[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Proposed Rules]
[Pages 57756-57765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24313]



[[Page 57756]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 801, and 1100

[Docket No. FDA-2015-N-2002]
RIN 0910-AH19


Clarification of When Products Made or Derived From Tobacco Are 
Regulated as Drugs, Devices, or Combination Products; Amendments to 
Regulations Regarding ``Intended Uses''

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing 
regulations to describe the circumstances in which a product made or 
derived from tobacco that is intended for human consumption will be 
subject to regulation as a drug, device, or a combination product under 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is 
intended to provide direction to regulated industry and to help avoid 
consumer confusion.

DATES: Submit either electronic or written comments on this proposed 
rule by November 24, 2015. See section IV.B of this document for the 
proposed effective date of a final rule based on this proposed rule.

ADDRESSES: You may submit comments, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-2002 for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bryant Godfrey or Darin Achilles, 
Office of Regulations, Center for Tobacco Products, Food and Drug 
Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, 
877-287-1373, [email protected].

Executive Summary

Purpose of the Proposed Rule

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) amends the FD&C Act and provides FDA with the authority to 
regulate tobacco products. Section 201(rr) of the FD&C Act (21 U.S.C. 
321(rr)), as amended by the Tobacco Control Act, defines the term 
``tobacco product'' as any product made or derived from tobacco that is 
intended for human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). Excluded from the definition of a tobacco product is 
any article that is a drug, device, or combination product. Any article 
that is a drug, device, or combination product will be regulated as 
such rather than as a tobacco product.
    Because some ambiguity surrounds the circumstances under which a 
product that is made or derived from tobacco would be regulated as a 
drug, device, or combination product, and the circumstances under which 
it would be regulated as a tobacco product, FDA is initiating this 
rulemaking to provide clarity regarding our interpretation of the drug 
and device definitions in the FD&C Act with respect to products made or 
derived from tobacco. This rulemaking will provide assistance for 
entities intending to market products made or derived from tobacco. FDA 
expects the rule will also assist investigators planning to use 
products made or derived from tobacco for an investigational use in 
determining the investigational use requirements that apply to their 
proposed studies. The rulemaking will increase clarity regarding the 
types of claims and other evidence that make a product made or derived 
from tobacco subject to regulation as a drug, device or combination 
product, helping consumers distinguish products made or derived from 
tobacco that are intended for medical use from products marketed for 
other uses.
    In addition, FDA is taking the opportunity to propose corresponding 
changes to existing regulations at Sec. Sec.  201.128 and 801.4 (21 CFR 
201.128 and 801.4), and to conform them to how the Agency currently 
applies these regulations to drugs and devices generally.

Summary of the Major Provisions of the Regulatory Action

    Conceptually, the proposed rule follows the disease prong and the 
structure/function prong (with certain enumerated limitations) of the 
statutory definitions of ``drug'' and ``device'' (section 201(g) and 
(h) of the FD&C Act). Under the proposed rule, a product made or 
derived from tobacco and intended for human consumption would be 
regulated as a drug, device, or combination product in two 
circumstances: (1) If the product is intended for use in the diagnosis 
of disease or other conditions, or in the cure, mitigation, treatment, 
or prevention of disease; or (2) if the product is intended to affect 
the structure or any function of the body in any way that is different 
from effects of nicotine that were commonly and legally claimed in the 
marketing of cigarettes and smokeless tobacco products prior to March 
21, 2000. The proposed rule also attempts to clarify remaining 
circumstances where a product would be or could be regulated as a 
tobacco product.
    In addition, FDA is proposing to amend its existing intended use 
regulations for drugs and devices by inserting in Sec. Sec.  201.128 
and 801.4 a reference to the proposed rule to clarify the interplay 
between these regulations and this proposed rule, and to conform 
Sec. Sec.  201.128 and 801.4 to reflect how the Agency currently 
applies them to drugs and devices.

Costs and Benefits

    The proposed rule would generate some benefit by reducing the 
ambiguity in the development and marketing of products made or derived 
from tobacco. The proposed rule is not expected to impose significant 
additional costs on manufacturers who make products made or derived 
from tobacco, or on drug and device manufacturers generally.

SUPPLEMENTARY INFORMATION:

[[Page 57757]]

I. Background

A. Definition of ``Tobacco Product''

    The Tobacco Control Act was enacted on June 22, 2009 (Pub. L. 111-
31), amending the FD&C Act and providing FDA with the authority to 
regulate tobacco products. Section 101(a) of the Tobacco Control Act 
amends section 201 of the FD&C Act by adding paragraph (rr), which 
defines the term ``tobacco product.'' In general, a ``tobacco product'' 
is defined as any product made or derived from tobacco that is intended 
for human consumption, including any component, part, or accessory of a 
tobacco product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product). 
Section 201(rr)(2) of the FD&C Act excludes from the definition of a 
tobacco product any article that is defined as a drug under section 
201(g)(1), a device under section 201(h), or a combination product 
described in section 503(g) of the FD&C Act (21 U.S.C 353(g)). Section 
201(rr)(3) of the FD&C Act explains that any article that is a drug, 
device, or combination product will be regulated under chapter V of the 
FD&C Act (the authorities for drugs and devices) rather than chapter IX 
(the authorities for tobacco products).\1\
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    \1\ Section 201(rr)(4) of the FD&C Act prohibits a tobacco 
product from being marketed in combination with any other article or 
product regulated under the FD&C Act. This rulemaking does not 
address section 201(rr)(4).
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B. Drug/Device/Combination Product Definitions

1. Medical Product Definitions
    As noted in section I.A of this document, the definition of 
``tobacco product'' excludes anything that is a ``drug,'' ``device,'' 
or ``combination product'' under the FD&C Act. The FD&C Act defines 
``drug'' (in relevant part) as an article intended either: (1) For use 
in the diagnosis, cure, mitigation, treatment, or prevention of disease 
(referred to as the ``disease prong'' of the definition), or (2) to 
affect the structure or any function of the body (the ``structure/
function prong'') (section 201(g)(1) of the FD&C Act). The FD&C Act 
defines a ``device'' (in relevant part) as an instrument, apparatus, 
implement, machine, contrivance, implant, in vitro reagent, or other 
similar or related article, including any component, part, or 
accessory, intended either: (1) For use in the diagnosis of disease or 
other conditions, or in the cure, mitigation, treatment, or prevention 
of disease, or (2) to affect the structure or any function of the body, 
and which does not achieve its primary intended purposes through 
chemical action within or on the body of man and which is not dependent 
on being metabolized for the achievement of its primary intended 
purposes (section 201(h) of the FD&C Act).\2\ Combination products are 
products that constitute a combination of a drug, device, or biological 
product (section 503(g) of the FD&C Act). Under the FD&C Act, the 
Secretary's determination of the primary mode of action of a 
combination product determines which Center at FDA will have primary 
jurisdiction over the product (section 503(g) of the FD&C Act).
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    \2\ In this proposed rule, the cited language may be referred to 
as the ``drug/device definitions.''
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    FDA has previously interpreted the exclusion in the tobacco product 
definition to mean that if a product made or derived from tobacco is 
determined to have a drug or device ``intended use,'' it will be 
regulated as a medical product, not as a tobacco product. As discussed 
in greater detail in this document, this interpretation was qualified 
in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 
2010), in which the D.C. Circuit applied the holding of Food & Drug 
Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 156 
(2000), to all tobacco products. Thus, the determination of whether a 
product is a medical product or a tobacco product will be based on the 
FD&C Act and associated regulations and will also take into account 
relevant legal precedent (further described in section I.C of this 
document).
2. How Intended Use Is Determined
    In determining a product's intended use, the Agency may look to 
``any . . . relevant source,'' including but not limited to the 
product's labeling, promotional claims, and advertising (see, e.g., 
Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 
1980); United States v. Storage Spaces Designated Nos. ``8'' and 
``49,'' 777 F.2d 1363, 1366 (9th Cir. 1985), Hanson v. United States, 
417 F. Supp. 30, 35 (D. Minn.), aff'd, 540 F.2d 947 (8th Cir. 1976)). 
For example, FDA may take into account any claim or statement made by 
or on behalf of a manufacturer that explicitly or implicitly promotes a 
product for a particular use (see, e.g., Sec.  201.128 (drugs), Sec.  
801.4 (devices)).
    To establish a product's intended use, FDA is not bound by the 
manufacturer or distributor's subjective claims of intent, but rather 
can consider objective evidence, which may include a variety of direct 
and circumstantial evidence. Thus, FDA may also take into account any 
circumstances surrounding the distribution of the product or the 
context in which it is sold (see id.; see also U.S. v. Travia, 180 
F.Supp.2d 115, 119 (D.D.C. 2001)). In the context of medical products, 
generally, circumstantial evidence often ensures that FDA is able to 
hold accountable firms that attempt to evade FDA medical product 
regulation by avoiding making express claims about their products. As 
FDA has previously stated, however, the Agency would not regard a firm 
as intending an unapproved new use for an approved or cleared medical 
product based solely on the firm's knowledge that such product was 
being prescribed or used by doctors for such use (Ref. 5).
    Thus, when a product made or derived from tobacco is marketed or 
distributed for an intended use that falls within the drug/device 
definitions, it would be regulated as a medical product, subject to the 
limitations discussed further in this document. Courts have recognized 
that products made or derived from tobacco marketed with ``disease'' 
claims and certain ``structure/function'' claims are drugs (see United 
States v. 46 Cartons . . . Containing Fairfax Cigarettes, 113 F.Supp. 
336, 337, 338 (D. N.J. 1953) (cigarettes marketed for the prevention of 
respiratory diseases); United States v. 354 Bulk Cartons . . . Trim 
Reducing-Aid Cigarettes, 178 F.Supp. 847, 851 (D. N.J. 1959) 
(cigarettes marketed for weight reduction)).

C. History of 1996 Rulemaking and Relevant Litigation

    Although the courts have recognized that tobacco-derived products 
can be regulated as medical products under the FD&C Act in certain 
circumstances, courts have also held that there are limitations on how 
the drug and device definitions can be applied to products made or 
derived from tobacco. This section provides a summary of FDA regulatory 
action and related litigation relevant to those limitations.
    In 1996, FDA issued a regulation restricting the sale and 
distribution of cigarettes and smokeless tobacco to children and 
adolescents (the 1996 rule) (61 FR 44396, August 28, 1996). This rule 
included FDA's determination that it had jurisdiction over cigarettes 
and smokeless tobacco under the FD&C Act. The basis for this 
determination was that cigarettes and smokeless tobacco were intended 
to affect the structure or function of the body, within the FD&C Act 
definitions of the terms ``drug'' and ``device,'' because nicotine has 
significant pharmacological effects. In

[[Page 57758]]

addition, FDA found that cigarettes and smokeless tobacco were 
combination products consisting of the drug nicotine and device 
components intended to deliver nicotine to the body. In the 1996 rule, 
FDA concluded that cigarettes and smokeless tobacco should be regulated 
under the device authorities of the FD&C Act. The 1996 rule was 
challenged in court by a group of tobacco manufacturers, retailers, and 
advertisers on the grounds that FDA lacked jurisdiction to regulate 
tobacco products ``as customarily marketed;'' that the regulations 
exceeded FDA's authority to regulate devices; and that the advertising 
restrictions violated the First Amendment.
    The Supreme Court struck down the 1996 rule in Food & Drug 
Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 156 
(2000), holding that FDA lacked jurisdiction over tobacco products ``as 
customarily marketed.'' The Court found that Congress intended to 
exclude tobacco products from FDA's jurisdiction. In Brown & 
Williamson, the Court determined that tobacco products could not be 
made safe and effective for their intended uses, and therefore, FDA 
would have to remove them from the market, but that Congress had 
foreclosed such action (529 U.S. at 135-139). The Court also observed 
that Congress, in enacting statutes to regulate the labeling and 
advertising of conventional tobacco products, such as cigarettes and 
smokeless tobacco, had ``effectively ratified FDA's long-held 
position'' that the Agency lacked jurisdiction to regulate tobacco 
products ``absent claims of therapeutic benefit by the manufacturer'' 
(529 U.S. at 144).
    In 2008 and early 2009, FDA detained multiple shipments of 
electronic cigarettes from overseas manufacturers and denied them entry 
into the United States on the ground that electronic cigarettes were 
unapproved drug-device combination products under the FD&C Act. In 
April 2009, plaintiffs sought a preliminary injunction to enjoin FDA 
from regulating electronic cigarettes as drug-device combination 
products and from denying entry of those products into the United 
States.\3\ Between the filing of the lawsuit and a decision on the 
motion for a preliminary injunction, Congress passed the Tobacco 
Control Act and the President signed it into law. The District Court 
subsequently granted a preliminary injunction, relying on Brown & 
Williamson and the recently enacted Tobacco Control Act (Smoking 
Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62 (D.D.C. 2010)). FDA 
appealed the decision and the United States Court of Appeals for the 
District of Columbia Circuit (D.C. Circuit) affirmed in Sottera, Inc. 
v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010).\4\ The 
D.C. Circuit determined that the decision in Brown & Williamson was not 
limited to tobacco products that were the subject of the specific 
federal legislation discussed in that case. The D.C. Circuit found that 
under the Tobacco Control Act, all products made or derived from 
tobacco and intended for human consumption that are ``marketed for 
therapeutic purposes'' are subject to FDA's drug and/or device 
provisions, whereas ``customarily marketed tobacco products'' are 
subject to regulation as ``tobacco products'' (Sottera, 627 F.3d at 
898-899; see also Brown & Williamson, 529 U.S. at 144-156).
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    \3\ The original district court case was filed by Smoking 
Everywhere, Inc., and the case was joined by Sottera, Inc., which 
does business as NJOY.
    \4\ On January 24, 2011, the D.C. Circuit denied the 
government's petitions for rehearing and rehearing en banc (by the 
full court). See Sottera v. FDA, No. 10-5032 (D.C. Cir. Jan. 24 
2011) (per curiam).
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    The Court in Brown & Williamson frequently referred to ``tobacco 
products as customarily marketed,'' but never defined that phrase. The 
Court contrasted that phrase with ``claims of therapeutic benefit'' 
(see, e.g., 529 U.S. at 127, 158), which it also did not define. 
Neither of these terms is used in the FD&C Act. In Sottera, the D.C. 
Circuit relied on Brown & Williamson and repeated these phrases in 
describing contrasting types of products. The court in Sottera 
specifically equated ``therapeutic uses'' with the disease prong of the 
drug/device definitions in the FD&C Act and said that customarily 
marketed tobacco products were sold without therapeutic claims (627 
F.3d at 894) and should be regulated as tobacco products under the FD&C 
Act, as amended by the Tobacco Control Act. But neither court provided 
specific guidance about what might constitute claims of therapeutic 
benefit, nor did they explain the relationship between ``tobacco 
products as customarily marketed'' and the structure/function prong of 
the drug/device definitions of the FD&C Act. In addition, no court has 
addressed whether certain structure/function claims for products made 
or derived from tobacco that generally were not made for ``tobacco 
products as customarily marketed'' should be treated as drug or device 
claims.\5\
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    \5\ In Sottera, there are a few instances where the court's 
opinion could be read to suggest that all products made or derived 
from tobacco that do not have therapeutic claims are tobacco 
products as customarily marketed (627 F.3d at 895, 898-899). 
However, to the extent that the issue of drug/device jurisdiction 
over structure/function intended uses that are not related to the 
commonly understood effects of nicotine was not before the court, 
this reading is dicta in any case.
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II. Purpose of Rulemaking

    Because some ambiguity surrounds the circumstances under which a 
product that is made or derived from tobacco would be regulated as a 
drug, device, or combination product, and the circumstances under which 
it would be regulated as a tobacco product, we are initiating this 
rulemaking to provide clarity regarding our interpretation of the drug/
device definitions in the FD&C Act with respect to products made or 
derived from tobacco. We believe that this rulemaking will provide 
assistance for entities intending to market products made or derived 
from tobacco and for entities that plan to study these products. For 
example, the rule is expected to help sponsors determine which FDA 
Center should be consulted as they develop their products and make 
appropriate premarket submissions to bring new products to market. FDA 
expects the rule will also assist investigators planning to use 
products made or derived from tobacco for an investigational use in 
determining the investigational use requirements that apply to their 
proposed studies. In addition, we believe it is important to avoid 
consumer confusion about which products are intended for medical uses 
versus recreational or other uses. The rulemaking will increase clarity 
regarding the types of claims and other evidence that make a product 
made or derived from tobacco subject to regulation as a drug or device, 
which we expect will help consumers distinguish products made or 
derived from tobacco that are intended for medical use from products 
marketed for other uses. Finally, the rulemaking will provide clarity 
for drug and device manufacturers generally regarding FDA's 
interpretation and application of its existing intended use 
regulations.
    In both the Brown & Williamson and Sottera decisions, the courts 
set forth (but did not define) two poles--``tobacco products as 
customarily marketed'' and ``claims of therapeutic benefit''--and found 
that the ``customarily marketed'' pole was not within FDA's drug/device 
jurisdiction, but that the ``therapeutic benefit'' pole was within 
FDA's drug/device jurisdiction. As noted in section I.C of this 
document, the terminology used by the courts in establishing these two 
poles is not the terminology used by the FD&C Act in defining drugs and 
devices. Instead, the FD&C Act's drug and device definitions reference, 
in

[[Page 57759]]

relevant part, diagnosis, cure, mitigation, treatment, or prevention of 
disease (disease prong) and effects on the structure or any function of 
the body (structure/function prong). In addition, while certain 
products and claims may fall clearly at one pole or the other, a 
spectrum of products and claims may fall somewhere between the two 
poles. In the sections that follow, we describe our interpretation of 
the jurisdictional lines established by the FD&C Act's drug, device, 
and tobacco product definitions as informed by the decisions in Brown & 
Williamson and Sottera.

A. Claims About Products Made or Derived From Tobacco That Fall Within 
the Disease Prong

1. Disease Prong Claims
    As discussed in section I.B, articles intended for use in the 
diagnosis, cure, mitigation, treatment or prevention of disease are 
drugs, devices, or combination products under the FD&C Act. Products 
made or derived from tobacco have historically been regulated as 
medical products when they are marketed for intended uses that fall 
within the disease prong. For example, FDA has approved a number of 
drug products made or derived from tobacco as nicotine replacement 
therapies with indications to reduce withdrawal symptoms, including 
nicotine craving, associated with quitting smoking. Accordingly, FDA 
has long considered claims related to smoking cessation in the context 
of curing or treating nicotine addiction and its symptoms to be within 
FDA's ``disease prong'' jurisdiction.
    FDA has also taken enforcement action against products made or 
derived from tobacco that were marketed with claims of therapeutic 
benefit but that did not have approved new drug applications. For 
example, FDA seized cigarettes on the grounds that they were misbranded 
drugs when the manufacturer represented that the cigarettes were 
effective in preventing respiratory diseases, common cold, influenza, 
pneumonia, and various other ailments. (United States v. 46 Cartons . . 
. Containing Fairfax Cigarettes, 113 F.Supp. 336, 337, 338 (D. N.J. 
1953)).
    The ``therapeutic benefit'' language used by the Brown & Williamson 
and Sottera courts has a logical relationship to the disease prong of 
the drug/device definition, in that ``therapeutic'' can be defined as 
``relating to the treatment of disease or disorders by remedial agents 
or methods or to providing or assisting in a cure.'' \6\ As part of 
this rulemaking, FDA is clarifying the categories of claims relevant to 
products made or derived from tobacco that FDA considers to fall within 
the disease prong in light of the Sottera and Brown & Williamson 
decisions. As discussed previously, claims related to smoking cessation 
have long been recognized as claims conferring drug or device 
jurisdiction. Smoking cessation claims have also long been associated 
with curing or treating nicotine addiction and its symptoms. For 
example, the approved labeling for nicotine replacement therapies 
includes the following statements: ``Purpose: Stop smoking aid; Use: 
Reduces withdrawal symptoms, including nicotine craving, associated 
with quitting smoking.'' \7\ Against this backdrop, smoking cessation 
claims on any product generally create a strong suggestion of 
therapeutic benefit to the user that generally will be difficult to 
overcome absent clear context indicating that the product is not 
intended for use to cure or treat nicotine addiction or its symptoms, 
or for another therapeutic purpose.
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    \6\ See, e.g., Merriam-Webster Online Dictionary, available at 
http://www.merriam-webster.com/dictionary/therapeutic.
    \7\ See, e.g., approved labeling for Nicoderm CQ, Nicorette, 
Habitrol.
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    Given the availability of FDA-approved drugs for smoking cessation, 
FDA believes that consumers are particularly susceptible to confusion 
where products made or derived from tobacco that otherwise appear to be 
products intended for recreational use make claims related to quitting 
smoking. Therefore, FDA considers claims related to smoking cessation 
to require careful scrutiny. Where products making claims related to 
quitting smoking also attempt to disclaim that use in some way, FDA 
intends to view such disclaimers skeptically because of the likelihood 
of consumer confusion. In most cases, FDA does not believe that 
disclaimers will sufficiently mitigate consumer confusion related to 
the intended therapeutic use of the product.
    FDA proposes to treat several other categories of claims for 
products made or derived from tobacco as falling within the disease 
prong of the drug/device definition. These categories of claims are 
discussed further in section IV (Description of Proposed Regulation). 
We note that sections 911(c) and 918 of the FD&C Act (21 U.S.C. 387k(c) 
and 387r), as amended by the Tobacco Control Act, contemplate that 
products intended for the treatment of tobacco dependence and for 
relapse prevention, among other things, may be subject to FDA's drug/
device jurisdiction.
2. Distinction Between Disease Prong Claims and Modified Risk Claims
    Through this rulemaking, FDA is also clarifying the relationship 
between FDA's regulation of a certain category of tobacco products--
modified risk tobacco products (MRTPs)--and FDA's regulation of medical 
products that are intended to mitigate disease. MRTPs are tobacco 
products that are sold or distributed for use to reduce harm or the 
risk of tobacco-related disease associated with commercially marketed 
tobacco products (section 911(b)(1) of the FD&C Act). The phrase ``sold 
or distributed for use to reduce harm or the risk of tobacco-related 
disease associated with commercially marketed tobacco products'' refers 
to a tobacco product:
    1. That represents in its label, labeling, or advertising, either 
implicitly or explicitly, that:
     The tobacco product presents a lower risk of tobacco-
related disease or is less harmful than one or more other commercially 
marketed tobacco products;
     the tobacco product or its smoke contains a reduced level 
of a substance or presents a reduced exposure to a substance; or
     the tobacco product or its smoke does not contain or is 
free of a substance;
    2. That uses the descriptors ``light,'' ``mild,'' ``low,'' or 
similar descriptors in its label, labeling, or advertising; \8\ or
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    \8\ Although cigarettes had been marketed with such descriptors 
before the Tobacco Control Act was enacted, as of June 22, 2010, 
manufacturers were prohibited from manufacturing for sale or 
distribution any tobacco products for which the label, labeling, or 
advertising contains the descriptors ``light,'' ``low,'' or 
``mild,'' or any similar descriptor, without an FDA order in effect 
under section 911(g) of the FD&C Act (section 911(b)(3) of the FD&C 
Act). Furthermore, as of July 22, 2010, manufacturers, including 
importers of finished tobacco products, were prohibited from 
introducing into the domestic commerce of the United States any 
tobacco product for which the label, labeling, or advertising 
contains the descriptors ``light,'' ``low,'' or ``mild,'' or any 
similar descriptor, irrespective of the date of manufacture, without 
an FDA order in effect under section 911(g) of the FD&C Act (id).
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    3. For which the tobacco product manufacturer has taken any action 
directed to consumers through the media or otherwise, other than by 
means of the tobacco product's label, labeling, or advertising, after 
June 22, 2009, respecting the product that would be reasonably expected 
to result in consumers believing that the tobacco product or its smoke 
may present a lower risk of disease or is less harmful

[[Page 57760]]

than one or more commercially marketed tobacco products, or presents a 
reduced exposure to, or does not contain or is free of, a substance or 
substances.
    See section 911(b)(2) of the FD&C Act.\9\
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    \9\ No smokeless tobacco product shall be considered to be sold 
or distributed for use to reduce harm or the risk of tobacco-related 
disease solely because its label, labeling, or advertising uses the 
following phrases: ``smokeless tobacco,'' ``smokeless tobacco 
product,'' ``not consumed by smoking,'' ``does not produce smoke,'' 
``smokefree,'' ``smoke-free,'' ``without smoke,'' ``no smoke,'' or 
``not smoke'' (section 911(b)(2)(C) of the FD&C Act).
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    Because MRTPs have the potential to be marketed as less harmful 
than other tobacco products, including as presenting a lower risk of 
tobacco-related disease than another tobacco product, FDA recognizes 
that there might be questions about how these products relate to FDA's 
medical product jurisdiction over products made or derived from tobacco 
that are intended for use in disease mitigation. MRTPs may have the 
ultimate effect of lowering disease risk for users who would otherwise 
use another, more harmful tobacco product. However, an important 
distinction between MRTPs and medical products is that, while medical 
products approved for disease mitigation act affirmatively to combat a 
disease or health condition, MRTPs present relatively less risk of 
disease (e.g., by presenting reduced exposure to harmful constituents 
relative to another tobacco product), but do not affirmatively act to 
mitigate or otherwise treat disease. In addition, while medical 
products approved for disease mitigation are determined to be both safe 
and effective for their approved use, MRTPs are reviewed based, in 
part, on a ``benefit the health of the population as a whole'' 
standard, and like other tobacco products, still expose users to 
inherent (if reduced) harms.
    For purposes of illustration, claims of modified risk might include 
claims like ``contains less nicotine than [tobacco product X]'', 
``using [MRTP] reduces your risk of lung cancer compared to using 
[tobacco product X]'', and ``lower level of nitrosamines than other 
smokeless tobacco products.'' In contrast, a claim that a product 
``inhibits the progression of disease in adult patients with chronic 
obstructive pulmonary disease (COPD)'' is not an appropriate modified 
risk claim, but would be appropriate for a medical product approved for 
such an indication.

B. Claims About Products Made or Derived From Tobacco That Fall Within 
the Structure/Function Prong

    As discussed in sections I.B and I.C of this document, the drug/
device definitions in the FD&C Act include articles ``intended to 
affect the structure or any function of the body,'' and FDA's assertion 
of jurisdiction over cigarettes and smokeless tobacco in 1996 was 
predicated on the pharmacological effects of nicotine on the structure 
or function of the body. In addition, as explained previously, the 
Court in Brown & Williamson rejected that assertion of jurisdiction, 
finding that Congress did not intend for FDA to have jurisdiction over 
cigarettes ``as customarily marketed.''
    Based on the Brown & Williamson holding and the Sottera court's 
application of that holding to all tobacco products, FDA believes that 
the appropriate inquiry in determining whether a particular product 
made or derived from tobacco is ``customarily marketed''--and therefore 
outside of FDA's drug/device jurisdiction--is to determine whether any 
claims related to structure/function relate to effects of nicotine that 
were commonly and legally claimed in the marketing of cigarettes and 
smokeless tobacco products prior to the date of the Supreme Court's 
decision in Brown & Williamson (March 21, 2000).
    For example, claims related to satisfaction, pleasure, enjoyment, 
and refreshment have been recognized as euphemisms for the delivery of 
a pharmacologically active dose of nicotine. While these claims relate 
to effects on the structure or function of the body, FDA does not 
consider these tobacco satisfaction and enjoyment claims to fall within 
its drug and device regulatory authority. Similarly, FDA does not 
consider claims suggesting that a tobacco product provides an 
alternative way of obtaining the effects of nicotine, or that a tobacco 
product will provide the same effects as another tobacco product--such 
as ``satisfying smoking alternative,'' ``provides all the pleasure of 
smoking,'' ``get your nicotine fix,'' or ``provides smokers the same 
delight, physical and emotional feelings''--to fall within its drug and 
device authority; however, we invite comment on this.
    The Brown & Williamson and Sottera decisions do not reach the issue 
of intended uses that fall outside the disease prong of the drug/device 
definition and that are outside the area of ``customarily marketed'' 
tobacco product claims. FDA believes certain structure/function claims 
for products made or derived from tobacco continue to fall within our 
drug/device regulatory authority. FDA believes these structure/function 
claims fall into two main categories: (1) Claims that are unrelated to 
the pharmacological effects of nicotine, and (2) claims that were not 
commonly and legally made for cigarettes and smokeless tobacco products 
(i.e., the products addressed in the 1996 rule) prior to the Supreme 
Court's decision in Brown & Williamson. Thus, to the extent 
manufacturers intend products made or derived from tobacco to be used 
to affect the structure or function of the body in some manner that is 
not related to the effects of nicotine commonly and legally claimed 
prior to March 21, 2000, FDA would consider these intended uses to 
remain within its drug/device jurisdiction under the proposed rule. For 
example, if a product made or derived from tobacco is marketed with 
structure/function claims such as ``maintain healthy lung function,'' 
``relieve tension,'' ``restore mental alertness,'' ``maintain memory,'' 
``support the immune system,'' or ``promote weight loss,'' FDA would 
consider such intended uses to fall within its drug/device 
jurisdiction.
    FDA believes that it is important to distinguish structure/function 
intended uses that were not commonly and legally claimed in the 
marketing of cigarettes and smokeless tobacco products prior to the 
decision in Brown & Williamson. Structure/function intended uses are a 
long-standing and important aspect of FDA's medical product 
jurisdiction, grounded in the statutory definitions of ``drug'' and 
``device'' in the FD&C Act. We recognize that products made or derived 
from tobacco are unique because of the regulatory regime for tobacco 
products under the FD&C Act, and that some products made or derived 
from tobacco making certain structure/function claims are now outside 
our drug/device jurisdiction. However, we believe it is important from 
a public health perspective, and consistent with the FD&C Act and case 
law, to preserve our traditional medical product authority over 
products made or derived from tobacco whose intended use includes 
effects on the structure or function of the body that are distinct from 
the pharmacological effects of nicotine that were commonly and legally 
claimed before March 21, 2000.
    FDA believes this proposed rule will provide clarity to 
manufacturers about how products made or derived from tobacco will be 
regulated if they are marketed or distributed for certain intended 
uses. This clarification will

[[Page 57761]]

allow regulated industry to plan accordingly during the product 
development and postmarketing phases and will help researchers 
understand the applicable regulatory requirements associated with the 
investigational use of products made or derived from tobacco.
    In addition, we believe this proposed rule will help to avoid 
consumer confusion about which products made or derived from tobacco 
are intended for a medical use (i.e., as a drug/device) versus for a 
recreational use. Specifically, FDA wishes to avoid situations where 
products intended to be sold as tobacco products are marketed with the 
same claims as products sold as drugs or devices. If tobacco products 
are marketed in ways that make them hard to distinguish from certain 
medical products, consumers may use tobacco products, which are 
inherently dangerous, in place of FDA-approved medical products that 
have been determined to be safe and effective for their intended use.

C. Proposed Changes to Existing ``Intended Use'' Regulations

    FDA is also proposing changes to Sec. Sec.  201.128 and 801.4. 
First, the proposed rule would insert a reference to Sec.  1100.5 to 
clarify the interplay between these regulations and the proposed rule. 
Second, as discussed previously, the Agency does not regard a firm as 
intending an unapproved new use for an approved or cleared medical 
product based solely on that firm's knowledge that such product was 
being prescribed or used by doctors for such use (see Ref. 5). 
Accordingly, FDA is taking this opportunity to amend Sec. Sec.  201.128 
and 801.4 to better reflect FDA's interpretation and application of 
these regulations. These changes would not reflect a change in FDA's 
approach regarding evidence of intended use for drugs and devices. 
These clarifying changes to the intended use regulations would apply to 
drugs and devices generally, and not just to products made or derived 
from tobacco and intended for human consumption.

III. Legal Authority

    Among the provisions of the FD&C Act that provide authority for 
this proposed rule are sections 201, 503(g), and 701(a) of the FD&C Act 
(21 U.S.C. 321, 353(g), 371(a)). Section 201 of the FD&C Act defines 
``drug,'' ``device,'' and ``tobacco product'' (subsections (g)(1), (h), 
and (rr)(1)), and section 503(g) of the FD&C Act provides that 
combination products are those ``that constitute a combination of a 
drug, device, or biological product.'' Under section 701(a) of the FD&C 
Act, FDA has authority to issue regulations for the efficient 
enforcement of the FD&C Act.
    FDA regulates the manufacture, sale, and distribution of drugs, 
devices, combination products, and tobacco products under the authority 
of the FD&C Act. Although the regulatory pathways for each product 
category differ, each product category is subject to similar types of 
regulatory requirements. For example, FDA's regulatory authority for 
drugs, devices, combination products, and tobacco products includes 
authority to review and authorize the marketing of new products as well 
as to oversee product labeling and advertising. Thus, whether a product 
meets the definition of a drug, device, or tobacco product under the 
FD&C Act and this proposed regulation, the manufacture, sale, and 
distribution of the product are subject to the applicable requirements 
of the FD&C Act.

IV. Description of Proposed Regulation

A. Exclusion From Tobacco Product Regulation (Proposed Sec.  1100.5)

    As described in section II of this document, the goal of this 
proposed rule, when finalized, is to provide clarity regarding the 
types of intended uses of products made or derived from tobacco that 
may fall within the drug/device definitions and therefore cause those 
products to be regulated as medical products under the FD&C Act. In 
describing these intended uses, the proposed rule aims to assist 
regulated entities in the research and development of products made or 
derived from tobacco by clarifying which regulatory framework (i.e., 
the drug/device frameworks or the tobacco framework) will apply to 
particular products based on their intended use. The proposed rule is 
also intended to reduce consumer confusion regarding which products are 
intended for medical use (i.e., as a drug, device, or combination 
product) and which may be marketed for recreational or other purposes. 
The proposed rule reflects the legal and regulatory considerations 
discussed in sections I and II of this document, including the Brown & 
Williamson and Sottera holdings. Finally, the proposed rule would amend 
the existing intended use regulations for drugs and devices by 
inserting in Sec. Sec.  201.128 and 801.4 a reference to Sec.  1100.5 
to clarify the interplay among these regulations and this proposed 
rule.
    The proposed codified language states the circumstances in which a 
product made or derived from tobacco would be excluded from the 
definition of ``tobacco product'' and be subject to regulation as a 
drug, device, or combination product. Under the proposed rule, this 
exclusion could apply in two circumstances: (1) If the product is 
intended for use in the diagnosis of disease or other conditions, or in 
the cure, mitigation, treatment, or prevention of disease; or (2) if 
the product is intended to affect the structure or any function of the 
body, in any way that is different from effects of nicotine that were 
commonly and legally claimed in the marketing of cigarettes and 
smokeless tobacco products prior to March 21, 2000.
    Conceptually, the proposed codified language follows the disease 
prong and the structure/function prong (with certain limitations) of 
the drug and device definitions.

1. Disease Prong

    Proposed Sec.  1100.5(a) follows the disease prong. The proposed 
paragraph elaborates on the statutory language for the disease prong by 
describing several categories of intended uses that would cause a 
product made or derived from tobacco to be regulated as a medical 
product. The categories identified in proposed Sec.  1100.5(a) are not 
intended to constitute an exhaustive list; nor are these categories 
necessarily mutually exclusive. In addition, these categories are 
intended to capture concepts, rather than to suggest that the use (or 
omission) of particular words is dispositive with respect to FDA's 
medical product jurisdiction. These categories are included as examples 
of types of intended uses that we believe are particularly relevant for 
products made or derived from tobacco and that fall within the disease 
prong.
2. Structure/Function Prong
    Proposed Sec.  1100.5(b) follows the structure/function prong, but 
with some changes to reflect the court decisions in Brown & Williamson 
and Sottera. Specifically, the language in proposed Sec.  1100.5(b) 
beginning ``in any way that is different from . . . '' reflects the 
fact that, under Brown & Williamson and Sottera, certain structure/
function claims about the effects of nicotine will not confer drug/
device jurisdiction to the extent they reflect those made for 
``customarily marketed'' tobacco products. This language also 
references ``the marketing of cigarettes and smokeless tobacco 
products'' because these were the product categories considered by the 
Supreme Court in Brown & Williamson. March 21, 2000, is the date of the 
Supreme Court's ruling in Brown & Williamson.

[[Page 57762]]

    FDA believes that it is important to include a date limitation in 
proposed Sec.  1100.5(b) to provide greater certainty about the 
universe of structure/function claims the Agency intends to consider 
when determining whether a product made or derived from tobacco is 
``customarily marketed.'' This bright-line limitation also avoids 
creating a shifting standard that will cause confusion among consumers 
and regulated industry. FDA intends to look to the marketing of 
cigarettes and smokeless tobacco products prior to March 21, 2000, to 
determine the types of structure/function claims that constitute 
customary tobacco product marketing. Examples of these types of claims 
include those related to satisfaction, pleasure, enjoyment, and 
refreshment (e.g., ``[Brand X] refreshes while you smoke''). Cigarettes 
and smokeless tobacco products provide a reasonable proxy for 
determining how nicotine-related structure/function claims were 
conveyed in tobacco product marketing generally. The proposed codified 
language, however, applies to all products made or derived from 
tobacco, not just cigarettes and smokeless tobacco. The proposed 
codified language also applies regardless of whether a product made or 
derived from tobacco has been deemed to be subject to the tobacco 
product authorities in the FD&C Act.
3. Intended Use
    As noted in section I.B.2 of this document, intended use may be 
determined from any relevant source and is not based solely on claims 
made in a product's labeling or advertising materials. For purposes of 
illustration, however, claims such as ``treatment of tobacco 
dependence,'' ``wean yourself off of nicotine,'' ``for people who wish 
to quit smoking,'' ``stop smoking aid,'' ``prevent relapse,'' or ``stay 
quit'' generally would fall within the intended uses described in 
proposed Sec.  1100.5(a).\10\
---------------------------------------------------------------------------

    \10\ These and other specific claims mentioned in this document 
are provided solely as examples. Other claims not mentioned in this 
document could also reflect an intended use described in the 
proposed codified language. In addition, as discussed elsewhere in 
this document, FDA intends to consider the full context of claims 
for products made or derived from tobacco in making jurisdictional 
determinations.
---------------------------------------------------------------------------

    Claims such as ``to reduce withdrawal symptoms,'' ``helps reduce 
symptoms including things like [list of withdrawal symptoms]'' and 
``relieve withdrawal symptoms while you are on the plane'' would be 
associated with an intended use for relief of nicotine withdrawal 
symptoms, and would also fall within the intended uses described in 
proposed Sec.  1100.5(a). Withdrawal symptoms that are medically 
recognized as relevant to nicotine addiction may be determined by 
reference to standard classification and diagnostic tools such as the 
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition 
(DSM-5) and the tenth revision of the International Statistical 
Classification of Diseases and Related Health Problems (ICD-10).
    Certain structure/function claims that were not commonly and 
legally made in the marketing of cigarettes and smokeless tobacco 
products before March 21, 2000, such as ``promotes weight loss,'' would 
fall within the intended uses described in proposed Sec.  1100.5(b).
    In contrast to the examples of medical product intended use claims 
given in the previous paragraphs, certain other claims made about 
products made or derived from tobacco would not on their own create an 
intended use that falls within the proposed codified language.\11\ For 
example, claims such as ``smoke free, spit free tobacco pleasure'' or 
``full taste and satisfaction'' may be associated with the marketing of 
tobacco products for refreshment, satisfaction, or enjoyment. Claims 
such as ``great tasting tobacco satisfaction when you can't smoke,'' 
``satisfying tobacco alternative,'' or ``provides the look, feel, and 
experience of a cigarette'' may be associated with the marketing of 
tobacco products as smoking substitutes. And claims such as ``healthier 
alternative to smoking,'' ``contains less nicotine than [another 
product],'' or ``reduces your risk of lung cancer compared to 
cigarettes'' might be associated with MRTPs, as discussed in section 
II.A of this document.
---------------------------------------------------------------------------

    \11\ As previously, the specific claims mentioned in this 
paragraph are provided solely as examples. Other claims not 
mentioned here could fall outside the intended uses described in 
proposed Sec.  1100.5.
---------------------------------------------------------------------------

    In addition, as discussed previously, a manufacturer's knowledge 
that an approved or cleared medical product is being used for an 
unapproved use, would not by itself establish a medical product 
intended use. To clarify FDA's policy on this point, as well as the 
interplay among Sec. Sec.  201.128, 801.4, and proposed 1100.5, FDA is 
proposing revisions to Sec. Sec.  201.128 and 801.4.
    For products made or derived from tobacco that are intended for 
investigational use, FDA will consider whether the product is being 
used in a clinical investigation for an intended use that brings it 
within the proposed codified language. If it is, the product would meet 
the definition of ``investigational new drug'' in Sec.  312.3 (21 CFR 
312.3), and the clinical investigation would be subject to the 
applicable requirements in 21 CFR part 312.\12\ Products made or 
derived from tobacco that are intended for investigational use but that 
do not meet the definition of ``investigational new drug'' in Sec.  
312.3 may be subject to regulation as investigational tobacco products 
under section 910(g) of the FD&C Act (21 U.S.C. 397j(g)). FDA 
encourages sponsors and researchers with questions about whether a 
product being used in a clinical investigation would be subject to 
regulation as an ``investigational new drug'' or as an 
``investigational tobacco product'' to contact either the Center for 
Drug Evaluation and Research or the Center for Tobacco Products.
---------------------------------------------------------------------------

    \12\ Note that studies performed to meet statutory requirements 
in chapter IX of the FD&C Act relating to the impact of tobacco 
products on cessation behavior are not required to be designed as 
clinical investigations subject to the investigational new drug 
application (IND) requirements in 21 CFR part 312. Whether a study 
is considered a clinical investigation of an ``investigational new 
drug'' would depend on the study's design and specific objectives.
---------------------------------------------------------------------------

B. Proposed Effective Date

    The Agency proposes that any final rule based on this proposal will 
become effective 30 days after the date of publication of the final 
rule in the Federal Register. During the pendency of this rulemaking, 
manufacturers will continue to be under an obligation to comply with 
all applicable provisions of the FD&C Act and applicable regulations.

V. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

VI. National Environmental Policy Act

    FDA has determined under 21 CFR 25.30(h) and (k) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore,

[[Page 57763]]

neither an environmental assessment nor an environmental impact 
statement is required.

VII. Analysis of Impacts

A. Introduction and Summary

1. Introduction
    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this proposed rule is not a 
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. By clarifying when products made or derived from 
tobacco will be subject to regulation as medical products, the 
ambiguity that currently exists in the regulatory environment will be 
reduced. We cannot predict how many companies will revise labeling, 
advertising, or other marketing materials for their products following 
issuance of this rule. We note, however, that this regulation is 
intended to provide clarity regarding existing jurisdictional lines for 
products made or derived from tobacco and for drug and device 
manufacturers regarding FDA's interpretation and application of its 
existing intended use regulations; as such, any need to revise 
labeling, advertising, or other marketing materials or submit 
applications should have predated the regulation. Therefore, the Agency 
proposes to certify that the proposed rule will not have a significant 
economic burden on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million (Ref. 1), using the most current (2014) 
Implicit Price Deflator for the Gross Domestic Product. FDA does not 
expect this proposed rule to result in any 1-year expenditure that 
would meet or exceed this amount.
2. Summary
    The proposed rule would reduce the ambiguity in the market for 
products made or derived from tobacco and clarify FDA's interpretation 
and application of its existing intended use regulations. The rule 
clarifies the types of claims and other evidence that would result in 
these products being regulated as medical products rather than tobacco 
products. The reduction in ambiguity should increase appropriate market 
participation and thus increase welfare in the market, including 
greater clarity and less confusion for producers and consumers. While 
these clarifications would impact future marketing strategies, it is 
not expected to result in significant changes to current marketing 
costs.

B. Preliminary Regulatory Impact Analysis

1. Benefits
    Adopting the proposed rule would clarify the regulatory status of 
products made or derived from tobacco and how FDA interprets and 
applies its existing intended use regulations. This is expected to 
reduce the ambiguity associated with submitting a new product for 
approval or marketing authorization, or with initiating research of a 
new product. It is expected that industries are ambiguity averse.
    Ambiguity aversion is preference of certainty over uncertainty 
(Ref. 2). It is assumed that industries developing and manufacturing 
products made or derived from tobacco prefer a regulatory environment 
with greater certainty than one with greater ambiguity. Previous 
research has shown that reduction in the uncertainty of financial 
markets increases participation by both traders and investors (Refs. 3 
and 4). The proposed rule is expected to reduce ambiguity, and this 
reduction in ambiguity will encourage investment and innovation.
2. Costs
    The proposed rule is not expected to impose significant additional 
costs on drugs, devices, or tobacco products. FDA's regulatory 
authority for drugs, devices, and tobacco products includes authority 
to review and authorize marketing of new products, as well as to 
oversee product labeling and advertising. Thus, whether a product meets 
the definition of a drug, device, or tobacco product under the FD&C Act 
and this proposed regulation, its manufacture, sale, and distribution 
is subject to the applicable requirements of the FD&C Act. Companies 
may revise marketing practices to conform to the rulemaking and to 
ensure they are incurring the appropriate costs for their product type. 
We do not have evidence that this will affect many currently marketed 
products and as such is unlikely to impose significant new costs.
    The proposed rule does not extend FDA's authority to additional 
products and it does not impose any additional labeling requirements on 
currently regulated products. The proposed rule does not change the way 
FDA regulates medical products or tobacco products; it clarifies the 
applicable regulatory framework for products made or derived from 
tobacco and FDA's interpretation and application of its existing 
intended use regulations. This will reduce ambiguity for firms 
potentially seeking marketing authorization for a product as a drug, 
device, or tobacco product, will assist those seeking to study products 
made or derived from tobacco, and will help consumers differentiate 
between products that are intended for medical use and products 
marketed for other uses.
3. Summary and Discussion
    The proposed rule is expected to reduce regulatory ambiguity in the 
research, development and marketing of drugs, devices, and tobacco 
products, as well as consumer confusion in the marketplace. The 
reduction in ambiguity will encourage investment and innovation. The 
proposed rule may affect marketing strategies, but is only clarifying 
when products made or derived from tobacco will be regulated as drugs 
or devices and FDA's interpretation and application of its existing 
intended use regulations. Accordingly, any costs to revise marketing 
strategies predated the rule, and as such the rule itself is not 
expected to impose significant costs.

C. Small Entities Effects

    The Regulatory Flexibility Act requires Agencies to prepare a 
regulatory flexibility analysis if a proposed rule would have a 
significant effect on a substantial number of small businesses, non-
profit organizations, local jurisdictions, or other entities. The 
proposed rule would reduce ambiguity in the regulatory environment for 
products made or derived from tobacco. We do not expect this 
clarification to significantly increase costs associated

[[Page 57764]]

with marketing products made or derived from tobacco, and thus certify 
that the proposed rule would not significantly affect a substantial 
number of small businesses, non-profit organizations, local 
jurisdictions, or other entities.

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

IX. Request for Comments

A. General Information About Submitting Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document.

B. Public Availability of Comments

    Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov. As a matter of Agency 
practice, FDA generally does not post comments submitted by individuals 
in their individual capacity on http://www.regulations.gov. This is 
determined by information indicating that the submission is written by 
an individual, for example, the comment is identified with the category 
``Individual Consumer'' under the field titled ``Category (Required),'' 
on the ``Your Information'' page on http://www.regulations.gov. For 
this proposed rule, however, FDA will not be following this general 
practice. Instead, FDA will post on http://www.regulations.gov comments 
to this docket that have been submitted by individuals in their 
individual capacity. If you wish to submit any information under a 
claim of confidentiality, please refer to 21 CFR 10.20.

C. Information Identifying the Person Submitting the Comment

    Please note that your name, contact information, and other 
information identifying you will be posted on http://www.regulations.gov if you include that information in the body of your 
comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://www.regulations.gov along with your state/province and country (if 
provided), the name of your representative (if any), and the category 
identifying you (e.g., individual, consumer, academic, industry). For 
written submissions submitted to the Division of Dockets Management, 
FDA will post the body of your comments on http://www.regulations.gov, 
but you can put your name and/or contact information on a separate 
cover sheet and not in the body of your comments.

X. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and 
are available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

1. U.S. Department of Commerce, Bureau of Economic Analysis. 
National Income and ProductAccounts, Table 1.1.9 Implicit Price 
Deflators for Gross Domestic Product, December 23, 2014 (http://www.bea.gov/national/Index.htm#gdp).
2. Ellsberg, D. ``Risk, Ambiguity, and the Savage Axioms.'' The 
Quarterly Journal of Economics 75, no. 4: 643-669, November 1961.
3. Easley, D., and M. O'Hara. ``Ambiguity and Nonparticipation: The 
Role of Regulation.'' Review of Financial Studies 22, no. 5: 1817-
1843, 2009.
4. Dimmock, S. G., R. Kouwenberg, O. S. Mitchell, et al. ``Ambiguity 
Aversion and Household Portfolio Choice: Empirical Evidence.'' NBER 
Working Paper Series, Working Paper 18743, January 2013.
5. Defendant's Memorandum of Points and Authorities In Support of 
Motion to Dismiss or Summary Judgment. Allergan Inc., v. United 
States of America, et. al., 1:09-cv-01879-JDB (D.D.C. Jan. 11, 
2010).

List of Subjects

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 1100

    Combination products, Devices, Drugs, Smoking, Tobacco.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR chapter I be amended as follows:

PART 201--LABELING

0
1. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

0
2. Revise Sec.  201.128 to read as follows:


Sec.  201.128  Meaning of ``intended uses''.

    The words intended uses or words of similar import in Sec. Sec.  
201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this 
chapter refer to the objective intent of the persons legally 
responsible for the labeling of drugs. The intent is determined by such 
persons' expressions or may be shown by the circumstances surrounding 
the distribution of the article. This objective intent may, for 
example, be shown by labeling claims, advertising matter, or oral or 
written statements by such persons or their representatives. It may be 
shown, for example, by circumstances in which the article is, with the 
knowledge of such persons or their representatives, offered and used 
for a purpose for which it is neither labeled nor advertised. The 
intended uses of an article may change after it has been introduced 
into interstate commerce by its manufacturer. If, for example, a 
packer, distributor, or seller intends an article for different uses 
than those intended by the person from whom he received the drug, such 
packer, distributor, or seller is required to supply adequate labeling 
in accordance with the new intended uses.

PART 801--LABELING

0
3. The authority citation for 21 CFR part 801 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

0
4. Revise Sec.  801.4 to read as follows:


Sec.  801.4  Meaning of intended uses.

    The words intended uses or words of similar import in Sec. Sec.  
801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the 
objective intent of the persons legally responsible for the labeling of 
devices. The intent is determined by such persons' expressions or may 
be shown by the circumstances surrounding the distribution of the 
article. This objective intent may, for example, be shown by labeling 
claims, advertising matter, or oral or written statements by such 
persons or their representatives. It may be shown, for example, by 
circumstances in which the article is, with the knowledge of such

[[Page 57765]]

persons or their representatives, offered and used for a purpose for 
which it is neither labeled nor advertised. The intended uses of an 
article may change after it has been introduced into interstate 
commerce by its manufacturer. If, for example, a packer, distributor, 
or seller intends an article for different uses than those intended by 
the person from whom he received the device, such packer, distributor, 
or seller is required to supply adequate labeling in accordance with 
the new intended uses.

PART 1100--TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY

0
5. The authority citation for 21 CFR part 1100 continues to read as 
follows:

    Authority:  21 U.S.C. 387a(b), 387f(d); Secs. 901(b) and 906(d), 
Pub. L. 111-31; 21 CFR 16.1 and 1107.1; 21 CFR 1.1, 1.20, 14.55, 
17.1, and 17.2. Section 1100.5 is issued under 21 U.S.C. 321, 
353(g), and 371(a); 21 CFR 1.1.

0
6. Part 1100, as proposed to be added on April 25, 2014 (79 FR 23142 at 
23202), is amended by adding Sec.  1100.5 to read as follows:


Sec.  1100.5  Exclusion from tobacco regulation.

    If a product made or derived from tobacco that is intended for 
human consumption is intended for use for any of the purposes described 
in paragraph (a) or (b) of this section, the product is not a tobacco 
product as defined in section 201(rr) of the Federal Food, Drug, and 
Cosmetic Act and will be subject to regulation as a drug, device, or 
combination product.
    (a) The product is intended for use in the diagnosis of disease or 
other conditions, or in the cure, mitigation, treatment or prevention 
of disease, including use in smoking cessation, the cure or treatment 
of nicotine addiction, relapse prevention, relief of nicotine 
withdrawal symptoms, or prevention or mitigation of disease;
    (b) The product is intended to affect the structure or any function 
of the body in any way that is different from effects related to 
nicotine that were commonly and legally claimed in the marketing of 
cigarettes and smokeless tobacco products prior to March 21, 2000.

    Dated: September 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24313 Filed 9-24-15; 8:45 am]
BILLING CODE 4164-01-P