Comments Submitted by Gluten Free Watchdog, LLC: FDA draft guidance: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act￼
To everyone who must follow a gluten-free diet for medical reasons or loves someone who does, please comment on this draft guidance.
You can access the guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-fda-staff-and-stakeholders-evaluating-public-health-importance-food-allergens-other
You can comment at https://www.regulations.gov/commenton/FDA-2021-N-0553-0005
You can view comments posted to date at https://www.regulations.gov/docket/FDA-2021-N-0553/comments
This draft guidance is taking the preemptive position that FDA will NOT consider a petition asking FDA to establish regulatory requirements for gluten-containing grains under FALCPA standards because FDA will only consider regulating allergens that cause acute and sometimes life-threatening immune responses, and because FDA implies in Footnote No. 42 that consumers with celiac disease are already protected under FDA’s gluten-free labeling rule (20 CFR. § 101.91).
Please read the text of the comment posted by Gluten Free Watchdog, LLC. Please feel free to use any of the text in your personalized comment or simply state you support the comments submitted by Gluten Free Watchdog, LLC. See https://www.glutenfreewatchdog.org/news/wp-content/uploads/2022/05/CommentGlutenFreeWatchdogFDA-2021-N-0553-0005.pdf