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.
For food manufacturers, this update signals tighter alignment between inspections and modern labeling standards. According to FDA, the revised program helps ensure labels are “truthful, not misleading, and compliant with federal regulations.”
Key Changes
- Sesame Allergen Labeling: The update incorporates sesame as the ninth major allergen, in line with the FASTER Act. Manufacturers must now clearly declare sesame on labels, either within the ingredient list or in a “Contains” statement.
- Gluten-Free Claims: FDA has added a focus on verifying compliance with gluten-free labeling regulations. Any product using a “gluten-free” claim must contain less than 20 ppm of gluten and meet all related requirements.
- Updated Nutrition Facts Panel: Inspectors will check for compliance with the 2016 Nutrition Facts label revisions. This includes formatting changes, updated Daily Values, and the inclusion of “Added Sugars.” Labels using outdated formats may be flagged.
Implications for the Food Industry
FDA has emphasized that the updated program will “enhance oversight of domestic and imported foods, guide enforcement activities, and improve data consistency.” In practical terms, food manufacturers should:
- Audit product labels to ensure that all major allergens, including sesame, are declared properly.
- Confirm that any “gluten-free” claims meet FDA’s standard and retain documentation to support compliance.
- Update any outdated Nutrition Facts panels to reflect the latest format and content requirements.
Because this program applies to both US and imported foods, which can be easily sampled and detained at entry, foreign manufacturers and US importers should verify that product labels meet FDA requirements. FDA’s notice did not provide a phased compliance timeline or general grace period for nonconforming products. Noncompliant labels could thus be subject to immediate enforcement actions, including detentions at the border.
Likewise, these changes create potential litigation risk. The plaintiffs’ bar is expected to monitor for noncompliant labels, which creates exposure to false labeling class actions. These actions most often seek recovery of economic losses predicated on the theory that consumers would not have purchased the products if they were properly labeled—or at a minimum, they would have paid less for them. Failure to disclose allergens in compliance with labeling requirements may support claims for personal injuries resulting from an adverse reaction.
Accordingly, food companies are encouraged to review their labeling practices now to avoid regulatory and litigation issues down the road.