Tobacco
In June 2009, the Family Smoking Prevention Tobacco Control Act (the Tobacco Act) became law, giving the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products. Pursuant to the new legislation, FDA, through its Center for Tobacco Products (CTP), has the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco and any other tobacco products (OTPs) deemed by regulation to be subject to the Tobacco Act. OTPs that FDA will likely deem subject to the new law in the near future include cigars, electronic cigarettes, and dissolvable tobacco.
The Tobacco Act establishes numerous new pre-market review, ingredient disclosure, labeling, manufacture, distribution, advertising, modified risk, and safety data requirements, among others, for manufacturers and importers of regulated tobacco products. Our attorneys and scientists work with clients to assist them with developing plans for meeting the new FDA requirements.
Keller and Heckman's comprehensive and extensive experience dealing with the regulation of food, drug, medical device and dietary supplements before the FDA uniquely positions us to guide tobacco product companies through the myriad of new FDA requirements for tobacco products. We provide legal and scientific support to tobacco product companies and their suppliers with respect to the statutory and regulatory requirements specifically imposed by the Tobacco Act, including:
- Ingredient, additive, and harmful and potentially harmful constituent disclosure requirements;
- Health document submissions;
- Manufacturing facility registration;
- Good Manufacturing Practice guidance;
- Substantial equivalency determinations and exemptions;
- New Tobacco Product applications;
- Modified Risk Tobacco Product applications;
- Labeling requirements;
- Retailer Compliance Issues; and
- Tobacco product testing requirements.
Since the law's enactment, attorneys and scientists at Keller and Heckman have followed the development and litigation of the Tobacco Act, and continue to monitor the development of FDA Guidance Documents and implementing regulations. In particular, we are carefully tracking legislative and regulatory developments related to the possible regulation of the big and little cigar industries, electronic cigarettes, and other novel tobacco products. Our attorneys and scientists also participate in tobacco industry meetings, FDA-sponsored workshops, and actively contribute to the Food, Drug Law Institute (FDLI) Tobacco Law, Regulation & Policy Resource Center. In particular, several of our attorneys contributed to FDLI's recent publication, Tobacco Regulation and Compliance: An Essential Resource.