Kleinfeld, Kaplan & Becker represents clients in the tobacco and nicotine industry on matters of compliance arising under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA), the Comprehensive Smokeless Tobacco Health and Education Act, the Federal Cigarette Labeling and Advertising Act, the Internal Revenue Code, the Prevent All Cigarette Trafficking Act (PACT Act), and other federal, state, and local laws regulating the manufacture, labeling, promotion, distribution, taxation, importation, exportation, and sale of tobacco products.
Our firm has been closely involved with regulators throughout the development of tobacco product regulations and guidelines by engaging in meetings with the FDA Center for Tobacco Products (CTP), the White House Office of Management and Budget (OMB), and the Government Accountability Office (GAO), and by submission of correspondence and comments. We were instrumental in drafting the TCA Small Business provisions and actively represented small business interests during the development process of the so-called “deeming regulation.”
Approval and Marketing Requirements
Our firm provides advice on all aspects of tobacco product premarket review and other TCA marketing requirements, including issues related to:
- Substantial Equivalence Reports and Exemptions
- Modified Risk Tobacco Product Applications
- Premarket Tobacco Applications (PMTAs)
- Ingredient, health document, and harmful and potentially harmful constituent submissions
- Establishment registration and product listing
- User fees
In addition, we assist clients in deciding whether a tobacco- or nicotine-containing product qualifies for regulation under the FFDCA as a tobacco product, a drug, or a drug-delivery product. Based on the determination, we then direct manufacturers, distributors and importers through the steps needed to market their products.
Delivery Sales & MSA
Our firm has considerable experience in all areas of the regulation of delivery sales of tobacco products. We frequently advise on issues related to:
- Registration and reporting requirements
- Shipping tobacco products into and within the United States
- The PACT Act’s taxation provisions
- Compliance with the Tobacco Master Settlement Agreement (MSA) and the settling states’ so-called MSA complementary statutes, as well as other state and local requirements applicable to tobacco products.
Labeling and Advertising
Our firm advises on all aspects of tobacco-related product labeling and advertising, including wording and formatting of elements required to appear on product packaging and advertisements (such as warnings). We also advise our clients on advertising campaigns and promotional activities related to tobacco products, including websites and social media. For example, we help clients evaluate if claims could be interpreted as causing a product to be a modified risk tobacco product, the marketing of which requires an order from the FDA, or could subject the product to FDA regulation as a drug, device, or combination product. We have also worked extensively with electronic cigarette and vapor products, including the development and review of advertising copy and claim substantiation.
Our firm represents clients in responding to enforcement actions by FDA and other federal, state, and local regulatory agencies relevant to tobacco activities, including FDA Warning Letters and Inspectional Observations (FDA Form 483).