FDA Boosts Protein Preemption Defense

Recent FDA guidance for determining and declaring the protein grams in a serving has helped muscle a class action out of federal court.

FDA's guidance clarifies that protein nutrient content claims under 21 CFR 101.9(c)(7) can be based on either a direct or indirect methodology. Under the first method, protein content can be determined by calculating the amino acid content of the food item (which directly correlates with the amount of protein in a food). Under the second method, protein content can be determined by using the nitrogen-content method (which indirectly measures the amount of protein in a food because the more nitrogen that is present, the more protein there is).

For manufacturers using the second approach, protein content may be calculated on the basis of the factor 6.25 times the nitrogen content of the food. Further, as provided in the regulations, manufacturers using the nitrogen-content method may have to also provide a "corrected amount of