FDA’s Temporary Policy Regarding Certain Food Labeling Requirements: Implications for Those with Celiac Disease

FDA’s Temporary Policy Regarding Certain Food Labeling Requirements: Implications for Those with Celiac Disease

Many of you have reached out about the FDA’s guidance document regarding labeling entitled “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines.” The entire document is available at https://www.fda.gov/media/138315/download. If you haven’t yet read this guidance, 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.

Allowed substitutions include those for minor ingredients (generally comprising 2% or less by weight of the product). FDA states that these changes should* be consistent with safety factors meaning that “the ingredient being substituted for the labeled ingredient does not cause any adverse health effect (including food allergens, gluten, sulfites, or other ingredients known to cause sensitivities in some people, for example, glutamates).” Allowed substitutions also include “different varieties of the same ingredient.”

* The use of “should” in an FDA guidance document means that something is suggested or recommended, but not required.

How does this guidance impact folks with celiac disease?

1. GFWD is concerned that foods appearing to be free of gluten-containing ingredients but not labeled gluten-free could possibly have had a barley ingredient substituted in– such as malt, malt syrup, malt extract, or yeast extract (from spent brewer’s yeast)–without being declared in the ingredients list. Unfortunately, gluten is mentioned only once in the guidance document and it isn’t defined. Not all manufacturers are well versed in what constitutes a gluten-containing ingredient.

2. GFWD is NOT concerned that manufacturers will add undeclared wheat to products. Wheat is covered under the Food Allergen Labeling and Consumer Protection Act. Manufacturers are well-versed in allergen labeling for major allergens.

3. GFWD is concerned that during this time less seasoned manufacturers of labeled gluten-free foods may think it is okay to substitute regular oats or naturally gluten-free grains and flours NOT labeled gluten-free for the labeled gluten-free versions typically used in their products.

4. To date, USDA hasn’t released similar guidance on ingredient substitutions. Currently, there is no impact on USDA-regulated foods: meat products, poultry products, egg products (dried, frozen, or liquid eggs, with or without added ingredients), or mixed ingredient food products that contain more than 3% raw meat, 2% or more cooked meat, or 2%
or more cooked poultry.


1. It may be a good idea to stock up (but please don’t stockpile!) on your favorite brands of labeled gluten-free foods, if possible. In particular, you may want to stock up on trusted brands of gluten-free oats and other labeled gluten-free grains, flours, and legumes, as well as your favorite labeled gluten-free foods that include these ingredients.

2. It also may be a good idea to stock up on your preferred brands of foods appearing to be free of gluten containing ingredients (but not labeled gluten-free). FDA’s guidance was published recently, and older stock will remain on store shelves for a period of time. You may want to photograph the front of the package and the ingredients list and keep these photos handy. If you have any questions in the future, contact the manufacturer and ask if there have been any formula changes not acknowledged in the ingredients list.

Gluten Free Watchdog reached out to FDA on Monday about our concerns. This space will be updated if we hear back from the agency.

If you would like to comment on this FDA guidance document, please see https://www.regulations.gov/document?D=FDA-2020-D-1139-0009

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