Background
Compliance Policy Guides provide information for FDA staff regarding FDA compliance policy and regulatory actions. The major allergen labeling and cross-contact draft compliance policy guide1 summarizes the statutory and regulatory requirements surrounding major allergen labeling and the manufacturing requirements applicable to preventing cross-contact of major food allergens.
Major Allergen Labeling Requirements
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that major food allergens, defined as milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, must be declared on a food label either in the ingredient list or in a “Contains” statement. If relying on disclosure in the ingredients list, the allergen must be identified as the food source it is derived from (e.g., declaring the use of “whey” must include a reference to “milk”). When using a “Contains” statement, the allergen must be named as the food source from which it is derived and all major allergens must be listed in the “Contains” statement regardless of if they are also disclosed in the ingredient statement.
Separate from a company’s statutory and regulatory labeling obligations, some companies choose to provide voluntary allergy information on their products. The draft CPG identifies examples of these statements as “may contain [allergen]” and “produced in a facility that also uses [allergen].” Including these types of statements does not allow a company to avoid addressing allergens under current good manufacturing practice (GMP) or preventive control requirements. Additionally, FDA addresses “allergen free” claims. The draft CPG states that other than “gluten free” claims, which are defined, there are no definitions for “allergen free” claims. FDA states such claims must be truthful and not misleading and notes if a product is labeled “milk free” FDA would expect “there to be no milk allergen in the product.”
Allergen Cross-contact in Manufacturing
The draft CPG addresses allergen cross-contact and manufacturing requirements applicable to prevent cross-contact with major food allergens. FDA states allergen cross-contact refers to the unintentional incorporation of a food allergen into a food and occurs between foods with different allergen profiles. FDA notes cross-contact may occur due to practices such as failure to adequately clean shared equipment, failure to properly segregate allergens, improper rework addition, or improper production scheduling. The Food Safety Modernization Act (FSMA) requires that food manufacturers take steps to prevent allergen cross-contact as part of both current good manufacturing practice (GMP) requirements and as part of the hazard analysis of a hazard requiring a preventive control. The relevant GMPs include considerations related to personnel cleanliness, plant construction and design, sanitation and handling of food-contact surfaces, segregation of materials, manufacturing operations, and warehousing.
Additionally, the preventive controls regulations require that food facilities implement a food safety plan that includes a hazard analysis related to the handling of major food allergens and the risk of cross-contact. When a hazard requiring a preventive control is a major food allergen, the draft guidance states, “preventive controls must ensure that the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 of the FD&C Act (21 U.S.C. 342(a)) or misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) (see 21 CFR 117.135).” FDA provides two examples of inadequate programs under a food safety plan: (1) inadequate sanitation control, such as failure to adequately clean shared equipment between production runs of products with different allergen profiles to significantly minimize or prevent allergen cross-contact, may render the product adulterated under section 402(a)(4); and (2) inadequate allergen label controls, such as failure to check the product label to ensure major food allergen ingredients intended to be in the food are labeled as required, may result in a product misbranded under section 403(w). Interestingly FDA cites 402(a)(4), which deems a food adulterated if it is prepared under insanitary conditions that may render it injurious to health, as the legal authority to render the food adulterated due to inadvertent cross-contact with a major food allergen.
The draft guidance also has numerous references to “significantly minimize or prevent allergen cross-contact” indicating the agency expects companies to take appropriate measures to minimize or prevent allergen cross-contact. As mentioned above, including a precautionary statement regarding potential allergen cross-contact does not limit an entity’s GMP and preventive control responsibilities and the broad scope of the preventive control provisions provides FDA significant discretion in challenging assertions that an allergen cannot be controlled by GMPs. FDA recognizes precautionary labeling is appropriate when cross-contact cannot be avoided by GMPs, but the agency does not provide any insight or examples in the draft guidance of a situation when cross-contact cannot be avoided by GMPs and an advisory labeling would be considered appropriate. The draft CPG also recognizes that the presence of allergen advisory statements may be considered a health risk mitigating factor when allergen cross-contact is appropriately managed consistent with GMPs, preventive controls, or other controls.
FDA Enforcement Policy
As a general matter, FDA states in the draft CPG that “if an allergen misbranding or adulteration situation presents a reasonable likelihood of serious adverse health consequences or death to humans or animals, immediate action to remove the food from commerce should be considered.” FDA directs field staff to focus efforts on situations where allergens are intentionally present in a food but not declared on the label and situations where poor GMPs or inadequate preventive controls have led or may lead to allergen cross-contact. FDA may request additional information from a company, such as product formulation, ingredient information, and information about other products made on the production line or in the environment, in order to identify whether the presence of an allergen in a food was intentional or the result of cross-contact. Additional scrutiny may also be applied to labels with incomplete or inconsistent allergen information and instances when a company provides information to justify not labeling major food allergens. Field staff are directed to consult with the CFSAN Office of Compliance Policy Staff for questions regarding allergen health hazards.
In addition to these general principles, the draft CPG defines and provides examples of three specific types of violations that could lead to enforcement action, including: (1) misbranding due to an undeclared allergen, (2) adulteration due to allergen cross-contact, and (3) misbranding due to incomplete or inconsistent allergen information.
Misbranding due to Undeclared Allergens
A misbranding labeling violation occurs when a food is formulated to contain a major food allergen but does not declare the allergen as part of the ingredient list or in a “Contains” statement. Examples provided include:
- The product label declares an ingredient derived from a major food allergen (e.g. whey), but does not declare the food source (e.g., milk).
- A product includes an allergen that can be listed as an ingredient under a collective term (e.g., spices or coloring) or incidental additive but does not include the food source in the ingredient list or “Contains” statement.
- A product declares an ingredient that contains a major food allergen (e.g., mayonnaise containing eggs) but does not declare the major food allergen in the ingredient list or “Contains” statement.
- The label declares an allergen as a “tree nut,” “fish,” or “Crustacean shellfish” without declaring the specific type.
Adulteration due to Allergen Cross-contact
When inspectional evidence or other information indicates that the company does not have sufficient GMPs, preventive controls, or other controls to significantly minimize or prevent allergen cross-contact, products produced by the company may be considered adulterated due to allergen cross-contact under 402(a)(4), even when the product bears an allergen advisory statement. FDA identifies the following activities as examples of firms failing to have the appropriate GMPs or preventive controls:
- Inadequate GMPs that resulted in failure to ensure that personnel practices, plant equipment and utensils, and other activities do not lead to allergen cross-contact;
- Inadequate sanitation controls (e.g., cleaning) that resulted in allergen cross-contact from shared equipment or utensils;
- Inadequate food allergen controls (e.g., lack of controls during ingredient or product storage, handling, and use) that resulted in cross-contact; and
- Not addressing allergen cross-contact under the juice or seafood HACCP regulations when necessary (e.g., either through the standard sanitary operational procedures or the HACCP plan).
If analytical testing results are available, FDA will work to understand the health-hazard posed by the product and conduct a case-by-case review encompassing:
- The estimated exposure to the allergen per eating occasion (note, the draft CPG would use the reference amount customarily consumed (RACC) rather than the 90th percentile intake);
- The probability an allergic consumer will consume the product and any mitigating allergen information; and
- Other available evidence such as insanitary practices, the type of allergen control problems, the characteristics of the allergen residue, and consumer adverse reactions.
Misbranding due to Incomplete or Inconsistent Allergen Information
Misbranding can occur when there are discrepancies in the allergen information on the label. Provided examples include:
- The product label includes a “Contains” statement which does not include an allergen declared in the ingredients list;
- The product label makes an allergen-free type claim but there is evidence suggesting the food contains a major food allergen; and
- Case-by-case review of available product information that indicates incomplete or inconsistent allergen labeling.
Why it Matters
Overall, this guide provides a topline assessment of the major allergen labeling and cross-contact regulatory landscape setting basic principles. FSMA requires operators to take action to significantly minimize or prevent the occurrence of cross-contact events and allergen misbranding. This standard provides FDA with a fair amount of discretion when challenging a company’s position that an allergen cannot be avoided by GMPs. Additionally, the guidance supports FDA taking the position a food containing a precautionary statement is adulterated if it is determined that the entity did not have sufficient allergen controls in their food safety plan. While none of this information represents a change in FDA policy, it provides clarity for industry going forward.
Next Steps
While there is not a final deadline on submitting comments to the CPG’s related docket, FDA has asked that all comments be submitted by July 16, 2023 to ensure they are considered before the development of a final compliance policy guide begins.2 If you would like help drafting comments related to this CPG or assistance regarding your allergen labeling and control programs, please do not hesitate to reach out to us.
