FDA Issues Final Rule on Tobacco 21

The U.S. Food and Drug Administration (FDA) issued a final rule on the prohibition of sale of tobacco products to persons younger than 21 years of age. Today’s action by FDA is the agency’s effort to align with the Further Consolidated Appropriations Act of 2020 (FCAA). This final rule includes:

1. 1. Increasing the minimum age of sale for cigarettes, smokeless tobacco, and covered tobacco products from 18 to 21 years of age.
   2. Increasing the minimum age for age verification with photo ID from under 27 to under 30.
   3. Raising the minimum age for individuals allowed in facilities with vending machines selling tobacco products from 18 to 21.
   4. Raising the minimum age for individuals allowed in facilities with self-service displays selling tobacco products from 18 to 21.

This final rule was expected, as the agency was under a mandate to conform to the FCAA. The most important takeaway from this final rule, however, is that FDA has been very precise in their language in conforming to the FCAA.

This precision is likely a reflection of post-Loper hesitance by agencies to stray from explicit legislative guidance to avoid future legal challenges under the new Loper standard.

Additionally, this final rule directly alludes to applicability limitations to only “covered” products under their purview. The term ‘covered’ here is likely a direct call-out to premium cigars not being currently regulated by FDA as a result of the August 9, 2023 decision by the U.S. District Court to vacate FDA regulatory authority over the product class.

Press release by CRA