FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-Contact

On May 16, the U.S. Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact.  The draft CPG reflects the three major laws and regulations that form the foundation of FDA’s regulatory framework for major food allergens and which became effective since the issuance of the current CPG, CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens, which was first issued in 2001 and last revised in 2005.  Since then, the science and legal and regulatory framework for food allergens have evolved considerably:  Congress enacted the Food Allergen Labeling and Consumer Protection Act (2004) and the Food Safety Modernization Act (2011), and FDA implemented the regulatory requirements set forth in 21 C.F.R. Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021).

The draft CPG describes FDA’s enforcement policy and cross-contact controls for major food allergens, including:

• The labeling requirements for major food allergens identified in the Federal Food, Drug and Cosmetic Act;
• FDA’s position on the proper use of the ingredient list and “Contains” statement for major food allergen declarations:
  • Major food allergens unintentionally incorporated into a food may not be declared in the ingredient list or the “Contains” statement;
  • When a “Contains” statement is used on a food label, then the food source of all major food allergens present in the food must be declared in the “Contains” statement, even if they are also declared in the ingredient list;
• Requirements for firms to implement controls that prevent or significantly minimize allergen cross-contact and a note that the allergen advisory statement does not relieve the manufacture from the obligation to minimize or prevent allergen cross contamination; and
• Additional allergen labeling violations (e.g., the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement).

The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.  Specifically, field staff are advised to pay close attention to situations where allergen cross-contact may occur because of poor current good manufacturing practices (cGMPs), inadequate preventive controls, or inadequate controls under the juice or seafood HACCP regulations.

In the announcement of the release of the draft CPG, FDA acknowledged that “some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence” to avoid implementing difficult and costly practices to prevent cross-contamination.  FDA noted that it “does not support” intentionally adding sesame as a regulatory compliance strategy, because it “may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume.”  Although the draft CPG does not address this industry practice, FDA commented that it is engaged with stakeholders on this issue.

The Center for Science in the Public Interest publicly condemned FDA’s “tepid” and “not adequate” statements regarding this practice—a practice which began shortly after the addition of sesame to the major food allergen list, and which has faced mounting criticism from other consumer advocacy groups and lawmakers.

To be considered, comments to the draft CPG must be submitted to the docket by July 17, 2023.  We expect to see comments urging FDA to act against the industry practice of intentionally adding sesame to foods, but it is unclear what actions FDA could take without interfering with manufacturers’ choice over the ingredients in their products.  We will have to wait and see whether FDA will add sesame-specific guidance addressing this issue (which seems to be limited to sesame) to its CPG for major food allergens.