Even though the primary regulatory authority for the alcoholic beverages is the TTB, the FDA does have some power in the industry. Since many alcohol manufacturers aren’t sure when or where they may be subject to FDA regulations, I thought I’d shed some light on the agency.
Currently, the TTB and the FDA operate together under a non-binding Memorandum of Understanding, which basically outlines when, why, and how the TTB refers issues to the FDA. These issues are largely related to health and safety. For example, if you submit a formula to the TTB for a distilled spirit containing an unusual ingredient, the TTB will deny your application unless you can provide documentation certifying that the ingredient is Generally Regarded as Safe (GRAS) by the FDA for use in alcoholic beverages. You may recall the big industry upset circa 2010 when the FDA declared caffeine as an unsafe food additive for alcoholic beverages.
Beyond issuing certificates and declarations, there are circumstances where the FDA has more active authority. As part of the agency’s mission to promote food items that are properly labeled and safe for consumption, the FDA can take action in cases of adulterated or contaminated food products – including domestic and imported alcoholic beverages. Specifically, if alcoholic beverages have been reported as adulterated, the FDA has the power to seize those products, refuse their importation, and actively discourage their distribution through consumer markets. Generally, this happens when a manufacturer has been slow or ineffective at implementing a product recall.
In addition to formulation approvals, food safety compliance, and product recall procedures, alcohol manufacturers may also need to interact with the FDA on issues including:
• Registration of food facilities
• Labeling of wines and ciders containing less than 7% alcohol by volume
• Labeling of beers that do not contain barley or hops
• Facility inspections
If you have any questions about FDA jurisdiction in your business or other regulatory compliance issues, I’d be happy to help.
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