FDA Action Alerts

FDA Action Alert: Add your voice to help FDA modernize recalls

On October 18, 2023 Gluten Free Watchdog submitted comments to the public docket No. FDA-2023-N- 2393 (Modernizing the Recall Process) expanding upon our September 29, 2023 presentation Improving FDA Recalls: A Texas Case Study given at the public meeting held by FDA. Our comments can be viewed at https://www.glutenfreewatchdog.org/news/wp-content/uploads/2023/10/FDACommentreRecallsGFWDfinal.pdf. Please consider submitting a comment to the docket in support of comments submitted by Gluten Free Watchdog. Comments are due soon--October 27th. To submit, please go to https://www.regulations.gov/document/FDA-2023-N-2393-0001 and click on "comment."...

Let’s get gluten declared on medication labels: Contact your representative today and urge them to support the ADINA Act

This bill would require medication labels to identify ingredients in drugs that are derived directly or indirectly from major food allergens or gluten-containing grains. Has your representative cosponsored this bill (H.R.4263)? Original Cosponsors: Rep. Lawler, Michael [R-NY-1] Rep. Sherrill, Mikie [D-NJ-11] Rep. Gallagher, Mike [R-WI-8] Additional Cosponsors as of September 22, 2023: Rep. Lofgren, Zoe [D-CA-18]   Rep. Fitzpatrick, Brian K. [R-PA-1]       Rep. Vargas, Juan [D-CA-52]   Rep. Allred, Colin Z. [D-TX-32] Rep. Bacon, Don [R-NE-2]       Rep. Grothman, Glenn [R-WI-6]         Rep. Matsui, Doris O. [D-CA-7]           Rep. Goldman, Daniel S. [D-NY-10]    Rep. Mullin, Kevin [D-CA-15]  Rep. Kuster, Ann M....

Public FDA meeting on recalls: Register to attend virtually

The Food and Drug Administration is holding a public meeting, Modernizing Recalls of FDA-Regulated Commodities on September 29, 2023 09:00 AM Eastern Time (US and Canada). You can register to attend the listening session virtually at https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-public-meeting-modernize-recalls-fda-regulated-commodities Adam Rapp, pro-bono counsel to Gluten Free Watchdog will be presenting on our experiences. We have been advised that our presentation has been slotted between 11 am and noon (eastern time). Hope to "see" you there!

Cargill recall of soy flour products: Additional information received from Gluten Free Watchdog FDA FOIA request

August 31, 2023 Brief background: On March 30, 2023, Cargill issued a voluntary recall for soy flour and textured soy flour products manufactured between October 5, 2022, and March 29, 2023, after receiving test results with levels of gluten between 20 ppm and 50 ppm. The source of gluten is believed to be from agricultural co-mingling with rye that was planted as a cover crop. The soy flour is not sold directly to consumers. What we learned from the FOIA materials: Cargill learned of the...

Sample scripts for contacting members of Congress asking them to support the ADINA Act–A bill requiring drug labels to disclose ingredients made from allergens or gluten

This bill was introduced with bipartisan support in the House. We are hopeful that it gains traction. If you would like to reach out to your members of Congress asking them to support this bill, you can find your representatives at https://www.house.gov/representatives and your senators at https://www.senate.gov/senators/senators-contact.htm. For more information on this bill, please see the post at https://www.glutenfreewatchdog.org/news/a-bipartisan-bill-to-require-major-food-allergens-and-gluten-to-be-identified-in-medications/ Phone Script Example (please personalize) Hello, my name is ____________________________, and I’m one of your constituents from __________________________.  I’m calling to ask ____________________________________ to support the ADINA...

Gluten-Free Claim Removed from KA-ME Hong Kong Express Rice Noodles

In May 2022, Gluten Free Watchdog (GFWD) reported KA-ME Hong Kong Express Rice Noodles to the Food and Drug Administration (FDA) via the Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS). At the time, product packaging included a gluten-free claim yet barley amylase was declared in the ingredients list. In February 2023, GFWD submitted a Freedom of Information Act (FOIA) request with FDA to find out what action was taken on our complaint. One of the...

Soy Sauce: More insightful news from FDA based on Gluten Free Watchdog FOIA requests

We recently filed 3 Freedom of Information Act requests with FDA for products containing hydrolyzed/fermented protein. All products had been reported to FDA for facial misbranding by Gluten Free Watchdog. What follows is a summary of the information received from FDA to date. A huge thank you to Adam, one of GFWD’s pro-bono attorneys for filing these requests. FOIAs were submitted for the following products: Three Crabs Fish Sauce. Ingredients list reads, “hydrolyzed vegetable protein.” This ingredient declaration hasn’t been allowed since...

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...

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...

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...