Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER IX — TOBACCO PRODUCTS › § 387d
Tobacco product manufacturers and importers must give the Secretary certain information about their products. Within 6 months after June 22, 2009, they must list all ingredients (including tobacco, additives, paper, and filter) and the amount by brand and subbrand. They must report nicotine content in milligrams per product under the Secretary’s rules. Starting 3 years after June 22, 2009, they must list all constituents the Secretary has identified as harmful or potentially harmful (and the amounts) in each product and in the smoke, and follow any related reporting rules. Starting 6 months after June 22, 2009, they must provide any documents created after that date about health, toxicology, behavior, or physiological effects of their products, ingredients, or additives. At the Secretary’s request, they must also give research documents on health effects, possible risk-reduction technology, and marketing research. Importers of products made outside the U.S. must provide the same information. For timing and changes: new products not on the market June 22, 2009 must have the required information provided at least 90 days before being sold across state lines. If a manufacturer adds or increases an additive, it must notify the Secretary in writing at least 90 days before. If it removes or decreases an additive, or adds/increases an additive the Secretary has said is not harmful, it must notify the Secretary within 60 days. The Secretary must create a public list of harmful and potentially harmful constituents within 24 months after June 22, 2009, publish that list in plain form not later than 3 years after that date and annually after, do consumer testing, and report results and recommendations to Congress within 5 years after June 22, 2009.
Full Legal Text
Food and Drugs, Source: USLM XML via OLRC
Legislative History
Reference
Citation
21 U.S.C. § 387d
Title 21, Food and Drugs
Last Updated
Sep 22, 2026
Release point: 119-110