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.
Well Done
YOUR SOURCE ON FOOD LITIGATION AND REGULATION
On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including food additives, color additives, GRAS ingredients, and food contact substances. The announcement is the agency’s latest step in its effort to modernize the framework for identifying and prioritizing substances in food for review based on public health concerns. FDA is soliciting public comment on the Prioritization Tool.
The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process” for chemicals already on the market. Under this program, FDA will proactively reevaluate existing ingredients, including ingredients generally recognized as safe (GRAS), food contact substances, additives, and contaminants.
Both state and federal government authorities have recently turned their attention toward artificial coloring in foods. The Food and Drug Administration (FDA) announced a series of measures in April 2025 to phase out all petroleum-based synthetic dyes from food, including initiating the process to revoke authorization for Citrus Red No. 2 and Orange B and working with industry to remove six other synthetic food dyes from the food supply. This follows FDA’s January 2025 order revoking authorization for manufacturers to use Red Dye 3 in food and ingested drugs after studies confirmed that the dye causes cancer in male rats.
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
Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products.
On October 1, 2024, the US Food and Drug Administration (FDA) announced the implementation of its long-promised reorganization, with the establishment of the unified Human Foods Program (HFP). The HFP now oversees all FDA activities related to food safety and nutrition, organized in a single group working under the Deputy Commissioner of Human Foods.
The Association of American Feed Control Officials (AAFCO) and the US Food and Drug Administration (FDA) announced on August 2, 2024 that their long-standing Memorandum of Understanding (MOU) governing the development and review of definitions of animal feed ingredients will not be renewed once it expires on October 1, 2024. FDA described AAFCO and its relationship as “evolving” rather than “ending” and noted in a Letter to Stakeholders that FDA will continue to work closely with AAFCO and state authorities “to help ensure the safety of the animal food supply.”
The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for evaluating the safety of foods derived from genome-edited plant varieties. The Genome-Edited Plants Guidance also describes two voluntary processes for developers to inform and engage with FDA regarding the steps taken to ensure the safety of foods from their genome-edited plant varieties.