Debunking the Myth That Dietary Supplements Aren’t Regulated

Written by Parris M. Kidd, PhD

Published July 5, 2024
Last Updated July 5, 2024

Quality Matters is a monthly column by Parris M. Kidd, PhD, designed to inform consumers and practitioners about supplement purity, efficacy, ingredients, manufacturing, and legal requirements. The views expressed in this piece are the author’s own and do not necessarily reflect those of INM.

Although most people in the United States take dietary supplements, there are parties in the society that encourage skepticism about their effectiveness—and safety. One of the most common contentions is that supplements aren’t regulated by the U.S. government. This claim is untrue.

FDA Is the Main Regulator

The Food and Drug Administration (FDA) regulates supplements all the way from suppliers through to consumers. Their advertising and marketing are additionally regulated by the Federal Trade Commission (FTC). These agencies collaborate with federal, state, county, or even city public health organizations to identify and eliminate products that may be unsafe to the public.

On an everyday basis, the FDA has the main responsibility. They regulate the types of health claims that can be made. They regulate the label on the supplement container. They regulate the ingredient quality and quantity in supplements. They regulate the manufacturing process, step by step. When manufacturing mistakes are made, or safety may be an issue, they can require the product be recalled. And they require prompt reporting of serious adverse events according to a strict format.

Labeling and Product Information

Bottle of magnesium supplement turned on side

FDA requires the dietary supplement label to carry specific information within a specific layout. The label format is rigidly controlled, down to font sizes and thicknesses of the lines that demarcate ingredient listings. They require mandatory placement of the term “Dietary Supplement” on the center panel of the label, specific placement of the Supplement Facts panel, and strictly defined ingredient names and amounts within that panel. They also require that any common allergens in the product be listed on the label.

The FDA also requires the product label to carry the identity and contact information of the party responsible for the product. This facilitates a consumer being able to report any negative reaction after taking the product. If the adverse event is serious, the contact party listed on the container must investigate and report it to the CFSAN Adverse Event Reporting System (CAERS),¹ a publicly accessible database, within 15 business days.

The FDA also regulates all promotional content related to any dietary supplement. This includes everything the owner of the product says about the product on its label, posts online, or even states on the phone to prospective customers. Blogs, promotional or educational emails, website product descriptions, and even the content of testimonials from customers all can be vetted by the FDA for inappropriate health claims. Essentially, anything said about a product by its owner must conform with rules and regulations.

Health and nutrient content claims are regulated by the FDA, within four main categories:

Structure-function claims, based on the preponderance of evidence from human studies
General well-being claims, which require a lower burden of proof
Health claims, based on FDA scientists’ assessments of lengthy required submissions
Nutrient content claims, from FDA assessments of dose-related ingredient data

How are these claims developed? To paraphrase the FDA:

Claims must be based on reliable evidence from peer-reviewed scientific publications, represent the whole body of published evidence and avoid selective use of favorable studies.
Human studies—particularly randomized controlled clinical trials—must be prioritized over animal and other studies. Scientific methodology must be strictly applied to developing the claims.
Claims made about specific ingredients should be based on the dosages proven effective in clinical trials.

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FTC Is the Main Marketing Regulator

The FDA allows that where marketing claims are involved the FTC can choose to lead the way. The FTC looks mainly for false advertising, judged by the inadequacy of scientific support for advertised claims.

With its own requirements for scientific proof—sometimes tougher than the FDA’s—the FTC cracks down on companies that exaggerate claims for supplements. In April 2023, they cautioned hundreds of advertisers against making false marketing claims²:

By sending notices of penalty offenses to approximately 670 companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, or functional foods, the agency is placing them on notice [that] they could incur significant civil penalties if they fail to adequately substantiate their product claims in ways that run counter to the litigated decisions of prior FTC administrative cases.

Notices of penalty offenses allow the agency to seek civil penalties—up to $50,120 per violation….

The notices outline specific unlawful acts and practices, including failing to have: 1) a reasonable basis consisting of competent and reliable evidence for objective product claims; 2) competent and reliable scientific evidence to support health or safety claims; and 3) at least one well-controlled human clinical trial to support claims that a product is effective in curing, mitigating, or treating a serious disease.

While the FDA typically works by issuing warning letters that give the offending party time to correct their violations, the FTC can be much more aggressive. In 2019 the FTC won a judgment of $12.8 million against a supplement company that paid a third-party website to write fake reviews of their product on Amazon.

Manufacturers, Suppliers, and Distributors Are All Regulated

The FDA regulates dietary supplement production according to Current Good Manufacturing Practice (CGMP or GMP for short).³ Supplement GMP parallel pharmaceutical GMP but are not quite as strict. The extensive GMP regulations require that manufacturers take all necessary steps to ensure the finished product meets predetermined standards for ingredient identity, purity, potency, and freedom from contamination.

GMP regulations require that everyone involved in a supplement’s product development be accountable for its ingredients’ compositions, the mixing together of the ingredients in accurate amounts, and the finished product being adequately packaged and accurately labeled. Everyone involved is also responsible for preventing adulteration and for the product’s overall safety. No one in the process can shift blame to another if a problem arises.

Dietary supplement ingredients are sourced globally. Demands that supplements have ingredients all “Made in America” most often can’t be met because some ingredients simply can’t be made in this country. The sad fact is that suppliers anywhere can make excellent ingredients or bad ingredients. Therefore, GMP regulations mandate that ingredients be tested and verified, regardless of origin.

The FDA’s GMP regulations require dietary supplement manufacturers to thoroughly vet suppliers, with onsite inspections (including overseas) where feasible. In addition, they must thoroughly test the bulk ingredients they receive from these suppliers.

New Ingredient Notifications Further Protect Consumers

The FDA is now further tightening its requirements for supplement ingredients, an effort eight years in the making. Any ingredient not marketed in the U.S. before October 15, 1994, is now classified as a new dietary ingredient (NDI) and must be registered.

To register an NDI, a manufacturer or distributor must submit a New Dietary Ingredient Notification⁴ at least 75 days before introducing the product into interstate commerce. This document must include a range of details on the ingredient category (e.g., herbal), identity (including full scientific or chemical name), purity, identities, levels of any impurities or contaminants, safety, level of dosing planned in finished products, and target populations.

The NDI notification process aims to further protect consumers from supplements with dangerous ingredients. In December 2023 a physician reported to the New Jersey Poison Information and Education System about a child in crisis after having taken a supposed Mexican tejocote root dietary supplement product. The product turned out to contain not tejocote root but toxic yellow oleander.⁵ This issue quickly reached the Centers for Disease Control and Prevention, then the FDA, after which 18 such products were identified and the FDA moved to get them off the market.

Though they tend to move slowly, the FDA has at times worked with the U.S. Department of Justice to jail dietary supplement executives and have their companies forfeit profits. This happened in 2020 to execs who put a liver-toxic drug into workout supplements.⁶ And the FDA can move faster: during the COVID pandemic, they issued warning letters that required action within 48 hours.

The United States has a highly developed system for regulating dietary supplements. There is definitely room for improvement, and the system needs to move faster, especially because there are numerous opportunistic players in the marketplace wanting to make a quick buck and seemingly not caring about consumer safety. Despite these challenges, dietary supplements are thoroughly regulated and, as a healthcare product category, have far superior benefit–risk profiles compared with pharmaceuticals.

Footnotes

1
CFSAN Adverse Event Reporting System. U.S. Food and Drug Administration. https://www.fda.gov/food/compliance-enforcement-food/cfsan-adverse-event-reporting-system-caers
2
FTC warns almost 700 marketing companies that they could face civil penalties if they can’t back up their product claims. Press release. Federal Trade Commission. April 13, 2023. https://www.ftc.gov/news-events/news/press-releases/2023/04/ftc-warns-almost-700-marketing-companies-they-could-face-civil-penalties-if-they-cant-back-their
3
U.S. Food and Drug Administration. Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Updated September 20, 2018. Accessed June 27, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-current-good-manufacturing-practice-manufacturing-packaging-labeling
4
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes—Dietary Supplements. March 5, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-new-dietary-ingredient-notification-procedures-and-timeframes-dietary-supplements
5
Berland N, Kababick J, Santos C, Calello DP. Notes from the field: online weight loss supplements labeled as tejocote (Crataegus mexicana) root, substituted with yellow oleander (Cascabela thevetia)—United States, 2022. MMWR Morb Mortal Wkly Rep. 2023;72(37):1016-1017. https://doi.org/10.15585/mmwr.mm7237a3
6
Two individuals and two companies sentenced in scheme to fraudulently sell popular dietary supplements. Press release. U.S. Department of Justice, Office of Public Affairs. October 15, 2020. https://www.justice.gov/opa/pr/two-individuals-and-two-companies-sentenced-scheme-fraudulently-sell-popular-dietary

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About The Author(s)

Dietary Supplement Quality Advisor Writer

Parris M. Kidd, PhD

Parris M. Kidd, PhD, is an advisor for the Quality Matters program and member of INM’s Research Committee. Dr. Kidd, a thought leader in dietary supplement application, has developed and overseen quality programs for multiple supplement brands. He earned his BSc from the University of the West Indies in Jamaica and completed his PhD at the University of California, Berkeley. Dr. Kidd is a steadfast advocate for ensuring product safety and efficacy through rigorous clinical research.

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