FDA Overhauls Food Labeling Enforcement for the First Time in 15 Years
On June 24, 2025, the Food and Drug Administration updated its food labeling compliance program for the first time in 15 years. The overhaul gives FDA inspectors new enforcement tools and puts food manufacturers on notice: labels that do not meet current requirements can face immediate action, including border detentions for imported products. There is no grace period.
The update to Compliance Program 7321.005 (now titled "General Food Labeling Requirements and Labeling-Related Sample Analysis, Domestic and Import") incorporates three major changes that affect nearly every packaged food product sold in the United States.
Sesame Becomes the Ninth Major Allergen
The most consumer-facing change is the formal incorporation of sesame as the ninth major food allergen. The FASTER Act (Food Allergy Safety, Treatment, Education, and Research Act) added sesame to the list of major allergens in January 2023, but the labeling compliance program had not been updated to reflect this until now.
Manufacturers must clearly declare sesame on packaging, either within the ingredient list using its common name or in a separate "Contains" statement. FDA inspectors are now specifically trained to check for sesame declaration compliance during facility inspections.
An estimated 1.6 million Americans have a sesame allergy, according to food allergy research organizations. Before the FASTER Act, sesame could be hidden behind vague terms like "spices" or "natural flavors" on ingredient labels, leaving allergic consumers unable to identify products that could trigger severe reactions.
Gluten-Free Claims Under Scrutiny
Products carrying "gluten-free" claims must now demonstrate compliance with the FDA's standard of less than 20 parts per million of gluten. Inspectors will verify these claims during field examinations, and products that fail testing could face enforcement action.
This matters because the gluten-free market has grown significantly over the past decade, driven by consumers with celiac disease, gluten sensitivity, and those who choose to avoid gluten for other health reasons. The FDA's gluten-free rule has been in place since 2014, but without active compliance enforcement in the labeling program, violations could persist without consequence.
The updated program ensures that "gluten-free" actually means something measurable on the package rather than functioning as a marketing claim with no verification.
Nutrition Facts Panel Enforcement
The third major change addresses the Nutrition Facts panel. The FDA revised the Nutrition Facts label format in 2016, updating Daily Values, changing serving sizes to reflect actual consumption habits, and requiring declaration of "Added Sugars." The compliance deadline passed years ago, but some manufacturers continued to use outdated label formats.
Under the new compliance program, inspectors will specifically check whether labels include the "Added Sugars" line. This distinction between total sugars and added sugars helps consumers understand how much sugar a manufacturer deliberately put into a product versus sugar naturally present in ingredients like fruit or milk.
Products using the old label format, which lacks Added Sugars and uses outdated Daily Values, may be flagged during inspections. For imported products, the consequences could be immediate: FDA can detain noncompliant products at the border.
No Grace Period
What makes this update particularly significant is what the FDA did not include: a transition period. According to analysis from the law firm Morgan Lewis, "FDA's notice did not provide a phased compliance timeline or general grace period for nonconforming products."
This means that as of the announcement date, any product with a noncompliant label is subject to enforcement. For domestic manufacturers, this could mean warning letters, seizure orders, or injunctions. For importers, it could mean products sitting in customs.
The lack of a grace period signals a shift in the FDA's enforcement posture. For years, the agency has been criticized for issuing labeling rules without follow-up enforcement. Updating the compliance program, the document that tells field inspectors exactly what to check and how to act on violations, removes that gap.
What Changed Since 2010
The previous version of this compliance program was written before sesame became a recognized allergen, before Added Sugars appeared on labels, and before the current wave of state-level food safety legislation pushed food transparency into the national conversation.
In the 15 years since the last update, consumers have become far more label-conscious. Research from NSF shows Americans demand greater clarity and standardization in food labeling. State legislatures across the country have passed their own food additive restrictions and labeling requirements, often outpacing federal standards.
The FDA's update brings its enforcement toolkit into alignment with what the law already requires but was not actively being checked. For consumers, this should mean more accurate labels on the products they buy.
What This Means for You
If you have a sesame allergy, food labels should now more reliably declare its presence. If you rely on gluten-free labels because of celiac disease, the FDA is now actively verifying those claims. If you read the Added Sugars line to make dietary decisions, more products should display this information accurately.
Tools like VeriFoods that scan and analyze product labels can help identify products with outdated or incomplete labeling, giving consumers an additional layer of verification beyond what they can read in the store aisle.
The update does not create new rules. It enforces existing ones. That distinction matters because many consumers assumed these rules were already being enforced. Now, for the first time in 15 years, they are.
Sources
- Morgan Lewis - "FDA Updates Food Labeling Compliance Program: What It Means for Food Manufacturers" - July 2025. https://www.morganlewis.com/blogs/welldone/2025/07/fda-updates-food-labeling-compliance-program-what-it-means-for-food-manufacturers
- Food Safety Magazine - "FDA Issues Updates to Food Labeling Requirements Compliance Program" - June 2025. https://www.food-safety.com/articles/10471-fda-issues-updates-to-food-labeling-requirements-compliance-program
- National Law Review - "FDA Updates Compliance Program Requirements for Food Labeling" - June 2025. https://natlawreview.com/article/fda-updates-food-labeling-requirements-compliance-program
- Eurofins - "FDA Updates General Food Labeling Requirements Compliance Program" - June 2025. https://www.eurofinsus.com/assurance/food/resources/articles-press-releases-whats-new/fda-updates-general-food-labeling-requirements-compliance-program/