On May 16, 2023, FDA released a draft compliance policy guide (“draft CPG”) for major food allergen labeling and cross-contact, which updates the 2005 CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens. CPGs are intended to advise FDA staff, including investigators, of the agency’s strategy for assessing and enforcing industry compliance. The draft CPG contains FDA’s current policies on major food allergen labeling requirements, allergen cross-contact, voluntary allergen information (e.g., advisory label statements), thresholds, and regulatory actions. The draft CPG is more comprehensive than the 2005 CPG and is intended to create a uniform standard and minimize the possibility that individual FDA staff will follow differing regulatory approaches.    

The draft CPG details the allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act. We do not discuss those requirements here, but instead focus on the policies the draft CPG discusses that are not addressed, in detail, in other FDA allergen documents, such as the recent draft guidance, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act.

I. Allergen Cross-Contact

Allergen cross-contact is the unintentional incorporation of a food allergen into a food that does not contain that allergen as an ingredient. The draft CPG notes that the likelihood an allergen will be present due to cross-contact can be impacted by factors such as the characteristics of the food, the distribution of the allergen within a food (homogeneous versus particulate), the type of manufacturing process, the equipment used, and the cleaning procedures applied (e.g., dry cleaning versus wet cleaning). While FDA acknowledges these factors, the agency states that cross-contact may occur due to practices such as the failure to clean shared equipment adequately or segregate allergens properly, improper rework addition, or improper production scheduling. The draft CPG does not explicitly acknowledge that even with adequate CGMPs, sanitation, and preventive controls, cross-contact can still occur.

The draft CPG also confirms FDA’s position that “[m]ajor food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the ‘Contains’ statement.”

If testing detects an allergen in food or FDA suspects an allergen is present because of one or more adverse consumer reactions, but the origin of the allergen in the product is not known, FDA may follow up with the company to obtain additional information such as product formulation, ingredient information, and information about other products made on the same line or in the same process environment.

II. FDA’s Regulatory Approach to Allergen Violations

The draft CPG states that FDA’s regulatory approach to addressing allergen violations will be case-by-case (i.e., dependent on the facts of each situation). FDA generally will regard a product as adulterated if the agency’s review of the evidence (including evidence from facility inspections) demonstrates that allergen cross-contact may render the product injurious to health. The draft CPG explains that FDA may also consider a product adulterated if there is evidence of inadequate controls to minimize allergen cross-contact, even when the product bears an allergen advisory statement. When analytical test results are available that establish presence of an allergen not intentionally added to the food, the draft CPG directs investigators to consult with the CFSAN/Office of Compliance on the health hazard posed by the product to determine whether the product is adulterated. A case-by-case evaluation of the allergen health hazard will include factors such as estimated exposure to unintended allergen presence per eating occasion, likelihood of product consumption by allergic consumers, any mitigating allergen information on the product, and other evidence such as evidence of insanitary practices, type of allergen control problem resulting in cross-contact, characteristics of allergen residues due cross-contact (e.g., particulates, dusts, etc.), and consumer adverse reactions.

FDA also generally regards a product to be misbranded when case-by-case review of the evidence shows that the product’s label bears incomplete or inconsistent product information regarding major food allergens.

The draft CPG explains that if there is a reasonable likelihood of serious adverse health consequences or death due to allergen misbranding or adulteration, FDA may consider immediate action to remove the food from commerce. If the company does not initiate a voluntary recall, FDA will consider other appropriate actions, such as mandatory recall, administrative detention, and/or suspension of facility registration.

III. Voluntary Allergen Information

FDA notes that allergen advisory statements such as “may contain [allergen]” may be used to alert consumers to the possible presence of a major food allergen due to cross-contact. FDA continues to reiterate that advisory statements are not a substitute for adherence to CGMPs and preventive controls. In a footnote, however, FDA states that the “presence of allergen advisory statements may be considered a health risk mitigating factor when allergen cross-contact is appropriately managed consistent with CGMPs, preventive controls, or other controls (e.g., HACCP).” These statements appear to be among the few explicit, public statements FDA has made about when allergen advisory statements may be appropriate, though the advisory statements’ value would still be assessed on a case-by-case basis retrospectively.

The draft CPG also discusses the use of allergen-free claims and notes that such claims must be truthful and not misleading. FDA states expressly that if a product is labeled “milk-free,” the product should contain no milk allergen in the product. The draft CPG does not detail what controls or processes, e.g. final product testing, are needed to substantiate allergen-free claims.

FDA notes that consumer adverse reactions may provide some evidence that labeling information or other factors did not effectively mitigate health risk from exposure to the allergen hazard in the product. 

IV. Thresholds

FDA states in the draft CPG that it has not established a threshold for any major food allergen, but notes that it is aware of published dose response data that raises the possibility that certain low-level exposure to allergens “may not pose a health hazard to the majority of food allergic individuals.”

FDA states that where analytical test results are available when making the health hazard determination discussed above, it will consider the estimated exposure per eating occasion to the allergen in that food. This is only meaningful, however, if FDA also considers the allergenicity threshold of the particular allergic population. While not explicit, this appears to indicate that FDA will take into account threshold information on a case-by-case basis when considering whether a product is adulterated due to cross-contact.

FDA encourages comments on the draft CPG within 60 days (i.e., by July 17, 2023), although the agency accepts comments on guidance documents at any time.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.