[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07976]
39 CFR Part 113
Treatment of E-Cigarettes in the Mail
AGENCY: Postal ServiceTM.
SUMMARY: A forthcoming final rule will determine whether electronic
nicotine delivery systems (``ENDS'') may continue to be mailed pursuant
to certain statutory exceptions that are currently administered through
an application process. To the extent that such exceptions may
ultimately be made available for ENDS, this document provides mailers
with guidance to assist in preparing exception applications for
submission following the final rule. In addition, ENDS mailers are
advised to review and comply with all other applicable mailing
restrictions and requirements currently in effect for controlled
substances, drug paraphernalia, and hazardous materials.
DATES: April 19, 2021.
FOR FURTHER INFORMATION CONTACT: Dale E. Kennedy, 202-268-6592.
SUPPLEMENTARY INFORMATION: On February 19, 2021 (86 FR 10218), the
Postal Service published a notice of proposed rulemaking to amend
Publication 52, Hazardous, Restricted, and Perishable Mail, which is
incorporated by reference into 39 CFR part 113. The text of the
proposed edits to Publication 52 is available at https://pe.usps.com/FederalRegisterNotice/2021/E-Cigarettes%20Proposed%20Rule.pdf. The
proposed edits would implement the Preventing Online Sales of E-
Cigarettes to Children Act (``Act''), Public Law 116-160, div. FF,
title VI (2020), which adds ``electronic nicotine delivery systems''
(``ENDS'') to the definition of ``cigarettes'' subject to regulation
under the Jenkins Act, 15 U.S.C. 375 et seq. Consequently, ENDS will
also become subject to the mailability restrictions and exceptions in
18 U.S.C. 1716E (``PACT Act''), which rely on the Jenkins Act
definition of ``cigarettes.'' 18 U.S.C. 1716E(a)(1).
Certain such exceptions currently require application to and
approval by the Postal Service's Pricing and Classification Service
Center. See Publication 52 sections 472.221 (business/regulatory
purposes), 472.241 (consumer testing/public health). The Postal Service
proposed to apply the business/regulatory purposes exception to ENDS,
but not the consumer testing and public health exceptions, and invited
comments on that proposed approach. Those comments will be considered
in developing the final rule. The final rule will contain the Postal
Service's determination as to whether any of those exceptions will be
made available for nonmailable ENDS.
Until the final rule is issued, ENDS are not subject to the PACT
Act, although they may be nonmailable for other reasons. See, e.g., 18
U.S.C. 1716(a), (h) (poisonous, explosive, and other dangerous
materials, and advertising, promotional, or sales matter relating to
the same); 21 U.S.C. 843(b)-(c), 863 (controlled substances, drug
paraphernalia, and advertisements relating to the same); 39 U.S.C. 3018
(hazardous materials); Publication 52 sections 31-349, 453 & appx. A,
C. Regardless of the legal status of any products under state or local
laws, violations of these Federal mailability laws can result in civil
and/or criminal penalties.
The Postal Service has received numerous inquiries and comments
about the possibility of submitting exception applications for ENDS
products in advance of the final rule. Several commenters express the
ENDS industry's concerns about the continuity of supply chains and
regulatory compliance activities that rely on the mails, to the extent
that such reliance may permissibly continue under the PACT Act. The
Postal Service understands that those concerns are heightened by
Congress's decision to make ENDS nonmailable immediately upon
publication of the final rule, rather than applying the 30-day notice
period that typically follows a final rule under the Administrative
Procedure Act. Therefore, this document is intended to clarify the
state of the exception application process in advance of the final rule
and to provide guidance to mailers interested in availing themselves of
any exceptions that may ultimately be made available.
Exception Application Process; Preparatory Guidance
The Postal Service cannot accept early applications for PACT Act
exceptions relating to ENDS products at this time. The Postal Service
has not yet determined whether and to what extent those exceptions will
be extended to ENDS. Early acceptance of applications would pose
significant administrative challenges for the very Postal Service
personnel who are developing the final rule amid substantial public
comment under a tight timeframe.
If any of the relevant exceptions are ultimately made available for
ENDS, then, given the highly decentralized nature of the ENDS industry
relative to the industries historically covered by the PACT Act, the
Postal Service anticipates receiving ENDS-related exception
applications at a rate several orders of magnitude above the historic
norm. Moreover, those applications are expected to involve numbers of
parties and products far greater than past PACT Act applications. These
factors translate into a load on Postal Service resources that would
massively outstrip historically allocated levels. The Postal Service is
contemplating reforms to its application process to contend with this
manifold near-term increase in complexity that would result from
extending the exceptions to ENDS, as well as studying how to improve
the process's efficiency and accessibility in the longer term.
Whether any ENDS mailers may ultimately be allowed to use the
exceptions remains to be determined. The Postal Service is not in an
administrative position to begin accepting ENDS-related exception
applications at this time, and it may not be in such a position until
issuance of the final rule. If, contrary to expectation, circumstances
permit earlier acceptance of ENDS-related exception applications on a
provisional basis, the Postal Service will issue further notice to that
If the final rule does make the business/regulatory purposes and/or
consumer testing/public health exceptions available for ENDS and
applications are accepted through a reorganized process, applicants
should expect review of their applications to require potentially
substantial processing time, in light of the statutory requirements for
Postal Service verification of mailers' and recipients' eligibility. 18
U.S.C. 1716E(b)(3)(B)(ii)(I)-(II), (b)(5)(C)(ii)(I). 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 following guidance is aimed at facilitating Postal Service
review and potentially reducing processing times for any potential
exception applications relating to ENDS, should they be permitted under
the final rule.
Documentation. With respect to the relevant exceptions, the PACT
Act requires the Postal Service to verify mailers' and recipients'
eligibility, which includes whether they are ``legally operating'',
``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.'' 18
U.S.C. 1716E(b)(3)(A)(i), (b)(3)(B)(ii)(I)-(II), (b)(5)(A),
(b)(5)(C)(ii)(I). Applicants for the consumer testing exception must
also be (or be legally authorized agents of) legally operating
cigarette manufacturers with ``a permit, in good standing, issued under
section 5713 of the Internal Revenue Code of 1986.'' Id. at
To the extent that the final rule may make any of these exceptions
available for shipments of ENDS, prospective applicants may wish to
prepare by compiling electronic copies of all relevant license and
permit documentation for themselves and, with respect to the business/
regulatory purposes exception, each addressee that they intend to
identify in their exception application.
For intended business/regulatory purposes exception applications by
organizations engaged in testing, investigation, or research and those
listing such organizations as addressees, relevant documentation may
include such materials that would demonstrate the organizations'
authorization to engage in the relevant activities (e.g., grant or
contract approval documents showing the scope and duration of a
relevant research project).
Indexing. Prospective applicants for the business/regulatory
purposes exception should prepare a spreadsheet that contains the
following data elements with respect to each sender and recipient
address that they intend to identify in their exception application:
a. Business or governmental entity name.
c. The Postal Service retail or business mail acceptance office(s)
where each intended sender would tender shipments.
d. The Postal Service retail office(s) where each intended
recipient would retrieve shipments.
e. A description of the business or governmental entity (e.g.,
battery manufacturer, retail store, wholesale distributor, testing
f. For each permit or license, the issuing jurisdiction; the permit
or license number; the expiration date (if any); and the activity
covered by each current permit or license (e.g., general business
operations; sale or manufacture of tobacco products or ENDS).
g. For each sender or addressee engaged in testing, investigation,
or research, the entities authorizing the conduct of such activities;
the expiration date (if any) of such authorization; and a brief
statement of the subject of each authorization (e.g., health effects of
flavor substances, medical effects of cannabidiol (``CBD''), battery
h. The brand name and a description of each product intended to be
shipped by each sender or to each addressee.
i. Whether any identified products or other intended shipments from
each sender or to each addressee contain lithium batteries, nicotine,
CBD, or tetrahydrocannabinol (``THC'').
j. For products containing nicotine or THC, the intended quantity
of the product per shipment and the concentration of nicotine or THC.
k. For products containing CBD with a THC concentration not
exceeding 0.3 percent, whether the CBD derives from hemp.
Mailability Beyond the PACT Act
ENDS implicate mailability statutes and regulations beyond the PACT
Act. These statutes and regulations already
render certain substances and components nonmailable, and they will
continue to do so with respect to any ENDS shipments that remain
mailable pursuant to exceptions or exclusions under the impending final
rule. ENDS that become nonmailable under the PACT Act can additionally
violate other mailability statutes and regulations. These restrictions
and requirements govern the use of the federal mail system, regardless
of the legal status of any items under state or local law. Violations
of these mailability laws can result in civil or criminal penalties.
Therefore, all persons currently or prospectively engaged in the
mailing of ENDS--including, in particular, those who intend to continue
mailing ENDS under any potentially available PACT Act exceptions--are
advised to review Publication 52 carefully. Certain pertinent issues
are highlighted below, but this list is not necessarily exhaustive.
CBD products. For hemp-based products containing CBD with a THC
concentration not exceeding 0.3 percent, mailers must retain, and
prepare to make available upon request, records establishing compliance
with all applicable federal, state, and local laws pertaining to hemp
production, processing, distribution, and sales, including the
Agricultural Act of 2014 and the Agricultural Improvement Act of 2018.
Such records may include laboratory test results, licenses, and
compliance reports. See Publication 52 section 453.37.
Controlled substances and drug paraphernalia. All other substances
that contain THC are Schedule I controlled substances for purposes of
federal law, 21 CFR 1308.11(d)(31), and are therefore nonmailable in
most instances. 21 U.S.C. 843(b); Publication 52 section 453. Products
used with such substances may qualify as nonmailable drug
paraphernalia. See 21 U.S.C. 863; Publication 52 section 453. This
federal mailing prohibition is unaffected by whether the mailing of
THC-containing substances violates state or local law and by the
restriction of Department of Justice appropriations relating to medical
marijuana. See Public Law 116-260, div. B, title V, section 531 (2020).
Advertisements for controlled substances and drug paraphernalia. It
is unlawful to mail advertisements for, or to advertise the mailing of,
federally controlled substances or drug paraphernalia. 21 U.S.C.
843(b), (c)(1); Mailing Standards of the United States Postal Service,
Domestic Mail Manual (``DMM'') section 601.9.4.1.
Hazardous materials: Solutions. Toxic and flammable substances are
nonmailable except subject to requirements designed to render them
nonhazardous in the mails and/or in air transportation. 18 U.S.C.
1716(a)-(b); 39 U.S.C. 3018; Publication 52 sections 31-349, 711-728 &
appx. A, C. Mailers of ENDS solutions should carefully review the
chemical constituents of those products and ascertain the flashpoint of
each constituent substance, its toxicological profile, and its
concentration in the relevant solution. Nicotine is a toxic substance,
for example. In addition, ENDS liquids--including non-nicotine-
containing liquids--may contain acetals, acetoin (acetyl methyl
carbinol), aldehydes, butanol, diacetyl (butanedione), propanol, and
other compounds that qualify as flammable or toxic substances. Compare
49 CFR 172.101; Publication 52, appx. A, with Hanno C. Erythropel et
al., Formation of Flavorant-Propylene Glycol Adducts with Novel
Toxicological Properties in Chemically Unstable E-Cigarette Liquids, 21
Nicotine & Tobacco Research 1248 (2018); Joseph G. Allen et al.,
Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and
Acetoin in a Sample of 51 Products, Including Fruit-, Candy-, and
Cocktail-Flavored E-Cigarettes, 124 Enviro. Health Perspectives 733
Depending on a substance's flashpoint or lethal dose
(LD50) and its concentration in a solution, the substance
may or may not be prohibited or subject to special Department of
Transportation requirements as a hazardous material. See generally
Publication 52 sections 343, 346 & appx. A, C. Such items may be
prohibited from or restricted in air transportation and may not be
eligible for shipping via Priority Mail Express, Priority Mail, First-
Class Mail, or First-Class Package Service. Id. sections 327, 711-728.
Even nonregulated toxic liquids and solids may be subject to quantity
restrictions, packaging requirements, and restrictions on the
availability of Postal Service shipping options. See Publication 52
Hazardous materials: Lithium batteries. Mailers of lithium metal or
lithium-ion batteries should be aware of applicable restrictions and
requirements, which may determine mailability, packaging, product
design, shipping quantities, and the availability of relevant Postal
Service products. See Publication 52 section 349.221-.222, 711-728.
Non-hazardous liquids. Mailers of liquids that are not regulated as
hazardous materials (whether or not such liquids contain nicotine)
should be aware of applicable packaging requirements. See Publication
52 section 451.3 and DMM section 601.3.4.
Hazardous and restricted materials: Advertising, promotional, or
sales matter. To the extent that ENDS may be subject to special
requirements as hazardous or otherwise restricted materials, then
matter that solicits or induces the mailing of such items is mailable
only if it contains all pertinent packaging instructions and any other
mailing limitations. 18 U.S.C. 1716(h); DMM section 601.9.4.1.
Again, it is emphasized that the Postal Service has yet to
determine whether and to what extent any PACT Act exceptions may be
made available for ENDS. Nevertheless, mailers of ENDS products may
find the preparatory information above useful in preparing for the
potential availability of such exceptions following a final rule. In
addition, all persons currently or prospectively engaged in the mailing
of ENDS products should carefully review non-PACT-Act-related mailing
prohibitions, restrictions, and other requirements that may apply to
ENDS products, to ensure that their use of the mail system is safe and
compliant with Federal law.
Joshua J. Hofer,
Attorney, Ethics & Legal Compliance.
[FR Doc. 2021-07976 Filed 4-16-21; 8:45 am]
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