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FDA Loosens Food Label Requirements: What People With Allergies Should Know

Nutrition label

 

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Key Takeaways

  • The FDA is allowing food manufacturers to make small ingredient changes to their products without adjusting the food label if COVID-19 causes supply chain issues.
  • This policy will remain in effect for as long as HHS deems COVID-19 a public health emergency, plus longer as needed.
  • Food label leniencies, even for minimal ingredient changes, can pose significant risks for people with food allergies.

The COVID-19 pandemic has forced the world to adapt to many changes, including changes to the food supply chain. Many farmers and food companies have experienced supply shortages, labor disruptions, and changes in demand. As a result, the Food and Drug Administration (FDA) has allowed for temporary flexibilities, the latest of which include changes to food labeling requirements.

The guidance, published on May 22, allows food manufacturers to substitute, omit, reduce, or re-source ingredients in their products without changing the labels. This was not permissible two months ago.

"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," the FDA guidance says.

While many food companies welcome this change to ensure they can continue to sell their products, even minor formulation changes can pose a risk to the 32 million Americans with food allergies.

What This Means For You

Most people probably won't care too much about minor changes to their food products. But people with allergies—both common and rare—should contact manufacturers for updates regarding any ingredient changes that won't be reflected in the label.

What Exactly Does the Policy Change Entail?

Prior to COVID-19, if a manufacturer was changing an ingredient in their food, the FDA required that the label reflect that change, which took time and resources.

Now, with a shortage of supplies and a disruption of the supply chain, the FDA's guidance aims to assist manufacturers who many need to make minor changes to their products while also making sure people's safety is unaffected.

Ideally, the FDA says, manufacturers should make label updates when they need to change product formulations due to COVID-19-related supply disruptions or shortages, or add stickers reflecting any changes if entire new labels can't be printed. But the FDA acknowledges limited resources may make this impractical. As a result, it is "providing temporary labeling flexibilities."

The FDA guidance allows for minor formulation changes if they align with the factors below.

Safety

The ingredient change does not cause any adverse health effects by adding the top allergens:

  • Milk
  • Eggs
  • Fish
  • Shellfish
  • Tree nuts
  • Peanuts
  • Wheat
  • Soybeans
  • Gluten
  • Sulfites

If these ingredients are added or substituted, manufacturers must change the label. The addition of other potential allergens more prominent in other countries, such as sesame, lupin, buckwheat, and celery, also warrants a label change.

Quantity and Prominence

The ingredient being substituted for the labeled ingredient cannot be a major component in the product. Unlisted substitutions are only permitted for ingredients that are present in the food at 2% or less.

For example, if your pasta sauce says "made with mushrooms" and the ingredient list includes portobello mushrooms, the FDA does not object to a temporary unlisted substitution of button mushrooms.

Characterization

The ingredient substitution does not change the product entirely. If you set out to buy raisin bread, for example, the manufacturer can't use cranberries in place of raisins.

Claims

Swapping or omitting ingredients does not change any voluntary health or nutrition claims already printed on the label.

Nutrition/Function

The ingredient substitution or omission cannot change the nutrition of the product. For example, a product cannot have less fiber than is listed on the label due to an ingredient change.

Examples of FDA-Accepted Ingredient Changes

The FDA guidance lays out specific examples of instances in which minor formulation changes without changes to the label are permissible.

  • Reductions and omissions: A vegetable quiche may have fewer peppers in it than before or an instant soup may not contain any peas.
  • Sourcing locations: Ingredients can be temporarily sourced from domestic or international locations different from what appears on the label. For example, a label may say "California raisins," but they can be from another state or another country.
  • Artificial colors: Color additives that are not certified by the FDA may be used as replacements for certified colors as long as they do not pose an allergy risk.
  • Flavors and spices: Some labeling flexibility has always existed with generic terms like flavorings and spices. The new guidance says these types of ingredients can be changed without a label change as long as there is no potential for an allergic reaction.

Small changes to flavors and spices can be problematic for people with very rare allergies to flavors that may be derived from proteins like milk and peanuts.

  • Fat and oils: Fats and oils can be changed if they are highly refined, if substitutions do not pose an allergy risk, and if they are within the same family of oils. For example, canola oil cannot be substituted with beef tallow, because you can't substitute a vegetable oil for an animal fat. But canola oil can be substituted with sunflower oil.

While the FDA does not consider highly refined oils like peanut oil, tree nut oil, sesame oil, and soybean oil to be allergenic, some people can still react to them. A person with a corn allergy may react to the replacement of canola oil with corn oil.

How Long Will This Last?

The FDA says these labeling flexibilities will remain in place as long as needed to ensure adequate food supply during and after the pandemic.

"This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19," the FDA says. "However, we recognize that the food and agricultural sector may need additional time to bring its supply chains back into regular order. Therefore, upon termination of the public health emergency, the FDA intends to consider and publicly communicate regarding whether an extension, in whole or in part, is warranted, based on comments received to this guidance and our experience with its implementation."

In other words, it's unclear exactly how long this will last.

What Can People With Food Allergies Do?

Relaxing rules around ingredient labeling can be worrisome, both for people with food allergies and parents of kids with food allergies.

"We have to question why the FDA recommendations are so vague and why they give manufacturers so much leeway." Dave Bloom, CEO of SnackSafely.com and the parent of a child with a food allergy, tells Verywell. "Consumers need to call manufacturers and ask detailed questions. Can I rely on the label?"

Bloom says you should ask if the ingredients have changed or if the ingredients in the processing facility have changed. In addition, stick to brands you know and trust.

According to Bloom, SnackSafely.com has reached out to its 120-plus partner manufacturers for their pledge to not change ingredients in their products without reflecting them on the label. So far, almost half have taken the pledge, and he anticipates more will be on board.

Allergy non-profits are approaching the FDA with calls for reform regarding this label flexibility. You can make your voice heard by submitting electronic or written comments.

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Article Sources
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  1. Food and Drug Administration. Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines. May 22, 2020.

  2. Food Allergy Research & Education. Food Allergy Facts and Statistics for the U.S.

  3. Food and Drug Administration. FDA Announces Temporary Flexibility Policy Regarding Certain Labeling Requirements for Foods for Humans During COVID-19 Pandemic. May 22, 2020.