On January 9, 2017, the Food and Drug Administration (FDA) released a final rule describing when a tobacco product intended for human consumption is subject to regulation as a drug, device, or a combination product under the Food, Drug, and Cosmetic Act (FDCA) (Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products, 82 Fed. Reg. 2193-05 (Jan. 9, 2017)).

The FDA regulates tobacco products under the FDCA, as amended by the Family Smoking Prevention and Tobacco Control Act. The FDCA defines "tobacco product" to include any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (21 U.S.C. § 321(rr)). However, this definition does not include any article that is a drug, device, or combination product, which are regulated under different provisions of the FDCA. This rule clarifies the circumstances when the FDA would regulate a product that is made or derived from tobacco as either:

Under this final rule a product made or derived from tobacco and intended for human consumption is regulated as a drug, device, or combination product if the product is intended either:

This final rule generally follows the disease prong and the structure/function prong of the statutory definitions of drug and device (see Practice Note, FDA Medical Devices Regulations: FDA Classifications for Medical Devices).

This rule becomes effective on February 8, 2017.

For more information on tobacco regulations, see Practice Notes, Advertising: Overview: Industry Specific Regulation: Tobacco and Online Advertising and Marketing: Legal Regulation of Online Advertising and Marketing: Tobacco Products.

For more information on the FDA's regulations for medical devices and drugs, see Practice Note, FDA Medical Devices Regulations and Medicinal product regulation and product liability in the United States: overview.

To determine a product's intended use under this rule and the FDCA, the FDA can consider any relevant source, including the product's labeling, promotional claims, and advertising.

This rule clarifies that the FDA is not bound by the manufacturer's or distributor's subjective claims of intent. The agency can also consider objective evidence, including:

For more information on advertising and product labeling, see Practice Note, Advertising: Overview and Legal Update, Watch that Label: An Introduction to Product Labeling and Advertising.

On February 7, 2017, the FDA announced that the effective date of this rule would be delayed from February 8, 2017, to March 21, 2017. The delay is in accordance with the January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review." The memorandum directs the heads of Executive Departments and Agencies to temporarily postpone the effective date of regulations that have been published but not yet implemented, to allow the new administration to review questions of fact, law, and policy.

On March 20, 2017, the FDA announced the further delay of the effective date of this rule until March 19, 2018. The FDA has further delayed the effective date to reconsider the meaning of "intended uses" and invite the public to comment on the rule.