y is affected by amino acid composition and digestibility. The more “indispensable” amino acids a protein contains (amino acids that are not produced by the body and are derived solely from food) and the more digestible a protein is, the higher its nutritional quality. There are a variety of methods of measuring protein content, each with advantages and disadvantages. The nitrogen or Kjeldahl method is inexpensive, easy to reproduce, and is considered the universal standard of protein quantification. However, the method typically overstates protein content and other methods are more accurate. To reflect protein quality and nutritional value more precisely, manufacturers may apply a protein digestibility-corrected amino acid score (PDCAAS) to measure protein quantity.Thirty-three years ago, Congress amended the Food, Drug, and Cosmetic Act through the Nutrition Labeling and Education Act (NLEA), which mandated nutrition labeling and the now ubiquitous Nutrition Facts Panel (NFP). Under 21 C.F.R. § 101.9, the FDA requires manufacturers to disclose the quantity of protein and other nutrients contained in the product within the NFP. The FDA also regulates protein content claims that are made outside of the NFP. For example, 21 C.F.R. § 101.13(i)(3) authorizes manufacturers to make nutrient content claims regarding the “amount or percentage of a nutrient” if the claim “does not in any way implicitly characterize the level of the nutrient in the food and it is not false or misleading in any respect.”Section 101.13 does not include specific rules dictating how protein should be measured in nutrient content claims. Rather, it provides that “compliance with [the] requirements for nutrient content claims… will be determined using the analytical methodology prescribed for determining compliance with nutritional labeling in section 101.9.” The pertinent part of that regulation, section 101.9(c)(7), requires that manufacturers include protein quantity in the NFP measured by “the number of grams

[11]Declaration of Quantitative Amounts of Vitamins and Minerals In the draft guidance, the FDA discusses the requirements for the declaration of quantitative amounts of vitamins and minerals declared on the nutrition and supplement facts labels. 21 CFR 101.9(c)(8)(iii) requires that: the quantitative amounts of vitamins and minerals, excluding sodium, be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv)(which refers to the Reference Daily Intakes (RDI) table).

The relevant regulations have been in effect for approximately two decades and the conflict is not new, so it is unclear what induced FDA to issue this guidance now.So what is it all about? The nutrition labeling regulations, 21 C.F.R. §§101.9(c)(1)-(8); 101.36(b)(2)(ii), specify how to declare nutrients and dietary ingredients. Notably, the regulations specify the rounding of nutrients, e.g., the quantitative amount of total fat present at 5 g or less must be rounded to the nearest 0.5 increment.

4; Cal. Code Regs. tit. 4, §§15718-25. 21 U.S.C. § 343(q); 21 C.F.R. 101.9(c). 21 U.S.C. §343(a). 21 C.F.R. 101.13(i).

Since use of the phrase “gluten-free” on a product label is voluntary on the part of the seller, and since gluten is not a nutrient whose levels must be disclosed on labels under FDA regulations, use of “gluten-free” labeling does not come within the nutrition labeling mandates of Subpart A of Title 21, Part 101 of FDA regulations governing food labeling. See 21 C.F.R. 101.9(c) Furthermore, there are nutrition labeling exemptions for small businesses under FDA regulations. See:(a) 21 C.F.R. 101.9(j)(1) (“The following foods are exempt from this section [on nutrition labeling of food]: Food offered for sale by a person who makes direct sales to consumers who has annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, provided that the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising”); and(b) 21 C.F.R. 101.9(j)(18) (“The following foods are exempt from this section: Food products that are low-volume [meaning] the person claiming the exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the United States”).However, for those Cupcake Businesses who may elect to affix “gl

Recent FDA guidance for determining and declaring the protein grams in a serving has helped muscle a class action out of federal court.FDA’s guidance clarifies that protein nutrient content claims under 21 CFR 101.9(c)(7) can be based on either a direct or indirect methodology. Under the first method, protein content can be determined by calculating the amino acid content of the food item (which directly correlates with the amount of protein in a food).

Medical foods are not prescription medicines and are not dietary supplements. So, what are they? Federal law and FDA regulation define medical food as, “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation” (§ 5(b) of the 1988 Orphan Drug Act (21 U.S.C. 360ee(b)(3)) and FDA regulation 21 CFR 101.9(j)(8)).To provide greater clarity on this definition, the FDA in 2016 published, “Frequently Asked Questions About Medical Foods; Second Edition; Guidance for Industry.” This guidance explained that “medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who requires use of the product as a major component of a disease or condition’s specific dietary management.”

By Riëtte van Laack – On April 10, 2017, the American Bakers Association (ABA) submitted a Citizen Petition and a Petition for Stay of Action on FDA’s new definition of dietary fiber in 21 C.F.R. § 101.9(c)(6)(i), and the accompanying recordkeeping requirement in 21 C.F.R. § 101.9(g)(10) and (11). By way of background, FDA’s final rule issued in May 2016 defined dietary fiber as: non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic nondigestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.

The court also concluded that plaintiff’s claims related to defendants’ use of the common names of vitamins were preempted. See, e.g., 21 C.F.R. § 101.9(c)(8)(v) (recognizing that “Vitamin C” and “Ascorbic acid” are “synonym[s]” that may be used in the alternative in a product’s nutritional information labeling); 21 C.F.R. § 101.9(k)(4) (stating that the FDA will consider a food “misbranded” if its “label or labeling represents, suggests, or implies” that “a natural vitamin in food is superior to an added or synthetic vitamin”).Significantly, the court concluded that plaintiff could not avoid preemption of these claims by arguing that his claim related solely to defendants’ “all natural” representations and that he included his fruit name and vitamin name claims only as support for his “all natural” claim. Such an argument would effectively allow a plaintiff to always avoid preemption of those claims, and would undermine the purpose of the federal labeling standards which includes avoiding a patchwork of different state standards.

[8] Id. at *4.[9]Nacarino v. Kashi Co., No. 22-15377 (9th Cir.) (appeal filed March 14, 2022);Chong v. Kind LLC, No. 22-15368 (9th Cir.) (appeal filed March 11, 2022).[10] See 21 C.F.R. § 101.9(c)(7).[11] Id.[View source.]