter proposed that the Postal Service 
preclude this purportedly untoward construction by appending, to the 
statutory definition of ENDS (``any electronic device that, through an 
aerosolized solution, delivers nicotine, flavor, or any other substance 
to the user inhaling from the device'') an implied limitation: ``into 
the lungs.''
    We note again that ATF, not the Postal Service, is charged with 
administering the definitional statute. Nevertheless, we note that the 
commenter's concern may be misplaced. The POSECCA definition restricts 
the scope of covered ENDS products based on delivery of a substance 
``to the user inhaling from the device.'' 15 U.S.C. 375(7)(A) (emphasis 
added). This language could suggest physical contact or proximity 
between the user's nose or mouth and the vapor-emitting ENDS device. By 
contrast, the products described in the comment release aerosolized 
matter into the ambient air, which in turn is breathed by persons in 
the room without directly placing their nose or mouth on the product. 
While these products may aerosolize solution to be inhaled by a user, 
the user arguably does not inhale directly ``from the device.'' As 
such, these products (and their components, liquids, parts, and 
accessories) might not fall within the scope of the POSECCA's 
definition of ENDS.\11\ Again, however, these observations are 
necessarily tentative; for a definitive interpretation, parties are 
advised to contact ATF as directed in the new rules.
---------------------------------------------------------------------------

    \11\ We further note that the commenter's proposed addition of 
``into the lungs'' would not have any material effect. By 
definition, all inhalation, whether of ambient air or of vapor 
directly from the emitting device, is ``into the lungs.''
---------------------------------------------------------------------------

5. Natural vs. Synthetic Nicotine
    One ENDS manufacturer, two public-health-oriented commenters, and a 
Federal agency partner asked the Postal Service to clarify that ENDS 
products include those containing or used with all forms of nicotine, 
whether natural or synthetic in origin.
    The POSECCA defines ENDS products by reference to the delivery of 
``nicotine,'' among other things. There is no statutory basis to read 
this term as referring only to natural-origin nicotine, as opposed to 
synthetic nicotine. As discussed in section III.C.1, this scope of 
regulation is different from that under the FD&C Act, for which 
purposes the FDA regulates nicotine-related ENDS products to the extent 
that the nicotine is made or derived from tobacco. Beyond this 
observation about the POSECCA's plain language, interested

[[Page 58409]]

parties are encouraged to contact ATF for further interpretive 
guidance.
6. Scope of Components and Parts
    In addition to fully assembled vaping devices, the POSECCA includes 
in its definition of ENDS ``any component, liquid, part, or accessory 
of [an ENDS], without regard to whether the component, liquid, part, or 
accessory is sold separately from the device.'' 15 U.S.C. 
375(7)(B)(vii). Some pro-ENDS commenters found this definition to 
create a line-drawing conundrum, noting that certain materials used in 
ENDS devices and liquids are used in a wide array of non-ENDS consumer 
products. A partner agency also suggested that the terms could be 
interpreted in a manner similar to the definitions of ``accessory'' and 
``component or part'' for purposes of the FDA's regulation of certain 
ENDS products. See 21 CFR 1100.3.
    The Postal Service recognizes the point and notes that it resonates 
with other contexts in which parts, components, or accessories of a 
given type of item may be regulated. E.g., 18 U.S.C. 921(4)(C), (24), 
(29)(B); 22 U.S.C. 2778(b)(1)(B); 26 U.S.C. 5845(b), (f)(3); 15 CFR pt. 
774, supp. no. 1; 22 CFR 121.1. It is necessarily a fact-specific 
question whether an item has a sufficient nexus to the regulated end 
product to itself warrant control; as such, such questions may require 
case-by-case determination.
    Here, too, interpretative questions about whether the POSECCA 
definition codified in the Jenkins Act applies to specific precursor 
parts, components, or accessories should be directed to ATF.

E. Exclusion of Tobacco Cessation and Therapeutic Products

    The POSECCA excludes from the definition of ENDS products any such 
products that are approved by the FDA for sale as a tobacco cessation 
product or for any therapeutic purpose, and that are marketed and sold 
solely for such purposes. 15 U.S.C. 375(7)(C).
    Multiple public-health-oriented commenters and law students 
recommended that the Postal Service disallow the exclusion at this 
juncture, or at least establish a presumption that mailed ENDS products 
are not covered by the exclusion. These commenters pointed out that no 
such products have been approved by the FDA. Hence, given the 
prevalence of non-validated tobacco-cessation and other health claims 
by the industry in association with ENDS products, allowing mailers to 
purport to use the exclusion would arguably invite deceptive practices 
and complicate enforcement.
    Two public-health-oriented commenters and one law student went 
farther and offered specific proposals for how the Postal Service could 
administer the exclusion if and when the FDA issues a pertinent 
approval. As envisioned by one public-health-oriented commenter, the 
FDA would formally inform the Postal Service of its approval, whereupon 
the Postal Service would collaborate with the FDA and manufacturers to 
establish a list of eligible shippers (e.g., medical-product 
distributors, health departments, or healthcare facilities) who might 
apply for permission to mail under the exclusion. The second such 
commenter proposed that mailers should have to provide an FDA approval 
letter at the time of mailing, not merely mark the package as an 
excluded tobacco-cessation or therapeutic product. The law student 
recommended that mailers be required to clearly mark the manufacturer 
and brand on the exterior of mailpieces, to ease verification against a 
Postal Service list of approved products, and that age verification be 
required at delivery.
    One ENDS industry commenter opined that the exclusion pertains to 
drug protocols and would paradoxically exclude the ENDS industry. The 
commenter went on to quote from a court opinion to the effect that the 
FDA is authorized to regulate ``customarily marketed tobacco products--
including e-cigarettes--under the Tobacco Control Act'' and 
``therapeutically marketed tobacco products under the [FD&C Act's] 
drug/device provisions.'' Sottera, Inc. v. FDA, 627 F.3d 891, 898-99 
(D.C. Cir. 2010).
    A manufacturer of herbal vaporizers proposed that mailers be 
allowed to self-certify the eligibility of a product for the exclusion 
via distinctive labeling on the package, backed by recordkeeping 
requirements similar to those for hemp-based cannabidiol (``CBD'') 
products. See Publication 52 section 453.37.b. The commenter considered 
the analogy to be apt because of the difficulty in distinguishing CBD 
products that do and do not qualify for the CSA exception, similar to 
the likely difficulty in distinguishing ENDS products that do and do 
not qualify for the POSECCA exclusion. The commenter opined that this 
approach would provide a credible means of verifying eligibility, while 
minimizing burdens on the Postal Service's operational and enforcement 
personnel.
    Finally, a large number of individual ENDS consumers commented 
about the perceived tobacco-cessation benefits of ENDS products, both 
in their own experience and in relation to U.K. studies and purported 
official European health recommendations.\12\ Other individual ENDS 
consumers wrote of the perceived therapeutic benefits of cannabis or, 
in rare instances, aromatherapy delivered using ENDS products.
---------------------------------------------------------------------------

    \12\ See M[aacute]irtin S. McDermott et al., ``The Effectiveness 
of Using E-Cigarettes for Quitting Smoking Compared to Other 
Cessation Methods Among Adults in the United Kingdom,'' __Addiction 
__(2021), https://onlinelibrary.wiley.com/doi/10.1111/add.15474; 
Peter Hajek et al., ``A Randomized Trial of E-Cigarettes Versus 
Nicotine-Replacement Therapy,'' 380 New Eng. J. Med. 629 (2019), 
https://www.nejm.org/doi/full/10.1056/NEJMoa1808779; Jamie Brown et 
al., ``Real-World Effectiveness of E-Cigarettes When Used to Aid 
Smoking Cessation: A Cross[hyphen]Sectional Population Study,'' 109 
Addiction 1531 (2014), https://onlinelibrary.wiley.com/doi/full/10.1111/add.12623. It should be noted that the Hajek article website 
includes a number of letters by other researchers pointing out 
limitations in the study design and questioning the reliability of 
its findings.
---------------------------------------------------------------------------

    The first set of commenters is correct: The FDA has not approved 
any ENDS product for smoking-cessation or other therapeutic use.\13\ 
Unless and until the FDA approves any ENDS product for smoking-
cessation or another therapeutic use, then, the statutory exclusion 
lies dormant and has no real-world import.
---------------------------------------------------------------------------

    \13\ FDA, [email protected]: FDA-Approved Drugs, https://go.usa.gov/xHHxa (search for ``nicotine'' conducted Oct. 14, 2021 yielded no 
ENDS-related results); Hassan Z. Sheikh, Regulation of Electronic 
Nicotine Delivery Systems (ENDS): Background and Select Policy 
Issues in the 117th Congress 5 (Cong. Research Serv. Sept. 30, 
2021); Richard J. Wang et al., ``E-Cigarette Use and Adult Cigarette 
Smoking Cessation: A Meta-Analysis,'' 111 Am. J. Pub. Health 230 
(2020), https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2020.305999 (``E-cigarettes have been promoted for smoking 
cessation even though, as of November 2020, no e-cigarette has been 
approved as a smoking cessation medication by the FDA Center for 
Drug Evaluation and Research (CDER).'' (citations omitted)).
---------------------------------------------------------------------------

    While the distinction between excluded and nonmailable ENDS 
products may be difficult to get right in practice, it is essential to 
get it right, given the PACT Act's directive that the Postal Service 
not ``accept for delivery or transmit through the mails'' any package 
as to which ``reasonable cause'' exists to believe that it contains 
nonmailable ENDS products. See 18 U.S.C. 1716E(a)(1). Whatever merit 
the ideas raised by commenters on this topic may have, the Postal 
Service finds it inadvisable to attempt (in consultation with ATF) to 
set forth appropriate standards in the abstract. Rather, if and when 
any product is approved by the FDA, concrete circumstances will guide 
the development of a practical approach.
    Therefore, the final rule contains language clarifying that the 
exclusion does not apply at this time, but inviting

[[Page 58410]]

any ENDS manufacturer of an FDA-approved product to notify ATF and the 
Postal Service in the event of such approval. At that time, ATF and the 
Postal Service may develop appropriate rules governing the exclusion.
    The FDA likewise has not approved any ENDS product for therapeutic 
delivery of any non-nicotine substance, including, in particular, CBD 
or other substances derived from marijuana.\14\ Once again, except for 
hemp-derived CBD containing no more than 0.3 percent THC by dry weight, 
cannabis and cannabis derivatives remain nonmailable under the 
Controlled Substances Act regardless of the POSECCA and notwithstanding 
any State or local laws on ``medical'' marijuana. See supra section 
III.C.2; 84 FR at 12970. Far from taking marketing claims of 
therapeutic benefit at face value, the FDA has undertaken enforcement 
action against companies making such claims about CBD and other 
cannabis-related products absent new drug approvals from the FDA. See 
84 FR at 12970.
---------------------------------------------------------------------------

    \14\ The FDA has approved a small number of drugs that contain 
CBD, a synthetic THC (dronabinol), and a synthetic chemical similar 
to THC (nabilone), but only for oral delivery in capsule or solution 
form, not via an ENDS. FDA, [email protected]: FDA-Approved Drugs (searches 
conducted Oct. 14, 2021); see Scientific Data and Information About 
Products Containing Cannabis or Cannabis-Derived Compounds, 84 FR 
12969, 12972-12973 (2019).
---------------------------------------------------------------------------

    The concern that the statutory exclusion pertaining to FDA drug or 
device protocols would paradoxically exclude the ENDS industry appears 
to be off-base. The very court opinion quoted by the commenter notes 
that the FDA's regulatory authority extends to ``therapeutically 
marketed tobacco products under the [FD&C Act's] drug/device 
provisions.'' Sottera, 627 F.3d at 898-99. Moreover, with respect to 
ENDS comprising, containing, or used with CBD, the FDA's authority to 
approve drugs and medical devices extends to cannabis and cannabis-
derived products that could form part of an ENDS. See 84 FR at 12972-
12974.
    Finally, a Federal agency partner suggested that the Postal Service 
clarify the scope of ``other therapeutic purposes,'' perhaps in line 
with the Sottera court's borrowing of ``diagnosis, cure, mitigation, 
treatment, or prevention of disease'' phraseology from the FD&C Act's 
``drug'' and ``device'' definitions. Sottera, 627 F.3d at 894 (quoting 
21 U.S.C. 321(g)(1)(B)); accord 21 U.S.C. 321(h)(1)(B). Such an 
interpretation may be reasonable, and even tautological, given that the 
POSECCA exclusion requires FDA approval of an ENDS product, which 
itself would require an FDA determination that the product meets the 
purposive criteria for a ``drug'' or ``device.'' However, it may also 
be that ``therapeutic purposes'' means something narrower in this 
context, given the term's juxtaposition with ``tobacco cessation.'' The 
Postal Service declines to announce any particular interpretation of 
``therapeutic purposes'' at this time, both out of deference to ATF's 
authority to interpret the relevant statute and because no ENDS 
products have been FDA-approved for any arguably relevant purpose at 
any rate. In the event that any such product garners FDA approval for a 
use other than tobacco cessation, then ATF may find it appropriate to 
opine on whether that product fulfills a ``therapeutic purpose'' for 
purposes of the POSECCA exclusion.

F. Intra-Alaska/Intra-Hawaii Shipments

    One public-health-oriented commenter proposed that the Postal 
Service clarify that, while the PACT Act's exception for intrastate 
shipments within Alaska and Hawaii may apply to ENDS products, it does 
not apply to interstate ENDS shipments into or out of either state.
    The Postal Service does not believe that such clarification is 
necessary. The PACT Act is already abundantly clear that the exception 
applies only to ``mailings within the State of Alaska or within the 
State of Hawaii.'' 18 U.S.C. 1716E(b)(2) (emphasis added). Longstanding 
Postal Service rules, which will now encompass ENDS products, make this 
even more explicit, by requiring such a mailing to be tendered to a 
Postal Service employee in a face-to-face transaction within the 
relevant State, to destinate in the same state as the state of origin, 
and to bear a valid, complete return address within the state of 
origin. Publication 52 section 472.21.a-.c.\15\ These requirements 
allow Postal Service personnel at the point of acceptance to verify 
that the shipment will destinate in the noncontiguous state of origin. 
Treatment of Cigarettes and Smokeless Tobacco as Nonmailable Matter, 75 
FR 24534, 24535 (2010) (notice of proposed rulemaking). It is difficult 
to imagine how the geographic limitation on this exception could be 
made any clearer.
---------------------------------------------------------------------------

    \15\ All citations to Publication 52 chapter 47 throughout this 
section III refer to the version in effect prior to this final rule.
---------------------------------------------------------------------------

G. Business/Regulatory Purposes Exception

    The Business/Regulatory Purposes exception was a major area of 
commenter discussion, and so it is discussed extensively here. In 
short, the exception permits shipments between legally operating 
businesses in certain industry sectors and between such businesses and 
Federal or State government agencies, subject to multiple conditions. 
18 U.S.C. 1716E(b)(3)(A). Those conditions include Postal Service 
verification of the sender and recipient's respective eligibility, as 
well as the recipient's age and employee status; restriction of 
available products to those that allow tracking and confirmation of 
delivery; capture and retention of package-specific identifying 
information by the Postal Service; and certain package markings. Id. at 
(b)(3)(B).
    In implementing these requirements, the Postal Service adopted a 
process whereby potential senders must first submit an advance 
application to the Postal Service's Pricing and Classification Service 
Center (PCSC) for an eligibility verification as to the applicant and 
any anticipated recipients of that applicant's shipments. Publication 
52 section 472.221. Upon a PCSC determination of eligibility, the 
authorized sender must show the resulting authorization letter when 
tendering any covered mailing via a face-to-face transaction with a 
Postal Service employee at an approved acceptance location. Id. section 
472.222. The mailer may use only certain combinations of postal 
services that allow for age verification, tracking, and confirmation of 
delivery, as well as a return receipt returnable to the PCSC for 
recordkeeping purposes. Id. section 472.222.a-.b. Finally, the Postal 
Service conducts the requisite verification of age, identity, and 
employment status upon face-to-face delivery. Id. section 472.223.
    In the notice of proposed rulemaking, the Postal Service proposed a 
simple amendment to the terminology used in the Business/Regulatory 
Exception rules, such that the same rules would automatically apply to 
ENDS products as to other PACT Act-covered products. 86 FR at 10220.
1. Availability in General
    As an initial matter, a few comments dealt with existential aspects 
of the exception. Two ENDS industry commenters sought confirmation that 
the exception would extend to ENDS products, in order to sustain 
industry supply chains, regulatory activities, and the channeling of 
ENDS to retail outlets subject to State and local law (in lieu of 
direct-to-consumer shipments). Conversely, one law student urged the 
abolition of the exception for ENDS

[[Page 58411]]

products except as necessary for regulatory activities.
    As discussed in section III.A.2, the Business/Regulatory Purposes 
exception is established by statute, and the Postal Service lacks the 
delegated authority to modify or restrict the exception's applicability 
on policy grounds. Unlike the Consumer Testing and Public Health 
exceptions discussed in section III.I, nothing in the statutory 
language concerning the Business/Regulatory Purposes exception 
indicates Congressional intent to exclude ENDS products from the 
exception, and there is no other basis to find such products to be 
incompatible with the exception's terms. As such, the exception is 
available in connection with ENDS products as a legal matter, 
regardless of whatever policy arguments might militate for or against 
it.
    Another pro-ENDS commenter feared that the conditions for the 
exception could be expanded into termination of the exception 
altogether. This comment appears to misconstrue the exception as a 
freestanding entitlement, upon which the Postal Service somehow 
discretionarily grafted conditions as a means to subvert the intended 
scope of the exception. In fact, however, Congress itself specified the 
criteria as conditions precedent that must be met in order to qualify 
for the limited exception: The conditions are therefore integral to the 
statutory framework for the exception. The longstanding conditions in 
Publication 52 merely bear out that framework, either by literally 
transmuting the statutory requirements or by means designed to fulfill 
those requirements. The regulatory framework has applied to cigarettes 
and smokeless tobacco since 2010. The POSECCA charges the Postal 
Service with clarifying the applicability of the limited exception, 
with its eligibility conditions, to ENDS products, and the final rules 
here do that.
    One public-health-oriented commenter viewed the Business/Regulatory 
Purposes exception as being cabined by 18 U.S.C. 1716, such that 18 
U.S.C. 1716(a) and (e) would preclude use of the Business/Regulatory 
Purposes exception as a ``bulk distribution method'' for manufacturers 
and wholesalers to transport ENDS products to retailers. It is true 
that eligibility to use the Business/Regulatory Purposes exception to 
the PACT Act does not excuse a mailer from compliance with other 
applicable mailability statutes, including 18 U.S.C. 1716. But the 
Postal Service cannot join the commenter's sweeping conclusion that all 
``bulk distribution'' shipments of ENDS products that could be sent 
under the Business/Regulatory Purposes exception would necessarily be 
prohibited or restricted under 18 U.S.C. 1716. Many ENDS products do 
not qualify as injurious articles subject to 18 U.S.C. 1716, and as 
discussed in section III.A.2, Postal Service regulations permit many 
hazardous materials to be mailed pursuant to specified precautions. The 
precautions in existing regulations have historically been deemed 
sufficient to fulfill 18 U.S.C. 1716 for otherwise mailable shipments 
of ENDS products; it has never been the case that otherwise mailable 
ENDS products were deemed so extraordinarily dangerous as to warrant 
outright prohibition in the face of lesser applicable hazardous-
materials safeguards. While the scope of generally mailable ENDS 
products will now be limited by the PACT Act's exceptions, the Postal 
Service perceives no rational basis to upset the highly reticulated 
harm-based framework for hazardous-materials regulation.
    In the course of its 18 U.S.C. 1716 argument, the same commenter 
raised policy concerns about use of the Business/Regulatory Purposes 
exception to evade state and local taxes. But 18 U.S.C. 1716 has 
nothing to do with tax collection or evasion. Nor has Congress 
specifically conditioned eligibility for the Business/Regulatory 
Purposes exception on any particular standard of tax compliance, as it 
expressly did for the Consumer Testing exception. 18 U.S.C. 
1716E(b)(5)(A)(iv), (b)(5)(C)(ii)(III) (Consumer Testing exception). Of 
course, noncompliance with applicable tax laws may subject a business 
to penalties under other Federal, State, local, or Tribal laws. It may 
also affect the business's ability to obtain relevant licenses or 
permits, which is a prerequisite for eligibility to use the Business/
Regulatory Purposes exception. Id. at (b)(3)(A)(i). Where information 
may indicate that an entity that may be authorized to use the Business/
Regulatory Purposes exception is not, in fact, operating lawfully, all 
parties are encouraged to bring such information to the attention of 
the Postal Inspection Service.
    Finally, a Federal agency partner sought clarification of whether 
the Business/Regulatory Purposes exception encompasses shipments from 
businesses to Federal regulatory agencies and vice versa for 
enforcement or investigational purposes. The PACT Act permits use of 
the exception ``for regulatory purposes between any [covered] business 
. . . and an agency of the Federal Government or a State government.'' 
Id. at (b)(3)(A)(ii) (emphasis added). The word ``between'' plainly 
denotes movement in either direction. See, e.g., Atlas Aerospace LLC v. 
Advanced Transp., Inc., No. 12-1200-JWL, 2012 WL 5398027, at *1 (D. 
Kan. Nov. 2, 2012); Union Pacific Corp. et al., 2 S.T.B. 276, 280 
(1997) (``Citation is hardly necessary on this point.''). It is further 
apparent that ``regulatory purposes'' encompasses enforcement against 
and investigation of regulated entities, among other governmental 
activities. Therefore, shipments from a business to a Federal or State 
governmental body and vice versa are within the ambit of the Business/
Regulatory Purposes exception, provided that all of the other 
conditions for use of the exception are met.
2. Eligible Parties
    The Business/Regulatory Purposes exception permits shipments of 
PACT Act-covered products between ``legally operating businesses that 
have all applicable State and Federal Government licenses or permits 
and are engaged in tobacco product manufacturing, distribution, 
wholesale, export, import, testing, investigation, or research'' and 
between such businesses and Federal or State government agencies. 18 
U.S.C. 1716E(b)(3)(A)(i)-(ii).
    A number of ENDS industry commenters opined that ``businesses . . . 
engaged in . . . distribution'' should be understood to include 
retailers, common carriers, and contract delivery services. This 
interpretation accords with the Postal Service's longstanding practice 
in applying the statutory term, as well as with dictionary and related 
statutory definitions. See, e.g., Distribute, Black's Law Dictionary 
(11th ed. 2015) (``3. To deliver.''); Distribute, Merriam-Webster.com 
(last visited Oct. 14, 2021) (``2b: To give out or deliver especially 
to members of a group''); cf. 21 U.S.C. 802(8), (11) (distribution of a 
controlled substance or listed chemical generally means transfer 
between parties). Because the Postal Service considers this meaning to 
be plain from the statutory term, there does not appear to be a basis 
to deviate from or elaborate upon the statutory language. It is 
emphasized that the statutory Business/Regulatory Purposes exception 
permits shipments between a retail or other distributor and another 
industry business or regulator, but not a distributor's (or any other 
entity's) direct shipments to consumers. The measures discussed in 
sections III.G.3-.7 are designed to ensure that the Business/Regulatory 
Purposes exception is used only for eligible business-to-business or 
business-to-government shipments and not for shipments to or

[[Page 58412]]

from ineligible parties, including retail consumers.
    An ENDS industry association proposed to clarify that ``testing, 
investigation, or research'' includes contracted research organizations 
and laboratories. It seems self-evident that such entities would be 
covered, to the extent that they are ``engaged in . . . testing, 
investigation, or research'' as to PACT Act-covered products; the 
statute provides no basis for distinction according to such entities' 
contractual relationships. Here, too, the Postal Service regards the 
statutory language as sufficiently clear in encompassing the relevant 
entities, without further elaboration. While the statute does not 
appear to preclude eligibility for such parties generally, verification 
of any particular research organization or laboratory's eligibility 
will involve a case-specific determination based on the documentation 
submitted with the relevant application.
    The same ENDS industry association asked that marketing firms be 
treated as eligible. The PACT Act does not appear to permit such 
treatment. None of the categories of business activity enumerated in 
the statute encompasses marketing or related activities, such as 
advertising or promotion. Nor does the statute extend eligibility to 
agents of enumerated businesses, in contrast to the Consumer Testing 
exception. Cf. 18 U.S.C. 1716E(b)(5)(A). As an exception to a general 
policy of nonmailability, the Business/Regulatory Purposes exception 
merits narrow construction. See, e.g., Maracich v. Spears, 570 U.S. 48, 
60 (2013) (quoting Comm'r v. Clark, 489 U.S. 726, 739 (1989)). The PACT 
Act delegates to the Postal Service only the authority to ``establish 
the standards and requirements that apply to all mailings'' defined by 
the statutory criteria for the Business/Regulatory Purposes exception, 
18 U.S.C. 1716(b)(3)(B)(i), and the POSECCA permits the Postal Service 
only to ``clarify the applicability'' of the PACT Act's prohibition 
(and, by implication, its exceptions). POSECCA section 603(a). As 
discussed in section III.A.1, neither statute permits the Postal 
Service to modify those criteria themselves. As such, the Postal 
Service lacks any authority or basis to add businesses engaged in 
marketing to the roster of eligible entities.
    An ENDS manufacturer asserted that licensed independent mystery-
shopper contractors should count as entities ``engaged in . . . 
testing, investigation, or research.'' To the extent that such a 
contractor is a business entity, then it could potentially come within 
the scope of the exception, depending on the Postal Service's 
assessment of the documentation submitted with the relevant 
application. To the extent that the contractor is an individual tester, 
however, then it would appear to fall outside of the scope of the 
exception, which is restricted to ``legally operating businesses that 
have all applicable State and Federal Government licenses or permits.'' 
Rather, shipments from businesses to individual testers would appear to 
be akin to the shipments governed by the Consumer Testing and Public 
Health exceptions, which Congress narrowly circumscribed and, as 
discussed in section III.I, did not make available for ENDS products in 
any event. To the extent that individual testers may wish to send ENDS 
products to a manufacturer, testing firm, or other entity, these 
shipments would fall within the scope of the Certain Individuals 
exception, subject to the relevant criteria and limitations.
    The same manufacturer inquired whether ``between legally operating 
businesses'' would be construed to include shipments between two 
offices of the same eligible firm, in addition to shipments between 
separate firms. The Postal Service agrees that this construction makes 
sense, provided that all relevant intra-firm sender and recipient 
addresses are listed in the firm's application and approved by the 
Postal Service. Indeed, it is difficult to conceive of why Congress 
would permit shipments between duly authorized facilities of separate 
firms, while prohibiting them between identical facilities that happen 
to be within the same corporate structure. This understanding accords 
with the Postal Service's historical practice in administering the 
exception prior to the POSECCA.
    Certain pro-ENDS commenters suggested that the Business/Regulatory 
Purposes exception could be used to facilitate the return of ENDS 
products from consumers to businesses. The PACT Act does not permit 
this use of the Business/Regulatory Purposes exception. Eligibility for 
the Business/Regulatory Purposes exception is restricted to shipments 
between eligible businesses or between such businesses and Federal or 
State government agencies. By contrast, 18 U.S.C. 1716E(b)(3) does not 
contain any indication of legislative intent to encompass shipments 
either to or from individual consumers. That said, business-to-business 
product returns and recycling- or reuse-related shipments may be 
permissible between eligible and approved businesses, and consumer-to-
business shipments for such purposes may be permissible under the 
Certain Individuals exception, as discussed in section III.H.
    State and local attorneys general opined that a business's status 
as ``legally operating'' implies compliance with all pertinent laws, 
and that a business does not qualify as ``legally operating'' for 
purposes of the Business/Regulatory Purposes exception if it markets 
products that are counterfeit, that are not the subject of a timely 
premarket application to the FDA, or that are otherwise inconsistent 
with applicable law. The Postal Service agrees that all mailers must 
comply with all applicable laws with respect to products that they 
mail, and that a pattern of violations may rise to a level where a 
business may no longer be considered ``legally operating.'' It seems 
equally apparent, however, that a business may violate a law with 
respect to certain of its products while operating legally in other 
respects. Therefore, the Postal Service regards the question of whether 
and when violations suffice to render a business no longer ``legally 
operating'' to be a case-specific one, dependent on the totality of 
relevant facts and circumstances in a particular situation. The Postal 
Service encourages its Federal, State, local, and Tribal governmental 
partners, as well as any other party, to bring to the attention of the 
Postal Inspection Service any indication that an ENDS-industry business 
mailer may have committed material legal violations such that it may no 
longer be considered ``legally operating.''
    The same commenters proposed that the Business/Regulatory Purposes 
exception be restricted to recipients using their physical address as 
the delivery address and that recipients using a different delivery 
address (such as a Post Office Box or private rental mailbox) be barred 
from eligibility. The Postal Service declines to adopt this 
recommendation. Such a restriction is not among the statutory 
eligibility criteria. Even if the Postal Service had the policy 
discretion to adopt such a categorical restriction, the basis for such 
a potentially overbroad rule is unclear. The Postal Service notes that 
Post Office Boxes and private rental mailboxes are used by a variety of 
business and governmental actors for a variety of reasons.\16\ Most 
such uses are presumably lawful and legitimate, and while some such 
mail recipients may engage in unlawful activity, the same is

[[Page 58413]]

true of persons who use a physical mailing address. The commenters 
offer no empirical support for the implied notion that addressees who 
use certain types of mailboxes are more likely than other addressees to 
engage in activity disqualifying them from the Business/Regulatory 
Purposes exception, let alone to such an overwhelming and disparate 
degree as to warrant barring all persons using such mailboxes from 
otherwise permissible eligibility for the exception. That said, if any 
person or entity believes that a sender or recipient is using a Post 
Office Box or private mailbox to violate the law, such persons and 
entities are encouraged to notify the Postal Inspection Service and/or 
to nominate the entity to the List of Unregistered or Noncompliant 
Delivery Sellers compiled by the Attorney General under section 2A(e) 
of the Jenkins Act (``Noncompliant List''), if appropriate.
---------------------------------------------------------------------------

    \16\ Indeed, in subscribing to this set of comments, one of the 
commenting State attorneys general provided contact information that 
listed a Post Office Box address.
---------------------------------------------------------------------------

    Two Federal agency partners inquired whether the Business/
Regulatory Purposes exception, or some other exception, would 
accommodate shipments from one governmental actor to another, such as 
between a governmental field agent and an agency laboratory or between 
two separate agencies. Congress has made the Business/Regulatory 
Purposes exception available only for shipments (1) from one covered 
business to another and (2) from such a business and governmental actor 
or vice versa, 18 U.S.C. 1716E(b)(3)(A)(i)-(ii), but not (3) from one 
governmental actor to another. Nor does any other PACT Act exception 
encompass such shipments. While the Postal Service understands that 
effective regulation may require shipments of tobacco and ENDS products 
between governmental actors, such shipments must occur through non-
postal channels unless and until Congress amends the PACT Act to permit 
the use of the mails for such shipments.
3. Application Process
    The PACT Act charges the Postal Service with verifying that any 
person submitting an otherwise nonmailable tobacco product into the 
mails, and any person receiving such a product through the mails, as 
authorized under the Business/Regulatory Purposes exception, is a 
business or government agency within the scope of the exception. 18 
U.S.C. 1716E(b)(3)(B)(ii)(I)-(II); see also id. at (b)(3)(B)(ii)(VI) 
(markings must enable Postal Service employees' awareness that the 
mailing ``may be delivered only to a permitted government agency or 
business''). To fulfill these eligibility verification requirements, 
the Postal Service created a centralized application process. 76 FR at 
24535-24536; 76 FR at 29665-29666. The Postal Service reasonably 
determined that centralization of eligibility determinations would 
allow for more effective and efficient assessment of eligibility, and 
would be less disruptive to retail and delivery operations and the 
customer experience, than the alternative of having retail and delivery 
personnel attempt to verify documentation and other criteria for 
eligibility each and every time an ENDS mailing is tendered or 
delivered.\17\ Eleven years of the existing practice have provided no 
fresh basis to think that a decentralized approach to eligibility 
verification would work better.
---------------------------------------------------------------------------

    \17\ The Postal Service is statutorily obligated to pursue 
economy and efficiency in its operations. 39 U.S.C. 101(a), 403(a), 
(b)(1), 2010, 3661(a).
---------------------------------------------------------------------------

    In general, pro-ENDS commenters expressed concern that the 
centralized authorization process set forth in Publication 52 section 
472.221, in combination with the fact that the POSECCA's mailing 
prohibition would take effect immediately upon adoption of the final 
rule, would have an unduly disruptive effect on the ENDS industry, at 
least to the extent that supply-chain-related and regulatory mailing 
activity might ultimately be deemed permissible under the Business/
Regulatory Purposes exception.
    Some industry commenters recommended that the Postal Service 
develop a streamlined process involving an online application portal. 
The Postal Service agrees that this recommendation might well benefit 
applicants, as well as improve the effectiveness and efficiency of 
Postal Service review. Unfortunately, the Postal Service's existing 
information technology infrastructure does not allow for such a 
solution in the near term, and the need for prompt implementation 
precludes development and implementation of an online application 
portal prior to adoption of the final rule. The Postal Service will 
continue to explore the feasibility of digitizing the application 
process and may amend its rules appropriately at a later time.
    Particularly given the lack of a digital-based application process, 
at least one industry commenter expressed concern that the Postal 
Service may not be prepared for a potential flood of applications, and 
two others asked the Postal Service to ensure adequate staffing to 
process applications. The Postal Service recognizes that the ENDS 
industry is less consolidated, more complex, and more reliant on the 
mail than the industries previously subject to the PACT Act. As such, 
the Postal Service shares the commenter's anticipation of a large 
number of applications that far exceeds the historical rate of such 
applications and involves numbers of parties and products far greater 
than past applications. See 86 FR at 20288. The Postal Service is 
therefore undertaking multiple steps in an effort to improve the 
efficiency of the application review process and to mitigate the likely 
increase in processing times:
     The Postal Service provided advance guidance to ENDS 
industry actors about application documentation that they could compile 
while awaiting the final rule, in the interest of filing an application 
as soon as possible following the final rule and minimizing the chances 
of delayed processing due to insufficient supporting documentation. Id.
     The Postal Service also provided advance guidance about 
other mailability restrictions that might apply to ENDS products, so 
that potential applicants may preemptively consider whether their 
products would be nonmailable in any case and, in appropriate cases, 
narrow the scope of their Business/Regulatory Purposes applications 
accordingly or forgo applying altogether. See id. at 20,289.
     For at least a temporary period, the Postal Service is 
assigning additional analyst resources to assist the PCSC with 
reviewing Business/Regulatory Purposes exception applications. This 
internal workload-management change does not affect any aspect of the 
rules themselves and therefore is not reflected in the text of the 
final rule.
    Despite these measures, it must be recognized that the Postal 
Service has limited financial and other resources with which to fulfill 
its universal service mission and fulfill myriad other statutory 
obligations,\18\ and Congress did not provide the Postal Service with 
any additional funding for POSECCA implementation activities. As such, 
there are limits to the Postal Service's ability to timely process 
substantial numbers of Business/Regulatory Purposes applications at any 
given time. The statutory requirements for Postal Service verification 
of mailers' and

[[Page 58414]]

recipients' eligibility, 18 U.S.C. 1716E(b)(3)(B)(ii)(I)-(II), 
(b)(5)(C)(ii)(I), leave the Postal Service unable to simply suspend 
such verification. Hence, applicants and other interested parties 
should expect review of their applications to require potentially 
substantial processing time. The duration of any review would be 
determined by the number and complexity of the applications that the 
Postal Service receives and the amount of engagement with applicants 
during processing. The Postal Service recommends that applicants 
provide complete, accurate information in their applications and limit 
their current and anticipated mailing activity to bona fide mailable 
content, so that applications can be processed as efficiently and 
expeditiously as possible.
---------------------------------------------------------------------------

    \18\ Unlike most Federal agencies, the Postal Service is 
supported almost entirely by revenues, not appropriations of 
taxpayer dollars. See generally 39 U.S.C. 2401. The Postal Service 
incurred multibillion-dollar net losses in each the past fourteen 
years, with a cumulative deficiency of $87.0 billion as of the end 
of FY 2020 and liquidity levels that place the current and future 
fulfillment of its statutory mission at risk. U.S. Postal Serv., 
2020 Report on Form 10-K, at 68, https://about.usps.com/what/financials/10k-reports/fy2020.pdf.
---------------------------------------------------------------------------

    A number of pro-ENDS commenters expressed concern that an immediate 
effective date, coupled with a time-consuming application process for 
the Business/Regulatory Purposes exception, would disrupt the very 
industry supply chains and regulatory activities that the exception is 
intended to safeguard. To avoid such anticipated harms, these 
commenters asked the Postal Service either to accept Business/
Regulatory Purposes exception applications in advance of the final 
rule, or else to defer the mailing ban until applications can be 
approved. In the April 2021 Guidance, the Postal Service explained that 
it would not accept early applications, as it was yet undetermined to 
what extent the exceptions would be available for ENDS products at all 
and on what terms. 86 FR at 20288. It is tautological that the Postal 
Service cannot announce and give effect to an exception to a mailing 
ban before the ban takes effect; prior to the ban, mailability is the 
rule, not an exception. As for accepting and processing applications in 
advance of the final rule, the course of intra- and interagency 
deliberations over the final rule--particularly in light of the 
voluminous number and range of public comments--required an 
extraordinary amount of time to process, to the point where any early 
acceptance period would have been too short to provide the substantial 
buffer that commenters sought. Nor is the Postal Service at liberty to 
further defer the effective date simply for the sake of a small group 
of pro-ENDS commenters, for the reasons discussed in section III.A.3. 
As it was, the same complex deliberations required far more time to 
complete the final rule than Congress had allotted in the POSECCA, and 
the policy interests evident in the statutory text and legislative 
history--none of which include solicitude toward industry supply chains 
or regulatory activities--do not support additional, discretionary 
delay beyond what was necessary to complete the final rule.\19\
---------------------------------------------------------------------------

    \19\ Moreover, it is difficult to see how the proposal to delay 
effectiveness until applications can be approved would work in 
practice. The Postal Service cannot predict how many applications it 
will receive, their timing and pacing, or their extensiveness, and 
so it cannot predict how long it will take to process even an 
initial batch of applications.
---------------------------------------------------------------------------

    Out of similar concerns over at least temporary disruption of 
industry supply chains, two ENDS industry commenters proposed that the 
Postal Service allow applicants to continue mailing ENDS products 
within the scope of the exception while awaiting approval of their 
application, subject to a sworn certification of eligibility, a bond or 
other security, or a provisional eligibility number provided by the 
Postal Service. The Postal Service declines to adopt this proposal as 
inconsistent with the aforementioned statutory requirements that the 
mailing ban take effect immediately and that the Postal Service verify 
the sender and recipient's eligibility prior to permitting any mailing 
under the Business/Regulatory Purposes exception.
    Even if 18 U.S.C. 1716E(b)(3)(B)(ii)(I)-(II) were arguably 
ambiguous as to whether verification may happen after acceptance or 
even after delivery, the Postal Service considers the only reasonable 
interpretation to be that verification must occur prior to acceptance. 
Congress clearly expressed its intent that verification of the 
recipient occur prior to delivery: 18 U.S.C. 1716E(b)(3)(B)(ii)(VI) 
requires package markings apprising Postal Service personnel that a 
given mailing ``may be delivered only to a permitted government agency 
or business.'' Hence, ``permitted'' status must be ascertained as a 
condition precedent to delivery. Moreover, the exception is available 
``only'' to eligible businesses and government agencies. 18 U.S.C. 
1716E(b)(3)(A). The exception therefore may not be used to justify a 
mailing to or from an ineligible entity, regardless of whether the 
entity is the subject of a pending application. Because eligibility is 
not determined until it is determined, the presumption must necessarily 
be that a mailing is ineligible until demonstrated to be eligible, not 
the other way around. Moreover, the Postal Service is mindful that the 
Business/Regulatory Purposes exception is carved out from the general 
rule that ENDS products ``shall not be deposited in or carried through 
the mails.'' Id. at (a)(1). As such, the narrow construction typically 
due exceptions, discussed in the preceding section, militates against a 
liberal presumption of eligibility on the sheer basis of a mailer's 
self-certification or payment of a bond. Even if such a presumption 
were not inconsistent with the statute, the Postal Service would 
decline to adopt it as a policy matter, given the undue opportunity for 
abuse that it would present.
    The same commenters urged the Postal Service to streamline or 
eliminate the process for updates to approved applications, which, the 
commenters argued, should not require a further application and 
approval process. The requirements for approval of updated applications 
were set forth and explained in the Postal Service's 2010 final rule 
implementing the PACT Act. As the Postal Service explained then, the 
PACT Act charges the Postal Service with verifying the eligibility of 
senders and addressees pursuant to the Business/Regulatory Purposes 
exception, and so mailers must be responsible for maintaining the 
accuracy of all information in their applications and await 
verification of eligibility before any mailing may be treated as 
permissible under the exception. 76 FR at 29666.
    Indeed, an update may be just as substantive as the original 
application (e.g., the addition of parties or products), and it may 
materially change circumstances relevant to mailability. Even updates 
to a single entry on the form can be material: A change of address 
could be legitimate or used to mask an ineligible party; ``legally 
operating'' status can hinge on rescission or extension of a permit; 
and a change in product composition may change its status vis-[agrave]-
vis controlled-substance or hazardous-materials rules. Vetting only an 
initial application but not updates to it would invite efforts to evade 
review through overreliance on unreviewed updates, in violation of both 
the letter and the spirit of 18 U.S.C. 1716E(b)(3)(B)(ii)(I)-(II).
    Nothing about the statutory verification requirement has changed 
since 2010, and so there is no basis to rethink the need to verify 
updated applications. That said, as noted earlier, the Postal Service 
will undertake to explore possibilities for streamlining the 
application process, including updates to applications, through 
automation and digitization.
    Some pro-ENDS commenters opined that the centralized application 
process imposes red tape that favors large industry actors and poses 
undue obstacles to smaller businesses. While

[[Page 58415]]

the Postal Service is sympathetic to the challenges faced by small and 
medium-sized enterprises, Congress has mandated that use of the 
Business/Regulatory Purposes exception be conditioned on Postal Service 
verification of eligibility. The PACT Act's verification requirements 
apply to all entities sending or receiving items under the exception, 
without distinction as to size. The Postal Service considers the 
alternative to centralized verification--verification at the point of 
acceptance and delivery of each mailing--to pose similar obstacles in 
terms of paperwork burden, as the sender or recipient would still need 
to compile and present the same license, permit, and other 
documentation to demonstrate eligibility. The only difference would be 
that the sender and recipient would have to do so for each and every 
mailing, rather than on a less frequent basis under the centralized 
process. It is difficult to see how the decentralized-verification 
alternative would be superior in terms of reducing administrative 
burden for small and medium-sized enterprises, given Congress's 
requirement of eligibility verification in all cases. That said, 
smaller businesses may benefit from proportionally faster processing 
times (within the bounds of application processing as discussed later 
in this section), to the extent that their applications involve fewer 
parties and products than those of larger businesses.
    Two ENDS industry commenters suggested that the Postal Service 
provide a checklist for applicant documentation. Simultaneously to the 
final rule, the Postal Service is issuing a distinct version of its 
application form to account for ENDS products. The amended form will 
include detailed instructions and documentation requirements, as well 
as supporting worksheets.
    Two ENDS industry commenters requested that the Postal Service 
confirm that it would process applications on a ``first in, first out'' 
(FIFO) basis, in the interest of equal treatment for all businesses. 
The PCSC generally uses a FIFO system for each stage of application 
processing, although the precise sequencing of application processing 
may be complicated somewhat by the expanded distribution of workload 
discussed earlier in this section.\20\ It is certainly not the case 
that applications will be prioritized according to business size, 
industry reputation, or other applicant-specific circumstances.
---------------------------------------------------------------------------

    \20\ For example, if multiple analysts are conducting initial 
review of a batch of applications received on the same day, a later-
filed application may advance in the review queue before an earlier-
filed one that is still being reviewed by a different analyst. It 
would remain the case that any given reviewer will operate on a FIFO 
basis, however.
---------------------------------------------------------------------------

    State and local attorneys general proposed that the Postal Service 
share applications with State and local law enforcement officials to 
spread out the investigative workload. The Postal Service appreciates 
the suggestion and is willing to consider possibilities for enhancing 
application processing via intergovernmental and/or interagency 
information-sharing, subject to feasibility, appropriate protections 
for third-party information, and other pertinent conditions. The Postal 
Service regards such intergovernmental cooperation as part of what 
should be the normal administration of the PACT Act, see 18 U.S.C. 
1716E(g), and looks forward to further dialogue with partners outside 
of the ambit of this rulemaking.
    State and local attorneys general also proposed that the Postal 
Service use State and local governments' lists of licensees to verify 
eligibility. This suggestion is facially reasonable, but the Postal 
Service is unaware of any consolidated data source that would enable 
efficient and fair incorporation of such a resource into the 
application review process. Here, too, the Postal Service welcomes 
further dialogue with its intergovernmental partners about potential 
enhancements to PACT Act administration.
4. Documentation of Legally Operating Status
    To support verification of eligibility as legally operating under 
18 U.S.C. 1716E(b)(3)(A) and (b)(3)(B)(ii)(I), preexisting Publication 
52 section 472.221.a required an applicant to submit information about 
its legal status, any applicable licenses, and authority under which it 
operates; information about the legal status, any applicable licenses, 
and operational authority for all entities to which the applicant's 
mailings under the exception would be addressed; and all locations 
where mail containing cigarettes and smokeless tobacco would be 
presented.
    Some ENDS industry stakeholders expressed concern that the 
documentation requirements were geared exclusively toward tobacco 
licensing and would prejudice mailers of non-nicotine-related ENDS 
products. This concern is unfounded. Nothing in either 18 U.S.C. 
1716E(b)(3)(A) or Publication 52 section 472.221.a is specific to 
tobacco or nicotine licensing. Instead, the statute conditions 
eligibility on the sender and recipient having ``all applicable State 
and Federal Government licenses or permits'': In other words, any 
license or permits that entitle the sender or recipient to engage in 
business activities relating to the product being shipped, whatever 
that product may be. 18 U.S.C. 1716E(b)(3)(A) (emphasis added). 
Similarly, Publication 52 section 472.221.a frames the documentation 
requirements solely in terms of licenses, permits, and authority, 
without specific reference to tobacco or nicotine or to documentation 
used exclusively with tobacco or nicotine. The existing language 
therefore requires no change to accommodate licensing, permit, or other 
documentation that may demonstrate legal authority to engage in 
business dealings concerning any or all types of ENDS products relevant 
to a shipment.
    Insofar as the concern may pertain to a separate phrase in 18 
U.S.C. 1716E(b)(3)(A)--``engaged in tobacco product manufacturing [or 
other specified types of business activity]''--it is evident that 
Congress used ``tobacco product'' in the PACT Act as a catch-all term 
encompassing all PACT Act-covered products, regardless of actual 
tobacco content. See 86 FR at 10219. To be sure, the phrase's import 
was clearer prior to POSECCA, when all PACT Act-covered products were 
derived from tobacco. But even after POSECCA's inclusion of non-
tobacco-related ENDS products, see supra section III.D.1, the intent 
remains sufficiently clear. Given the thorough reliance on ``tobacco 
product'' throughout the PACT Act, construing the somewhat antiquated 
phrase literally as covering only bona fide tobacco-derived products 
and excluding non-tobacco-based ENDS products would vitiate the very 
language whereby Congress has now subjected to the PACT Act ENDS 
products related to delivery of any ``substance,'' including non-
tobacco-derived substances. Indeed, the POSECCA places ENDS products 
within the definition of ``cigarette;'' however linguistically awkward 
this may be, it is evident that ``cigarette'' is now a term of art 
signaling the PACT Act's application to both tobacco and non-tobacco 
products. It is reasonable to extend the same understanding to 
``tobacco product,'' within which ``cigarettes'' are subsumed. Thus, 
the only reasonable construction faithful to the POSECCA's text and 
intent is to treat ``tobacco product'' not as a term of limitation, but

[[Page 58416]]

rather as a catch-all term encompassing all products subject to the 
PACT Act.\21\
---------------------------------------------------------------------------

    \21\ To promote clarity, however, the Postal Service will use a 
different terminological approach in its regulations. See infra 
section III.J.3.
---------------------------------------------------------------------------

    In any event, the instance of ``tobacco product'' in 18 U.S.C. 
1716E(b)(3)(A) cabins only the activity-based classes of entities 
eligible for the exception, and not the nature of the licenses or 
permits under which they may operate. Rather, licenses and permits go 
to whether the entity--whatever its market and field of activity--is 
legally operating.\22\ As such, a cigarette manufacturer, for example, 
must have licenses and permits relating to cigarette manufacture, but 
whether it is legally operating may additionally depend on more general 
business licensure not specifically related to cigarettes. The same is 
true of an ENDS-related business. Indeed, the business activity that is 
the subject of an ENDS-related Business/Regulatory Purposes application 
may implicate multiple levels of licensure. For example, consider a 
business engaged in ENDS distribution and applying for the Business/
Regulatory Purposes exception in connection with CBD-related products: 
``All applicable State and Federal Government licenses or permits'' 
bearing on ``legally operating'' status might include a general 
operating license, permission to distribute ENDS products, and 
permission to distribute hemp-derived (e.g., CBD) products, among other 
things, to the extent that any such licenses are required by applicable 
State or Federal law.
---------------------------------------------------------------------------

    \22\ It is possible that the commenters' concern arises not from 
the portion of the PACT Act that governs mailability, but from the 
separate portion that governs delivery sales more generally via 
modification of the Jenkins Act. See 15 U.S.C. 376a(a)(3)(B) 
(requiring delivery sellers to comply with ``all State, local, 
tribal, and other laws generally applicable to sales of cigarettes 
and smokeless tobacco,'' including ``licensing and tax-stamping 
requirements''). But that provision applies only to ``delivery 
sales'' to consumers. See 15 U.S.C. 375(5). Except for intrastate 
shipments within Alaska and Hawaii, such sales are beyond the scope 
of the exceptions to the PACT Act's mailing ban, and so they cannot 
be effectuated through the mails. As such, if the Jenkins Act 
provision is the basis for the commenters' concern, then it appears 
to be largely inapposite in this context. As noted in section 
III.C.3, inquiries about the application of Jenkins Act requirements 
to delivery-sale-related postal shipments of ENDS products within 
Alaska and Hawaii should be directed to ATF.
---------------------------------------------------------------------------

    Certain other ENDS industry commenters inquire about a situation 
where neither Federal nor State law imposes any particular license or 
permit requirements on the same of a given ENDS product. The commenters 
propose that an applicant be permitted to simply cite a State statute 
allowing general business operations. The Postal Service appreciates 
the novelty of the situation, which would not have arisen with respect 
to the comprehensively regulated products previously subject to the 
PACT Act. As noted earlier, the PACT Act requires verification of all 
applicable State and Federal Government licenses or permits. If there 
are no applicable licenses or permits upon which ``legally operating'' 
status as to the relevant business activity depends, then that is that. 
At the very least, however, it seems unlikely that any State's laws 
would permit an applicant business to operate without a general 
business license. To the extent that the applicant's relevant business 
activity is not subject to any other license or permit requirements, 
then the applicant should be prepared to attest to and document that 
circumstance, either affirmatively or in response to further PCSC 
inquiry. Particularly where no other documentation may exist, a 
government-issued certificate of good standing may be helpful, although 
not necessarily dispositive. Applicants are reminded that they bear the 
burden of proof in establishing eligibility to the satisfaction of the 
PCSC, and applications will likely be processed faster if applicants 
affirmatively provide robust information about their legal status up 
front.
    It should be noted that the same verification requirements apply 
with respect to all senders and recipients under the exception, 
regardless of their status as business actors or government agencies. 
See 18 U.S.C. 1716E(b)(3)(A), (b)(3)(B)(ii)(I)-(II). At the same time, 
however, only businesses' eligibility is conditioned upon ``legally 
operating'' status as evidenced by licenses and permits, compare id. at 
(b)(3)(A)(i) with id. at (b)(3)(A)(ii), and indeed, government agencies 
are not typically subject to licensure by other governmental bodies. 
Nevertheless, because the Postal Service is required to verify 
eligibility for governmental senders and recipients, applicants must 
provide the Postal Service with sufficient information to determine 
that the relevant governmental entity is an eligible one, and not 
merely an ineligible entity using a name identical to or resembling 
that of a bona fide governmental entity. Such information would include 
not only the entity's name and address, but also citations to the legal 
authority under which it operates.\23\
---------------------------------------------------------------------------

    \23\ While the Postal Service will retain the preexisting rule 
permitting waiver, upon request, of application requirements for 
mailings sent by State or Federal Government agencies, such waivers 
are not available to business applicants sending to government 
agencies.
---------------------------------------------------------------------------

    One ENDS business asked about how the documentation requirements 
would apply to contract research organizations and trade shows. The 
same principles would apply as discussed earlier in this section: To 
the extent that lawful operation of a contract research organization or 
trade show relating to the relevant PACT Act-covered products requires 
Federal or State licensing or permitting, then copies of such 
documentation must be included with an application concerning such a 
party. Again, particularly where other license or permit documentation 
may not exist, a government-issued certificate of good standing may be 
helpful, albeit not necessarily dispositive.
    It is emphasized that the Postal Service is required not merely to 
collect Federal and State licenses and permits, but also to verify more 
broadly that a business is ``legally operating'' and ``engaged in'' the 
relevant business activity. This may require the submission of 
documentation beyond merely licenses and permits. For example, a 
university performing research on behalf of ENDS industry participants 
may need to submit not only copies of relevant licenses and permits, 
but also grant or contract documentation indicating that the research 
is within the scope of a legally authorized undertaking.
    State and local attorneys general proposed that the Postal Service 
require applicants to provide information about the products that they 
intend to ship under the Business/Regulatory Purposes exception. The 
product suggestion is well-taken, given the various other regulatory 
and mailability concerns apart from the PACT Act that may pertain to 
certain ENDS products. The new application form and worksheet 
incorporate requirements for applicants to provide brand names and 
descriptions of each product that they intend to ship, as well as 
additional supporting documentation regarding products that contain 
lithium batteries, nicotine, THC, or CBD and any other ENDS liquids or 
solutions.
    State and local attorneys general also recommended that applicants 
be required to certify that they will ship only between authorized 
persons (i.e., persons whom the Postal Service has verified as 
eligible). While the concern for attestation is valid, the Postal 
Service believes that it is already adequately addressed, to the point 
where attestation at the point of acceptance would be redundant. The 
Business/Regulatory Purposes application form requires the customer to 
completely list all intended recipients and to certify as to the 
entries'

[[Page 58417]]

completeness and accuracy. Any materially false or fraudulent statement 
or omission in the application could subject the applicant to liability 
under the False Claims Act. See 18 U.S.C. 1001(a). Furthermore, the 
PACT Act makes clear that the exception does not cover a shipment to an 
ineligible party, and so a shipment to such a party could subject the 
shipper to liability under the PACT Act. Moreover, the new rules, like 
the former rules, require shippers to present their PCSC eligibility 
determination letter to acceptance personnel for verification of the 
sender and addressee's eligibility. Here, too, presentment of false or 
misleading information, or concealment of relevant information, could 
subject a shipper to False Claims Act liability. As such, there does 
not appear to be any clear incremental value in adding a redundant 
attestation at the point of acceptance, let alone such value as might 
outweigh the administrative costs of doing so.
5. Qualifying Postal Service Products
    Several pro-ENDS commenters asked the Postal Service not to limit 
the use of the Business/Regulatory Purposes exception to shipments via 
Priority Mail Express with Hold for Pickup service, but rather to allow 
such shipments via Priority Mail as a more affordable alternative. This 
concern appears to refer to the PACT Act rules initially implemented in 
2010, and not to the current rules. Although Priority Mail Express with 
Hold for Pickup service was the only combination of services available 
at the time of original PACT Act implementation in 2010 that could 
permit the Postal Service to fulfill the PACT Act's age-verification, 
identity-verification, and tracking requirements, see 75 FR at 29665-
29666, the subsequent creation of Adult Signature service enabled the 
Postal Service to expand the range of available product combinations to 
Priority Mail Express or Priority Mail with Adult Signature service. 
See Adult Signature Services, 76 FR 30542 (2011); Publication 52 
section 472.222.a. Hence, the Postal Service has long since offered 
Priority Mail-based options. In this rulemaking, no commenter expressed 
opposition to the continued availability of Priority Mail Express or 
Priority Mail with Adult Signature Service for shipments under the 
Business/Regulatory Purposes exception, and the Postal Service is aware 
of no reason to restrict such availability in the context of ENDS 
products.
    Upon further consideration, however, it is apparent that Hold for 
Pickup is now an inferior alternative for fulfilling the PACT Act's 
verification requirements. Unlike Adult Signature service, Hold for 
Pickup does not inherently require age or identity verification; 
rather, personnel must be instructed and expected to identify when a 
particular Hold for Pickup item requires such verification, based on 
mailers' compliance with the marking requirement. Because Adult 
Signature service now provides a more effective means to ensure 
verification, the Postal Service is discontinuing the option of 
Priority Mail Express with Hold for Pickup service for mailings under 
the Business/Regulatory Purposes exception, as well as all other PACT 
Act exceptions.
6. Methods of Tender
    The Postal Service's preexisting PACT Act regulations require 
Business/Regulatory Purposes shipments to be tendered via a face-to-
face transaction with a Postal Service employee, other than through 
package pickup by a letter carrier. Publication 52 section 472.222.a. A 
number of ENDS industry commenters asked the Postal Service to 
reconsider what they characterized as a requirement to tender at a Post 
Office and to allow Pickup on Demand, package pickup, or business mail 
acceptance for excepted shipments. Some such commenters noted that the 
purported requirement is not grounded in the text of the PACT Act.
    The commenters misperceive somewhat the import of the face-to-face 
transaction requirement. For customers using the Business/Regulatory 
Purposes exception, only Pickup on Demand and package pickup are 
precluded; nothing in Postal Service regulations prohibits tender at a 
business mail entry unit or at authorized acceptance locations at a 
Post Office other than the retail counter, so long as a Postal Service 
employee accepts the items via an in-person, face-to-face encounter. 
But see DMM section 503.8.1.3 (requiring tender at a retail counter for 
customers using Adult Signature service to mail under the Certain 
Individuals exception). To promote clarity, the final rule includes 
explicit mentions of retail and/or business mail acceptance locations. 
The Postal Service hopes that this clarification should help to dispel 
the commenters' fears of bottlenecks at retail counters.
    That said, the Postal Service declines to reconsider the 
prohibition on Pickup on Demand and package pickup. The centralized 
application process is intended to streamline the extent of 
verification that would otherwise be required upon acceptance pursuant 
to 18 U.S.C. 1716E(b)(3)(B)(ii)(I)-(II), but it cannot supplant 
acceptance verification entirely. Something must be done to associate 
the PCSC's determination of eligibility with a given mailing: 
otherwise, the Postal Service personnel faced with an apparent mailing 
of a prohibited product have no way to determine its legitimacy, 
defeating the whole purpose of PCSC verification. For this reason, 
while a mailer need not submit the entire dossier of eligibility 
documentation with each mailing, the mailer must at least show a Postal 
Service employee the PCSC's determination of eligibility, so that the 
Postal Service can be assured that the package may lawfully be 
accepted.
    Pickup on Demand and package pickup do not provide adequate 
assurance that the face-to-face interaction necessary to connect PCSC 
authorization with a given package will occur in all cases. Much of the 
customer convenience underlying Pickup on Demand and package pickup is 
in the fact that packages may be left passively for a carrier to pick 
up without the need for in-person interaction. If Pickup on Demand and 
package pickup services were made available subject to a requirement 
for face-to-face interaction and verification, then this would raise 
secondary questions of how a carrier would know when the requirements 
apply and, more importantly, how the Postal Service could guard against 
circumvention by customers who do not engage in the requisite request 
for face-to-face pickup. Moreover, requiring carriers to take the time 
for face-to-face verification would increase the time required for 
carriers to service their routes, with negative effects on efficiency 
and service to other customers.\24\ Because allowing Pickup on Demand 
and package pickup for excepted mailings would diminish the fulfillment 
of the Postal Service's obligations under both the PACT Act (i.e., 
verification of eligibility prior to acceptance) and its governing 
statutes more generally, the Postal Service determines that Pickup on 
Demand and package pickup remain unacceptable.
---------------------------------------------------------------------------

    \24\ As noted in section III.G.3, the Postal Service is 
statutorily obligated to pursue economy and efficiency in its 
operations.
---------------------------------------------------------------------------

7. Delivery Requirements
    In addition to ensuring that the addressee is eligible to receive 
shipments under the Business/Regulatory Purposes exception, the PACT 
Act requires the Postal Service to ensure (1) that delivery is made 
only to a verified employee of the addressee; (2) that the receiving 
employee be verified to be at least the minimum age for

[[Page 58418]]

purchase or sale of the relevant products; and (3) that the receiving 
employee be required to sign for the mailing. 18 U.S.C. 
1716E(b)(3)(B)(ii)(II), (VII). Accordingly, the Postal Service's PACT 
Act regulations have required recipients to show proof of employment 
status with the addressee business or government agency; to show proof 
of age; and to sign the return receipt. Publication 52 section 472.223. 
The Postal Service did not propose to change these requirements.
    Some ENDS industry commenters asked that delivery options be 
expanded from Priority Mail Express with Hold for Pickup service to 
allow carrier delivery. As discussed in section III.G.5, this request 
has long since been fulfilled. The Postal Service in 2011 expanded the 
range of available services to include Priority Mail Express or 
Priority Mail with Adult Signature service. Unlike Hold for Pickup, 
which requires a recipient to retrieve a package from a local Post 
Office, Adult Signature service can be fulfilled by a letter carrier. 
As such, the Postal Service's longstanding regulations already include 
carrier delivery options. As also noted in section III.G.5, however, 
the Postal Service has now determined to discontinue the availability 
of the Hold for Pickup option; this does not affect the availability of 
Adult Signature options that are compatible with carrier delivery.
    One ENDS industry association recommended that the final rule 
expressly contemplate a signed letter from an employer as proof of 
employment. The Postal Service recognizes that the preexisting PACT Act 
regulations are not specific on this point, and that lay readers may 
benefit from additional clarity. Therefore, the final rule offers 
examples of acceptable employment documentation, including an employee 
identification badge or card, a recent letter on company or agency 
letterhead attesting to the recipient's employment, or any other 
documentation that the local postmaster deems to be of comparable 
reliability. In addition, where delivery is made to a business address, 
the carrier will be permitted to infer employment status from such 
factors as the recipient's uniform and presence at a reception desk or 
retail counter.
    Finally, State and local attorneys general asked that the Postal 
Service bar delivery of shipments under the Business/Regulatory 
Purposes exception to Post Office Box or private mailbox addresses. The 
Postal Service declines to do so, for the reasons discussed in section 
III.G.2.

H. Certain Individuals Exception

    As extended to ENDS, this exception allows individual adults to 
mail a limited number of lightweight packages containing ENDS products 
for noncommercial purposes. 18 U.S.C. 1716E(b)(4)(A). Some pro-ENDS 
commenters requested clarification on whether the return of damaged 
ENDS products to the manufacturer is covered by this exception. By way 
of clarification, the statute requiring this exception expressly 
includes the return by an individual of damaged or unacceptable goods 
to the manufacturer. Id. This language is mirrored in Publication 52 
section 472.23, which the final rule extends to ENDS.
    For additional clarity, the final rule adds language making 
explicit the permissibility of returning damaged or unacceptable 
products under this exception. The new language also clarifies the 
application of the exception's noncommercial-purpose condition to 
returns of damaged or unacceptable products, in that a product return 
remains noncommercial so long as any value offered to the sender is 
limited to the consumer's original outlays for the returned product and 
the cost of its return. Any additional exchange of value would not 
merely restore the consumer to their status quo ante; it would be 
tantamount to a higher-priced sale and thus no longer a noncommercial 
transfer.
    Noting the noncommercial-purpose requirement, some ENDS industry 
commenters sought clarification regarding whether used disposable ENDS 
products, which they claim have no commercial value and are similar to 
damaged products, would be included as ``damaged or unacceptable'' 
goods under this exception if returned to manufacturers or other 
businesses for recycling.
    The Certain Individuals exception allows shipments by individuals 
regardless of the type of recipient or the specific reason for mailing 
(subject to various limitations, including the noncommercial-purpose 
condition). Although the statute expressly lists the return of damaged 
or unacceptable products as an example, the use of ``including'' before 
this statutory phrase makes clear that it is merely illustrative, not 
exhaustive.
    As noted earlier in this section, the Certain Individuals exception 
does contain a requirement that the mailing be ``for noncommercial 
purposes.'' Id. As the commenters maintain, the depleted merchandise is 
effectively scrap with no intrinsic commercial value to the consumer. 
Thus, this exception permits the mailing of used ENDS products for 
recycling purposes only so long as no net commercial value, such as a 
rebate, credit, or discount on future purchases, is offered to the 
mailer in exchange for the used or depleted merchandise. This 
clarification is reflected in new language expressly discussing the 
possibility of recycling-oriented shipments under this exception. It is 
possible that some arrangements involving the recycling of used 
merchandise might not constitute a commercial exchange and therefore 
might be permissible under the Certain Individuals exception, such as 
where the merchandise is merely loaned to an individual user subject to 
a deposit payment that is refundable upon return of the material. 
Persons seeking guidance about whether a particular program would 
constitute a legitimate use of the Certain Individuals exception are 
encouraged to seek a mailability ruling pursuant to Publication 52 part 
215.
    One commenter reasoned that, because the return of damaged or 
unacceptable goods to the manufacturer is expressly allowed under this 
exception, the manufacturer should be allowed to use the exception to 
mail warranty replacement goods to adult consumers. However, the 
Certain Individuals exception provides only for adult ``individuals'' 
to mail ENDS for ``noncommercial purposes.'' Id. The exception thus 
does not authorize shipments by businesses (or other organizational 
entities) for any purpose, not even to fulfill a repair or replacement 
triggered by a consumer's use of the exception. Nor does any other PACT 
Act exception permit business-to-individual mailings for such purposes.
    A Federal agency partner inquired whether the availability of the 
Certain Individuals exception for products exchanged as gifts could be 
construed as allowing businesses to distribute free samples, 
notwithstanding the FDA's general ban on free samples of tobacco 
products. See 21 CFR 1140.16(d). The Postal Service emphasizes that its 
mailability regulations, including those administering the PACT Act, do 
not supersede any other applicable regulation that might restrict or 
prohibit a given transfer, distribution, or other activity effected 
through the mails. See Publication 52 part 412 (``The mailer is 
responsible for ensuring that all Postal Service requirements, as well 
as all federal and state laws and local ordinances that apply to the 
shipment of an article of restricted matter, have been met.''). That 
said, as the name indicates, the Certain Individuals exception is not 
available for any and all noncommercial

[[Page 58419]]

shipment of PACT Act-covered products, but rather only for such 
shipments by individuals. As such, while gifts from one individual to 
another may be within the exception's scope, it does not permit 
businesses to distribute free samples to consumers. Nor does any other 
exception permit promotional samples to consumers.\25\
---------------------------------------------------------------------------

    \25\ The Consumer Testing exception does permit the distribution 
of cigarettes to individual consumers solely for testing purposes, 
subject to various conditions and, again, only to the extent 
consistent with applicable laws and regulations. As discussed in 
section III.I, the Consumer Testing exception does not apply to 
smokeless tobacco or ENDS products.
---------------------------------------------------------------------------

    Some anti-ENDS commenters suggested that this exception should be 
altogether abolished or disallowed, reasoning in one instance that the 
return of damaged or unacceptable ENDS products through the mail by 
individuals unlikely to be aware of hazmat requirements poses health 
risks to Postal Service employees. As discussed in section III.A.2, 
absent a legal impediment to its application to ENDS, the Postal 
Service lacks a delegation of legislative authority to disallow this or 
any other PACT Act exception on policy grounds.
    Moreover, hazardous-materials concerns are already addressed 
through comprehensive mailing requirements in Publication 52. Those 
requirements have applied to individual mailers of ENDS products since 
long before the POSECCA, and they will continue to apply to mailings 
under the Certain Individuals exception. The hazardous-materials rules 
will continue to function to protect the health and safety of all who 
handle the mail. ENDS industry actors are strongly encouraged to 
promote awareness of all relevant mailing restrictions and 
requirements, including hazardous-materials rules, among ENDS 
consumers. See DMM section 601.9.4.1 (advertising, promotional, and 
sales matter soliciting or inducing the mailing of nonmailable 
hazardous materials is itself nonmailable).
    Some anti-ENDS commenters recommended that mailers using the 
exception be required to sign a sworn, written statement or provide 
other verification that the recipient is above the age of 21, as 
opposed to the oral affirmation required under the preexisting rules 
and the proposed rule. See Publication 52 section 472.231.d. These 
commenters purported that such a measure is necessary because underage 
recipients continue to access mailed products that are putatively 
nonmailable under the PACT Act.
    Such a requirement would be superfluous and unnecessarily 
burdensome. Age verification is already required at delivery. 18 U.S.C. 
1716E(b)(4)(B)(ii)(V)-(VI). By contrast, the mailer is required merely 
to ``affirm that the recipient is not a minor.'' Id. at 
(b)(4)(B)(ii)(II). To the extent that any minors allegedly continue to 
receive mailings of products made nonmailable under the PACT Act, the 
commenters have pointed to no evidence that this is due to a deficiency 
in administration of the Certain Individuals exception.\26\ Therefore, 
this recommended measure does not appear to address a demonstrable 
shortcoming in the Certain Individuals exception, let alone to do so in 
a way that would meaningfully improve compliance.
---------------------------------------------------------------------------

    \26\ The academic literature cited by these commenters is inapt. 
One cited study purports to present findings about a lack of age 
verification for postal deliveries of e-cigarettes in 2014 in 
violation of the PACT Act, but neither the PACT Act nor any age-
verification condition on mailing applied to e-cigarettes at that 
time. See generally Rebecca S. Williams et al., ``Electronic 
Cigarette Sales to Minors Via the Internet,'' 169 JAMA Pediatrics 
e1563 (2015). The other allegedly relevant article claims that 
Postal Service letter carriers did not attempt to conduct age 
verification for deliveries of cigarettes by online businesses (not 
individuals, such as might be relevant to the Certain Individuals 
exception). Rebecca S. Williams et al., ``Cigarette Sales to Minors 
Via the Internet: How the Story Has Changed in the Wake of Federal 
Regulation,'' 26 Tobacco Control 415 (2017). That article focuses on 
the consumers' interactions with online vendors and the Postal 
Service. As recipients, of course, consumers' knowledge or behavior 
is not transparent to the Postal Service; rather, from the Postal 
Service's perspective, the mailer (here, the internet vendor) is 
responsible for compliance with mailing requirements. Publication 52 
section 212. The article provides no basis to think that the mailers 
gave the Postal Service (and thus letter carriers) any indication, 
let alone a reasonable one, to perceive that the contents of their 
packages might be nonmailable or require age verification. Indeed, 
the researchers expressly allowed minor test subjects to 
misrepresent their age and use their parents' drivers' licenses to 
bypass age-verification questions. Rebecca S. Williams et al., 
``Cigarette Sales to Minors Via the Internet.'' Notably, another 
study cited by the commenters attests that nearly 90 percent of 
youth access to tobacco products (including ENDS products) occurs 
via a third-party intermediary (e.g., one who purchased them either 
lawfully or fraudulently), and not via an attempt by the underage 
user to order and obtain delivery the products directly. Sherry T. 
Liu, ``Youth Access to Tobacco Products in the United States, 2016-
2018,'' 5 Tobacco Regulatory Science 491 (2019).
---------------------------------------------------------------------------

    A coalition of State and local attorneys general urged the Postal 
Service to impose a host of additional conditions on this exception by 
reference to their proposals under the Business/Regulatory Purposes 
exception. Although it was not entirely clear from the comment, the 
recommended additional conditions presumably include requiring product 
identification, certification of mailer and recipient eligibility, 
exclusion of delivery to Post Office Boxes and commercial mail 
receiving agencies (``CMRAs''), and signature upon delivery. These 
commenters argued that delivery provisions set out in 15 U.S.C. 
376a(b)(4)(ii) should apply because they assert that 18 U.S.C. 
1716E(b)(4)(B), supposedly lacking comparably stringent age 
verification protocols, does not go far enough to prevent illegal 
deliveries.
    As noted in section III.A.2, the Postal Service has no discretion 
to impose additional conditions that Congress did not specify in 18 
U.S.C. 1716E(b)(4)(B). If anything, the contrast with measures that 
Congress simultaneously adopted through amendments to the Jenkins Act 
indicates that Congress did not intend for such measures to govern 
mailability. As such, the final rule maintains the age-verification and 
delivery requirements set out for this exception in Publication 52 
section 472.23.
    An industry coalition suggested that the Postal Service allow 
prepaid mailing labels to be used for this exception, so that consumers 
would not bear the costs of returns to manufacturers. As explained in 
section III.G.5, the Postal Service has determined that Adult Signature 
service permits the fulfillment of the Postal Service's verification 
responsibilities under the PACT Act. At present, Adult Signature 
service is not available in conjunction with domestic return services 
that would allow for the use of prepaid mailing labels in this manner. 
See DMM ex. 503.1.4.1, .1.4.3; Postal Regulatory Comm'n, Mail 
Classification Schedule sections 2120.5, 2645.1.1.d (last edited Oct. 
3, 2021), available at https://go.usa.gov/xFmHg.

I. Consumer Testing and Public Health Exceptions

    The Consumer Testing exception allows ``legally operating cigarette 
manufacturer[s]'' (and their legally authorized agents) ``to mail 
cigarettes to verified adult smoker[s] solely for consumer testing 
purposes.'' 18 U.S.C. 1716E(b)(5)(A). The exception is subject to a 
number of conditions regarding manufacturer permitting, cigarette 
quantity, shipment frequency, tax compliance, payments from the 
manufacturer to recipients (not the other way around), age and identity 
verification, tracking and delivery confirmation, and recordkeeping, 
among other things. Id. at (b)(5)(A)-(C).
    The Public Health exception permits Federal agencies ``engaged in 
the consumer testing of cigarettes for public health purposes'' to mail 
``cigarettes'' in the same manner as manufacturers under the Consumer 
Testing exception,

[[Page 58420]]

except that the payment requirement is waived. Id. at (b)(6).
    As relevant to both exceptions, ``consumer testing'' is limited to 
``formal data collection and analysis for the specific purpose of 
evaluating the product for quality assurance and benchmarking purposes 
of cigarette brands or sub-brands among existing adult smokers.'' Id. 
at (b)(5)(D).
    In the notice of proposed rulemaking, the Postal Service noted that 
the use of ``cigarettes'' in these provisions raises an interpretive 
question. On the one hand, the POSECCA subsumes ENDS products within 
the term ``cigarettes.'' 15 U.S.C. 375(7). On the other hand, the 
exceptions are confined to packages containing ``not more than 12 packs 
of cigarettes (240 cigarettes)''--quantities that denote standard 
packaging of combustible cigarettes but not ENDS products--and Congress 
did not amend those provisions to indicate how the quantity limits 
should apply to ENDS products. 18 U.S.C. 1716E(b)(5)(A)(ii), 
(C)(ii)(III). The Postal Service tentatively opined that it would be 
reasonable to construe the lack of accommodation for ENDS products here 
as rendering the exceptions inapplicable to ENDS products, and the 
Postal Service invited views and proposed alternative standards from 
commenters. 86 FR at 10220.
1. Testing by Manufacturers
    Public-health commenters generally opposed extending the Consumer 
Testing exception to ENDS manufacturers. One group of public-health 
organizations agreed with the notice of proposed rulemaking, in that 
the wide variety of ENDS packaging and Congressional silence on the 
matter indicate that Congress did not intend the exception to cover 
ENDS products. Another public-health organization noted that ENDS 
products do not have the same degree of standardization as cigarettes: 
For example, an ENDS pod containing 5 percent nicotine liquid may 
contain a roughly comparable amount of nicotine to 1-1.5 packs of 
combustible cigarettes, but more of the combustible cigarettes' 
nicotine is wasted, and less delivered to the user, due to so-called 
``sidestream smoke.'' Moreover, ENDS liquids' sizes and concentrations 
vary widely. A third such organization raised policy objections 
regarding the likelihood that ENDS shipments would contain hazardous 
materials, would promote dangerous product returns under the Certain 
Individuals exception, and would pose difficulties in policing 
companies' representations about bona fide consumer testing.
    On the other hand, one public-health organization, two law 
students, and certain ENDS industry commenters advocated for making the 
exception available to ENDS manufacturers. ENDS industry commenters 
relied on the POSECCA's inclusion of ENDS products within the term 
``cigarette,'' concluding that ENDS products' entitlement to the 
exception must precede construction of the quantity condition, rather 
than the other way around. One such commenter, after repeating its 
general view that Congress did not intend to make ENDS products 
nonmailable, pointed out that consumer testing is necessary for ENDS 
manufacturers to fulfill requirements for FDA authorization. These and 
other commenters proposed various approaches to the quantity condition:
     Nicotine-content equivalency: Limit liquids to 12 units or 
cartridges, as the purported equivalent to 12 packs of cigarettes 
(based on the assumption that one 5 percent-nicotine ENDS pod equals 
one pack of cigarettes); either no limit on devices, or limit devices 
to the amount necessary to enable the use of that quantity of liquid.
     Nicotine-consumption equivalency: The quantity needed to 
supply the average user for the same period as 240 cigarettes. For 
example, if the average smoker consumes 14 cigarettes per day, then 240 
cigarettes equates to 17 days of average consumption.\27\ According to 
this commenter, most human studies of CBD use dosages ranging between 
20 and 1,500 milligrams per day.\28\ Thus, a median dosage of 740 
milligrams per day would translate into 12,580 milligrams for 17 days.
---------------------------------------------------------------------------

    \27\ See CDC, Press Release, Smoking Is Down, But Almost 38 
Million American Adults Still Smoke, Jan. 18, 2018, https://go.usa.gov/x6qSt (2016 data).
    \28\ Sian Ferguson, ``CBD Dosage: Figuring Out How Much to 
Take,'' Healthline, Aug. 1, 2019, https://www.healthline.com/health/cbd-dosage.
---------------------------------------------------------------------------

     Weight limit: 5 pounds.
     Package limit: One package, regardless of contents, as the 
Postal Service allegedly cannot investigate the contents of shipments 
anyway; defer to FDA as to limits of consumer tests themselves.
     Size limit: Package dimensions equivalent to a package 
containing 12 packs of combustible cigarettes. This commenter submitted 
that one pack is typically 3.5 inches by 2.25 inches by 0.88 inch, for 
a volume of 6.93 cubic inches, hence 12 packs would be 83.16 cubic 
inches. The commenter noted that these external characteristics are 
objective and observable, thereby averting the need to open a package 
and inspect contents.
     To be determined: Collaborate with FDA and CDC to devise 
an appropriate equivalency standard, which may evolve with further 
data.
    The Postal Service appreciates these thoughtful suggestions, which 
are discussed in greater depth later in this section. Upon further 
review, however, it is unnecessary to evaluate the suitability of a 
quantity standard for ENDS products in connection with the Consumer 
Testing exception. Beyond the interpretive difficulties posed by the 
quantity limit, Congress has provided at least two other indications of 
legislative intent that the Consumer Testing exception applies only to 
combustible cigarettes and not to ENDS products, notwithstanding their 
technical inclusion within the term ``cigarette'' generally. After all, 
even statutorily defined terms can give way where context indicates 
that Congress intended a different meaning. See, e.g., Int'l Primate 
Prot. League v. Adm'rs of Tulane Educ. Fund, 500 U.S. 72, 80, 83 
(1991); In re Korean Air Lines Co., 642 F.3d 685, 692-93 (9th Cir. 
2011).
    First, the exception is available only to ``cigarette 
manufacturer[s]'' with a permit ``issued under section 5713 of the 
Internal Revenue Code of 1986.'' Id. at (b)(5)(A)(i). The only entities 
eligible for such permits are manufacturers and importers of cigars, 
cigarettes, smokeless tobacco, pipe tobacco, and roll-your-own tobacco, 
with ``cigarette'' restricted here to rolls of tobacco wrapped in paper 
or another substance. 26 U.S.C. 5702(b)-(c), 5713(a). This definition 
does not describe ENDS products, and so manufacturers of ENDS products 
are not subject to the Internal Revenue Code section 5713 permit 
requirement. Accordingly, ENDS manufacturers are not within the ambit 
of manufacturers eligible to use the mails under the Consumer Testing 
exception. Here, too, the POSECCA contains no amendment expanding the 
scope of eligible manufacturers to cover ENDS.
    Second, the exception refers repeatedly to cigarettes in connection 
with a ``smoker.'' 18 U.S.C. 1716E(b)(5)(A), (b)(5)(C)(ii)(II)(aa), 
(b)(5)(D)(ii). This language clearly denotes combustion, rather than 
the sub-combustion-level heating that occurs in most ENDS products.\29\ 
The

[[Page 58421]]

POSECCA contains no amendment that expands the term ``smoker'' to 
encompass the manner in which ENDS products are consumed.
---------------------------------------------------------------------------

    \29\ ``E-cigarettes purportedly do not produce a combusted 
smoke; rather, they deliver an aerosol containing nicotine and other 
tobacco-related compounds.'' Megan J. Schroeder & Allison C. 
Hoffman, ``Electronic Cigarettes and Nicotine Clinical 
Pharmacology,'' 23 Tobacco Control ii30 (2014), https://tobaccocontrol.bmj.com/content/tobaccocontrol/23/suppl_2/ii30.full.pdf. ``Smoking'' and ``vaping'' are frequently placed in 
opposition to one another in popular discourse. See, e.g., Julia 
Savacool, ``Vaping Vs. Smoking: Is One Better for Your Lungs? Here's 
What Experts Say,'' Parade, Feb. 20, 2021, https://parade.com/1093720/julia-savacool/vaping-vs-smoking; Scott Roberts Law, 
``What's the Difference Between Smoking and Vaping?,'' Michigan 
Cannabis Business Blog, May 14, 2020, https://scottrobertslaw.com/whats-the-difference-between-smoking-and-vaping; Nick English, ``I 
Started Vaping to Quit Smoking, and It Was a Huge Mistake,'' Men's 
Health, Oct. 22, 2018, https://www.menshealth.com/health/a23937726/vaping-vs-smoking. Pro-ENDS commenters engaged in the same tendency 
when touting ENDS use as a beneficial alternative to combustible 
cigarettes. Two industry associations even styled themselves as 
promoters of ``smoke-free alternatives'' and ``smoking 
alternatives.''
---------------------------------------------------------------------------

    It should be noted that the Consumer Testing exception is unique 
among the PACT Act's exceptions in that it pertains specifically to 
``cigarettes'' and not to the full range of ``mailings'' or ``tobacco 
products'' covered by the PACT Act. Compare id. at (b)(2)-(4) with id. 
at (b)(5). Prior to the POSECCA, it was therefore clear that the 
Consumer Testing exception was confined to combustible cigarettes and 
did not apply to smokeless tobacco. While this history alone might not 
be relevant if Congress had used broader language in the Consumer 
Testing exception, Congress's retention of combustible-cigarette-
specific conditions in the post-POSECCA Consumer Testing exception 
shows Congress's continuing intent that the exception apply only to 
combustible cigarettes, and not to other products that might now be 
encompassed within the otherwise-applicable statutory definition of 
``cigarettes.''
    Against this backdrop regarding Congress's intent to apply the 
Consumer Testing exception only to combustible cigarettes and not to 
ENDS products, it is all the more clear that the quantity limit of ``12 
packs of cigarettes (240 cigarettes)'' is intended to govern only 
combustible cigarettes, in which context such quantities are 
commonplace, and not ENDS products, which are not so standardized. The 
language itself suggests this conclusion; the context solidifies it.
    While the commenters have proposed a range of original ideas for a 
potential equivalency standard, the Postal Service finds no occasion to 
consider application of such a standard here, where Congress's intent 
to exclude ENDS products from the exception is clear. That decision is 
buttressed by the fact that no proposed equivalency standard is self-
evident or compelling.
    Proposals focused on the exterior of the package, rather than its 
contents, would impose virtually no limit on the amount or type of ENDS 
products sent in an ostensible consumer testing shipment. This 
unfettered latitude is far from Congress's design of limiting the 
quantity of product within a package.
    Proposals focused on the amount of nicotine fail to account for the 
multiple layers of variability that complicate such an exercise: The 
range of nicotine content among combustible cigarettes,\30\ the range 
of nicotine delivered to smokers \31\ and users of nicotine-related 
ENDS products,\32\ and the range of nicotine contained in ENDS 
products, which may contain as little as zero nicotine or be used with 
a limitless quantity of nicotine-containing solution, and which may 
vary even within the same brand and batch.\33\ The difficulties in 
comparability are further compounded when considering how to equate 
combustible cigarettes with ENDS products related to non-nicotine 
substances, such as CBD.\34\ And the ranges of variation increase still 
further when scaled up from a single cigarette to 240. Thus, it does 
not appear that an equivalency standard can be readily devised to 
reliably translate 240 cigarettes into some comparable number of ENDS 
products. The apparent impossibility of shoehorning ENDS products into 
the 240-cigarette limit underscores the conclusion--already apparent 
from other conditions of the Consumer Testing exception--that Congress 
intended this exception to be available only for combustible cigarettes 
and not for ENDS.
---------------------------------------------------------------------------

    \30\ The nicotine content of combustible cigarettes in the 
United States has been measured to range from 7.2 to 13.4 mg per 
cigarette, or about 30 percent around the mean of 10.2 
mg per cigarette. Lynn T. Kozlowski et al., ``Filter Ventilation and 
Nicotine Content of Tobacco in Cigarettes from Canada, the United 
Kingdom, and the United States,'' 7 Tobacco Control 369, 370 (1998), 
https://tobaccocontrol.bmj.com/content/tobaccocontrol/7/4/369.full.pdf; see also Tobacco Product Standard for Nicotine Level 
of Combusted Cigarettes, 83 FR 11818, 11826 (2018) (10-14 mg of 
nicotine per cigarette in the United States, per Kozlowski et al. 
and others).
    \31\ One study measured nicotine delivery from the combustible 
cigarettes surveyed as averaging 1.04 mg 0.36 mg, or a 
range of about 35 percent. Neal L. Benowitz & Peyton Jacob III, 
``Daily Intake of Nicotine During Cigarette Smoking,'' 35 Clinical 
Pharmacology & Therapeutics 499 (1984), available at https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1038/clpt.1984.67; see also 
83 FR at 11826 (1.1-1.7 mg nicotine yield per cigarette)). In the 
Benowitz/Jacob study, cigarette smokers' daily nicotine intake 
averaged 37.6 mg 17.7 mg at 1 standard deviation, but 
ranged overall from 10.5 to 78.6 mg, for a total range of more than 
75 percent around the median.
    \32\ The amount of nicotine emitted depends on multiple 
variables: Device power, nicotine concentration, ratio of propylene 
glycol to vegetable glycerin, and puff duration. Kathleen Stratton 
et al., Public Health Consequences of E-Cigarettes 92-94 (Nat'l 
Acads. of Scis., Eng'g, & Med. 2018), https://www.ncbi.nlm.nih.gov/books/NBK507171/pdf/Bookshelf_NBK507171.pdf; Soha Talih et al., 
``Transport Phenomena Governing Nicotine Emissions from Electronic 
Cigarettes: Model Formulation and Experimental Investigation,'' 51 
Aerosol Sci. & Tech. 1, 8-13 (2016); Ivan Gene Gillman et al., 
``Effect of Variable Power Levels on the Yield of Total Aerosol Mass 
and Formation of Aldehydes in E-Cigarette Aerosols,'' 75 Reg. 
Toxicology & Pharmacology 58, 60 (2016); Maciej L. Goniewicz et al., 
``Nicotine Content of Electronic Cigarettes, Its Release in Vapour 
and Its Consistency Across Batches: Regulatory Implications,'' 109 
Addiction 500, 503 (2014). Although Gillman et al. describe the 
amount of total aerosol produced, the same percent range should 
apply to the amount of nicotine aerosolized, given the homogeneity 
of constituents throughout a solution. Variability in nicotine 
delivered by ENDS does not end with nicotine emitted, however; the 
amount delivered to a user's bloodstream also depends on user- and 
product-specific factors. See generally Schroeder & Hoffman, 
``Electronic Cigarettes and Nicotine Clinical Pharmacology.''
    \33\ Stratton et al., Public Health Consequences of E-Cigarettes 
89-92; Goniewicz et al., ``Nicotine Content of Electronic 
Cigarettes,'' 109 Addiction at 502.
    \34\ With respect to the proposal to equate CBD to combustible 
cigarettes based on daily use, even the CBD-dosage figures provided 
by the commenter present a range that is so wide (20-1,500 mg/day) 
as to render the commenter's focus on the average essentially 
meaningless. Moreover, the scholarly article referenced in the 
commenter's popular source does not discuss whether these dosages 
are representative of therapeutic practice; rather, they are 
characterized only as quantities that have been shown to be 
tolerated by humans from a safety perspective. Kerstin Iffland & 
Franjo Grotenhermen, ``An Update on Safety and Side Effects of 
Cannabidiol: A Review of Clinical Data and Relevant Animal 
Studies,'' 2 Cannabis & Cannabinoid Research 139, 140 (2017), 
https://go.usa.gov/x6cWG, cited in Ferguson, ``CBD Dosage.''
---------------------------------------------------------------------------

    For these reasons, the Postal Service concludes that the PACT Act 
does not make the Consumer Testing exception available for ENDS 
products. It should be noted that the Intra-Alaska/Intra-Hawaii 
exception would permit the mailing of ENDS products for any purpose, 
including consumer testing, with the only restriction being that the 
mailing occur entirely within Alaska or Hawaii. Otherwise, barring 
further legislative change, such activities must employ transportation 
and delivery methods that do not involve the mails.
2. Testing by Federal Agencies
    Two of the public-health organizations that opposed allowing the 
Consumer Testing exception for ENDS products nonetheless favored 
allowing the Public Health exception. One such commenter analogized the 
situation to the restrictions on mailing dangerous goods, which contain 
exceptions for scientific-use mailings, see 18 U.S.C. 1716(c), (e), and 
suggested that the Postal Service make the exception available only 
upon agreement with the relevant Federal agency. Federal agency 
partners with which the Postal Service consulted also expressed an 
interest in making the Public Health exception available for ENDS 
products, in order

[[Page 58422]]

for them to carry out testing activities that they consider necessary 
for effective regulation. Law-student commenters asserted that Congress 
likely intended to permit continued Federal testing of ENDS products 
for public-health regulation, which one such commenter submitted is 
unlikely to contribute materially to youth-access and other policy 
concerns that motivated the POSECCA and the PACT Act. Although ENDS 
industry commenters did not express views specifically about the Public 
Health exception, the linkage between the Public Health and Consumer 
Testing exceptions suggests that such commenters' views on the 
availability of the Consumer Testing exception would likewise carry 
over to the Public Health exception.
    The Postal Service reiterates that it must be guided by the 
parameters and policy decisions expressed in the statute; Congress did 
not authorize the Postal Service to make its own policy decisions about 
whether any exception, including the Public Health exception, ought to 
be extended to ENDS products. Particularly given that lack of policy 
discretion, the Postal Service is not at liberty to speculate about 
what Congress might have intended regarding public-health testing of 
ENDS products by Federal regulatory agencies, in the absence of any 
statutory language or legislative history clearly addressing the 
question.
    Like the Consumer Testing exception, the statutory language 
establishing the Public Health exception, which Congress likewise did 
not amend in the POSECCA, makes clear that the exception applies only 
to combustible cigarettes and not to ENDS products.
    First, the Public Health exception repeatedly uses the term 
``consumer testing,'' a defined term restricted to testing involving 
``smokers.'' 18 U.S.C. 1716(b)(5)(D)(ii), (b)(6). As discussed in the 
preceding section, the plain meaning of ``smoker'' indicates that the 
context is combustible cigarettes, not ENDS products.
    Second, the Public Health exception allows Federal agencies to 
``mail cigarettes under most of the same requirements, restrictions, 
and rules and procedures that apply to consumer testing mailings of 
cigarettes by manufacturers under'' the Consumer Testing exception. Id. 
at (b)(6).\35\ Among those applicable requirements is that the entity 
mailing any shipments verify ``that the recipient is an adult 
established smoker'': a term that, again, indicates application only to 
combustible cigarettes and not to ENDS products. Id. at 
(b)(5)(C)(ii)(II)(aa).
---------------------------------------------------------------------------

    \35\ One requirement is specifically excepted in the statute. 
Moreover, it is also reasonable to construe the Internal Revenue 
Code permit requirement as inapplicable to Federal regulatory 
agencies, given Congress's clear intent that they be eligible to 
mail under the Public Health exception notwithstanding their 
ineligibility for such permits.
---------------------------------------------------------------------------

    Third, the quantity limit discussed in the preceding section also 
governs the Public Health exception in the same manner as the Consumer 
Testing exception. As discussed in the preceding section, the quantity 
limit reinforces the conclusion that only combustible cigarettes, and 
not ENDS products, are amenable to these exceptions.
    Given these clear indications of Congressional intent and the 
Postal Service's general lack of statutory authority over the scope of 
PACT Act exceptions, the Postal Service finds no basis to treat the two 
exceptions as differing in scope due to policy reasons that were not 
expressed by Congress.\36\ It may be that Federal regulatory agencies, 
like manufacturers, will continue to conduct consumer testing without 
using the mails, or via use of the mails only within Alaska and Hawaii 
(as permitted by the Intra-Alaska/Intra-Hawaii exception). To the 
extent that Federal agencies find those options to be insufficient, 
then Congress, not the Postal Service, is the appropriate outlet for 
policy concerns regarding this statutory scheme.
---------------------------------------------------------------------------

    \36\ Regarding one commenter's comparison to 18 U.S.C. 1716(c)-
(e) as a suggested basis for decoupling the Consumer Testing and 
Public Health exceptions vis-[agrave]-vis their applicability to 
ENDS products, the comparison is inapt. First, that statute is 
distinct from the PACT Act, which expressly provides that the same 
requirements apply to activities conducted under the Consumer 
Testing and Public Health exceptions. Second, 18 U.S.C. 1716(c)-(e) 
expressly confer discretion upon the Postal Service over the 
mailability of dangerous items for scientific purposes; the PACT Act 
does not provide such discretion. Third, 18 U.S.C. 1716(c)-(e) do 
not concern the mailing of otherwise nonmailable items to 
individuals, as the Consumer Testing and Public Health exceptions 
do; rather, the mailings covered by those provisions are more 
analogous to mailings under the PACT Act's Business/Regulatory 
Purposes exception. See 18 U.S.C. 1716(c) (shipments of live 
scorpions ``to be used for purposes of medical research or for the 
manufacture of antivenom''); id. at (d) (shipments of poisonous 
drugs and medicines from manufacturers or dealers to licensed 
medical professionals); id. at (e) (shipments of poisons for 
scientific use between manufacturers, dealers, laboratories, and 
Federal, State, or local government agencies).
---------------------------------------------------------------------------

3. Testing by Public-Health Researchers
    Certain public-health-oriented commenters urged the Postal Service 
to permit the mailing of ENDS products from independent researchers or 
research organizations--not manufacturers or Federal agencies--to 
individuals for purposes of federally-funded public health research.
    As explained in section III.A.1, the Postal Service lacks statutory 
authority to create new exceptions. Congress provided narrow exceptions 
for consumer testing only by manufacturers and Federal agencies, and 
not by any other entity. Moreover, as explained in the preceding two 
sections, even those exceptions do not cover ENDS products. Therefore, 
other than mailings entirely within Alaska and Hawaii (as authorized by 
the Intra-Alaska/Intra-Hawaii exception), researchers must find ways to 
conduct their consumer testing that do not involve use of the mails. To 
the extent that a policy case can be made for this use of the mails, 
that case should be directed to Congress, which has reserved to itself 
the discretion to modify or augment the PACT Act's exceptions.

J. Other Issues

1. International, Military, and Diplomatic Mail
    Except for the Intra-Alaska/Intra-Hawaii exception, the PACT Act's 
exceptions are not expressly confined to domestic mail. As the Postal 
Service explained in the 2010 rulemaking concerning PACT Act 
implementation, however, the complex verification requirements for the 
PACT Act's exceptions, combined with the strict consequences of any 
noncompliance, render it impracticable, if not impossible, for these 
requirements to be fulfilled as to mail originating or destinating 
outside of the United States. 75 FR at 29665; 75 FR at 24535. In the 
notice of proposed rulemaking, the Postal Service proposed to maintain 
the same approach to the exceptions in the context of ENDS products, 
except potentially with respect to any products that may eventually be 
covered by the tobacco-cessation/therapeutic exclusion. 86 FR at 10219.
    One group of public-health-oriented commenters applauded the 
disallowance of exceptions for international mail and the extension of 
that policy to ENDS products. Contrariwise, one ENDS manufacturer 
asserted that the policy violates the statute, which, according to the 
commenter, frames the exceptions in terms that provide an affirmative 
entitlement to mail without restriction to domestic mail. The commenter 
noted that the Business/Regulatory Purposes exception expressly 
encompasses businesses involved in ``export'' and ``import,'' see 18 
U.S.C. 1716E(b)(3)(A)(i), and opined that the statutory conditions for 
each exception

[[Page 58423]]

can be applied to international as well as domestic mail, without any 
statutory basis for distinction on the basis of feasibility. One 
Federal agency partner also asked the Postal Service to reconsider the 
restriction, in the interest of facilitating effective Federal 
regulation of foreign parties' tobacco and ENDS products.
    The final rule maintains the approach outlined in the notice of 
proposed rulemaking. The issue is not whether the statute expressly 
addresses international mail or whether it expressly provides for 
feasibility-based discretion. Rather, the statutory exceptions permit 
mailing only to the extent that the Postal Service is able to verify 
certain things about the mailer and/or recipient. See, e.g., id. at 
(b)(3)(B)(ii)(I)-(II), (b)(3)(B)(ii)(VII), (b)(4)(B)(ii)(I)-(II), 
(b)(4)(B)(ii)(V). In contrast to private-sector delivery carriers' 
integrated international networks, the Postal Service does not collect 
or deliver international mail outside of the United States (other than 
in the Freely Associated States); it must rely on foreign postal 
operators and other third-party agents to perform acceptance and 
delivery abroad. Given the specificity of the statutory verification 
obligations and their lack of extraterritorial applicability to or 
contemplation of foreign postal operators and agents, the Postal 
Service is unable to fulfill, and is not confident in its ability to 
ensure reliable fulfillment of, the verification tasks upon which these 
exceptions condition mailability. To the extent that the Postal Service 
cannot ensure verification, then the statute bars exceptional 
mailability for the relevant class of shipments.
    As the industry commenter observes, the Business/Regulatory 
Purposes exception is available to legally operating businesses 
``engaged in tobacco product . . . export [and] import.'' Id. at 
(b)(3)(A)(i). But these descriptors are used only to define the class 
of businesses that may be eligible to mail to other eligible parties 
under the exception; it does not, by itself, establish entitlement to 
use the mails for export and import activities. Thus, upon fulfilling 
all of the conditions for the exception, an export business could 
receive ENDS products from a domestic manufacturer or wholesaler, for 
example, and an import business could send ENDS products to domestic 
wholesalers and distributors. To the extent that the Postal Service can 
verify all required facts about these senders and recipients, their 
shipments are mailable under the exception. But because the Postal 
Service cannot conduct the statutorily required verification for 
overseas parties, the exporter's exports and importer's imports cannot 
themselves qualify for use of the mails. Those legs of the products' 
journey must be accomplished through commercial export and import 
channels, not through the international mail channel.
    In response to the Federal agency partner's concern regarding 
effective regulation, the Postal Service is sympathetic to this policy 
interest. Again, however, Congress has imposed verification conditions 
for use of the mails that the Postal Service is unable to fulfill with 
respect to international shipments. Non-postal delivery channels may be 
available to facilitate the transfer of samples and covered items 
between foreign businesses and U.S. regulators. To the extent that use 
of the mails would be necessary or expedient to effective regulation, 
it is for Congress to weigh whether that policy interest warrants 
relaxation of the PACT Act's verification mandates, creation of a new 
exception, or some other legislative accommodation.
    Certain pro-ENDS commenters urged the Postal Service to ensure that 
ENDS products will be mailable to U.S. military service members 
overseas on the same terms as cigarettes and smokeless tobacco. As 
stated in the notice of proposed rulemaking, the PACT Act exceptions 
have long been inapplicable to ``mail presented at overseas Army Post 
Office (APO), Fleet Post Office (FPO), or Diplomatic Post Office (DPO) 
locations and destined to addresses in the United States.'' 86 FR at 
10219 (emphasis added). This is because these overseas acceptance 
locations are operated not by the Postal Service, but by the Department 
of Defense's Military Postal Service Agency (MPSA) and by the 
Department of State. Although U.S. postal laws and regulations apply to 
U.S. mail operations in these locations, it was determined that the 
acceptance conditions for the PACT Act's exceptions cannot reliably be 
fulfilled at these overseas sites.
    Upon further review and interagency consultation, it appears that 
the same is true for the PACT Act exceptions' requirements of age, 
employment, and identity verification at the place of delivery. See 18 
U.S.C. 1716E(b)(3)(B)(ii)(II), (b)(3)(B)(ii)(VII), 
(b)(4)(B)(ii)(V),\37\ (b)(5)(C)(ii)(VI)-(VII). The postal services that 
enable fulfillment of these requirements--Adult Signature Required and 
Adult Signature Restricted Delivery--are not currently available for 
items sent to APO/FPO/DPO addresses. Because the verification 
requirements cannot reliably be fulfilled upon delivery to APO/FPO/DPO 
addressees, shipments to such addressees are incompatible with the 
statutory criteria for the exceptions.
---------------------------------------------------------------------------

    \37\ Under the Certain Individuals exception, the Postal Service 
is not itself required to perform the age verification, so long as 
it duly transfers the items to MPSA. 18 U.S.C. 
1716E(b)(4)(B)(ii)(VI). However, the age-verification requirement 
remains, pursuant to a standalone condition that MPSA would be 
obliged to fulfill. Id. at (b)(4)(B)(ii)(V).
---------------------------------------------------------------------------

2. Reasonable Cause
    The PACT Act bars the acceptance or transmission of mailed packages 
as to which the Postal Service ``knows or has reasonable cause to 
believe contains'' matter made nonmailable by the PACT Act. 18 U.S.C. 
1716E(a)(1). ``Reasonable cause'' can be based upon certain public 
statements of intent to mail nonmailable items or the presence of a 
person on the Noncompliant List. Id. at (a)(2). Under the Postal 
Service's longstanding PACT Act regulations, the presence of reasonable 
cause imposes on the mailer a burden of establishing eligibility to 
mail. Publication 52 section 472.1.
    In the notice of proposed rulemaking, the Postal Service noted that 
the statute's use of ``includes'' before these enumerations of 
``reasonable cause'' plainly indicates that the list is illustrative, 
rather than exhaustive, and the Postal Service proposed to make 
explicit in its regulations the possibility that other indicia 
regarding a package, individually or in combination with other 
packages, may give rise to reasonable cause. 86 FR at 10219. In the 
highly circumstantial context of ENDS products, the Postal Service 
further proposed to elaborate on the burden-shifting principle by 
calling for affirmative, credible, and verifiable indications of 
mailability in order to dispel the presumed nonmailability of such 
products. Id. at 10219-10220.
    Some anti-ENDS commenters expressed general support for these 
changes, and no party expressed opposition. Therefore, the Postal 
Service adopts the proposed changes in this final rule.
    State and local attorneys general, a public-health organization, 
and a law student proposed enumerating additional bases for identifying 
parties whose association with a package may give rise to reasonable 
cause:
     Identification of a party in scientific journal articles 
about ENDS products;
     Involvement of an ENDS manufacturer or distributor in 
litigation;
     Public statements on social media;
     Other media sources;

[[Page 58424]]

     The presence of markings on a package pursuant to section 
2A(b)(1) of the Jenkins Act;
     Lists of entities licensed by a State or local government 
to engage in tobacco or ENDS industry activities;
     The use of a Post Office Box or CMRA; and
     A mailer's past practice of sending or receiving items 
made nonmailable under the PACT Act.

The Postal Service finds it unnecessary to incorporate these 
suggestions into the final rules. Statements in social media and other 
media are covered by 18 U.S.C. 1716E(a)(2)(A) and existing Publication 
52 section 472.1(a). Information on a mailpiece (e.g., Jenkins Act 
markings and address information) would be among the indicia taken into 
account under the new provision. So, too, would a mailer's past 
practices, insofar as the new provision accounts for information about 
a mailing ``in combination with other packages.''
    Because the list of ``reasonable cause'' indicia in Publication 52 
section 472.1 is merely illustrative, the other proposed information 
sources remain potentially available, even if they are not expressly 
enumerated. To the extent that any relevant information not only exists 
at large, but is brought to the actual attention of Postal Service 
personnel authorized to determine how to interpret and act upon that 
information, then that awareness may reasonably justify the Postal 
Service's treatment of associated mailings as nonmailable, absent 
contrary information sufficient to dispel reasonable cause.
    One law-student commenter expressed concern that the Noncompliant 
List may be unreliable, given the purported ease with which listed 
actors could rebrand or establish a new address. The Postal Service is 
not responsible for maintaining the Noncompliant List. However, it 
should be noted that section 2A(e)(1)(C) of the Jenkins Act directs the 
Attorney General to update and distribute the Noncompliant List at 
least once every four months, and related provisions require the 
Attorney General to include entities identified by State, local, and 
Tribal governments and to maintain the accuracy and completeness of the 
list. Moreover, no provision bars other parties from identifying 
inaccuracies or suggesting updates to the Attorney General.
    State and local attorneys general requested a point of contact for 
non-Postal-Service law-enforcement actors, the industry, and the 
general public to report suspicious mailing behavior. The Postal 
Inspection Service (https://www.uspis.gov) is the law-enforcement 
component of the Postal Service, and suspicious mailing behavior may be 
reported through the Postal Inspection Service hotline (1-877-876-
2455). Mailing addresses for local Postal Inspection Service division 
offices can be found at https://postalpro.usps.com/ppro-tools/inspection-service.
    One law-student commenter encouraged the Postal Service to ensure 
that relevant personnel are trained and given up-to-date information 
about the Noncompliant List and market research on ENDS mailers. The 
Postal Service has internal processes to communicate such information 
to relevant personnel, and it will take this comment under advisement 
in administering those internal communications.
    Another law-student commenter proposed that a suspected ENDS mailer 
be required to furnish a sworn certification of mailability, punishable 
by a fine. The Postal Service finds such a measure to be unnecessary. 
Under the reasonable cause standard, mailability is based on indicia of 
suspicion--a collection of facts indicating for and against 
mailability--weighed in the administrative and law-enforcement 
discretion of Postal Service personnel. It is difficult to conceive of 
why facts tending in one direction should require the submission of 
paperwork when other facts would not. Moreover, the making of 
materially false statements or representations to the Postal Service is 
punishable under 18 U.S.C. 1001, regardless of whether the person has 
made a sworn declaration or received specific notice of potential 
punishment. As such, the Postal Service does not perceive any practical 
benefit that would arise from this suggestion.
3. Terminology
    In the notice of proposed rulemaking, the Postal Service discussed 
the semantic difficulties posed by the POSECCA's technical inclusion of 
ENDS within the relevant statutory definition of ``cigarettes.'' 86 FR 
at 10219. While this has a pronounced legal effect--generally 
subjecting ENDS to the same legal treatment as combustible cigarettes--
there are clear differences in the two types of products, particularly 
given the broad scope of POSECCA-covered ENDS products. Hence, using 
the term ``cigarette'' in Publication 52 to denote ENDS products as 
well as combustible cigarettes might not offer sufficient clarity to a 
lay reader. The Postal Service proposed to use ``tobacco products'' as 
a catch-all term to encompass combustible cigarettes, smokeless 
tobacco, and ENDS products, due to Congress's use of that term in the 
PACT Act (and the lack of any amendment to that usage in the POSECCA). 
In doing so, the Postal Service acknowledged that even ``tobacco 
products'' is imperfect as applied to ENDS products, many of which do 
not derive from tobacco, and solicited commenters' suggestions.
    Commenters presented various views, often independent of their 
position on ENDS products generally. Some commenters accepted and even 
agreed with ``tobacco products'' as a catch-all term, noting that at 
least some ENDS liquids contain tobacco-derived nicotine and that 
Congress intended ENDS to be regulated in the same manner as cigarettes 
and smokeless tobacco. Others supported a slightly disaggregated catch-
all term, such as ``tobacco and vapor products,'' ``cigarettes and 
alternative tobacco products,'' ``nicotine products and delivery 
devices,'' or ``tobacco and nicotine-related delivery products.'' Still 
other commenters opposed the use of a catch-all term, but rather 
proposed a continued serial listing (``cigarettes, ENDS, and smokeless 
tobacco''). This last group opposed the use of an umbrella term for 
various reasons: ENDS products might not be thought of as ``tobacco 
products;'' ``tobacco products'' is a term with special significance 
but a different scope in other legal contexts; and ENDS products should 
not be equated with cigarettes due to purported differences in their 
level of harmfulness.
    Upon consideration of these views, the Postal Service agrees that 
the umbrella term ``tobacco products,'' while consistent with statutory 
usage, might pose an undue risk of misleading lay readers of the 
regulations. Notwithstanding the post-POSECCA PACT Act's continued use 
of ``tobacco products'' as an apparent (albeit undefined) umbrella 
term, catch-all terms relying on ``tobacco'' or ``nicotine'' do not 
adequately capture the wide range of ENDS products covered by the 
POSECCA. Of the proffered options, ``tobacco and vapor products'' best 
captures the distinction between cigarettes and smokeless tobacco, on 
the one hand, and potentially non-nicotine-based ENDS products, on the 
other hand. Yet even it has its shortcomings: It elides the degree of 
overlap between the two categories, and the level of generality may 
sacrifice clarity.
    The Postal Service has determined that the well-taken semantic 
concerns can be avoided through use of the more generic, all-
encompassing term ``covered products'' to refer collectively to 
cigarettes, smokeless tobacco, and

[[Page 58425]]

ENDS products subject to the PACT Act.\38\ At the same time, because 
certain requirements pertain uniquely to ENDS products, the final rule 
treats ENDS products as a standalone category of covered products, 
rather than subsuming them within the definition of ``cigarette'' as 
the POSECCA does. Although this terminological approach differs 
formally from the statutory framework, the Postal Service is confident 
that its regulations yield the same functional result. To the extent of 
any inadvertent conflict, however, the statute would naturally control.
---------------------------------------------------------------------------

    \38\ The Postal Service recognizes that the FDA uses the term 
``covered tobacco product'' in reference to ENDS products subject to 
FDA regulation as ``deemed'' tobacco products. See 21 CFR 1140.3. As 
discussed in section III.C.1, the scope of such FDA-regulated ENDS 
products differs from the scope of PACT Act-covered products. Given 
the explicit definitions in each set of regulations and the 
differing regulatory contexts, the Postal Service is confident that 
readers of Publication 52 chapter 47 will understand ``covered 
products'' to mean products covered by that chapter and the PACT 
Act, and not ``covered tobacco products'' for purposes of 21 CFR 
part 1140.
---------------------------------------------------------------------------

4. Communications
    Three ENDS industry commenters asked the Postal Service to issue an 
updated Field Information Kit regarding the mailability of ENDS 
products, similar to the ones that it issued upon implementing the 
original and earlier amended PACT Act. See Postal Service, Field 
Information Kit: PACT Act, Postal Bulletin No. 22,287, June 17, 2010, 
at 3-17, https://about.usps.com/postal-bulletin/2010/pb22287/pdf/pb22287.pdf; Postal Service, Field Information Kit: PACT Act, Postal 
Bulletin No. 22,292, Aug. 26, 2010, at 3-18, https://about.usps.com/postal-bulletin/2010/pb22292/pdf/pb22292.pdf. One law student also 
recommended that the Postal Service set up web pages to educate the 
public about the new requirements, as well as trainings for employees.
    In conjunction with this Federal Register notice, the Postal 
Service is issuing a Field Information Kit. Like its 2010 counterparts, 
the Field Information Kit contains training materials and job aids to 
be distributed to Postal Service employees, as well as background 
information and frequently asked questions for both employees and the 
public. The Postal Bulletin is available at https://about.usps.com/postal-bulletin/2021.
5. Enforcement
    A group of State and local attorneys general asked the Postal 
Service not to return to sender matter made nonmailable under the PACT 
Act, but to seize and destroy it instead. These commenters adverted to 
ongoing litigation that some of them have brought on this issue. See 
generally City of New York v. U.S. Postal Serv., No. 1:19-CV-05934 
(E.D.N.Y. filed Oct. 22, 2019). Because this matter is the subject of 
ongoing litigation, the Postal Service declines to address it at this 
time.
    One ENDS consumer expressed skepticism that the POSECCA will be 
enforceable, to the extent that vendors send products below the 
supposed weight threshold for Postal Service enforcement without 
publicly advertising or marking their product. While it is conceivable 
that some illegal activity will evade detection in any law-enforcement 
scheme, each of the commenter's premises is false. First, there is no 
weight threshold for Postal Service enforcement of mailability; the 
Postal Service can and does enforce mailability laws regardless of 
weight, shape, or other mailpiece characteristics. Second, a vendor 
that does not advertise its sales is unlikely to remain a vendor for 
long. Third, the presence of identifying markings is not a prerequisite 
for detection of nonmailable matter; indeed, few shippers of the 
substantial quantities of nonmailable contraband detected by the Postal 
Inspection Service and its Federal law-enforcement partners 
transparently indicate the illicit contents that they are shipping.
    Finally, a commercial mailing agent asked for clarification of its 
duty to enforce the POSECCA and PACT Act and its liability for its 
customers' mailings. As already provided in Postal Service regulations, 
all mailers, including mail service providers and mailing agents, must 
comply with applicable Postal Service laws and regulations governing 
mailability and preparation for mailing, as well as non-postal laws and 
regulations on the shipment of particular matter. Publication 52 
section 212. In other words, a mail service provider or mailing agent, 
as a mailer on behalf of a third party, is liable for violations of 
mailing laws in the same manner as any other mailer. Mail service 
providers and mailing agents may limit their liability risk by taking 
robust measures to identify attempts to use their services for unlawful 
purposes.
6. Availability of Rules' Text
    Some commenters urged the Postal Service to make the text of the 
proposed or new rules available as soon as possible. At the time of the 
notice of proposed rulemaking, Publication 52 was incorporated by 
reference in 39 CFR 113.2. As such, the Office of the Federal Register 
did not permit the text of revisions or proposed revisions to 
Publication 52 to appear in the attendant Federal Register notice. In 
the interest of transparency and facilitating informed public comment, 
the Postal Service posted the proposed rules' text on its website and 
directed readers of the Federal Register notice of proposed rulemaking 
to that posting. This afforded commenters a reasonable opportunity to 
review the proposed revisions, and several of the comments demonstrate 
that their authors did so. Subsequently, the Postal Service, in 
consultation with the Office of the Federal Register, amended Title 39, 
CFR, and the DMM to clarify the status of Publication 52. 86 FR 53220. 
As a result of those changes, the text of revisions to Publication 52 
is now permitted to be published with the attendant Federal Register 
notice, as is the case with this final rule.
    Three ENDS industry commenters urged the Postal Service to publish 
the text of the final rules in advance of formal publication. It is 
unclear what this suggestion is supposed to mean. The Postal Service is 
unaware of any rulemaking practice whereby a final rule is published 
twice, once ``informally'' and once ``formally.'' There is only 
publication of the final rule, which, in this case, immediately 
triggers the nonmailability of ENDS products. If the commenters' idea 
is that the Postal Service should publish the rules first and the 
response to comments later, then this, too, does not appear to comport 
with regular Federal rulemaking practices, and it might raise concerns 
about due process and APA compliance. As such, the Postal Service has 
opted for consistency with normal practices, while attempting to 
enhance awareness and clarity through issuance of the April 2021 
Guidance.
7. Updates
    One law student recommended that the Postal Service periodically 
review the final rule for potential revisions to account for subsequent 
research regarding ENDS products. The commenter suggested that the 
review occur one year after the end of the FDA's period for premarket 
tobacco product applications and every three years thereafter.
    The Postal Service appreciates that research on the public-health 
risks and benefits arising from ENDS products, as well as the market 
for ENDS products itself, is in a state of rapid evolution. This final 
rule itself is likely to have its own effects on the ENDS market and on 
public health.
    As discussed in section III.A, however, this rulemaking is not an

[[Page 58426]]

instance of policy discretion by the Postal Service, such as the Postal 
Service might revisit as facts and policy considerations change. The 
Postal Service is fulfilling a severely circumscribed statutory command 
to make ENDS products nonmailable except in certain limited 
circumstances. The decision about the public-health risks and benefits 
was made by Congress. While further scientific research may alter 
Congress's policy decision, the Postal Service does not anticipate that 
it will bear on the limited manner in which it is carrying out 
Congress's mandate. As such, the Postal Service also does not 
anticipate a need to revisit this final rule on the basis of further 
scientific research.
    That said, the Postal Service may eventually have other reasons to 
revisit this final rule, such as further changes in applicable law; 
evolution in the ENDS market; further guidance from ATF on the scope of 
covered ENDS products; potential FDA approval of ENDS products for 
tobacco-cessation or other therapeutic uses; advances in technology 
that may facilitate alternative methods for administering the Business/
Regulatory Purposes exception; and the development of regulatory and 
enforcement experience regarding ENDS products. Because these (and 
other, unforeseen) circumstances are not predictable, the Postal 
Service finds it imprudent to prescribe a schedule of revisions at this 
time.

IV. Explanation of Changes From Proposed Rule

    The final rule includes substantive revisions and additions to 
Publication 52, as well as non-substantive corrections for consistency 
and organization, such as extensive renumbering to accommodate 
substantive revisions.
    Material substantive revisions from the proposed rule that are 
incorporated throughout the final rule include the following:
     ``Covered products,'' defined in section 471.6 as any 
cigarette, smokeless tobacco, or ENDS, replaces ``tobacco products'' 
where applicable.
     Marking requirements for mailings under nonmailability 
exceptions are revised to provide options for distinguishing among 
covered products and eligible recipients where applicable.
     Application requirements for the Business/Regulatory 
Purposes, Consumer Testing, and Public Health exceptions are revised to 
(1) allow for submission of applications by email to a specified Postal 
Service email address; (2) require submission of specified Postal 
Service forms and/or worksheets; (3) clarify that copies of licenses 
may be furnished (in lieu of originals); (4) clarify the timeframe 
(i.e., at least 15 days) for updating application materials prior to 
mailings to or from parties to which the updated information relates; 
and (5) clarify that Postal Service personnel will have access to 
current lists of authorized senders/recipients under applicable 
exceptions.
     Application requirements for the Business/Regulatory 
Purposes and Public Health exceptions are revised to specify that the 
PCSC Director may suspend, modify, or rescind discretionary waivers for 
federal or state government agencies of certain application 
requirements.
     Mailing requirements for the Business/Regulatory Purposes 
and Consumer Testing exceptions are revised to require that a current 
PCSC eligibility letter be presented at acceptance, to acknowledge that 
lists of authorized senders and recipients will be made available to 
acceptance personnel, and to clarify that such mailings may be tendered 
at retail or BME locations.
     Mailing requirements for the Business/Regulatory Purposes 
and Certain Individuals exceptions are revised to reflect current 
Postal Service offerings by requiring the use of a combination of 
Priority Mail Express or Priority Mail with Adult Signature Required or 
Adult Signature Restricted Delivery. Mailing requirements for the 
Consumer Testing and Public Health exceptions are similarly revised to 
require the use of a combination of Priority Mail Express or Priority 
Mail with Adult Signature Restricted Delivery.\39\ For all exceptions, 
the former option of Priority Mail Express with Hold for Pickup is 
deleted.
---------------------------------------------------------------------------

    \39\ The PACT Act conditions use of the Consumer Testing and 
Public Health exceptions on delivery only to the named recipient. 
See 18 U.S.C. 1716E(b)(5)(A), (b)(5)(C)(ii)(VI)-(VII). This 
condition can be fulfilled via the use of Adult Signature Restricted 
Delivery, which restricts delivery to the named addressee, but not 
Adult Signature Required, which does not.
---------------------------------------------------------------------------

     Delivery requirements for the Business/Regulatory Purposes 
and Consumer Testing exceptions are revised to clarify that mailings 
lacking the PCSC eligibility number in the return block will not be 
released to recipients.
     Delivery requirements for the Certain Individuals and 
Consumer Testing exceptions are revised to clarify that the minimum age 
of recipients must be confirmed by Postal Service personnel before 
mailings may be released or delivered to recipients.
    Discrete substantive revisions include the following:
     The proposed definition of ``e-liquid'' in proposed 
section 471.3 is deleted as redundant.
     A consolidated definition of ``minimum age,'' defined as 
21 years of age, or older where required by local law for acceptance or 
delivery, is added in section 471.9.
     General provisions regarding nonmailability and reasonable 
cause in proposed 472.1 are reorganized as sections 472.1 and .2. The 
circumstances giving rise to nonmailability are delineated more 
specifically; the treatment of nonmailable matter found in the mails 
and not seized is clarified through a cross-reference to general 
provisions on that topic; and clarification is made that nonmailable 
covered products must not be accepted, forwarded, or delivered.
     The ``reasonable cause'' standard for Postal Service 
personnel in proposed section 472.1 is clarified to allow consideration 
of any potentially relevant circumstances.
     A new section 473.b clarifies that the PACT Act exceptions 
do not apply to mail from the United States to APO, FPO, or DPO 
addresses. As explained in section III.J.1, the postal services 
necessary to reliably fulfill the PACT Act exceptions' verification 
requirements are not currently available at such locations, and at this 
time, there does not appear to be any sufficiently reliable alternative 
means of ensuring that those requirements are fulfilled. In conformance 
with this change, provisions are removed from the Certain Individuals 
section that had formerly prescribed how shipments can be made to APO/
FPO addresses.
     A new section 473.1.e consolidates the requirement, common 
to all PACT Act exceptions, that all excepted shipments must be 
tendered through a face-to-face transaction with a Postal Service 
employee. For clarity, the requirement is framed here in the negative, 
as a prohibition on all other entry methods, and enumerates examples of 
prohibited entry methods.
     Language is added to the preamble of the Business/
Regulatory Purposes exception provisions to clarify not only the types 
of parties eligible to mail under the exception, but the specific 
sender-addressee pairings permitted by the PACT Act (i.e., business-to-
business, business-to-government, or government-to-business, but not 
government-to-government).
     Application requirements for the Business/Regulatory 
Purposes exception are further revised to include additional required 
information relating to (1) the

[[Page 58427]]

nature of the relevant business(es); and (2) for ENDS only, brand 
name(s) and product description(s), including information sufficient to 
confirm mailability under other applicable provisions (e.g., 
restrictions related to hazardous materials or controlled substances).
     Delivery requirements for the Business/Regulatory Purposes 
exception are revised to provide examples of methods for verifying a 
recipient's employment. Specifically, proof of employment may take the 
form of an employee identification card or badge containing the name 
and phone number of the employer/agency along with the name of the 
employee; a signed letter on employer/agency letterhead; or any form of 
identification the postmaster deems to be of comparable reliability. 
Further clarification is made that employee status may be inferred by 
Postal Service personnel based on observable factors.
     Provisions are added regarding the Certain Individuals 
exception to emphasize the noncommercial-purpose requirement and to 
clarify how it applies in the context of returns of damaged or 
unacceptable merchandise and of used products sent for recycling.
     Application requirements for the Consumer Testing 
exception are revised to require submission of a copy of the permit 
issued under 26 U.S.C. 5713. Conversely, language is added to the 
Public Health exception provision to clarify that a manufacturer's 
permit is not required for government agencies applying under that 
exception.
     The additional requirements set out in proposed section 
472.27 are relocated to section 472.3 and revised to clarify the 
applicability of other laws and regulations.
     Mailers' requirements to retain eligibility documentation 
under applicable nonmailability exceptions are increased from three to 
six years to align with potentially applicable statutes of limitations 
and are set out separately in section 472.4.
     Revisions and additions are made to clarify that 
applicants bear the burden, during initial determinations or appeals, 
of establishing eligibility for each sender and recipient, and must 
submit additional documentation as necessary. Further clarification is 
made that the PCSC Director may approve or deny applications in whole 
or with respect to certain mailers or recipients, and that eligibility 
may be suspended, modified, or revoked, in whole or in part, for 
failure to comply with applicable laws or regulations.
     A new section 474.1 is added to clarify that ATF 
administers the relevant statutory definition of ENDS and the exclusion 
of FDA-approved tobacco-cessation and therapeutic products. Persons 
interested in interpretive guidance concerning these two subjects are 
advised to contact ATF at the listed address, with a copy to the PCSC.
     The statutory exclusion of FDA-approved tobacco cessation/
therapeutic products from the definition of ENDS in proposed section 
471.2 is set out separately in section 474.2, and a requirement is 
added for persons who believe that a product qualifies for this 
exclusion to submit documentation to ATF, with a copy to the PCSC.

Joshua J. Hofer,
Attorney, Ethics & Legal Compliance.

    The Postal Service adopts the following changes to Publication 52, 
Hazardous, Restricted, and Perishable Mail, incorporated by reference 
into Mailing Standards of the United States Postal Service, Domestic 
Mail Manual (DMM), section 601.8.1, which is further incorporated by 
reference in the Code of Federal Regulations. 39 CFR 111.1, 111.3. 
Publication 52 is also a regulation of the Postal Service, changes to 
which may be published in the Federal Register. 39 CFR 211.2(a). 
Accordingly, for the reasons stated in the preamble, the Postal Service 
amends Publication 52 as follows:
* * * * *

4 Restricted Matter

* * * * *
    [Revise title of 47 to read as follows:]

47 Cigarettes, Smokeless Tobacco, and Electronic Nicotine Delivery 
Systems

* * * * *

471 Definitions

    [Revise the last sentence of 471.1 to read as follows:]

471.1 Cigarette

    * * * The term cigarette includes roll-your-own tobacco and 
excludes cigars.
* * * * *
    [Revise the title of 471.4 to read as follows:]

471.4 Roll-Your-Own Tobacco

* * * * *
    [Renumber 471.5 through 471.6 as 471.7 through 471.8, respectively, 
and insert after 471.4 the following:]

471.5 Electronic Nicotine Delivery System (ENDS)

    Any electronic device that, through an aerosolized solution, 
delivers nicotine, flavor, or any other substance to the user inhaling 
from the device. ENDS include but are not limited to, electronic 
cigarettes (e-cigarettes), electronic hookahs (e-hookahs), electronic 
cigars (e-cigars), vape pens, advanced refillable personal vaporizers, 
and electronic pipes. Any reference to ENDS also includes any 
component, liquid, part, or accessory of an ENDS device, regardless of 
whether the component, liquid, part, or accessory is sold or provided 
separately from the device.

471.6 Covered Product

    For purposes of chapter 47, any cigarette, smokeless tobacco, or 
ENDS.
* * * * *
    [Add after 471.8, as renumbered, the following:]

471.9 Minimum Age

    21 years of age (the federal minimum age for the sale or purchase 
of covered products), or such higher age that a state or municipality 
may impose for the legal sale or purchase of covered products at the 
place of acceptance or delivery, as appropriate.
* * * * *
    [Revise 472 to read as follows:]

472 Covered Products Generally Nonmailable

472.1 General

    The following are nonmailable:
    a. Shipments of covered products described in 473.1.a through .e.
    b. Shipments of covered products that are not described in 473.1.a 
through .e and that do not qualify for an exception under 473.2 through 
.6.
    c. Shipments of covered products that are not described in 473.1.a 
through .e and that would generally qualify for an exception under 
473.2 through .6, but for a failure to meet one or more conditions for 
the applicable exception. For example, a recipient may fail to be 
verified as being of at least the minimum age (see 473.34.a, .44.a, 
.54.a), or a Return Receipt may be absent or may lack the mailer's 
eligibility number (see 473.32.b, .52.c).

472.2 Treatment of Nonmailable Covered Products

472.21 Refusal of Acceptance and Transmission

    The Postal Service will not accept, forward, or deliver any package 
that it knows, or has reasonable cause to believe, contains nonmailable 
covered products. If the Postal Service reasonably suspects that a 
mailer is tendering nonmailable covered products, then the mailer bears 
the burden of proof in establishing eligibility to mail.

[[Page 58428]]

472.22 Seizure and Forfeiture

    Nonmailable covered products deposited in the mail are subject to 
seizure and forfeiture. Any nonmailable covered products seized and 
forfeited shall be destroyed or retained by the federal government for 
the detection or prosecution of crimes or related investigations and 
then destroyed.

472.23 Disposition of Nonmailable Covered Products Not Seized and 
Forfeited

    Any nonmailable covered products not seized and forfeited shall be 
handled in accordance with 216 and 414.

472.24 Penalties

    Persons involved in the shipment or attempted shipment of 
nonmailable covered products may be subject to seizure and forfeiture 
of assets, criminal fines, imprisonment, and civil penalties.

472.3 Reasonable Cause To Suspect Covered Products

    Among any other potentially relevant circumstances, the Postal 
Service has reasonable cause to suspect the presence of covered 
products based on:
    a. A statement on a publicly available website, or an 
advertisement, by any person that the person will mail matter which is 
nonmailable under this section in return for payment;
    b. The fact that the mailer or other person on whose behalf a 
mailing is being made is on the U.S. Attorney General's List of 
Unregistered or Noncompliant Delivery Sellers; or
    c. Any other characteristics of a package or label, individually or 
in combination with other packages or labels, that reasonably indicate 
the likely presence of covered products.

472.4 Applicability of Other Laws and Regulations

    Shipments permitted under 473 are subject to all other applicable 
federal, state, and local laws and regulations. For example, ENDS that 
consist of or contain controlled substances (including cannabis and 
cannabis derivatives), drug paraphernalia, lithium batteries, liquids, 
or any toxic or flammable substance (e.g., nicotine, diacetyl (butane-
2,3-dione), propanol, and other components of ENDS liquids) may be 
subject to prohibitions, restrictions, or additional requirements 
stated elsewhere in this publication. Mailers, recipients, and 
applicants are solely responsible for complying with all applicable 
Postal Service regulations and other federal, state, and local laws 
when mailing covered products.

472.5 Recordkeeping

    Mailers, recipients, and applicants must maintain records to 
establish compliance with the requirements in 473 for a 6-year period 
and must make such records available to the Postal Service upon 
request.
* * * * *
    [Insert after 472 the following:]

473 Mailability Exceptions

473.1 Scope of Exceptions

    Covered products are mailable if one of the conditions in 473.2 
through 473.6 is met. These exceptions do not apply to the following:
    a. Mail treated as domestic under DMM 608.2.2.
    b. Mail sent to Air/Army Post Office (APO), Fleet Post Office 
(FPO), or Diplomatic Post Office (DPO) addresses.
    c. Mail presented at APO, FPO, or DPO installations and destined to 
addresses in the United States.
    d. International mail as defined in DMM 608.2.3.
    e. Mail presented outside of a face-to-face transaction with a 
Postal Service employee at a Postal Service retail or business mail 
acceptance location. Examples of prohibited entry methods include, but 
are not limited to, Pickup on Demand; package pickup; an Approved 
Shipper location or other third-party acceptance location; a Contract 
Postal Unit; a Village Post Office; and placement in a customer 
mailbox, collection box, or Postal Service lobby drop.

473.2 Intra-Alaska and Intra-Hawaii Shipments

    Intra-Alaska and intra-Hawaii shipments of covered products are 
mailable, provided that such mailings:
    a. Are presented in a face-to-face transaction with a Postal 
Service employee within the state, and not through any entry method 
prohibited under 473.1.e;
    b. Destinate in the same state of origin;
    c. Bear a valid complete return address that is within the state of 
origin; and,
    d. Are marked with the following exterior marking on the address 
side of the mailpiece, with the relevant type of item selected: 
``INTRASTATE SHIPMENT OF [CIGARETTES/SMOKELESS TOBACCO/ENDS].''

473.3 Exception for Business/Regulatory Purposes

    Eligibility to mail and to receive mail under the business/
regulatory purposes exception is limited to federal and state 
government agencies and legally operating businesses that have all 
applicable state and federal government licenses or permits and are 
engaged in the manufacturing, distribution, wholesale, export, import, 
testing, investigation, or research of covered products. Mailings under 
this exception are permitted only for business purposes between 
eligible businesses or for regulatory purposes between such businesses 
and eligible government agencies. Mailability is further restricted to 
mailings that comply with all conditions in 473.31 to 473.34.

473.31 Application

    Each customer seeking to mail covered products under the business/
regulatory purposes exception must submit a complete application (PS 
Form 4615 or 4615E, as appropriate) and, for ENDS, complete Worksheets 
4615-EM and 4615-ER as appropriate, along with all supporting 
documentation requested on those forms and worksheets.
    a. Along with any other information requested on PS Form 4615 or 
4615E and Worksheets 4615-EM and 4615-ER, the applicant must furnish:
    1. Information about its legal status, copies of any applicable 
licenses, and authority under which it operates.
    2. Information about the legal status, copies of any applicable 
licenses, and operational authority for all recipients to which the 
mailings under this exception will be addressed.
    3. All locations where mail containing covered products will be 
presented.
    4. For each business mailer and/or recipient, the nature of the 
relevant business activities (e.g., manufacturing, wholesale, 
distribution, testing, investigation, import, export).
    5. The brand name and a description of each product intended to be 
mailed. For ENDS, descriptions must include information about the 
source of any CBD; the concentration of any THC; and safety data sheets 
or technical specification documentation for any hazardous materials 
(e.g., lithium batteries, nicotine, diacetyl (butane-2,3-dione), 
propanol).
    b. The applicant is responsible for establishing the eligibility of 
each sender and recipient and for the accuracy, completeness, and 
currency of all information provided in the application.
    c. Applications must be submitted as follows:
    1. For cigarettes and smokeless tobacco (PS Form 4615): by email to 
[email protected].
    2. For ENDS (PS Form 4615E and Worksheets 4615-EM and 4615-ER): by 
email to [email protected].

[[Page 58429]]

    d. The Director, PCSC, will make a determination of eligibility to 
mail under the business/regulatory purposes exception. The mailer bears 
the burden of establishing eligibility and must furnish any additional 
supporting documentation requested by the Director, PCSC, upon request 
as necessary to establish eligibility. The Director, PCSC, may approve 
or deny an application in its entirety or only with respect to certain 
mailers and/or recipients. A number is assigned to each letter of 
eligibility.
    e. The applicant must update the information in its application, 
including any updated documentation, in a timely manner, as necessary, 
at least 15 days prior to conducting any mailing to or from an entity 
to which the information pertains.
    f. Upon written request by a state or federal agency, the Director, 
PCSC, may, in his or her discretion, waive certain application 
requirements for mailings entered by the requesting state or federal 
agency for regulatory purposes. The Director, PCSC, may suspend, 
rescind, or modify any waiver at any time.
    g. Any determination of eligibility to mail under this exception 
shall lapse if the authorized mailer does not tender any mail under 
this exception within any 3-year period. After that time, the affected 
mailer must apply for and receive new authorization for any mailings 
under this exception.

473.32 Mailing

    All mailings tendered under the business/regulatory purposes 
exception must:
    a. Use one of the following combinations of services:
    1. Priority Mail Express with Adult Signature Required or Adult 
Signature Restricted Delivery service (see DMM 503.8.0).
    2. Priority Mail with Adult Signature Required or Adult Signature 
Restricted Delivery service.
    b. Be accompanied by a Domestic Return Receipt (PS Form 3811). The 
sender`s address block must bear the eligibility number issued by the 
PCSC and be made returnable to the address as shown below:
    PCSC, PACT MAILING OFFICE, USPS ELIGIBILITY NO. XX-00-0000, 90 
Church St., Ste. 3100, New York, NY 10007-2951.
    c. Bear the following marking, with the relevant type of item and 
recipient selected: ``[CIGARETTE/SMOKELESS TOBACCO/ENDS] MAILING--
DELIVER ONLY TO EMPLOYEE OF ADDRESSEE [BUSINESS/AGENCY] UPON AGE 
VERIFICATION'' on the address side of the mailpiece.
    d. Bear the business or government agency name and full mailing 
addresses of both the sender and recipient, both of which must match 
exactly those listed on the authorized mailer's application on file 
with the Postal Service.
    e. Be entered at a retail and/or business mail acceptance location 
specified in the application and authorized by the PCSC.

473.33 Entry and Acceptance

    Mailings under the business/regulatory purposes exception must be 
entered under the following conditions:
    a. Covered products must be tendered via a face-to-face transaction 
with a Postal Service employee. Applicable mailings may not be tendered 
through any entry method prohibited under 473.1.e.
    b. The mailer must present Postal Service acceptance personnel with 
the following:
    1. For shipments of cigarettes and/or smokeless tobacco, a letter 
from the PCSC showing that the PCSC has authorized the mailer, 
addressee, and acceptance location.
    2. For shipments of ENDS:
    i. A letter from the PCSC showing that the PCSC has authorized the 
mailer and has not withheld authorization as to the addressee;
    ii. A PCSC-approved Worksheet 4615-EM showing that the PCSC has 
authorized the mailer and the acceptance location; and
    iii. A PCSC-approved Worksheet 4615-ER showing that the PCSC has 
authorized the addressee.

473.34 Delivery

    Mailings bearing the marking for business/regulatory purposes are 
eligible for delivery only to a verified employee of the addressee 
business or government agency under the following conditions:
    a. The recipient must be an adult of at least the minimum age (see 
471.9) at the place of delivery. The recipient's age must be verified 
by a postal employee before releasing or delivering the item to the 
recipient. The recipient must furnish proof of age via a driver's 
license, passport, or other government-issued photo identification that 
lists age or date of birth.
    b. The recipient must demonstrate status as an employee of the 
business or government agency identified as the addressee on the 
mailing label. Proof of employment may take the form of an employee 
identification badge or card issued by the employer and including the 
employee's name, the employer's name, and the employer's telephone 
number; a signed letter on company or agency letterhead from a 
supervisor or human relations office attesting to the recipient's 
current employment; or any other form of identification that the 
postmaster deems to be of comparable reliability. Where delivery is 
made to a business address, employment status may be inferred from the 
carrier's observation of such factors as the recipient's uniform and 
presence at a reception desk or retail counter.
    c. Once the recipient's age and identity as an employee of the 
addressee are established, the recipient must sign for receipt of 
delivery and in the appropriate signature block of PS Form 3811.

473.4 Exception for Certain Individuals

    The exception for certain individuals permits the mailing of small 
quantities of covered products by individual adults for noncommercial 
purposes. Mailability is further restricted to mailings that comply 
with all conditions in 473.41 to 473.44. Eligible shipments may be made 
to any type of recipient (individual, business, government, or other 
organization).

473.41 Noncommercial Purposes

    Noncommercial purposes may include, but are not limited to, the 
following:
    a. Covered products exchanged as gifts between individual adults. 
For purposes of this rule, ``gifts'' do not include covered products 
purchased by one individual for another from a third-party vendor 
through a mail-order transaction, or the inclusion of covered tobacco 
products at no additional charge with other matter pursuant to a 
commercial transaction.
    b. Damaged or unacceptable covered products returned by a consumer 
to the manufacturer or other business. For purposes of the 
noncommerciality requirement, the manufacturer or other business may 
provide the consumer with a refund, credit, replacement product, or 
other form of value in exchange for the damaged or unacceptable covered 
product, so long as it does not exceed the amount that the consumer 
paid for the damaged or unacceptable product plus the cost of return 
shipping for the damaged or unacceptable product.
    c. Used covered products sent by a consumer to a manufacturer or 
other business for recycling. For purposes of this rule, the consumer 
must not receive anything of value (e.g., a discount, credit, or 
rebate) in exchange for a returned item.

[[Page 58430]]

473.42 Mailing

    No customer may send or cause to be sent more than 10 mailings 
under this exception in any 30-day period. Each mailing under the 
certain individuals exception must:
    a. Weigh no more than 10 ounces.
    b. Use one of the following combinations of services:
    1. Priority Mail Express with Adult Signature Required or Adult 
Signature Restricted Delivery service (see DMM 503.8.0).
    2. Priority Mail with Adult Signature Required or Adult Signature 
Restricted Delivery service.
    c. Bear the full name and mailing address of the sender and 
recipient on the Priority Mail Express or Priority Mail label.
    d. Bear the following exterior marking on the address side of the 
mailpiece, with the relevant type of item selected: ``PERMITTED 
[CIGARETTE/SMOKELESS TOBACCO/ENDS] MAILING--DELIVER ONLY UPON AGE 
VERIFICATION.''

473.43 Entry and Acceptance

    Mailings under the certain individuals exception must be entered 
under the following conditions:
    a. Covered products must be tendered via a face-to-face transaction 
with a Postal Service employee. Applicable mailings may not be tendered 
through any entry method prohibited under 473.1.e.
    b. The individual presenting the mailing must furnish a driver's 
license, passport, or other government-issued photo identification that 
lists age or date of birth. The name on the identification must match 
the name of the sender appearing in the return address block of the 
mailpiece. The customer must be an adult of at least the minimum age at 
the place of acceptance (see 471.9).
    c. For mailings addressed to an individual, at the time the mailing 
is presented, the customer must orally confirm that the addressee is an 
adult of at least the minimum age at the place of delivery (see 471.9).

473.44 Delivery

    Mailings bearing the marking for certain individuals are eligible 
for delivery only under the following conditions:
    a. The recipient receiving or signing for the article must be an 
adult of at least the minimum age at the place of delivery (see 471.9). 
This must be confirmed by postal employees before releasing or 
delivering the item to the recipient. The recipient must furnish proof 
of age via a driver's license, passport, or other government-issued 
photo identification that lists age or date of birth.
    b. Once age is established, the recipient must sign for receipt of 
delivery.

473.5 Consumer Testing Exception

    The consumer testing exception permits a legally operating 
cigarette manufacturer or a legally authorized agent of a legally 
operating cigarette manufacturer to mail cigarettes to verified adult 
smokers solely for consumer testing purposes. The manufacturer for 
which mailings are entered under this exception must have a permit, in 
good standing, issued under 26 U.S.C. 5713. The consumer testing 
exception applies only to cigarettes and not to smokeless tobacco or 
ENDS. Mailability is further restricted to mailings that comply with 
all conditions in 473.51 to 473.54.

473.51 Application

    Each person seeking to mail cigarettes under the consumer testing 
exception must submit a complete application (PS Form 4616), along with 
all supporting documentation requested on that form, by email to 
[email protected]. For each application, the following conditions must be 
met:
    a. The applicant must furnish the following information:
    1. A copy of the relevant manufacturer's permit issued under 26 
U.S.C. 5713.
    2. If the applicant is an agent of a manufacturer, complete details 
about the agency relationship with the manufacturer.
    3. All locations where mail containing cigarettes for consumer 
testing will be presented.
    b. As part of its application, the applicant must certify in 
writing that it will comply with the following requirements:
    1. Any recipient of consumer testing samples of cigarettes is an 
adult established smoker.
    2. No recipient has made any payment for the cigarettes.
    3. Every recipient will sign a statement indicating that the 
recipient wishes to receive the mailings.
    4. The manufacturer or the legally authorized agent of the 
manufacturer will offer the opportunity for any recipient to withdraw 
the recipient's written statement at least once in every 3-month 
period.
    5. Any package mailed under this exception will contain no more 
than 12 packs of cigarettes (maximum of 240 cigarettes) on which all 
taxes levied on the cigarettes by the state and locality of delivery 
have been paid and all related state tax stamps or other tax-payment 
indicia have been applied.
    c. The application must be submitted to the Director, Pricing and 
Classification Service Center (PCSC) via email to [email protected]. The 
applicant bears the burden of establishing eligibility.
    d. The applicant must provide any requested copies of records 
establishing compliance to the Director, PCSC, and/or the Director, 
Product Classification (see 214 for address), upon request, no later 
than 10 business days after the date of the request.
    e. The Director, PCSC, will make a determination of eligibility to 
mail under the consumer testing exception. The Director, PCSC, may 
approve or deny an application in its entirety or only with respect to 
certain mailers and/or recipients. A number is assigned to each letter 
of eligibility.
    f. An applicant or authorized mailer must update the information in 
its application with the Director, PCSC, as necessary, in a timely 
manner upon becoming aware of a change in application information, not 
later than 15 days prior to conducting any mailing, for as long as it 
continues to mail under the consumer testing exception.
    g. Any determination of eligibility to mail under this exception 
shall lapse if the authorized mailer does not tender any mail under 
this exception within any 3-year period. After that time, the mailer 
must apply for and receive new authorization for any further mailings 
under this exception.

473.52 Mailing

    All mailings under the consumer testing exception:
    a. Must be limited in tobacco content to no more than 12 packs of 
cigarettes (maximum 240 cigarettes) on which all taxes levied on the 
cigarettes by the destination state and locality have been paid and all 
related state tax stamps or other tax-payment indicia have been 
applied.
    b. Must use one of the following combinations of services:
    1. Priority Mail Express with Adult Signature Restricted Delivery 
service (see DMM 503.8.0).
    2. Priority Mail with Adult Signature Restricted Delivery service.
    c. Be accompanied by a Domestic Return Receipt (PS Form 3811). The 
sender's address block must bear the eligibility number issued by the 
PCSC and be made returnable to the address as shown below:
    PCSC, PACT MAILING OFFICE, USPS ELIGIBILITY NO. XX-00-0000, 90

[[Page 58431]]

Church St., Ste. 3100, New York, NY 10007-2951.
    d. Must bear the following marking: ``PERMITTED CIGARETTE MAILING--
DELIVER ONLY TO ADDRESSEE UPON AGE VERIFICATION'' on the address side 
of the mailpiece.
    e. Must bear the name and full mailing addresses of both the mailer 
and recipient, both of which must match exactly those listed on the 
authorized mailer's application on file with the Postal Service.
    f. May not be addressed to an addressee located in a state that 
prohibits the delivery or shipment of cigarettes to individuals in the 
destination state.
    g. May be sent only to an addressee who has not made any payment 
for the cigarettes, is being paid a fee for participation in consumer 
tests and has agreed to evaluate the cigarettes and furnish feedback to 
the manufacturer in connection with the consumer test.
    h. May not exceed more than one package from any one manufacturer 
to an adult smoker during any 30-day period.
    i. Must be entered at a retail and/or business mail acceptance 
location specified in the application and authorized by the PCSC.

473.53 Entry and Acceptance

    Mailings under the consumer testing exception must be entered under 
the following conditions:
    a. Covered products must be tendered via a face-to-face transaction 
with a Postal Service employee. Applicable mailings may not be tendered 
through any entry method prohibited under 473.1.e.
    b. The mailer must present Postal Service acceptance personnel with 
a letter from the PCSC showing that the PCSC has authorized the mailer 
and acceptance location.

473.54 Delivery

    Mailings bearing the marking for consumer testing are eligible for 
delivery only to the named addressee under the following conditions:
    a. The recipient signing for the article must be an adult of at 
least 21 years of age. The recipient's age must be verified by a postal 
employee before releasing or delivering the item to the recipient. The 
recipient must furnish proof of age via a driver's license, passport, 
or other government-issued photo identification that lists age or date 
of birth. The name on the identification must match the name of the 
addressee on the Priority Mail Express or Priority Mail label.
    b. Once the recipient's age and identity are established, the 
recipient must sign for receipt of delivery and in the appropriate 
signature block of PS Form 3811.

473.6 Public Health Exception

    Federal government agencies involved in the consumer testing of 
tobacco products solely for public health purposes may mail cigarettes 
(this does not apply to smokeless tobacco or ENDS) under the mailing 
standards of 473.5, except as follows:
    a. The federal agency is not required to have a manufacturer's 
permit issued under 26 U.S.C. 5713.
    b. The recipient is not required to be paid a fee for participation 
in consumer tests.
    c. Upon written request, the Director, PCSC, may waive certain 
application requirements for mailings entered by the requesting federal 
agency. The Director, PCSC, may suspend, rescind, or modify any waiver 
at any time.

473.7 Suspension or Revocation of Eligibility

    Eligibility to mail under one or more exceptions in 473.2 through 
.6 may be suspended or revoked by the Director, PCSC, in the event of 
failure to comply with any applicable law or regulation. A customer may 
appeal an adverse initial decision to the Director, Product 
Classification (see 214 for address). The mailer bears the burden of 
proof in establishing eligibility in any appeal of a suspension or 
revocation decision and of furnishing all supporting documentation when 
requested. Decisions by the Director, Product Classification, to revoke 
a customer`s eligibility under any exception may be appealed to the 
Judicial Officer under 39 CFR part 953.
* * * * *

474 Additional Guidance

474.1 Interpretative Guidance

    The definitions in 471.1 through. 5 and the exclusion in 474.2 are 
pursuant to section 1 of the Jenkins Act (15 U.S.C. 375), which is 
administered by the Bureau of Alcohol, Tobacco, Firearms, and 
Explosives (ATF). Interpretative guidance regarding these provisions 
may be requested by contacting ATF at the following address, with a 
copy to the Pricing and Classification Service Center (PCSC) (see 213 
for address): Bureau of Alcohol, Tobacco, Firearms and Explosives, 99 
New York Avenue NE, c/o 90 K St. NE, Ste. 250, Washington, DC 20226.

474.2 Exclusion of Products Approved for Tobacco Cessation or 
Therapeutic Purposes

    A product is excluded from the definition of ENDS in 471.5 (15 
U.S.C. 375(7)(C)) if:
    a. It is approved by the Food and Drug Administration for sale as a 
tobacco cessation product or any other therapeutic purpose; and
    b. Is marketed and sold solely for such purposes.
    Any party who believes that a product to be sent through the mails 
qualifies for this exclusion should provide appropriate documentation 
to ATF at the address in 474.1, with a copy to the PCSC.

[FR Doc. 2021-22787 Filed 10-20-21; 8:45 am]
BILLING CODE P