Alcohol Beverage and Non-Beverage Alcohol Products

Keller and Heckman’s Alcohol Beverage and Non-Beverage Alcohol Products practice counsels global clients in producing, distributing, marketing, and selling their products while ensuring compliance with a complex range of statutes and regulations. We leverage the firm’s international legal resources and scientific acumen to successfully support our global alcohol industry clientele. 

The legal and regulatory requirements for alcohol beverage and non-beverage alcohol products are complex and unique. In the U.S., they are subject to the overlapping jurisdiction of the Alcohol and Tobacco Tax and Trade Bureau (TTB), the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the U.S. Environmental Protection Agency (EPA). In the European Union (EU), strict and specific requirements are laid down for the marketing of alcoholic beverages, their composition and production, their labeling, as well as the protection of related geographical indications.

Keller and Heckman’s attorneys and scientists frequently communicate with the responsible institutions and agencies in the relevant jurisdictions and regularly assist clients in navigating this heavily regulated product category. Our clients include manufacturers, importers, wholesalers, distributors, and retailers of virtually all products containing alcohol, including clients who manufacture alcohol as a byproduct of another process.

Alcohol Beverages

Keller and Heckman attorneys and scientists have in-depth experience in ensuring that clients in the alcohol industry comply with the laws and regulations administered by TTB, FDA, USDA, and those adopted in the EU. We represent a multitude of entities in this space, including spirits producers, breweries, wineries, distilleries, wholesalers, and importers. Clients rely on Keller and Heckman’s extensive knowledge in preparing submissions to Federal and State regulators and to the European Commission and European Food Safety Authority (EFSA) on a variety of related matters.

Representative Matters

• Advised on the production, importation, and distribution of wine, beer, and distilled spirits
• Gained TTB and FDA approval/clearance for manufacturing equipment and materials used to produce alcohol, including material for distilled spirits containers
• Prepared and submitted Generally Recognized as Safe (GRAS) notices to FDA and companion applications to TTB for wine and beer processing aids and ingredients
• Established suitable FDA status of synthetic closures for wine and evaluated the use of emulsifiers for use in the fermentation pot in the manufacture of sugar cane alcohol
• Gained TTB approval for beverage alcohol formulas, wine manufacturing processes, beer adjuncts, and wine treating materials
• Complied with provisions governing cutting-edge products such as ready-to-drink canned cocktails and other alcopops, flavored alcohol, low-to-no alcohol beverages, and beverages infused with hemp and CBD
• Obtained and maintained U.S. Federal, State, and EU Member State registrations or approvals, operating permits, and licenses for facilities used to import, produce, distribute, and sell distilled spirits, and complied with recordkeeping requirements for these registrations, permits, and licenses 
• Ensured alcohol labels and advertisements comply with all applicable U.S. Federal (TTB and FDA labeling requirements, where applicable), State, and Municipal requirements, as well as EU and international requirements, including provisions regulating use of health claims, allergen claims, nutrition claims, organic claims, allusions, and compound terms
• Provided due diligence review for corporate mergers and acquisitions of companies that handle alcohol beverage or non-beverage alcohol products to ensure compliance with Federal, State, and local requirements, including the consideration of applicable trade practice laws and possible tied-house violations 
• Complied with EU regulatory market access requirements concerning the use of certain raw materials to produce distillates used in the production of alcoholic beverages
• Prepared legal arguments when EU Member State national import bans on alcoholic drinks based on purported ingredient safety concerns contradicted relevant EU regulatory requirements
• Protected trademarks, copyrights, patents, and geographical indications against intellectual property violations, and confirmed labels comply with provisions pertaining to American Viticultural Areas
• Ensured accurate and regular payment of customs duties, fees, and excise taxes, including under the Craft Beverage Modernization Act (CBMA)

Non-Beverage Alcohol (Ethanol)

Keller and Heckman attorneys, many with technical backgrounds, have in-depth knowledge of the industries – such as foods, drugs, cosmetics, solvents, pesticides, and fuels – that use alcohol, including specially denatured alcohol and completely denatured alcohol. Our attorneys and scientists prepare and submit applications to TTB and state regulators to: 

• Obtain registrations and operating permits for traditional distilled spirits plants, experimental distilled spirits plants, and alcohol fuel plants
• Obtain industrial alcohol permits for the use of specially denatured alcohol and tax-free alcohol
• Advise clients on excise tax compliance issues, formulation submissions, non-beverage drawback procedures, and compliance with the recordkeeping and other regulatory requirements applicable to the day-to-day operation of permitted facilities
• Assist clients in negotiating ethanol production and distribution agreements