Background
Under title 21 of the Codified Federal Regulations (21 C.F.R) Section 101.9(c)(7), nitrogen-containing compounds that are not used in protein synthesis can be used toward the calculation of protein content. “Protein content may be calculated on the basis of the factor 6.25 times the nitrogen content of the food as determined by the appropriate method of analysis… except when official AOAC procedures… require a specific factor other than 6.25, that specific factor shall be used.” While some of these N-containing compounds are considered to be amino acids by FDA (ie. L-citrulline and L-ornithine), they are not incorporated into protein from amino acid building blocks. FDA can clarify the regulation on calcuation of protein content so that consumers are not misled into thinking protein is in a finished product as opposed to a nitrogen-containing compound.
Issue
Companies who sell protein products must often compete in the marketplace against competitors selling cheaper ingredients containing only inexpensive amino acids or nitrogen-containing compounds. All three of these product types can list protein content based upon their nitrogen-containing content, but this is neither accurate nor truthful to a consumer. NPA does not believe FDA can adequately enforce against false and misleading products based upon the current calculation.
NPA Position
The current federal regulations instructing companies on how to calculate protein content can be used to include substances that are not protein as part of a protein declaration on a food or dietary supplement label. Tell representatives and senators to contact the FDA to change the way protein content is calculated because it may mislead consumers.
