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NPA files citizen petition requesting clear guidance on labeling caloric content for BCAA products, providing relief from frivolous lawsuits.
The Natural Products Association (NPA; Washington, D.C.) has filed a citizen petition requesting that the U.S. Food and Drug Administration amend the Federal Food Drug and Cosmetic Act (FD&C Act) to allow for zero calorie labeling of branched chain amino acid (BCAA) products. Currently, there is a discrepancy between 21 CFR 101.36(b)(2) and 21 CFR 101.9 pertaining to providing caloric values for BCAAs on supplement labels.
NPA writes in its petition:
“One component of 21 CFR 101.9 is the description of nutrients that are required to be listed on the Nutrition Facts panel, including protein. For supplement labels, protein and amino acids fall into the (b)(2) category of ingredients as defined in 21 CFR 101.36. According to FDA’s manufacturers, protein is considered to be a (b)(2)-dietary ingredient; however, dietary supplement labels may not declare protein content in grams on their label if the product contains only individual amino acids. The same section in the regulations provides information pertaining to the calculation of caloric content but does not reiterate the statement that protein, and therefore calories, from amino acids shall not be listed on product labels. This leaves consumers and manufacturers with significant ambiguity regarding the true caloric content of products that only contain amino acids.”
So, while it’s clear individual amino acid products, such as BCAAs, may not declare protein content, there is less clarity about how caloric content should listed if at all. And, if caloric content is listed, where do these calories come from, if protein content is not present on the label?
As the petition explains: “Consumers may not understand the nuance of complete versus incomplete proteins, however, they do realize that macronutrients (protein, carbohydrates, and fat) contribute to calories. If a manufacturer were to provide caloric values for a product that only contained BCAAs, as many amino acid supplements do, then a savvy consumer would question the source of the calories since many people assume that an amino acid would be considered a protein for the purpose of inclusion on a label.”
The conflicting guidelines, says NPA, have led to an increase in private litigation, an additional source of uncertainty for manufacturers, small businesses, and consumer during these hard times. The petition requests that FDA not only revise the regulations, but also issue an enforcement discretion policy while the Agency determines the appropriate revisions. This enforcement discretion policy would allow dietary supplement labels to include BCAAs without specifying the caloric values for those ingredients.
“This is a commonsense short-term solution to provide our businesses with some relief from the increase in frivolous lawsuits we’ve seen recently,” said Daniel Fabricant, PhD, president and CEO of NPA, in a press release. “Clear and consistent guidance from the FDA is the best way to ensure that consumers can make the most informed decisions about their health.”