§387a Fda Authority Over Tobacco Products

Summary

The FDA must regulate tobacco products under this part and not under subchapter V. That includes modified‑risk tobacco products that have an order under section 387k. The rules cover cigarettes, cigarette tobacco, roll‑your‑own tobacco, smokeless tobacco, any other tobacco products the FDA decides to include, and any product with nicotine that is not made or derived from tobacco. The rules do not change the FDA’s authority over products that are not tobacco products under other parts of the law. Tobacco leaf and growers are generally not covered when the leaf is not held by a tobacco product manufacturer. Growers, warehouses, and grower cooperatives are not covered, and FDA employees may not enter a farm without the grower’s written consent. If a producer is also a tobacco product manufacturer or controlled by one, that producer is covered as a manufacturer; contract growers who only grow under contract and do not take part in manufacturing are not covered. The FDA cannot make rules about growing tobacco leaf or growers except for manufacturer actions that affect production. All rulemaking must follow chapter 5 of title 5, and this does not change the special rulemaking rules in section 102(a) of the Family Smoking Prevention and Tobacco Control Act. Within 90 days after June 22, 2009, the FDA must create a Center for Tobacco Products to run these programs and report to the Commissioner. The FDA must also set up an office to give technical and other nonfinancial help to small tobacco product manufacturers. Before making rules, the FDA should try to consult other federal agencies.