FDA Action Alerts (Page 2)

When a regulatory agency (USDA) actually enforces the gluten-free labeling rule and recalls a product containing wheat-based soy sauce

On August 30, 2019, the United States Department of
Agriculture announced the recall of Heatherfield
Foods Inc. pork sausage products due to misbranding. The sausage is labeled
gluten-free yet contains wheat. https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-088-2019-release?permalink=35A47FAFA869093A250D7843C3A55B6D5ADD2BFB5919576B6453B59930E6CE26

Why is this
recall particularly significant?

It took
place because of a consumer complaint received by USDA.Based on
consumer photographs sent to Gluten Free Watchdog, the source of wheat in the
sausage is soy sauce.USDA
doesn’t have an agency defined gluten-free labeling rule. Instead
they require manufacturers under their labeling jurisdiction to adhere to the gluten-free
labeling rule […]

FOIA Request from Gluten Free Watchdog Pertaining to Product Complaints Submitted to CAERS

On June 11, 2019, Tricia Thompson, MS, RD, Founder of Gluten Free Watchdog and Kaki Schmidt, Esq. submitted a Freedom of Information Act (FOIA) request to the Department of Health and Human Services FOI/Privacy Acts Division concerning six product (food) complaints filed with CAERS following the instructions of FDA staff. Complaint numbers were not provided by CAERS for any of these complaints. Nor were any of the complaints acknowledged by CAERS.  

This FOIA requests ALL CAERS/FDA records pertaining to […]

Letter to FDA Regarding Restaurant Use of the Term Gluten-Free on Menus

Gluten Free Watchdog’s second call to action for Celiac Disease Awareness Month 2019 was a request for the community to submit photos of restaurant menus that designate items as gluten-free yet provide a disclaimer about the lack of suitability for someone with celiac disease. The response was overwhelming. Thank you! A handful of the photos are included in the attached letter to FDA regarding restaurants and their use of the term “gluten-free”. Please read the letter and let me […]

Call to Action: Gluten in Medicine Disclosure Act of 2019

Gluten in Medicine Disclosure Act of 2019. Representatives Ryan and Cole introduced this bill on April 3, 2019. The bill currently has 8 co-sponsors.

The text of the bill is available at https://www.congress.gov/bill/116th-congress/house-bill/2074/text?fbclid=IwAR3Xr7YABCf4sFERNHO00yOkq7HCV2h1DHTnVXWL1OzKlc6znHEb9nY9n9s.

Please support this bill by contacting your representative. A state-by-state directory is available at https://www.house.gov/representatives.

You can also find your representative by zip code at https://www.house.gov/representatives/find-your-representative?fbclid=IwAR0XjoajmDCz7loMHtt2-Tx8K6-Rvf6QifiyVklSPejTw1J7A7ene0gwbUA.

I was contacted by Representative Ryan’s office and asked
for my opinion regarding wording of the bill. The bill currently reads in part
that a drug […]

Video: Facial Misbranding of Gluten-Free Food

At the end of October, I gave a presentation on the facial misbranding of gluten-free foods at the Academy of Nutrition and Dietetics Food and Nutrition Conference and Expo. At the beginning of November, I gave a mini version of this presentation at the celiac disease conference hosted by the National Celiac Association. In this video I talk through printouts of the slides presented at the latter conference. The video runs about 15 minutes. Please let me know if […]

A Bit of Good News from the FDA on Gluten-Free Labeling Issues

We’ve received a bit of good news from the FDA but before you get too excited continue reading to the end of the post…

Gluten Free Watchdog periodically sends emails to FDA updating them on possible facial misbranding* related to the gluten-free labeling rule. An email sent on August 14, 2018 stated in part:

“I dealt with two product issues yesterday. A sauce labeled gluten-free yet containing beer with barley and malt listed as sub-ingredients AND a cookie labeled gluten-free containing […]

Is the FDA enforcing the gluten-free labeling rule?

Question: How many FDA food recalls have there been since January 1, 2016 and the reason/problem cited by the FDA is gluten?

Answer: Two

A search under “gluten” on FDA’s “Recalls, Market Withdrawals, & Safety Alerts” page resulted in the following:

May 3, 2018: Van’s Waffles: Product may contain gluten and undeclared milk https://www.fda.gov/Safety/Recalls/ucm606033.htm. This product is labeled gluten-free
September 1, 2016: Koi Palace Mooncakes: https://www.fda.gov/Safety/Recalls/ucm518878.htm. It is unclear whether this product was labeled gluten-free at the time of the recall.

How […]

Dear FDA, Please provide an update on our citizen petition asking for increased enforcement of misbranding violations under the gluten-free labeling rule


In honor of Celiac Disease Awareness Month 2018,

A series of bites, barks, tail wags, face licks, and pant tugs from Gluten Free Watchdog

May 4, 2018

Gluten Free Watchdog Bark (at FDA) & Pant Tug (at consumers), Post # 4

Please watch the video and then read the recommendations below.

It is important for all of us to document potential misbranding violations. Please do the following if you come across a product either in the store or after purchase that you believe is […]

Spot a labeled gluten-free food that’s misbranded? Here’s what to do

The FDA has issued an interim response to Gluten Free Watchdog’s petition requesting that the agency establish a specific protocol for increased surveillance, investigation and enforcement of potential facial misbranding violations under the gluten-free labeling rule. The agency response reads in part, “…we have not reached a decision on your petition within the first 180 days due to competing priorities. However, be advised that your petition is currently under active evaluation by our staff.”

At Gluten Free Watchdog, Kaki and […]

17 Misbranded Products Discovered in Circulation in 2017: Supplement to FDA Citizen Petition to Stop Labeling Violations Under the Gluten-Free Labeling Rule

On Sunday January 14, Kaki and I submitted a supplement to our FDA citizen petition requesting that the FDA establish a specific protocol for increased surveillance, investigation and enforcement of potential facial misbranding violations under the gluten-free labeling rule.

The supplement has not yet posted to the docket so we are posting it here for your information. Please take the time to read this supplement paying particular attention to page 3 and the listing of 17 misbranded products discovered in […]