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Alcohol/Tobacco Regulation

There are many federal and state agencies that extensively regulate the alcohol and tobacco industries.

ALCOHOL REGULATION

All alcoholic beverages are considered “foods” under the Federal Food, Drug and Cosmetic Act (FDCA), therefore subjecting them to U.S. Food and Drug Administration (FDA) regulations.

However, importing, distributing, label and labeling, product composition and permit requirements for alcohol products is also regulated by the Bureau of Alcohol Tobacco and Firearms (BATF) Alcohol and Tobacco Tax and Trade Bureau (TTB). All actors in the supply chain – including distributors, wholesalers, importers, warehouses, breweries, wineries, manufacturers, and distillers – must adhere to TTB permitting and regulatory requirements before beginning operations in the United States. These actors must also navigate specific requirements imposed by each state.

TOBACCO REGULATION

The Family Smoking Prevention and Tobacco Control Act of 2009 (TCA) and Federal Cigarette Labeling and Advertising Act (FCLAA) impose many requirements on the tobacco industry, and gives FDA and TTB broad regulatory powers. These requirements include: registration; tobacco ingredient and nicotine level reports; warnings; and label and advertising claim restrictions.

These agencies also have the authority to restrict use of flavors, nicotine, additives and ingredients. TTB requires all actors in the supply chain to obtain permits in order to sell their product in the United States. There are many different kinds of permits, and they differ based on the specific operation performed by a specific entity in the supply chain. Additionally, FDA imposes registration requirements on these actors. There are various state and local permitting requirements that must be addressed as well. These requirements must be met before bringing a product to market in the United States.

E-CIGARETTE REGULATION

Currently, FDA does not regulate e-cigarettes, as it has not yet extended its authority to regulate new forms of tobacco products, such as e-cigarettes, certain dissolvables that are not “smokeless tobacco,” gels and water pipe tobacco. While the agency has been slow to extend this authority – it will happen very soon. FDA submitted proposed regulations to the White House for review that would allow the agency to regulate e-cigarettes in much of the same way as it regulates regular cigarettes (gaining regulatory authority over e-cigarettes due to the use of nicotine derived from tobacco). This will have significant impact on this rapidly growing industry, as we know FDA and public health officials - on all levels - are becoming increasingly concerned with the potential risks of e-cigarettes and their various chemicals.

Our advisors are up to date on the alcohol and tobacco regulatory burdens, including the impending regulations for the e-cigarette industry. We can assist with:

  • Label and labeling reviews and submissions, including Certificate of Label Approval (COLA) submissions for alcoholic beverages
  • Federal and state registration and permitting requirements
  • Product composition regulatory requirements
  • Premarket review of new products
  • Registration and U.S. agent requirements
  • Guidance related to new e-cigarette regulatory proposals
  • Audits of your operations and associated risk assessment related to non-compliance
  • Ingredient safety reviews, including managing communications between FDA and TTB regarding various ingredients
  • New Dietary Ingredient premarket notification submission and requirements

For more information, please contact one of the following Alcohol/Tobacco Regulation attorneys.