Alcoholic Beverage Labeling: FDA or TTB?

Alcoholic beverages are an area of equal, albeit for somewhat separate reasons, interest for both the Food and Drug Administration (FDA) and the Tax and Trade Bureau (TTB). By law, FDA has jurisdiction over “any article used as food or drink for man or other animals.” That said, TTB has the authority to regulate beverages containing 0.5% or more alcohol by volume (ABV) at any time during their manufacture. Given this overlap in jurisdiction, FDA and TTB have established a Memorandum of Understanding (MOU) that allocates the responsibility of regulating alcohol labeling between the two agencies. As a manufacturer or labeler of alcohol, it’s important to determine which set of regulations applies.

The MOU appoints TTB as the primary agency for permitting, promulgating, and enforcing alcohol labeling regulations. Although FDA will defer to TTB in this area, TTB’s regulations cannot contradict labeling requirements outlined in the U.S. Food, Drug & Cosmetic Act (FDCA). Regardless of labeling jurisdiction, alcohol manufacturers must register their facilities with FDA and manufacture in compliance with FDA’s established good manufacturing practices (GMPs). However, alcoholic beverages are exempt from certain FDA requirements, such as the Foreign Supplier Verification Program (FSVP).

The jurisdictional determination is informed by a given alcohol product’s composition and alcohol content. TTB has jurisdiction over distilled spirits and wine containing at least 7% ABV, as well as beer/malt beverages. FDA has jurisdiction over wine containing under 7% ABV and beer made without barley and/or hops. Wines that contain under 7% ABV are a historically small category; however, recent years have seen a marked uptick in consumer demand for cider products, sugar-based hard seltzers under 7% ABV, and beer made without malted barley and hops, and all of these products fall within the scope of FDA’s regulatory purview. FDA also regulates kombucha (a fermented beverage derived from sweetened black or green tea) that remains below 0.5% ABV during production, at the time of bottling, and after bottling. This can be difficult for manufacturers to discern, as kombucha can continue to ferment after production and inadvertently exceed this threshold.

The determination of jurisdiction over an alcohol product raises a number of important and distinctive considerations. Manufacturers should note that while FDA has no premarket approval process for labels, TTB-regulated products must have their labels reviewed and approved by the TTB prior to distribution. Some label components – such as an ingredients list and nutritional information – are required on beverages under FDA regulations, but not under TTB requirements. Moreover, making certain claims can introduce the need to include nutritional information that would otherwise be optional.

Also, it is important to note the difference in serving size requirements under each agency’s regulatory paradigm. A wine regulated by FDA (under 7% ABV) will have a serving size of 12 fl. oz, while a wine serving size under TTB is 5 fl. oz. A proper serving size declaration is crucial not only for compliance with the applicable agency’s regulatory requirements but also because the ability to make certain claims is directly dependent on the serving size. 

Manufacturers and labelers of alcoholic beverages should ensure that key points such as the alcohol by volume, net quantity of contents, and product category are explicitly apparent on product labeling. Doing so will help make clear which agency should have jurisdiction over the product and help prevent the misapplication of regulations.

If you are unsure what labelling your product needs, or if you need confirmation on the labelling requirements for any alcohol-containing beverage, the consultants at FDAImports and the attorneys at Benjamin L. England and Associates, LLC can assist with this determination and with FDA labeling requirements.  Please feel free to contact us or call us directly at 410.220.2800.