Well Done


Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified by US law, which are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. By law, those allergens must be listed separately from other ingredients on food labels. As discussed in a prior blog post, sesame is set to become the ninth major food allergen on January 1, 2023.

In FDA’s press release regarding the issuance of the draft guidance, Susan Mayne, director for the Center for Food Safety and Applied Nutrition, explained that the “nine major food allergens don’t currently represent all foods nationwide that people are allergic to or that cause food hypersensitivities.” Through the draft guidance, FDA aims at analyzing emerging evidence on non-listed food allergens that can cause severe reactions, such as anaphylaxis, “in a consistent and transparent manner” to better help protect consumer health in the future.

The draft guidance is focused on immunoglobulin E antibody (IgE)-mediated food allergies, which, the agency explained, are linked to “the most severe and immediately life-threatening food allergic reactions, including anaphylaxis.” FDA also emphasized that all nine major food allergens are IgE-mediated. The agency’s proposed approach for assessing the public health importance of a non-listed 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 US population, particularly in “well-characterized allergic individuals”
  • Severity of said IgE-mediated food allergic reactions, which can be collected 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The draft guidance also recommends that stakeholders who want to identify and evaluate the relevant body of evidence to determine the public health importance of a specific non-listed food allergen follow the below steps:

  • 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 a substantive review of the full text of the identified publications.
  • Grade each identified publication based on a strength of evidence GRADE system.
  • Evaluate the information in each identified community report by first grouping the information based on the type of community report.
  • Evaluate the severity of an IgE-mediated food allergic reaction described in the identified scientific evidence using a GRADE system.

The draft guidance also describes the process FDA will follow when asked to evaluate the public health importance of a non-listed food allergen. Specifically, FDA noted that it generally intends to evaluate whether a food allergen is of public health importance if there is “robust evidence” of IgE-mediated food allergy. Regarding its evaluation of prevalence, severity, and potency, FDA explained that it would assess them on a “case-by-case basis,” stating it would likely not consider a food to be a food allergen of public health importance if the available scientific data and information for the above factors have a “low” grade on the GRADE system.

Importantly, although not mentioned explicitly, the draft guidance states in a footnote that such “[f]ood also includes dietary supplements.” Accordingly, FDA intends for the draft guidance to also apply to dietary supplements, since supplements are subject to the Food Allergen Labeling and Consumer Protection Act of 2004, which amended the Federal Food, Drug, and Cosmetic Act to authorize FDA to regulate major food allergens.

Finally, the draft guidance does not discuss the likelihood that a new substance could be a food allergen, nor does it address scientific research on cross-reactivity to a known food allergen and how this could help to determine whether a substance could be a food allergen. Interested parties have until August 17 to submit their comments.