04Oct
26Jul
FDA is acting on complaints filed by Gluten Free Watchdog
This spring we filed 6 Freedom of Information Act requests with FDA representing 11 products containing malt-based ingredients.* All products had been reported to FDA for facial misbranding by Gluten Free Watchdog. What follows is a summary of the information included in the materials obtained from FDA. A huge thank you to Adam, one of GFWD’s pro-bono attorneys for filing these requests. *We also filed FOIA requests for three additional products containing wheat. As of July 26, 2022, we have not...
05May
Comments Submitted by Gluten Free Watchdog, LLC: FDA draft guidance: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act
To everyone who must follow a gluten-free diet for medical reasons or loves someone who does, please comment on this draft guidance.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You can view comments posted to date at https://www.regulations.gov/docket/FDA-2021-N-0553/comments This draft guidance is taking the preemptive position that FDA will NOT consider a petition asking FDA to establish regulatory requirements for gluten-containing grains under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...
03May
Please comment on FDA draft guidance on adding allergens to FALCPA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 Please comment on the FDA draft guidance: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act [FALCPA]: Guidance for FDA Staff and Stakeholders The draft guidance is available at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...
23Feb
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 minute,...
13Jul
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 available...
22Jun
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 however...
04Jun
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 policy...
19May
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. The...
12May