Well Done

In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This program guides FDA inspectors in evaluating food labels during both domestic and import inspections. The update, now titled “General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import,” reflects current regulations, inspection priorities, and enforcement guidance.

The Alcohol and Tobacco Tax and Trade Bureau (TTB) has published a pair of proposed rules that if finalized could significantly reshape alcohol beverage labeling in the United States. In a move aimed at improving transparency and consumer awareness, TTB is proposing to mandate detailed nutritional and allergen disclosures on wine, distilled spirits, and malt beverages regulated under the Federal Alcohol Administration Act.

These changes are detailed in Notice No. 237, concerning mandatory “Alcohol Facts” labeling, and Notice No. 238, which proposes new allergen labeling requirements. TTB also issued Notice No. 239, which extends the public comment period on both proposals to August 15, 2025.

Alcohol Facts Labeling

Published in January 2025, Notice No. 237 revives efforts that began more than two decades ago to require standardized labeling on alcohol beverages. The proposal would require the inclusion of an Alcohol Facts panel on all TTB-regulated alcohol products. Similar to FDA’s Nutrition Facts labeling for food products, this panel would provide per-serving information on alcohol by volume (ABV), fluid ounces of pure alcohol, calories, carbohydrates, protein, and fat.

While TTB has allowed industry to include this information on product labels voluntarily since 2013, the proposed rule would make this information mandatory on the labeling of all covered products.

The proposed rule was issued in response to calls from public health groups and consumer advocates as well as recommendations in the US Department of the Treasury’s 2022 Competition in the Markets for Beer, Wine, and Spirits report. The report emphasized the need for consistent and meaningful disclosure of nutritional and alcohol content in these products to support consumer choice and public health.

The proposed rule also reflects discussions from public listening sessions TTB held in 2024 as well as more than 5,000 written comments TTB received.

If finalized, the rule would apply to wines containing 7% or more ABV, distilled spirits, and malt beverages. Industry would have a five-year window from the date of the rule’s final publication to comply with the new labeling requirements.

Allergen Disclosure Requirements

Notice No. 238 proposes requiring the disclosure of major food allergens on alcohol beverage labels. Under the proposal, producers would have to identify the presence of milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame, or ingredients containing proteins derived from such allergens, if they are used in the product process. The proposed rule draws from FDA’s Food Allergen Labeling and Consumer Protection Act framework and aims to protect consumers who are allergic or sensitive to these allergen ingredients.

The allergen rule would also apply to wine, distilled spirits, and malt beverages under TTB jurisdiction. The proposed rule, if finalized, would create greater alignment with FDA food labeling standards, although differences may remain due to FDA’s and TTB’s distinct authorities. As with the Alcohol Facts rule, this proposed rule includes a five-year compliance period.

Implications for Industry

Together, the proposals represent significant changes to alcohol labeling requirements. If the rules are finalized, they will require manufacturers to make operational adjustments to meet the proposed labeling requirements under the rules, including conducting an analysis of beverages to determine nutrient and allergen content, designing appropriate labels from a regulatory and marketing perspective, and instituting a procedure to ensure compliant labels for each product.

While the period for compliance is five years, these types of fundamental labeling changes can extend over a long period of time, especially if third-party vendors become backlogged. Further, businesses that manufacture products across both FDA and TTB jurisdictions will have to navigate potential inconsistencies and ensure compliance with both regulatory schemes as necessary.

Key Takeaways

Industry stakeholders should keep in mind the following:

• The comment periods for both rules are open until August 15, 2025
• Manufacturers will have to revise labeling to include nutrition and allergen information
• The rules, if finalized, both carry five-year compliance periods

The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two diabetes if the claims are not misleading and comply with other regulatory requirements.

FDA recently announced it does not object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease (CVD), provided that the qualified claim is appropriately worded so as not to mislead consumers.

Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified by US law, which are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. By law, those allergens must be listed separately from other ingredients on food labels. As discussed in a prior blog post, sesame is set to become the ninth major food allergen on January 1, 2023.

The US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on December 21, 2018, implementing the National Bioengineered Food Disclosure Standard (NBFDS). Beginning on January 1, 2022, the NBFDS will require manufacturers, importers, and retailers that package or sell food in bulk to disclose the presence of bioengineered food or food ingredients on product labels intended for retail sale.

Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve requirements related to summary nutrient information found on food labels.

The Federal Trade Commission (FTC) recently issued a final rule that marks a major shift in the regulatory landscape for labeling that has already begun to impact other regulatory bodies—namely, the US Department of Agriculture (USDA). The FTC’s new rule adds teeth to its longtime policy to prevent deceptive “Made in USA” (MUSA) claims, codifies its informal 1997 Enforcement Policy Statement on U.S. Origin Claims, and enables it to seek civil penalties of up to $43,280 for each violation of the rule.

US President Joseph Biden signed into law the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) in April, establishing sesame as the ninth major food allergen under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the first new major food allergen to join the list since its creation in 2004:

Harvard Law School’s Animal Law & Policy Clinic (Clinic) submitted a petition on June 9 to the USDA’s Food Safety and Inspection Service (FSIS), urging it to adopt a labeling approach for the emerging category of cell-based meat and poultry that “does not overly restrict speech and that respects the First Amendment.”[1] In its response of July 23, FSIS indicates that it considers the document a request for future rulemaking.[2]