FDA Outlines Approach to Assessing Non-Major Food Allergens in Draft Guidance | Morgan Lewis – Bravo
Last week, the FDA issued a orientation project which describes the agency’s proposed approach to assessing the public health significance of food allergens other than the eight major food allergens identified by U.S. law, namely milk, egg, fish, shellfish, nuts, peanuts, wheat and soy. By law, these allergens must be listed separately from other ingredients on food labels. As discussed in a previous blog postsesame is expected to become the ninth major food allergen on January 1, 2023.
In the FDA Press release Regarding the release of the draft guidelines, Susan Mayne, director of the Center for Food Safety and Applied Nutrition, explained that “the top nine food allergens do not currently represent all of the foods in the country that people are allergic to or that cause food sensitivities. “. Through the draft guidance, the FDA aims to analyze emerging evidence on unlisted food allergens that can cause serious reactions, such as anaphylaxis, “in a consistent and transparent manner” to better protect the health of consumers in the future.
The draft guidelines focus on food allergies mediated by immunoglobulin E (IgE) antibodies, which the agency says are linked to the “most serious and life-threatening food allergic reactions, including anaphylaxis.” The FDA also pointed out that the nine major food allergens are IgE-mediated. The approach proposed by the agency to assess the public health significance of an unlisted food allergen includes four scientific factors:
- Evidence of IgE-mediated food allergy, i.e. evidence of sensitization and reactivity
- Prevalence of said IgE-mediated food allergy in the U.S. population, especially among “well-characterized allergic individuals”
- Severity of said IgE-mediated food allergic reactions, which can be gathered from community reports
- Allergenic potency, i.e. the amount of food allergenic protein required to elicit an IgE-mediated food allergic reaction in a sensitized individual
The draft guidelines also recommend that stakeholders who wish to identify and assess all relevant evidence to determine the public health significance of a specific unlisted food allergen follow the steps below:
- Conduct a preliminary identification of published scientific literature applicable to the above four factors.
- Conduct a preliminary identification of community reports that are not in the published scientific literature.
- Narrow the identified body of published scientific literature to those publications most likely to be relevant to the above factors.
- Conduct an in-depth full-text review of identified publications.
- Grade each identified publication according to a GRADE system based on strength of evidence.
- Evaluate the information contained in each community report identified by first grouping the information according to the type of community report.
- Assess the severity of an IgE-mediated food allergic reaction described in the identified scientific evidence using a GRADE system.
The draft guidelines also outline the process the FDA will follow when asked to assess the public health significance of an unlisted food allergen. Specifically, the FDA noted that it generally intends to assess whether a food allergen is of public health significance if there is “strong evidence” of IgE-mediated food allergy. Regarding its assessment of prevalence, severity, and potency, the FDA explained that it would evaluate these “on a case-by-case basis,” stating that it likely would not consider a food to be a food allergen of importance for public health if the available scientific data and information for the above factors have a “low” rating on the GRADE system.
It is important to note that, although not mentioned explicitly, the draft guidelines state in a footnote that such “[f]The property also includes dietary supplements. Accordingly, the FDA intends that the draft guidelines also apply to dietary supplements, since supplements are subject to the Food Allergen Labeling and Consumer Protection Act of 2004, which amended the law. Federal Food, Drug and Cosmetic Authority to authorize the FDA to regulate major food allergens. .
Finally, the draft guidelines do not address the likelihood that a new substance could be a food allergen, nor does it address scientific research into cross-reactivity with a known food allergen and how this might help determine whether a substance could be a food allergen. . Interested parties have until August 17 to submit their comments.