On December 22, 2014, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the labeling of beers regulated by FDA. The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates the labeling of distilled spirits, wines, and malted beverages. TTB’s regulations are contained in the Federal Alcohol Administration Act (FAA Act). While many beers fall under TTB’s regulation, some beers do not meet the definition of a malted beverage found in the FAA Act. A beer is not considered a malted beverage if:
- It is not made from malted barley, but rather a substitute such as sorghum, rice, or wheat.
2. It is made without hops.
Beers that do not meet the definition of a malted beverage are regulated by FDA instead of TTB. Rather than those in the FAA Act, these beers are subject to the labeling requirements in FDA’s Food, Drug, and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FPLA). Requirements include:
- A statement of identity
- The net quantity of contents
- The name and place of business of the manufacturer, packer, or distributor
- A correctly formatted Nutrition Facts label
- A list of the ingredients contained in the beer, ordered by weight
- A list of all major food allergens contained in the beer
These are just a few of the labeling elements required by FDA. Beer labels regulated by FDA must conform to all the requirements in 21 CFR 101. Along with those requirements, the labels are still subject to some TTB labeling requirements, including the Government Health Warning Statement.
FDA’s labeling requirements are strict and extensive. For assistance with reviewing a beer label or other food and beverage label for FDA compliance, contact Registrar Corp.