The FDA just released a temporary relaxation of its food labeling policy. This temporary change comes into effect to prevent shortages and manage delays in the food chain supply during the COVID-19 crisis. This policy will remain in effect through the end of the public health crisis. Although the policy takes food allergies into consideration, it may have an affect on the safety of food particularly for those who allergies fall outside of the Top 8 (peanut, tree nut, dairy, egg, wheat, soy, fin fish, and shellfish).
“The food industry has requested flexibility when manufacturers need to make such minor formulation changes… that may cause the finished food label to be incorrect, but that do not pose a health or safety issue and do not cause significant changes in the finished food due to the temporary formulation modifications.”
The policy allows manufacturers to:
- Make minor formula changes consistent with the product’s taste, texture and integrity; and
- Continue labeling their original ingredient list without noting changes made.
The specifics of the policy offer a few important details:
- On page 6, FDA encourages manufacturers to make label changes whenever possible noting that consumers rely on those labels to make informed choices. They are not, however, required to alter their labels during this time. If labeling cannot be changed on the package, the FDA recommends companies use alternative means of informing consumers for transparency, such as posting information on their website or applying stickers to packaging.
- As always, flexibility remains in place for formulations of generically grouped ingredients, such as “spices”, “flavoring” or “color,” and can be changed without relabeling.
- The FDA is authorizing this flexibility for minor ingredient changes. When considering these “minor” ingredients, the FDA highlights:
- Safety: does the ingredient substitution cause an adverse health effect (such as food allergens)?;
- Quantity: the substitution must generally be for ingredients that comprise 2% or less of the finished food/final product;
- Prominence: the substitution should not conflict with a major component of the product (for example, wheat in a muffin);
- Characterizing Ingredient: the substitution/omission should not represent the ingredient that defines the product (such as raisins in a raisin bagel); and
- Nutritional/Other Claims: the substitution should not misrepresent nutritional or other claims made about the product.
Faced with supply issues of their own, manufacturers can now reduce the amount of ingredient they use or choose to omit it altogether. Additionally, they may temporarily substitute an ingredient that is less than 2% of its finished product. The FDA encourages manufacturers to consider allergens (the Top 8 allergens as well as many common allergens beyond) before making a change and suggest labeling should such a change be necessary [page 8].
The FDA policy outlines several areas where it will not object to substitutions [page 10]. One area of possible note for those with food allergies is Fats and Oils. The FDA will not object to a swap of fats and oils as long as they do not pose an obvious allergenic risk (say using peanut oil instead of vegetable oil) and is derived from the same source (plant, animal, etc) and are highly refined. They specifically mention a hypothetical scenario where a manufacturer might substitute canola oil for sunflower oil. Speak to your allergist about your personal risk with refined oils and these possible substitutions.
As we strive to understand how this policy will impact our community, we recommend that those with food allergies:
- Read ingredient labels carefully, looking for stickers or other notifications of ingredient substitutions;
- Call manufacturers and/or check on their websites frequently to understand which products may be affected by substitutions; and
- Speak with your allergist about these changes and how they may affect your specific allergies.
The FDA has issued this guidance without public comment due to the emergency circumstances. However, their policy notes, “This guidance document is being implemented immediately, but it remains subject to comment in accordance with FDA’s good guidance practices.
Comments may be submitted at any time for FDA consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. All comments should be identified with the docket number FDA-2020-D-1139 and complete title of the guidance in the request.”