CRN Guidelines for Labeling of Protein in Dietary Supplements and Functional Foods
CRN recommends that marketers of dietary supplements and functional foods adhere to the following guidelines in labeling the protein content in any such product:
- Notwithstanding the allowance in 21 CFR § 101.9(c)(7) to calculate the amount of protein to be declared in nutrition labeling of a dietary supplement or food on the basis of the factor of 6.25 times the nitrogen content of the food, the quantity of protein in a product should be calculated to include only proteins that meet the following definition: “A chain of amino acids connected by peptide bonds.”
- As further clarification, non-protein nitrogen-containing (NPN) substances should not be counted toward total protein content on product labels. NPN substances should be accounted for and subtracted from the total nitrogen content when protein is measured by nitrogen content.
- Nothing in this guidance is intended to replace or conflict with any regulatory requirement established under any other subpart or section of 21 CFR Part 101 for labeling of food and dietary supplement products.
Rationale: In the case of non-amino acid substances such as taurine or creatine, such ingredients are not components of proteins, and the nitrogen contained in these compounds does not play a direct role in protein nutrition. While amino acids are the building blocks of protein, the addition of individual amino acids to a protein product may not stimulate protein synthesis in the body.
High quality protein provides all of the amino acids required by the body, in the proper ratios, to allow for optimal rates of protein synthesis for physiological functions. Individual amino acids, if added in an unbalanced manner (i.e., distorting the amino acid ratio provided by high quality protein), may not further increase protein synthesis.
Implementation: CRN recommends its members comply with these guidelines for new product labels put into the marketplace as soon as practicable, given the realities of label stock, potential formulation changes and distribution chains, but no later than 12 months after adoption of the program by the association (approved April 2014).
Approved by CRN’s Board of Directors: April 24, 2014