11.05.20
The Natural Products Association (NPA) recently requested that the U.S. Food and Drug Administration (FDA) amend the Food, Drug, and Cosmetic Act to allow for zero calorie labeling for branched chain amino acids (BCAAs). Conflicting guidelines from FDA make it unclear whether calorie reporting is required on Nutrition Facts and Supplement Facts panels, which leaves an opening for “frivolous” litigation against BCAA manufacturers, suppliers, and companies, NPA said.
Because the amount of calories that BCAAs contain are minor, the trade association believes that the agency should clarify that BCAAs should be exempt from calorie reporting, based upon 2016 guidance related to minor ingredients which did not explicitly describe the agency’s position on BCAAs.
“While the agency is working through this amendment, we request that the Commissioner grant a formal enforcement discretion to allow the regulated community to follow 21 CFR 101.36(b)(2) rather than 21 CFR 101.9 when providing caloric values on dietary supplement labels for branched chain amino acids,” the organization said in its request to FDA.
In more recent history, FDA’s 2016 guidance, “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels,” NPA posits that the agency did not provide any clarity on the issue of BCAAs.
“Unlike nutrients in conventional food, the (b)(2) dietary ingredients can only be declared when they are present in dietary supplements in amounts that exceed the amount that can be declared zero in nutrition labeling according to 21 CFR 101.9 (c),” Daniel Fabricant, PhD, president and CEO of NPA, wrote. “The guidance was intended to address instances where the regulations [food and supplement nutrient regulations] overlap with one another, however, it did not touch on the issue of BCAA labeling. This incongruity leaves manufacturers with unclear guidelines regarding whether they should label their products with a caloric value for BCAAs when they are unable to list them as protein. 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.”
“This is a commonsense short-term solution to provide our businesses with some relief from the increase in frivolous lawsuits we’ve seen lately,” Fabricant said in a separate statement. “Clear and consistent guidance from the FDA is the best way to ensure that consumers can make the most informed decisions about their health.”
Because the amount of calories that BCAAs contain are minor, the trade association believes that the agency should clarify that BCAAs should be exempt from calorie reporting, based upon 2016 guidance related to minor ingredients which did not explicitly describe the agency’s position on BCAAs.
“While the agency is working through this amendment, we request that the Commissioner grant a formal enforcement discretion to allow the regulated community to follow 21 CFR 101.36(b)(2) rather than 21 CFR 101.9 when providing caloric values on dietary supplement labels for branched chain amino acids,” the organization said in its request to FDA.
In more recent history, FDA’s 2016 guidance, “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels,” NPA posits that the agency did not provide any clarity on the issue of BCAAs.
“Unlike nutrients in conventional food, the (b)(2) dietary ingredients can only be declared when they are present in dietary supplements in amounts that exceed the amount that can be declared zero in nutrition labeling according to 21 CFR 101.9 (c),” Daniel Fabricant, PhD, president and CEO of NPA, wrote. “The guidance was intended to address instances where the regulations [food and supplement nutrient regulations] overlap with one another, however, it did not touch on the issue of BCAA labeling. This incongruity leaves manufacturers with unclear guidelines regarding whether they should label their products with a caloric value for BCAAs when they are unable to list them as protein. 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.”
“This is a commonsense short-term solution to provide our businesses with some relief from the increase in frivolous lawsuits we’ve seen lately,” Fabricant said in a separate statement. “Clear and consistent guidance from the FDA is the best way to ensure that consumers can make the most informed decisions about their health.”
