FDA: Tobacco

Overview

The regulatory world surrounding tobacco and its progeny grows more tangled every day. We can guide you through the clearest legal path so that you can concentrate on what’s most important to your business.

We advise clients whose products are involved in growing, manufacturing, marketing, and retailing of tobacco and nicotine-containing products, including cigarettes, cigars, hookah, smokeless tobacco, e-liquids, e-cigarettes and other electronic nicotine delivery systems (ENDS), synthetic nicotine, pouches, and lozenges.

We guide you through Food and Drug Administration (FDA) premarket authorization requirements, including premarket tobacco product applications (PMTAs), substantial equivalence (SE) reports, and requests for exemption from substantial equivalence. We advise on the marketing and labeling of tobacco products. We help you create and maintain manufacturing practices that meet the requirements set by the FDA and help make sure that your products meet all necessary standards for market entry and beyond.

Our attorneys also handle enforcement actions and investigations by state and federal regulators, including compliance with the 1998 Tobacco Master Settlement Agreement (MSA) and the Family Smoking Prevention and Tobacco Control Act of 2009.

Experience

• Achieved a settlement on behalf of a manufacturer of hookah tobacco for more than a 95% reduction in the civil money penalty levied by the Food and Drug Administration. 
• Counseled on compliance with the Family Smoking Prevention and Tobacco Control Act and related interpretations administered by the FDA. 
• Advised a delivery platform on the federal and state laws that regulate the delivery of tobacco-related products.
• Assisted in obtaining FDA reversal of a refusal to accept substantial equivalence applications for hookah tobacco products.
• Assisted a tobacco retailer with FDA regulatory matters involving its tobacco and e-cigarette products.
• Provided legal and regulatory counsel on compliance with the Family Smoking Prevention and Tobacco Control Act.
• Advised on compliance before the FDA on the development, manufacture, and marketing of an accessory filter for use with electronic nicotine delivery systems (ENDS).
• Provided legal and regulatory counsel on business relationships involving the development and marketing of electronic cigarettes.
• Assisted makers and importers of tobacco products in conducting recalls.