FDA Action Alerts

Comments Submitted by Gluten Free Watchdog, LLC: FDA draft guidance: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act

To everyone who must follow a gluten-free diet for medical reasons or loves someone who does, please comment on this draft guidance.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This draft guidance is taking the preemptive position that FDA will NOT consider a petition asking FDA to establish regulatory requirements for gluten-containing grains under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 […]

Please comment on FDA draft guidance on adding allergens to FALCPA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 Please comment on the FDA draft guidance: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act [FALCPA]: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The draft guidance is available at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 […]

Lack of FDA enforcement action against manufacturers labeling products gluten-free that list barley malt ingredients

Several groups recently came together to ask FDA if they intend to take enforcement action against manufacturers labeling products gluten-free that list malt, malt syrup, malt extract, or malt vinegar in the ingredients. Thank you to the National Celiac Association, Beyond Celiac, the Society for the Study of Celiac Disease, the Gluten Intolerance Group, and Celiac Community Foundation of Northern California for joining Gluten Free Watchdog in this effort. It takes a unified gluten-free village!

When you have a spare […]

Plea to FDA: Turn your attention to the manufacturers who blatantly use fermented and hydrolyzed wheat or barley ingredients in labeled gluten-free foods

Text of email sent to FDA July 13, 2020:

Dear Dr. Mayne,

Gluten Free Watchdog has reported twelve products to CAERS for gluten-free facial misbranding in 2020. Six of these products have been recalled and posted on either FDA’s enforcement report page or recall listing. On behalf of the Gluten Free Watchdog community, thank you for the role you’ve played in these recalls. Please continue your efforts and recall the remaining six products.

Products that have not been recalled include (product photos […]

FDA responds to our concerns about their temporary policy on food labeling changes

The FDA has responded to the group letter submitted by Gluten Free Watchdog and six other patient/consumer advocacy and professional groups outlining our concerns about FDA’s temporary policy on food labeling changes during the COVID-19 pandemic and the impact it may have on the celiac disease community.

The FDA response further clarifies agency position and elaborates on the wording used in their guidance document. Regardless, it appears unlikely that FDA will be amending the current guidance. The agency has […]

Urgent Call to Action: Comment today on FDA’s temporary policy allowing manufacturers to make certain ingredient substitutions without changing the ingredients list

Background: If you are not familiar with this policy, it states in a nutshell that during this period of food shortages and supply disruptions, FDA is allowing manufacturers to make certain ingredient substitutions without changing the ingredients list. For additional background information, please read last week’s post on this guidance document available at https://www.glutenfreewatchdog.org/news/fdas-temporary-policy-regarding-certain-food-labeling-requirements-implications-for-those-with-celiac-disease/

Letter submitted to FDA In an extraordinary effort, seven patient/consumer advocacy and professional groups joined forces to submit a letter to FDA outlining concerns about this […]

Gluten Free Watchdog Call To Action: Contact FDA Today Asking For Enforcement Action Against Manufacturers Of Products Labeled Gluten-Free Yet Containing Fermented Or Hydrolyzed Wheat & Barley

We are making progress but there is still more work to do. To date, six of nine products reported to FDA by Gluten Free Watchdog in 2020 have been recalled. If you have the energy during these trying times, please send emails to the HHS and FDA personnel listed below. Emails are recommended at the moment because FDA personnel may be working remotely. However, if you prefer to mail letters or post cards, this is of course fine too. […]

Updating the community on gluten-free facial misbranding and FDA & USDA enforcement of gluten-free claims: Celiac Disease Awareness Month 2020

During the first 4½ months of 2020, Gluten Free Watchdog reported 8 products appearing to be facially misbranded to FDA and 1 product to USDA. Products are considered facially misbranded (a term coined by the GFWD team) when they are labeled gluten-free but the ingredients list includes an ingredient not allowed in foods making a gluten-free claim.

As of May 12, 2020, 6 products reported to FDA have been recalled for gluten-free misbranding. This is actually extraordinary given that very […]

Four of eight products recalled: YOU are making a difference!

We are making progress. To date, four of the eight products reported to FDA by Gluten Free Watchdog in 2020 have been recalled. If you have the energy during these trying times, please continue to send emails to the FDA personnel listed below (Secretary Azar and Commissioner Hahn have been removed from the list at this time as they have their hands full fighting COVID-19). Emails are recommended at the moment because FDA personnel may be working remotely. […]

Dietitians: Please join Dietitians in Gluten and Gastrointestinal Disorders (DIGID) and send a letter to FDA voicing your displeasure about the lack of enforcement of the gluten-free labeling rule

To my fellow dietitians, Gluten Free Watchdog recently launched a letter writing campaign to Food and Drug Administration personnel regarding the lack of enforcement of the gluten-free labeling rule. If you work with consumers with celiac disease or non-celiac wheat sensitivity, please make your voice heard by joining DIGID and sending emails and/or letters to the individuals included in the contact list below. The text of the letter sent by DIGID is also pasted below. Please […]

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