The Family Smoking Prevention and Tobacco Control Act, passed in 2009, gives the U.S. Food and Drug Administration authority to authorize tobacco products for sale. To date, the FDA has authorized 48 e-cigarette products and 43 nicotine pouches, among other tobacco products. In May 2026, however, the agency issued a guidance stating that it does not intend to pursue enforcement against e-cigarettes and nicotine pouches for which applications have been filed, subject to limited exceptions, an action that likely extends to thousands of products.

This matters because young people are more likely to use e-cigarettes and nicotine pouches than other tobacco products, especially those with flavors. While the agency has authorized numerous flavors of nicotine pouches, it has only authorized e-cigarettes in a few flavors. The May 2026 guidance marks a notable shift by the FDA toward permitting the sale of flavored tobacco products. This is despite the skepticism the FDA previously signaled toward flavors because of the risk of youth appeal, as in another guidance earlier this year.

The Campaign for Tobacco-Free Kids, several public health organizations and medical associations, a pediatrician, and a parent of youth addicted to nicotine filed suit on July 14, 2026, challenging the FDA’s guidance. The plaintiffs argue that the guidance violates the Tobacco Control Act by allowing unauthorized products to be sold, violates the Administrative Procedure Act because it was published without notice and comment, and is arbitrary and capricious because it provides no justification for creating a safe harbor for unauthorized products and changing the agency’s approach to flavored products.

On October 16, 2026, the Public Health Law Center filed an amicus brief in support of the plaintiffs’ motion for summary judgment, which requests that the court vacate the guidance and declare it contrary to law. The brief draws on the statutory text and legislative history of the Tobacco Control Act to argue that the FDA’s guidance is incompatible with congressional intent. First, the plain language of the statute reveals that Congress refused to allow an indefinite grace period for products with pending applications when it amended the Act to include synthetic nicotine in 2022. Second, Congress deliberately made premarket review for new tobacco products a core provision of the Tobacco Control Act. Premarket review was part of the earliest legislative precursor to the Act in 1997, and it remained in subsequent congressional drafts until the legislation was passed into law.

To stay up to date on this case, see the summary of it in the Center’s litigation tracker.

Luke I. Haqq, Staff Attorney
October 21, 2026