FDA Action Alerts

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 […]

Enough is Enough with Gluten-Free Misbranding: Contact FDA Today

Please email and mail ALL of the Health and Human Services and Food and Drug Administration personnel listed below. This list includes Alex Azar, Stephan Hahn, Susan Mayne, and Robin McKinnon. Make your voices heard! The letter I’m sending on behalf of the Gluten Free Watchdog community is in the photo and also pasted below. Please feel free to use any or all of the information in your own letter.

Contact information for HHS and FDA personnel

Mr. Alex M. […]

ANY Enforcement Action FDA??

ALL FOUR PRODUCTS ARE LABELED GLUTEN-FREE

ALL FOUR PRODUCTS APPEAR TO BE IN VIOLATION OF FALCPA

THREE CONTAIN WHEAT FLOUR

ONE CONTAINS BARLEY

PRODUCT 1: Update: Recalled! THE WRONG OUTER PACKAGING WAS USED; CHOWDER CONTAINS WHEAT FLOUR; WHEAT IS NOT INCLUDED IN THE INGREDIENTS LIST OR CONTAINS STATEMENT

PRODUCT 2: Update: Recalled! PACKAGING CONTAINS WHEAT PASTA; LABELED “GLUTEN-FREE (WITHOUT PASTA)”; WHEAT ISN’T DECLARED IN THE INGREDIENTS LIST OR SEPARATE CONTAINS STATEMENT (LISTED AS DURUM SEMOLINA FLOUR)

PRODUCT 3: WHEAT FLOUR IS INCLUDED IN THE […]

Call to Action to Stop Facial Misbranding of Gluten-Free Foods: Contact HHS Secretary Alex Azar

As we usher in 2020, facial misbranding of gluten-free foods continues to be a problem. Just this weekend, Gluten Free Watchdog filed three formal reports with FDA via CAERS for products labeled gluten-free but listing germinated barley seed powder, durum semolina flour, or enriched wheat flour in the ingredients.

While we have been advised by FDA that progress is being made, there continues to be lax enforcement of the gluten-free labeling rule and manufacturers continue to misuse the gluten-free labeling […]

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 […]

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