Proposed rule describes circumstances in which a product "made or derived from tobacco" will be subject to a non-tobacco product regulatory scheme

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:

  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, 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
  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 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.