Special Regulations for Protein Products

Protein intake is essential to human health.  Concern for the health of our planet has led to great interest in obtaining protein sustainably.  Some, such as the Savory Institute view proper management of continental grasslands as the best route to balancing planetary health.  Others are working to develop of plant, algal, and fungal protein products.  Advancements are being made in methods to culture animal-based meats without growing whole animals. There are also efforts to commercialize insects as food sources.

As interest in novel protein products soars, so do the risks. Each of these solutions to our need to consume proteins leads to regulatory challenges.  Let’s start with insects. A colleague and friend, Katrina Emmel, Ph.D., recently published a great article about insects as food.  As she noted, the European Food Safety Authority approved dried yellow mealworms as a new food ingredient.  However, she also noted that insect proteins have not been deemed Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration (FDA).  Novel food sources, including proteins isolated from plants, as well as animal/insect sources that have not been part of the U.S. food supply must be evaluated for safety prior to market introduction.

The FDA and USDA (United States Department of Agriculture) signed an interagency agreement on how proteins made by cell culture technologies will be regulated in 2019. Under this agreement FDA will have regulatory oversight and inspection authority for the culture/production process pre-harvest.  USDA will have oversight and inspection authority over the products once harvested from cell culture.  Labeling will be regulated by USDA as well.

As mentioned above, plant-based protein ingredients need to establish GRAS status if the plant sources are processed to purify or partially purify the proteins. Plant-based protein products also need to be evaluated for their protein quality.

Animal-derived proteins are considered ‘complete’ in that they deliver the amino acids essential to human health in ratios that are central to good human nutrition.  Most plant proteins lack one or more essential amino acids or provide less than ideal amino acid ratios for human health. FDA requires evaluation of the amino acid ratios for any product presented as a source of protein. The protein quality is used to adjust the protein percent daily value on those products.  Those of you familiar with U.S. labeling regulations will recognize that protein daily values are not declared on most food labels.

Foods and dietary supplements labeled with protein claims, even if they only make that claim by identifying the product as a protein source, must declare a corrected percent daily value for protein (21 CFR 101.9(c)(7)). One method to correct the protein daily value is to use a factor known as Protein Digestibility Corrected Amino Acid Score (PDCAAS).  The PDCAAS score must be determined for each ingredient and accounts for levels of essential amino acids that are deemed to be ‘limiting’ because they are present at lower levels than are best for human nutrition. The digestibility of the protein is also accounted for in the PDCAAS value.  Most legumes are low in the essential amino acids methionine and cysteine, with typical protein quality scores in the range of 50 to 65 percent.  Grains, on the other hand, are low in lysine and threonine with typical protein quality scores in the range of 40 to 50 percent. Very few vegan protein products found in the U.S. market include corrected protein daily values in their nutrition or supplement facts boxes.

FDA has been slow to take enforcement action against the many violative products on the market. However, the agency did reiterate this requirement in the Federal Register Notice regarding the revised final rule for nutrition labeling. The increase in vegan protein products in the marketplace may lead the agency to look into the issue out of concern for public health. Companies that fail to evaluate the protein quality of plant-based products also risk lawsuits, as seen in a recent action against Kodiak Cakes.

Protein is essential to health and proper protein labeling is essential.   Contact us with any questions about these or other FDA regulatory issues.


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