Following several years of lead-up, including public engagement, the review of more than 13,000 comments, and conducting focus group studies, on February 22, 2023, the U.S. Food and Drug Administration ("FDA") issued a draft guidance on the labeling of plant-based milk alternatives ("PBMA").
Plant-based milk labeling has received considerable scrutiny as the products have gained popularity and has been the subject of lawsuits, proposed federal legislation, U.S. Department of Agriculture ("USDA") investigations, and state bills and resolution as states try to fill a federal void. FDA's draft guidance on PBMA labeling now enters the fray.
In the draft, FDA takes the position that PBMA are non-standardized foods because no definition or standard of identity has been prescribed for them by regulation. Accordingly, the FDA maintains PBMA must be labeled with their common or usual names, or in the absence thereof, a statement of identity that accurately describes them. The names of some PBMA appear to be established by common usage (e.g., "soy milk," "almond milk"). While "plant-based" or "plant" may be used to describe PBMA, FDA, in the draft guidance, does not recommend using only these terms, since "plant-based milk" is not the common or usual name of PBMA.
Per FDA, since PBMA are not milk, they may not be offered for sale as "milk," although they may use the word "milk" in labeling, as long as it is qualified by the plant source. Notably, however, with such usage of the word "milk," FDA recommends that PBMA products that have a nutrient composition different than milk bear an additional nutrient statement on the product label. This statement-which is voluntary-should, according to the FDA, describe how the PBMA product compares with milk, based on the USDA's Food and Nutrition Service ("FNS") fluid milk substitutes nutrient criteria.
FDA notes that not all PBMA meet the definition of an imitation food, but to the extent they do, the agency intends to exercise enforcement discretion with respect to inclusion of the word "imitation" in the food name.
The draft guidance will likely continue the controversy and interested parties should comment by April 24, 2023.
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