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Dietary Supplement Label Claims

Written by Parris M. Kidd, PhD

Published September 9, 2024
Last Updated September 9, 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.

Part 1: Structure/Function Claims

Supplement companies can make claims that their products are better because they offer consumers more benefits. These statements, known as “label claims,” are regulated by the U.S. government, primarily through the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

The FDA’s authority over dietary supplements stems from the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act), as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under these laws, the FDA holds exclusive jurisdiction over the safety of dietary supplements and is primarily responsible for overseeing their label claims. The FTC, on the other hand, has primary jurisdiction over supplement advertising.¹

The FDA categorizes label claims into three types: 1) health claims, 2) nutrient content claims, and 3) structure/function (s/f) claims and related dietary supplement claims.² This article covers structure/function claims—the category most commonly used by supplement companies. Other label claims will be covered in a future column.

FDA ‘Guidances’ Are Strong Recommendations

The FDA uses guidance documents to educate the dietary supplement industry. Although they assert that guidances aren’t necessarily rules, supplement companies are well advised to stick closely to the recommendations:

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.… The use of the word should in Agency guidances means that something is suggested or recommended, but not required.¹

Section 403(r)(6) of the FD&C Act requires that supplement companies substantiate claims related to structure/function, general well-being, and nutrient deficiency diseases. However, even with the DSHEA amendment, the Act does not specify what constitutes adequate substantiation.

Following the DSHEA’s passage, the FDA worked with the FTC and a seven-member Commission on Dietary Supplement Labels,² to develop guidances for label claim substantiation. One clear regulation that emerged required companies to submit the actual text of claims to the FDA for any new supplement within 30 days of the product’s release to the market.

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FDA Requirements for Structure/Function Claim Substantiation

FDA guidances more or less translate into requirements. Structure/function claims must relate to a nutrient or dietary ingredient affecting the normal structure or function of the human body. These claims may also address how the proposed effect is achieved—for example, “antioxidants maintain cell integrity.”

All s/f claims must have a superscripted marker (*, for example) linked to a standard FDA disclaimer nearby on the label or other promotional document:

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

All s/f claims must also be scientifically validated. Although a supplement company may choose not to include label claims, any claims they make must be backed by solid scientific evidence. This requirement is impossible to get around.

Structure/function claims—and all others—must be supported by findings from peer-reviewed scientific publications and avoid selective use of favorable studies. Human studies, particularly clinical trials, must follow proven scientific methodology. Additionally, claims about specific ingredients must be consistent with the dosages proven effective in these trials.¹,³

Structure/function claims cannot explicitly or implicitly link the claimed effect of a nutrient or dietary ingredient to a disease or state of health that could lead to disease. This common violation often prompts the FDA to classify the supplement as an unapproved drug, as the agency equates disease claims with drug claims.

The gap between an s/f claim and a prohibited disease claim can be narrow. While “promotes good brain health” would likely be acceptable, “promotes good brain health and prevents the onset of dementia” would be considered a disease claim. “Helps ensure soothing sleep for people with occasional sleeplessness” is likely okay, but “helps counter insomnia” is not.

Single words can make or break an s/f claim. “Prevent,” “mitigate,” “cure,” or “treat” almost always signal disease claims. However, “support,” “maintain,” “promote,” and even “enhance” are typically safe to use. Regardless of the words used to describe the claim, it must be defendable from a clinical and scientific perspective.

The FDA monitors supplement products off the shelf, on marketing websites, and even those promoted by “influencers,” to ensure s/f claims are in regulatory compliance. When violations are found, they are typically documented in Form 483 warning letters, or “483s.” The recipient of a 483 generally has at least 15 working days to address and correct cited violations.

The FTC Has Considerable Power Over Label Claims

Trouble with the FDA pales in comparison with the serious consequences companies can face over FTC infractions. While the FDA often receives criticism for its oversight of dietary supplements, where label claim substantiation is concerned, the FTC actually takes the lead in this area¹:

The FTC has typically applied a substantiation standard of “competent and reliable scientific evidence” to claims about the benefits and safety of dietary supplements … FDA intends to apply a standard for the substantiation of dietary supplement claims that is consistent with the FTC approach.

So what, exactly, are the FTC’s standards? The agency expects “substantiation that experts in the field believe is reasonable.” Research must be “sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.”⁴

Instead of breaking down claims into categories such as structure/function like the FDA, the FTC examines overall evidence supporting a label claim. They may consult with experts not just on a particular ingredient or product but also on the relevant medical field. For example, the FTC might consult with cardiologists to substantiate a claim about heart benefits.

Altogether, the FTC expects “competent and reliable scientific evidence,” specifically “tests, analyses, research, or studies that have been conducted and evaluated objectively by experts and are generally accepted in the profession to yield accurate and reliable results.”³

Upholding Truth-in-Advertising Standards

The FTC regulates dietary supplement advertising across the board: mail, magazines, newspapers, radio, TV, internet, influencers, testimonials, billboards, and buses. They’ve previously taken legal action against corporate owners and officers, ad agencies, catalog companies, infomercial producers, expert endorsers, distributors, and retailers.

In a stern 2022 Health Products Compliance Guidance, the FTC declared that supplements’ health benefits must be substantiated by randomized, controlled human clinical trials.⁴ They encouraged marketers to consult with independent experts to provide unbiased assessments of trial validity, relevance, and “legitimate conclusions.”

The guidance also provided 52 examples of advertising that could get supplement products in trouble.⁴ Anyone working with supplements would be well advised to read it.

Why Solid S/F Claims Set Realistic Expectations

In my experience, many supplement companies that violate s/f label claim requirements do so unknowingly. These companies typically just need guidance from professionals familiar with the regulations. But there have always been parties who knowingly break the rules. Many reputable companies encourage consumers to visit their websites to access the scientific substantiation behind their claims.

Increasingly, supplement companies are also providing consumers access to trained personnel for technical assistance. I’ve done a lot of this work and been able to improve products based on consumer feedback. Consumers need not be shy about requesting the list of published clinical trials and summaries related to a specific product.

As with all other consumer products, if a supplement’s label promises results that seem too good to be true, it likely is. Structure/function claims are often the main interface between products and consumers. When these claims are based on sound science and presented honestly, everyone benefits—consumers, companies, and the industry as a whole.

Footnotes

1
Food and Drug Administration (FDA). Center for Food Safety and Applied Nutrition. Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act. 2009. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food
2
Commission on Dietary Supplement Labels. Report of the Commission on Dietary Supplement Labels. 1997. https://ods.od.nih.gov/pubs/DSHEA1997report.pdf
3
Food and Drug Administration. Label Claims for Conventional Foods and Dietary Supplements. 2024. https://www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements
4
Federal Trade Commission. Health Products Compliance Guidance. 2022. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

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This article is provided by

The Institute for Natural Medicine, a non-profit 501(c)(3) organization. INM’s mission is to transform health care in the United States by increasing public awareness of natural medicine and access to naturopathic doctors. Naturopathic medicine, with its person-centered principles and practices, has the potential to reverse the tide of chronic illness overwhelming healthcare systems and to empower people to achieve and maintain optimal lifelong health. INM strives to fulfil this mission through the following initiatives:

Education – Reveal the unique benefits and outcomes of evidence-based natural medicine
Access – Connect patients to licensed naturopathic doctors
Research – Expand quality research on this complex and comprehensive system of medicine

About The Author(s)

Writer Dietary Supplement Quality Advisor

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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