The Natural Products Association filed a citizen’s petition (FDA-2020-P-2134) in 2020 asking the FDA to address a discrepancy between 21 CFR 101.36(b)(2)* and 21 CFR 101.9 regarding the labeling of calories from branched chain amino acids (BCAAs).
The BCAAs in question, leucine, isoleucine and valine, 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.
The issue centers on the fact that while BCAAs are building blocks for protein, they do not count as protein on a Supplement Facts panel. However, they can contribute calories.
Marc Ullman, Of Counsel with Rivkin Radler, LLP, told us that there are some issues with the regulation, specifically with the very educated consumer.
“There’s no way to put these calories on a Supplement Facts panel in a way that people would recognize as a source of calories,” said Ullman. “You’re presenting the consumer with an inherent contradiction. By presenting calories but not a source [ie. carbohydrate, protein, or fat] then a consumer could argue this is also misleading. Companies are stuck between a rock and a hard place.”
Despite this, Ullman said he would recommend that people “label the calories and then add a creative statement outside of the supplement facts panel explaining the source of those calories.”
Other examples
Dr Rob Wildman, chair of AHPA’s Sports Nutrition Committee and regulatory expert at Demeter Consultants, told NutraIngredients-USA that BCAAs are not alone, and that the same applies to organic acids such as citric acid and malic acid, which are often used in flavoring efforts to express fruity flavors as well as in compounded nutrients like citrulline malate, which is commonly used at gram levels per serving. These organic acids can contribute calories but also do not fall neatly into carbohydrates, proteins, or fat, although often default to Total Carbohydrate in Nutrition Facts nutrient analysis protocols.
Dr Wildman added that the Citizens Petition signals a “progressive effort within the sports nutrition industry to better understand and accurately label all nutrition information, particularly calories on sports nutrition products”.
“This has been an ongoing point of discussion in the AHPA Sports Nutrition Committee and provides support of greater transparency and consumer confidence building in sport nutrition. While some have argued that some confusion might result when consumer see Calories, but not a listing for an energy macronutrient, the FDA has definitive guidance on the mandatory labeling of calories at a level of five calories or greater per serving**.”
“Just because you cannot label BCAAs as protein, doesn’t mean the calories go away,” added Dr Wildman. “In my humble opinion, the finest point of clarification for labeling calories for protein-building amino acids (e.g. BCAAs, EAA, Glutamine, Tryptophan, Glycine, etc.) and non-building block amino acids (e.g. citrulline) etc., is whether the industry simply defaults to the caloric density of protein.
“While some could argue that each amino acid is a little different and has a unique caloric content, the same argument could be made for proteins, especially when considering certain isolated proteins. The FDA has already provided an example Supplement Facts demonstrating such practice.”
FDA unable to reach a decision
The NPA petition was dated October 26 and the FDA is yet to address it. A letter from the Agency to NPA on April 16, 2021 said FDA has been unable reach a decision “because of other agency priorities and the limited availability of resources”.
When asked if there were any further updates, Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), said the association was still waiting for a response from FDA to its Citizen’s Petition.
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* 21 CFR 101.36(b)(2)
(2) Information on dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as established in § 101.9(c) and their subcomponents (hereinafter referred to as "(b)(2)-dietary ingredients"). (i) The (b)(2)-dietary ingredients to be declared, that is, total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with § 101.9(c). Calories from saturated fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohol may be declared, but they shall be declared when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in § 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for technological reasons, contain only individual amino acids.
** 21 CFR 101.9
Caloric amounts less than 5 calories may be expressed as zero