FDA Food Label Guidelines and Impact on Food Allergies

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The FDA did indeed recognize the importance of accurate food labels even amidst shortages or supply disruptions

“Consumers use the ingredient list to make purchasing decisions and determine whether a food contains an ingredient they want (e.g., whole grains) or ones they do not want (e.g., due to allergies).

“We strongly encourage manufacturers to comply with labeling requirements and continue to make conforming label changes when they need to make formulation changes due to unforeseen supply disruptions or shortages brought upon by the COVID-19 pandemic.”

What did not change due to the FDA’s new labeling guidelines:

  1. As before, shared manufacturing facilities and production lines still do not have to be labeled for cross contamination, even with the top 8 allergens (wheat, dairy, soy, shellfish, fish, egg, peanuts, tree nuts).
  2. Terms such as “spices” are still vague, and spices can be changed without notice to consumers.

What did change:

1. Country of origin may change without notice

“Some foods may voluntarily provide the geographical origin of certain ingredients. FDA does not intend to object to temporary substitutions of similar ingredients of different origin if the substitution is not for the food itself. For example, if a food states that it is made with “California raisins” and the manufacturer needs to substitute raisins from another domestic or international location, FDA does not intend to object. However, we note that specific inquiries regarding country of origin labeling should be directed to the U.S. Department of Homeland Security’s Customs and Border Protection (CBP) and the U.S. Department of Agriculture’s Agricultural Marketing Service (USDA/AMS).”

2. Manufacturers can omit/reduce ingredients that are listed provided the ingredient is not mandatory. For example, a fruit punch that usually contains grape juice and other juices could reduce the concentration of grape juice within the punch or eliminate it entirely.

“Considering the general factors provided in section B, we do not intend to object if minor, noncharacterizing ingredients are temporarily omitted from the formulation without corresponding labeling changes being made.”

3. “Minor substitutions” are allowed. However, the recommendations only mention major allergens like the top 9 and mustard in another part of the document as being “allergen concerns.” This leaves concern that this could especially endanger people with non-top 8 allergies.

“Considering the general factors provided in section III.B., we do not intend to object to substitution of minor ingredients described below in “Examples of Substitutions of Minor Ingredients,” where labels would be inconsistent with labeling requirements due to some minor formulation changes that involve temporary substitutions of non-characterizing ingredients, which are generally present at 2 percent or less, for other safe and suitable ingredients with similar technical functions, as long as there are no safety or allergen concerns introduced.” 

4. In addition, highly refined peanut, sunflower, or soybean oil could be used in place of another oil, as well. It is considered non allergenic to a majority of people. However there are still people that react and/or are advised by doctors to avoid the allergen. The website, Snacksafely, also makes a great point in that if you typically avoid shared lines or manufacturing facilities, you would want to avoid this type of oil.

“FDA does not intend to object to temporary substitutions without a label change of different fats or oils when the fats or oils are not prominent ingredients, 7 the oils are highly refined, the substitutions do not pose an allergenic risk, the replacement fats or oils are from the same category of vegetable, animal, or marine oils, and the oils have a similar fatty acid profile to minimize the impact on the nutritional profile. For example, substitution of canola oil for sunflower oil may be appropriate without a label change (both are vegetable sourced and have similar fatty acid profiles), but the substitution without a label change of beef tallow for sunflower oil would be outside the scope of this policy because the oils are from different categories (one is animal sourced and the other is vegetable sourced) and have different fatty acid profiles.”

The FDA’s new guidance was enacted “without prior public comment”

“This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or we) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)).”

Although the guidance document is being implemented immediately, it remains subject to comment in accordance with FDA’s good guidance practices.” Please add your own comment in the link listed under the header- “What can I do in under 5 minutes?”

Americans with food allergies and intolerances rely on accurate ingredient labels. The FDA, as of the publishing of our article, had met with some leading allergy and asthma advocates. I think it would be reasonable for companies to add sticker labels to account for any changes in ingredients other than the reduction or elimination of ingredients. 

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What can I do to help in under 5 minutes?

Please share this story. Help inform your friends and family. I found out about this story through social media, and I watch the news. Somehow I missed it. I have a feeling I’m not the only one.

Please consider commenting on the regulation via the government’s link here: https://www.regulations.gov/document?D=FDA-2020-D-1139-0009.

Here’s my comment if you want a quick example:

“I think many Americans can understand the reasoning behind these new guidelines. However, these guidelines create a lack of regulation that jeopardizes the health (and sometimes the life) of over 10% of the American population. Americans with food allergies and intolerances rely on accurate ingredient labels. I think it would be reasonable for companies to add sticker labels to account for any changes in ingredients other than the reduction or elimination of ingredients.”

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Reading my guide is a great start but not a perfect substitute for reading the guidance for yourself. The entire guidance is located here: Temporary Policy for Certain Food Labeling Requirements During COVID.