NPA asks FDA to help curb lawsuits over caloric values of BCAAs

By Hank Schultz contact

- Last updated on GMT

©Getty Images - Kittiya
©Getty Images - Kittiya

Related tags: Amino acid, BCAA, Sports nutrition products, Sports nutrition sector, Plaintiff

The Natural Products Association has asked FDA to clarify that the minor amount of calories contributed by certain amino acids do not need to be reported on labels. Publication of an official enforcement discretion would forestall frivolous lawsuits, NPA said.

The branched chain amino acids in question, leucine, isoleucine and valine, known collectively as BCAAs, are popular ingredients in supplements and food products, especially those aimed at a sports nutrition or active nutrition positioning.  BCAAs are essential amino acids that cannot be synthesized by the body and so must be consumed in the diet. BCAAs are thought to support increased muscle protein synthesis and so are particularly popular in preworkout products.

BCAAs are small molecules compared to the protein molecules they form a part of.  While protein is a macronutrient in its own right, BCAAs are dietary ingredients that are included in formulations at milligram quantities up to a top end of a few grams. Protein is often present in products at dosages up to as many as 30 grams or more per serving and so contributes a significant amount of calories.

It’s a similar situation with herbal extracts.  Blueberries are a macronutrient that pack a significant caloric punch which must be accounted for on labels; a blueberry extract does not, though that is not to say that such an extract would be entirely devoid of caloric value.

Lawsuits over calorie accounting

NPA filed a citizens’ petition this week with the US Food and Drug Administration asking FDA to clear up the muddy waters surrounding how these ingredients are accounted for on labels when it comes to total calorie counts.  Daniel Fabricant, PhD, president and CEO of NPA, said the current grey area surrounding BCAAs and their caloric value has given rise to what he termed frivolous lawsuits.

In one such lawsuit, a sports nutrition manufacturer was being taken to task for a discrepancy on a label of preworkout product that amounted to about 50 calories per serving.   The product claims 10 calories per serving, whereas the plaintiff claims that testing revealed it had more than 60.

“The argument is that you are somehow thereby contributing to the obesity problem in America, which is ridiculous,”​ Fabricant said.

NPA seeks stopgap solution

NPA said its petition seeks two main things:

  • That FDA 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 BCAAs on supplement labels.
  • And that while the Agency works to make this revision, that an enforcement discretion policy be issued to allow for dietary supplement labels to include BCAAs without specifying 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,”​ Fabricant said. “Clear and consistent guidance from the FDA is the best way to ensure that consumers can make the most informed decisions about their health.”

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