Please comment on FDA draft guidance on adding allergens to FALCPA

Please comment on FDA draft guidance on adding allergens to FALCPA

Call to Action. Please comment on the FDA draft guidance: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act [FALCPA]: Guidance for FDA Staff and Stakeholders

The draft guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-fda-staff-and-stakeholders-evaluating-public-health-importance-food-allergens-other

Comment at https://www.regulations.gov/commenton/FDA-2021-N-0553-0005

Purpose of the FDA Guidance (please read carefully): This FDA guidance is meant for (1) stakeholders who intend to submit a citizen petition asking FDA to establish regulatory requirements based on the public health importance of a food allergen NOT currently included under FALCPA and (2) FDA staff who are responsible for evaluating said petitions.

Bottom line: In the opinion of Gluten Free Watchdog, FDA, in this draft guidance is taking the preemptive position that it will NOT consider a petition asking them to establish regulatory requirements for gluten-containing grains under FALCPA standards because it will only consider regulating allergens that cause acute and sometimes life-threatening immune responses, and because FDA believes consumers with celiac disease are already protected under FDA’s gluten-free labeling rule (20 CFR. § 101.91).

Key points in the draft guidance:

  • FDA intends to consider whether a food allergen is of public health importance only when there is “robust evidence of an IgE-mediated adverse reaction” (among other criteria) causing severe and sometimes life-threatening reactions. Gluten-containing grains do not cause these types of reactions in patients with celiac disease.
    • Why is FDA narrowing petition rights to only those foods that cause severe reactions?  Unknown. File a comment to let them know what you think about that decision.
  • FDA cited its denial of a 2008 citizen petition asking them to “[amend] … FALCPA to include barley and rye in the list of common allergens requiring disclosure on packaging.”
    • Why was the petition denied? FDA says it’s “because the petition did not include adequate information to show that rye and barley are common causes of severe IgE mediated food allergies.”
  • FDA is ignoring the May 10, 2021 allergen recommendations of the FAO/WHO Expert Committee regarding Risk assessment of Food Allergens for Codex (cited in the FDA draft guidance at Ref.45). The Expert Committee, comprised of “scientists, regulators, physicians, clinicians, and risk managers from academia, government and the food industry,” reviewed a list of allergens in existence since 1999 and “determined that only foods or ingredients that cause immune-mediated hypersensitivities such as IgE-mediated food allergies and coeliac disease should be included on the list of foods and ingredients . . . .”  The Expert Committee then retained “cereals containing gluten” on the 1999 list of allergens whose presence should always be declared in the list of ingredients on a food label. 
    • Why won’t FDA follow the FAO/WHO Expert Committee recommendations on gluten-containing grains? Unknown. But FDA’s draft guidance includes a footnote referencing the gluten-free labeling rule, implying that rule adequately addresses gluten in the United States.

What FDA needs to hear from the celiac disease community:

The draft guidance unfairly and arbitrarily closes the door on consumers with celiac disease (a well-documented condition affecting millions of people) who wish to petition their government for more protective regulations.

  • FDA should be willing to receive citizen petitions regarding foods that cause any immune-mediated adverse reaction.  
  • FDA should not limit its review of citizen petitions to only foods causing IgE-mediated reactions and acute and life-threatening responses.
  • The FAO/WHO Committee reviewing Codex updates thinks gluten-containing grains are harmful enough to the population (based on prevalence, severity and potency) to require mandatory disclosure – How can FDA decide now that it will not later consider a citizen petition on this very same topic?

AND

The Gluten Free Labeling Rule (20 CFR. § 101.91) does not fully protect the celiac disease community.

  • The Rule only regulates products that carry a voluntary “gluten-free” claim.
  • For products not labeled “gluten-free,” consumers with celiac disease have no way of knowing if the food they are consuming contains gluten-containing grains other than wheat (already covered under FALCPA).
  • Therefore, citizens must be able to petition FDA for additional regulations for required disclosure of gluten-containing grains under FALCPA standards.

If you have any questions about the FDA’s draft guidance or information included in this post, please reach out info@glutenfreewatchdog.org.

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Comments (2)

  • Maggie Carter
    Reply

    Gluten is an ingredient that many are extremely sensitive to, and can cause bodily harm to a person and their health. Not regulating this area will cause people with Celiac disease undue stress and physical harm. My grandma is one of those included in this population, and she cannot eat food if it is not prepared in a gluten free kitchen, or at minimum, in areas of the kitchen that do not contain or permit gluten.

    May 11, 2022 at 5:38 pm

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