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Allergen Labeling: What’s New from FDA?

With food labels being the primary source of information on a product’s ingredients – particularly for those who have food allergies – FDA issued new draft and final guidances in November, both of which are titled: Questions and Answers Regarding Food Allergens. The draft guidance (Edition 5) provides new and revised allergen labeling questions and answers, the final guidance includes the questions and answers from the previous edition (Edition 4) that were not changed.

Of most significance is the application of the requirements to sesame, which became the U.S.’s ninth major food allergen with the passage of the 2021 FASTER Act, effective January 1, 2023. The guidance also clarifies that Crustacean shellfish (e.g., crab, lobster, or shrimp) are considered to be major allergens, whereas molluscan shellfish (e.g., oysters, clams, mussels, or scallops) are not priority allergens under the FD&C Act.  That being said, molluscan shellfish may be potent allergens for individuals allergic to these proteins.

The majority of the Q&A section focuses on clarification of the acceptable naming requirements for a number of the allergens. Key requirements are:

  • The specific type of allergen must be declared for Crustaceans (e.g., crab, lobster, or shrimp), fish (e.g., bass, flounder, or cod), and tree nuts (e.g., almonds, pecans, or walnuts). Thus, the ingredient list or “Contains” statement cannot broadly declare “tree nuts,” “fish,” or “Crustacean shellfish” as the major food allergen.
  • It is acceptable to use the singular term where the FD&C uses the plural (e.g., almond, pecan, walnut).
  • Soybean, soy, and soya are acceptable synonyms for soybeans.
  • The requirements apply to foods packaged by a retail or foodservice establishment, except those placed in a wrapper/container in response to a consumer’s order.
  • Single ingredient foods that are, or contain, protein from a major allergen may identify the food source in the Statement of Identity, i.e., name of the food (e.g., “All-purpose wheat flour”), or use Contains. Because a single-ingredient food does not require an ingredient list, a retail Contains statement should be placed above the manufacturer, packer, or distributor statement; those intended for further manufacturing should be placed on the front of the package near the statement of identity.
  • If a Contains statement is used, it must include all allergens in the product, even if they are already named in the ingredient list. In any case, the statement must be written as “Contains” with a capital “C” as the first word and use the same required terminology for the allergens.

All FDA-regulated packaged foods, including dietary supplements, that are domestically manufactured or imported into the U.S., are subject to the allergen labeling requirements of the FD&C Act and FALCPA (except most meat, poultry, catfish, certain processed egg products, and raw agricultural commodities, such as fresh fruits and vegetables in their natural state). If a food label fails to comply, it is considered to be misbranded. The product can be voluntarily recalled, or it may be subject to enforcement actions such as recalls, import refusal, and FDA seizure by FDA.

The food allergen labeling requirements of the FD&C Act do not require FDA to establish a threshold level for any food allergen. Given that, if a manufacturer has scientific evidence demonstrating that a food ingredient derived from a major food allergen does not cause an allergic response that poses a risk to human health or does not contain allergenic protein, they can ask FDA for a labeling exemption through a petition or notification process. However, this process is quite arduous and requires a high burden of proof.

The guidance also discusses the Food Code and its provisions regarding allergens, noting that the FD&C and FASTER Act allergen labeling requirements do apply in jurisdictions that have not adopted the 2017 FDA Food Code. FDA is accepting comments on the draft guidance until January 30, 2023.

With 85 million Americans living with life-threatening food allergies and intolerances and a food allergy reaction sending someone to the emergency room every three minutes, clear and accurate allergen labeling can, literally, be a matter of life and death. Yet, undeclared allergens continue to be the most common cause of food recalls each quarter. With its new guidance – much of which simply clarifies what has been law, it is likely that FDA will increase its focus in this area. So double checking ingredient statements, ensuring accurate label change at product changeovers, and guarding against cross-contact will not only help protect consumers, but will protect your brand.

Should you need assistance with allergen labeling or cross-contact prevention, give TAG a call. We can help.


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