The U.S. Food and Drug Administration (FDA) has issued a proposed rule
describing the circumstances in which a product made or derived
from tobacco 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).
The FD&C Act, as amended by the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act), provides FDA with the
authority to regulate tobacco products. A "tobacco
product" is any product intended for human use that is made or
derived from tobacco and that is not a drug, device, or combination
product. Drugs, devices, and combination products are subject to
differing regulatory requirements.
The Proposed Rule provides that a product made or derived from
tobacco and intended for human consumption would be regulated as a
drug, device, or combination product rather than as a tobacco
product in two circumstances:
- 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, 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"; or
- 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 first exclusion from tobacco regulation is based on the
"disease prong" of the statutory definitions for drug and
device, but adds specific references to smoking cessation, nicotine
addiction, relapse prevention, and relief of nicotine withdrawal
symptoms. The Agency states in the preamble of the Proposed Rule
that smoking cessation claims "generally create a strong
suggestion of therapeutic benefit to the user" and that such
claims "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." FDA also discusses the distinction
between disease prong claims and modified risk claims for tobacco
products under section 911(b)(1) of the FD&C Act, which relate
to reductions in risk rather than treatment or mitigation of
disease.
The second exclusion from tobacco regulation is based on the
"structure/function prong" of the drug and device
definitions, but provides that the exclusion will not apply to
effects of nicotine that were commonly and legally claimed in the
marketing of cigarettes and smokeless tobacco products prior to
March 21, 2000. This limitation is based on court decisions
restricting FDA's jurisdiction over tobacco products. See
Brown & Williamson Tobacco Corp., 529 U.S. 120, 156
(2000); Sottera, Inc. v. Food & Drug Administration,
627 F.3d 891 (D.C. Cir. 2010). The preamble to the Proposed Rule
provides numerous examples of claims that would fall into one
category or the other. For instance, euphemisms for nicotine effect
(e.g., satisfaction, pleasure, enjoyment, and refreshment
(e.g., "[Brand X] refreshes while you smoke")
and claims related to nicotine content as an alternative to smoking
(e.g., "satisfying smoking alternative,"
"provides all the pleasure of smoking," "get your
nicotine fix," or "provides smokers the same delight,
physical and emotional feelings") would not subject a product
to regulation as a drug, device, or combination product. Claims
such as "maintain healthy lung function," "relieve
tension," "restore mental alertness," "maintain
memory," "support the immune system," or
"promote weight loss" would subject a product to
regulation as a drug, device, or combination product.
If you have questions regarding the issues raised in this alert, or
if you would like to submit comments to FDA regarding the Proposed
Rule, please contact one of the authors.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.