FDA Tobacco Regulation Update: FDA announces first substantial equivalence decisions for tobacco products

On June 25, 2013, the FDA announced that for the first time since the passage of the Family Smoking Prevention and Tobacco Control Act, which granted the agency the authority to regulate cigarettes and other tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence pathway. A copy of the FDA’s press release can be read here.

While the FDA does not “approve” tobacco products as it would drugs, it does regulate which products may be marketed through the Tobacco Control Act. If FDA determines a new tobacco product meets the relevant legal requirements, FDA will issue a written notification permitting the marketing of the new tobacco product. Under the Tobacco Control Act, tobacco manufacturers may use one of three pathways when seeking to market “new tobacco products.” [A “new tobacco product” is a product that was not sold in the United States prior to February 15, 2007. Also any modification made to tobacco products which were in existence as of February 15, 2007 reclassifies the product as a “new tobacco product.”] These pathways are: 1) premarket review and approval; 2) substantial equivalence; or 3) exemption from substantial equivalence regulation. An overview of these pathways can be read on the FDA’s website here.

Generally speaking, pursuant to section 910 of the Food, Drug, and Cosmetic Act, prior to marketing a new tobacco product a manufacturer must submit a premarket tobacco product application and receive an order authorizing marketing from the FDA. The FDA’s traditional “safe and effective” standard for evaluating drugs does not apply to tobacco. Rather, premarket approval requires the applicant to demonstrate that the FDA permitting the marketing of the new tobacco product would be “appropriate for the protection of the public health.” The statute provides that the basis for this finding shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account: 1) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and 2) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

Premarket approval is required unless pursuant to section 905(j), 1) the manufacturer submits a report (known as a “905(j)” report) and is granted an order finding that its product is substantially equivalent to a tobacco product marketed in the U.S. prior to February 15, 2007; or 2) the tobacco product is exempt from the requirements of section 905(j) pursuant to a regulation issued under 905(j)(3). A new tobacco product is “substantially equivalent” to a predict tobacco product if the FDA has found that the new product:

  • Has the same characteristics as the predicate product; (“characteristics” means the materials, ingredients, design, composition, heating source, or other features of a tobacco product), or
  • Has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under section 910 because the product does not raise different questions of public health.

It should be noted that a new tobacco product may not be found to be substantially equivalent to a predicate tobacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated. The FDA has published additional guidance on 905(j) reports which can be read here. While similar to the scheme established for approval of medical devices there are some slight differences. The most glaring difference between tobacco product and medical device substantial equivalence determinations is that tobacco products may only rely on one predicate product whereas a medical device is free to use more than one predicate device to establish substantial equivalence.

The final pathway to marketing tobacco products is through the granting of an exemption from substantial equivalence by the FDA. Pursuant to 21 C.F.R. § 1107.1, the FDA may exempt  products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive if: 1) such modification would be a minor modification of a legally marketed tobacco product; 2) a 905(j) report is not necessary to ensure that permitting marketing would be appropriate for the protection of the public health; and 3) an exemption is otherwise appropriate.

While the FDA now plays an increased role in the regulation of tobacco products, it is important to note that tobacco product regulation in the United States also involves the U.S. Customs and Border Protection (CBP) and the U.S. Department of the Treasury, Alcohol, Tobacco, Tax and Trade Bureau (TTB). Additionally, the Department of Justice, Office of Consumer Protection Litigation (OCPL) regulates Cigarette labeling and advertising, and the Bureau of Alcohol, Tobacco, and Firearms (ATF) investigates and enforces interstate trafficking of contraband cigarettes. State laws may also be implicated.