FDA Temporary Labeling Requirements During COVID-19

FDA Temp Policy

On the evening of Friday, May 22nd 2020, the FDA issued new guidance relaxing the requirements around the labeling of ingredients due to the supply issues caused by the COVID-19 pandemic. As one might expect, this rocked the world of those with food allergies as well as those with gluten-related disorders.

Here are a few resources to help us learn more about this change.

United States Food and Drug Administration

Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines Guidance for Industry - May 2020

“FDA is issuing this guidance to food manufacturers to provide temporary and limited flexibilities in food labeling requirements under certain circumstances. Our goal is to provide regulatory flexibility, where fitting, to help minimize the impact of supply chain disruptions associated with the current COVID-19 pandemic on product availability. For example, we are providing flexibility for manufacturers to use existing labels, without making otherwise required changes, when making minor formula adjustments due to unforeseen shortages or supply chain disruptions brought about by the COVID-19 pandemic.”

Read More: https://bit.ly/3fziFy2
Download Guidance PDF: https://bit.ly/2Nemkoz

Gluten Intolerance Group

Webinar: Temporary label requirement changes by FDA may impact the status of gluten-free food - June 2020

Laura Allred, Ph.D. - GFCO Regulatory Manager and Lola O’Rourke, MS, RDN - GIG Education Coordinator discuss the impact of this ruling.

In response to the COVID-19 pandemic, the FDA is allowing manufacturers to make minor changes in packaged food ingredients without updating ingredient lists to reflect these changes. The guidance states that this should only be done when the ingredient being substituted does “not cause any adverse health effect”, with “gluten” being specifically noted as an example of an ingredient that should not be substituted in. In other words, this FDA guidance theoretically means that a product which was previously gluten-free would remain gluten-free, even if some ingredient(s) are modified. But the possibility does exist that companies could inadvertently substitute in a gluten-containing ingredient that would not be noted in the ingredient list.

Watch the Webinar: https://bit.ly/2YJeDfo


  • What does this temporary change do? Food manufacturers can make slight changes in ingredients in products without changing the ingredient label. This change is due to supply chain issues caused by the current health crisis.

  • The wording of this rule change needs work. The enforcement of gluten-free labeling needs work, as well.

  • Substitution are not allowed in the case of allergens, but there's room error.

  • FDA is careful in their wording of this guidance. They use the phrase "should not." That is different than "must not" or "cannot."

  • [We already know manufacturers have trouble with certain ingredients - like malt/barley.] GFCO knows that manufacturers need help. This regulation doesn't give them much guidance about what they can/cannot substitute.

  • We cannot rely 100% on ingredient lists.

  • What can we do? Contact the companies to inquire if there was change. Check their website for information regarding labeling.

  • Is there an end date? No specific end-date for this regulation. FDA states: "At the termination of the public health emergency" - whatever that means.

  • How can we be safe? Choose certified products. GFCO products cannot make a change without verifying ingredients first. GFCO standards require the ingredients and final product must contain less than 10 parts per million of gluten. FDA and other certification standards state 20 parts per million.

  • Products can remain in the stores and warehouses for months, so we won’t know what products may be following the temporary guidance.

  • Also discussed in this webinar are GFCO policies, procedures, and manufacturer requirements.

Stein & Vargas, LLP

Video: FDA’s Temporary Policy Change on Food Labeling - May 2020

Mary Vargas, partner, discusses some of the legal details of the FDA’s guidance.

“Ms. Vargas served on the expert panel to develop Voluntary Recommendations for Managing Celiac Disease in Schools, Child Care and Education Programs, a joint effort of Children’s National Medical Center, the Celiac Disease Foundation, and RESOLVE.”

Watch the Video: https://bit.ly/3d5bQT1


  • Some restrictions have been implemented:

  • Changes to a product should not affect safety. Manufacturers should not substitute ingredients without label change where the substitution would have no adverse effect on the health of consumers. Specifically referenced are the Top 8 Allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybean) plus sesame, celery, lupin, buckwheat, mollusks, mustard, glutamates, and sulfates.

  • The ingredient change should not affect more than 2% of the product.

  • Prominent ingredients cannot be changed without changing labels. (i.e., Raisin Bread - cannot remove raisins)

  • Changes cannot affect health claims on the label.

  • Changes cannot have a significant impact on nutrition or function.

  • Whether the policy should be extended in whole or part, or ended will be determined when the public health emergency is resolved in the opinion of the USA HHS department. The FDA's decision will be based mostly on the public comments received through regulations.gov.

Gluten-Free Watchdog

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

Gluten-Free Watchdog gives us their analysis of this policy and some suggestions for managing it.

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.

Gluten-Free Watchdog's Entire Article: https://bit.ly/2UOdQsm


  • Concerned about the possibility of a barley ingredient being substituted in products appearing to be free of gluten-containing ingredient but not labeled gluten-free. Because barley is not one of the top eight allergens, it is not required to be disclosed. Barley ingredients include malt, malt syrup, malt extract, brewer's yeast, or yeast extract from spent brewer's yeast. Not all manufacturers are clear on what ingredients can or cannot be included in products labeled gluten-free.

  • Not concerned about adding undeclared wheat. Because wheat is one of the Top 8 allergens, manufacturers have a handle on those ingredients.

  • Concerned about the substitution of regular oats, or naturally GF grains, and flours in products that are NOT labeled gluten-free by less experienced manufacturers. Said products may contain unacceptable amounts of gluten due to cross-contact.

  • As of now, USDA has not issued any guidance on ingredient substitution, as there is no impact on USDA-regulated foods (meat, poultry and egg products, and mixed food products that contain more than three percent raw meat or two percent or more cooked meat or poultry (e.g., soups, chilis, frozen entrees).

Urgent Call to Action: Comment today on FDA's temporary policy allowing manufacturers to make certain ingredient substitutions without changing the ingredients list - June 2020

Gluten-free Watchdog organized a collaborative effort between seven patient/consumer advocacy and professional groups to create and submit a letter to FDA voicing concerns about this policy and its impact on the gluten-free community. The groups include Beyond Celiac, Celiac Community Foundation of Northern CA, Dietitians in Gluten & Gastrointestinal Disorders, Gluten-Free Watchdog, Gluten Intolerance Group, National Celiac Association, and Society for the Study of Celiac Disease.

It's essential to have our voices heard about this policy. Future labeling practices maybe be defined by this [as of now] temporary policy. You can add your comment to Docket number FDA-2020-D-1139-0009.

Gluten-Free Watchdog suggests we can use any or all of the submitted letter. Or you can state that you are in support of the letter sent by Gluten-Free Watchdog. Here is a PDF of the letter submitted to the FDA: https://bit.ly/2Ndn2m7

Click here to let the FDA know how you feel: https://bit.ly/2NeXzsE

Gluten-Free Watchdog's Entire Article: https://bit.ly/2YzfgIw


Manufacturers Pledging to Label All Ingredient Changes Despite FDA Guidance - June 2020

SnackSafely.com is assembling a list of companies that have pledged to label all ingredients despite the changes. Excellent!

Special thanks to my friend Sarah @ Celiac in the City for sharing this list!

List of Manufacturers: https://bit.ly/2N69bha

Gluten-Free Certification Organizations and Their Logos

Know your certification organizations. When companies mark their products as GF it may appear as if they are actually certified. It might simply be a logo from their marketing or package design department.

GF cert logos-01

Today’s Dietitian

FDA’s Temporary Food Labeling Policy Changes by Kim Crudele, RDN - June 26, 2020

To be compliant, manufacturers must follow a few general guidelines when determining whether an undeclared ingredient substitution is allowed: The change can’t compromise the safety of the product (eg, introduction of major allergens or other sensitive ingredients). The omitted ingredient can’t be a major ingredient (eg, replacing wheat flour with rice flour in a muffin) or a characterizing ingredient (eg, replacing butter with margarine in a product with a “made with real butter” claim). The change can’t impact nutrient content or health claims made on the label. The change can’t have a significant impact on the nutritional quality of the finished product.

Substitutions of Different Varieties of the Same IngredientDifferent varieties of the same ingredient, such as fruits or vegetables, may be freely substituted without label changes. For example, a product listing “jalapeño peppers” in the ingredients list may substitute another variety of pepper, regardless of whether it’s a major or minor ingredient.Manufacturers also may temporarily substitute fats and oils without label changes if they’re from the same category of fat (animal/vegetable/marine animal) and have a similar fatty acid profile.Similarly, due to a low supply of bleaching agent, products declaring “bleached flour” as an ingredient may substitute unbleached flour without declaring it in ingredients lists.

Read entire article: https://bit.ly/386Hteg

Learn more about label reading

GIG of ECW’s Gluten-Free Label Reading

06/26/20 - Added Today’s Dietitian link.