A WHOLE NEW WORLD
FDA Regulations for Alcohol Manufacturers WRITTEN BY JANA CARACCIOLO & JOHN P. THOMAS, II
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any distilled spirits manufacturers have recently begun exploring different avenues to boost their profit margins and increase sales of their main distilled spirit product. These different avenues include everything from offering non-alcohol versions of the spirit to selling complementary products to pair with it, such as mixers. However, all distillers should be forewarned: Federal regulations applicable to these adjunct products differ from the federal regulations that apply to their traditional distilled fare. Under the Federal Alcohol Administration Act,1 the Alcohol and Tobacco Tax and Trade Bureau (TTB) has regulatory jurisdiction over distilled spirits containing seven percent or more alcohol by volume (ABV) and the U.S. Food and Drug Administration (FDA) has regulatory jurisdiction over alcohol beverages that contain spirits but are less than seven percent ABV, with several exceptions. While distilled spirits products typically fall well over the seven percent ABV threshold, distilled spirit manufacturers looking to expand their business into low-alcohol ready-to-drink beverages, including spirits-based seltzers and pre-mixed cocktails in a can, should be aware of FDA’s regulations pertaining to permitting, ingredients, and labeling.
PERMITTING The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires the FDA to take steps to protect the public from a threatened or actual terrorist attack on the United States food supply. In response to the Bioterrorism Act, the FDA promulgated regulations that, among other things, require food facilities to register with the federal government.2 Not only must food and beverage facilities register under the Bioterrorism Act and the related FDA regulations, but so must bonded wine premises, breweries, distilled spirits plants, alcohol beverage distributors, importers, warehouses, and wholesalers.3 Distilled spirit manufacturers wishing to expand their business into low- or no-alcohol products already should be registered with the FDA. Therefore, additional registration at the federal level should not be needed. However, such distilled spirit manufacturers should contact their state regulators to see what additional state regulations and registrations apply. 1
27 U.S.C., Chapter 8, §§ 201-212.
2
See 42 U.S.C. § 262a; 21 C.F.R. §§ 1.225-245.
3 See Public Law 107-188, Alcohol & Tobacco Tax & Trade Bureau (May 2, 2018), https://www.ttb.gov/laws-and-regulations/public-law-107-188. W W W . ARTISANSPIRITMAG . C O M
INGREDIENTS The Federal Food, Drug, and Cosmetic Act defines a “food additive” as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.”4 Excluded from the food additive definition are foods that are “generally recognized as safe” or GRAS, and foods proven to be safe due to their use in the food system prior to 1958. These laws and regulations apply regardless of whether a product is regulated by the TTB or FDA.5 Stated differently, distilled spirit manufacturers should be familiar with the FDA’s definitions of food additive and GRAS, because the ingredients used in TTB-regulated distilled spirits must be FDA-approved food additives or GRAS. If an ingredient is on the FDA’s GRAS list, then a food or beverage manufacturer may use that substance. However, if an ingredient is not on the FDA’s GRAS list, the food or beverage manufacturer should research whether the FDA has an authorizing regulation for it. If there is not an authorizing regulation, which states the food ingredient may be used in the way the food manufacturer intends for the ingredient to be used, then the food manufacturer must go through the FDA’s ingredient petition process.6 However, if a food manufacturer believes that a substance should be GRAS, the food manufacturer can submit a GRAS Notice to the 4
21 U.S.C. § 321(s).
5 See Determine If and How Ingredients May be Used in Your Beverage, Alcohol & Tobacco Tax & Trade Bureau (Aug. 16, 2016), https://www.ttb.gov/formulation/determining-if-and-how-ingredients-may-be-used-in-yourbeverage. 6 See Determining the Regulatory Status of a Food Ingredient, Food & Drug Admin (Sept. 20, 2018), https://www.fda.gov/food/food-ingredients-packaging/determining-regulatory-status-food-ingredient.
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