FDA — Low Alcohol Wines & Beers

Most alcohol beverage labels are regulated by the Alcohol and Tobacco Tax and Trade Bureau (“TTB”). But not all. There are major exceptions for certain wine, beer, hard seltzer, hard kombucha, and other drinks.

The U.S. Food and Drug Administration (“FDA”) regulates the labels of wines and hard ciders with a low alcohol content — i.e., less than 7% alcohol by volume — as well as alcohol-removed (or dealcoholized) wines and non-alcoholic (or alcohol-free) wines.  

These FDA labels, which approximate those found on packaged foods, differ significantly from those of traditional wine and cider products.  Among other differences, FDA regulated labels must include Nutrition Facts Panel, Ingredients Statement, and Statement of Identity.

The FDA’s unique labeling requirements also apply to the labels of beers that do not meet the federal definition of “malt beverages” under the Federal Alcohol Administration Act (“FAA Act”). 

A “malt beverage” is a beverage that is:

made by the alcoholic fermentation of an infusion or decoction, or combination of both, in potable brewing water, of malted barley with hops, or their parts, or their products, and with or without other malted cereals, and with or without the addition of unmalted or prepared cereals, other carbohydrates or products prepared therefrom, and with or without the addition of carbon dioxide, and with or without other wholesome products suitable for human food consumption.  27 U.S. Code § 211(a)(7).

Exceptions to this definition may include, among other things, gluten-free beer as well as hard seltzer products whose base fermentable is a sugar brew (not malted barley and hops).

As the market for and consumer interest in low alcohol wines, dealcoholized wines, non-alcohol wines, gluten-free beers, and hard seltzers grow, business owners struggle to comply with FDA’s food labeling requirements. The FDA regulations and corresponding compliance policy guides are lengthy and confusing with many cross-references to other regulations.

Products must be fully compliant before they reach consumers. If not, the business runs the risk that the federal government will bring a regulatory action.  It is up to the supplier to ensure that the label, labeling, and advertising comply with these requirements.

Complicating matters further, the FDA typically does not grant pre-market reviews or approvals of labels or packaging before the product hits the market. This is unlike the TTB, which administers the Certificate of Label Approval (or “COLA”) process.  

FDA — Low Alcohol Wines and Non-Malted/Hopped Beers: Services

Lindsey Zahn P.C. regularly works with alcohol beverage companies whose products fall within the jurisdiction of the FDA. Among other services, the firm may assist with the following:

• Drafting and filing a Small Business Nutrition Labeling Exemption for qualifying products
• Reviewing proposed Nutrition Facts Panels for formatting, rounding, or overall errors
• Advising on the use of health claims and/or structure/function claims
• Assisting with FDA food facility registration, renewals, and determining eligibility for exemptions
• Advising on scope and applicability of FDA’s jurisdiction 
• Providing a risk analysis of non-compliant practices
• Supporting your marketing and graphic design team in the development of a product’s label

As your outside compliance counsel, the firm will work with you to review proposed labels and advise your company on potential issues, missing mandatory information, and legal risks. 

Recent Representations

Some recent representations include: 

• Advised an importer on alcohol-removed wine labels for compliance under FDA food labeling regulations and policy guidelines
• Assisted a hard kombucha client and hard seltzer company in revising labels to meet the requirements of federal food labeling regulations 
• Guided and oversaw the design of hard cider labels for an under 7% alcohol by volume product 
• Advised a hard cidery on eligibility for the Small Business Nutrition Labeling Exemption

For more information about how Lindsey Zahn P.C. can help your company, please contact us at lindsey@zahnlawpc.com.

Prior results do not guarantee a similar outcome.