Washington, D.C.—The Natural Products Association (NPA) announced that it has submitted a citizen petition requesting that the Food and Drug Administration (FDA) amend the Federal Food Drug and Cosmetic Act (FDC Act) to allow for zero calorie labeling for branched chain amino acids (BCAAs). NPA explained in a press release that conflicting guidelines from the FDA have led to an increase in private litigation that creates more uncertainty for manufacturers and small businesses, as well as for consumers.
NPA notes in the petition that although FDA did not address this issue when it recently updated its Nutrition and Supplement Facts labeling rules, action from the Agency “is needed urgently so that determinations about the appropriate declaration of calories associated with amino acid content are appropriately made by the regulatory body authorized by Congress to make such determinations, rather than by the courts.”
In the petition, NPA requested that the FDA take the following actions:
- Revise the Nutrition Facts regulations to address the discrepancy between 21 CFR 101.36(b)(2) and 21 CFR 101.9 pertaining to providing caloric values for branched chain amino acids (BCAAs) on supplement labels.
- Issue an enforcement discretion policy to allow for dietary supplement labels to include BCAAs without specifying caloric values for those ingredients while the Agency works to make the above revision. NPA noted that the process for revising the Nutrition Facts rules would take a significant period of time, during which companies would be left without appropriate clarification. NPA stated in the petition: “This ambiguity could potentially leave reputable companies open to frivolous lawsuits due to the incongruities in the regulations. An enforcement discretion policy or guidance would allow reputable manufacturers to list amino acids on their labels without listing calories without being in violation of labeling regulations.”
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“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, Ph.D., President and CEO of NPA in the 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.”