§387a FDA authority over tobacco products

Summary

The Food and Drug Administration must regulate tobacco products under this part. That includes cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other products the FDA says belong here. It also covers tobacco products that claim lower risk if the FDA has issued an order under section 387k, and any product with nicotine that is not made or taken from tobacco. These products are not covered by subchapter V. The FDA’s rulemaking must follow the normal federal rule process (chapter 5 of title 5). The law does not change how the FDA regulates non-tobacco products under other laws. Tobacco leaf and tobacco growers are not covered unless they are also tobacco product manufacturers or controlled by one; a grower who only grows under contract and does not make products is not covered. FDA staff may not enter a tobacco farm without the grower’s written consent. Within 90 days after June 22, 2009, the FDA had to set up a Center for Tobacco Products to run this program. The FDA must also have an office to help small tobacco product makers with technical, nonmoney help, and it should try to consult other federal agencies before making rules.