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Distillery Requirements Under FSMA

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Distilleries & the Food Safety Modernization Act

Distilleries are now required to register with the Food & Drug Administration (FDA) as a facility that manufactures, processes, holds, transports alcohol for sales. This means that distillers could find the FDA knocking on their door, requesting to perform a Good Manufacturing Practices inspection of their distillery.

What is the Food Safety Modernization Act?

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011 and consists of the most-comprehensive reform to food safety laws in over 70 years. Its focus is on proactive food safety measures, rather than reactive actions when food safety has already been compromised.

Who is subject to FSMA regulations?

Any facilities that manufacture, process, pack, hold or transport an FDA-regulated food produced for consumption by humans or animals are subject to the final rules of FSMA. Exemptions do apply to specific business-types, including exemptions for companies making alcoholic beverages.

Do distilleries need to register with the Food & Drug Administration?

Any distillery whose primary sales route is wholesale distribution (more than 51% of sales) is subject to bi-annual registration with the FDA. After a firm is registered, registration must be renewed by December 31st on every, even-numbered year (December 31, 2022; 2024; 2026).

If your distillery’s sales are primarily direct-to-consumer (51% of sales or more), the distillery is exempt from FDA Registration. 

What changes could a distillery need to implement to be compliant with FSMA regulations?

Distilleries need documented training in job-specific, food safety for any employee that has responsibilities directly related to manufacturing operations as described in 21 CFR 117.4.

Any distillery that provides spent grain for use as animal feed must protect the grain from contamination & adulteration and provide sanitary transportation conditions.

Note: ANY additional processing of spent grains by the distillery (drying, pelletizing for animal feed) will require distillery to be in compliance with 21 CFR 507 – cGMP for Food for Animals.

What regulatory agency has jurisdiction over labeling requirements for alcoholic products?

Alcohol and Tobacco Tax & Trade Bureau (TTB) Food and Drug Administration (FDA)
Distilled spirits Wine & Cider with ≥ 7% ABV
Beers made with malted barley and/or hops Pre-mixed, packaged cocktails made with distilled spirits.
Wine & Cider with ≤ 7% ABV Beer made without malted barley and/or hops
Hard Seltzer with ≤ 7% ABV & is made from sugar substrates Kombucha with <0.5% ABV

What if a distillery wants to manufacture pre-packaged cocktails made with distilled liquor?

The cocktail formulation & label will require approval through the TTB prior to manufacturing. More information can be found on the TBB website.

What are the regulatory and labeling requirements if a company imports a distilled product from overseas?

Products that are imported are subject to the same jurisdictional requirements as products made within the U.S.A. This includes but is not limited to: labeling, further processing, bottling, holding or transporting the imported spirit.

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