Section 403(a) of the Federal Food, Drug and Cosmetic Act (FD&C) prohibits placing information that is “false or misleading in any particular" on a food or dietary supplement label. In addition to this general “neither false nor misleading" requirement, a variety of label claim categories have specific criteria in FDA regulation (e.g., “fresh," “gluten-free"), an FDA policy (e.g., “whole grain," “non-GMO"), or regulations of other federal agencies (e.g., “Organic"–USDA, “Made in USA"–FTC).
The three foremost FDA-regulated food label claim categories are nutrient-content claims, health claims, and structure/function claims. The FDA regulations prescribing use of the latter two claim categories include criteria requiring the truthfulness of the claim to have been substantiated by appropriate scientific evidence, typically as human clinical trial evidence. The health claim category has a requirement for pre-market substantiation review and approval by FDA. The structure/function claim category, although also having substantiating scientific evidence criterion, has neither FDA review nor approval requirements.
Instead, a dietary supplement firm using structure/function claims merely certifies to FDA that the firm has substantiation that the claim is truthful and not misleading. The substantiation requirement for nutrient-content claims is limited to quantitative analytical measurements that verify that the nutrient content claimed on the label complies with the criteria established in the FDA regulation on the nutrient-content claim being made.
The FDA nutrition labeling regulations revisions published in summer 2016 added a couple wrinkles in the existing order for substantiation of nutrient-content claims. One new aspect of nutrient content claim substantiation is a record keeping requirement for those nutrients that have no quantitative analytical methods available to measure the nutrients as they were defined by FDA in the 2016 nutrition labeling revisions. The included nutrients are “added sugars," dietary fiber, vitamin E and folate. The record keeping provisions added to the nutrition labeling regulation (in new §§ 101.9(g)(10) and (g)(11)) require manufacturers to keep written records (e.g., analyses of databases, recipes, formulations, information from recipes or formulations, or batch records) to verify the declared amount of the above four nutrients. These records must be keep for at least two years, and must be provided to FDA upon request.
A second new aspect of nutrient content claim substantiation concerns dietary fiber. Prior to 2016, FDA’s nutrition labeling regulation did not define dietary fiber; rather there was a default “analytical definition" under which dietary fiber included anything that would be measured by an appropriate “dietary fiber" quantitative analytical method.
In the 2016 nutrition labeling regulation revision, dietary fiber has being defined in two ways: (1) non-digestible carbohydrates of at least three monomeric units, and lignin, that are both intrinsic to and present in intact plant material; and (2) isolated or synthetic non-digestible carbohydrate substances (of at least three monomeric units) that have been determined by FDA to have physiological effects that are beneficial to human health (§101.9(c)(6)(i)). FDA stated that the inherent benefits of dietary fiber intrinsic and intact in plant foods are well established; however, the benefits of isolated or synthetic non-digestible carbohydrates must be substantiated before they can qualify as dietary fiber.
FDA recognized only five beneficial physiologic effects of dietary fiber: improved laxation, blood cholesterol attenuation, post-prandial blood glucose attenuation, reduced blood pressure and increased satiety. FDA included in the revised nutrition labeling regulation six isolated/synthetic carbohydrate substances they considered adequately substantiated as have the beneficial physiologic effect of blood cholesterol attenuation: beta-glucan soluble fiber, psyllium husk, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose. FDA included cellulose on its dietary fiber list as a non-digestible carbohydrate substantiated to improve laxation. Adding any isolated/non-digestible carbohydrate substance, other than the initial seven included in § 101.9(c)(i), will require submission of a petition to FDA that includes clinical trial scientific evidence that substantiates that the substance has one or more of the five physiologic effects beneficial to human health of dietary fiber.
Thus, to continue making dietary fiber content claims for many currently used isolated/synthetic non-digestible carbohydrate food ingredients will require substantiation, and pre-market FDA approval, in the form of clinical trial evidence of one or more of the five FDA-accepted dietary fiber beneficial effects. Dietary fiber content claims now have a structure/function claim character.
A large portion of foods now using dietary fiber content claims are foods formulated with isolated/synthetic non-digestible carbohydrate ingredients that are not among those initially listed in the new § 101.9(c)(i) isolated/synthetic dietary fiber list. To continue using dietary fiber content claims for these Ingredients will require substantiating a beneficial physiologic effect in humans rather than simply the quantitative analytical measure. FDA recently issued guidelines to explain the agency’s thinking on the appropriate level of scientific rigor necessary for the evidence relied upon to substantiate that an isolated/synthetic non-digestible carbohydrate substance will have the beneficial physiologic effects of dietary fiber (“Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30): Guidance for Industry." Nov 2016). FDA’s guidelines for scientific evaluation of beneficial physiologic effects for the purpose of being counted as dietary fiber are obviously closely copied from the agency’s earlier “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims."
The original FDA regulatory scheme for food label claims differentiated quantitative claims (i.e., nutrient-content claims) and health-effect claims (i.e., health claims). The 1994 Dietary Health and Education Act of 1994 (DSHEA) further carved out a category for non-disease related health effect claims (i.e., structure/function claims). With the 22016 nutrition labeling regulation revisions, the FDA label claim scheme has again evolved by making dietary fiber content claims implied health effect claims requiring a FDA premarket approval and regulation.
James E. Hoadley, Ph.D., is a senior consultant with EAS Consulting Group. Dr. Hoadley's 20-year FDA career, which began in 1987, includes work as a Research Scientist in the Center for Food Safety and Applied Nutrition (CFSAN), Division of Nutrition, and as a Toxicologist in performing food additive and GRAS petition safety reviews in the Office of Premarket Approval. With the passage of the Nutrition Labeling and Education Act (NLEA) he participated in the development of NLEA-implementing nutrition labeling and health claim regulations. During the last ten years, Dr. Hoadley's position had been as a senior regulatory scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) with primary responsibilities in food label claim regulations. In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims. During this period Dr. Hoadley was involved in some of the most precedent-setting health claim regulatory problems as CFSAN adapted to the FDA Modernization Act provision for authorization of food label claims based on authoritative statements, the 1999 Pearson v. Shalala federal court decision that led to qualified health claims, and Pearson-related lawsuits. Dr. Hoadley has been directly involved in the scientific review and drafting of authorizing regulation, or denials, of nearly all health claim petitions received by CFSAN over the last decade. Dr. Hoadley has received the CFSAN Distinguished Career Service Award. Dr. Hoadley earned his Ph.D. in Toxicology at the University of Cincinnati College of Medicine, and did postdoctoral research in Nutrition at the University of Florida. His Bachelor of Science degree is from Ohio State University with a Major in Agricultural Education.