FAQ: How Do Manufacturers Substantiate a Health Claim?

Ingredient launches often raise a common question for finished product manufacturers: what evidence is required to support a health-related claim on a label?

Gaps between ingredient-level research and a finished product's claims typically involve differences in dose, study population, or ingredient form rather than fabricated data. The below FAQ outlines what substantiation requires under current regulatory guidance and how to evaluate ingredient-level research against a finished product's specific dose and claims.

What Does "Substantiation" Actually Mean for a Health-Related Claim?

Under Federal Trade Commission (FTC) law, any claim about a health-related product's benefits or safety, whether stated outright or implied, must be backed by "competent and reliable scientific evidence" before it's advertised, not after.

The FTC defines that standard as tests, analyses, research, or studies that have been conducted and evaluated objectively by qualified experts in the relevant field, using methods generally accepted as capable of producing accurate results.¹ Substantiation isn't optional documentation gathered in case of a challenge; the FTC's position is that adequate substantiation must exist before a claim is made public.²

What's the Difference Between a Structure/Function Claim and a Health Claim?

Structure/function claims describe how an ingredient affects the body's normal structure or function, for example, "supports immune health" or "helps maintain healthy iron levels," and don't require FDA pre-approval under the Dietary Supplement Health and Education Act (DSHEA), although they still require substantiation and a standard DSHEA disclaimer.³

Health claims, by contrast, describe a relationship between a substance and reduced risk of a specific disease, and generally require FDA review or an authorized qualified health claim before they can be used. Structure/function language is far more common in the launches covered by Nutritional Outlook because it doesn't require FDA sign-off, but "doesn't require FDA approval" is not the same as "doesn't require evidence."

Does It Matter if the Clinical Research Used a Different Dose Than What's in the Finished Product?

Yes, and this is one of the most common gaps between ingredient-level science and a finished formulation. When Nutritional Outlook broke down TopGum's new cognition and vision gummy line, the eye health formula's 10 mg lutein and 2 mg zeaxanthin dosing matched the amounts used in the Age-Related Eye Disease Study 2, a National Eye Institute-funded trial.⁴ Its lion's mane formula, however, contained 100 mg per serving, compared with roughly 3 g daily used in the clinical trial most often cited for the ingredient's cognitive effects.⁵

FTC guidance is explicit on this point, saying that the amount and type of evidence must be relevant to the specific claim and the specific product, and research conducted at a substantially different dose, in a different population, or over a different duration doesn't automatically transfer to a lower-dose consumer formulation.²

Can Animal Studies, in Vitro Research, or Traditional Use History Count as Substantiation?

Generally, not on their own. FTC guidance states that as a general matter, competent and reliable scientific evidence for health-related claims takes the form of randomized, controlled human clinical testing; animal studies have limited predictive value for human effects, and in vitro studies may help establish a plausible mechanism but don't demonstrate benefit in people.⁶

This distinction came up directly in All G's LFX apo-lactoferrin launch, where a 2016 human gut-model study⁷ found that holo-lactoferrin, not apo-lactoferrin, was the form that delayed a specific pathogen's growth in that particular model, a reminder that even human-relevant research doesn't always point in the direction a marketing claim assumes.⁷ Claims based on a product's traditional or historical use are held to the same evidentiary standard as any other claim under FTC law.⁸

What Are the Most Common Ways Manufacturers Get Substantiation Wrong?

The recurring pattern across the launches isn't fabricated research, but rather research that's real but doesn't match the product. That includes citing a study conducted at several times the finished product's dose, citing general ingredient-class research (for example, a review of honey's moisturizing properties) as though it validates a specific formulation's claims, or omitting any reference to independent testing altogether, as was the case in a recent Costco haircare launch that made repair and conditioning claims without citing any product-specific research.

None of these are illegal on their face, but they represent exactly the kind of gap between "the ingredient category has evidence" and "this product's claim is substantiated" that the FTC's guidance is built to scrutinize.

How Can Manufacturers Reduce Their Risk When Making a Claim?

Evaluate the totality of the evidence rather than a single favorable study, disclose when research doesn't fully support a claim rather than omitting it, and match the ingredient dose and population in the underlying research as closely as possible to the finished product and its intended consumer.²

For manufacturers formulating with a new or differentiated ingredient form, whether that's a novel extraction method, a fermentation-derived protein, or a branded standardized extract, the underlying research should be evaluated against the specific form and dose used, not the ingredient category as a whole.

References

1. Federal Trade Commission. Health products compliance guidance. December 2022. Accessed July 23, 2026. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance

2. Natural Products Association. Federal Trade Commission (FTC). Accessed July 23, 2026. https://www.npanational.org/regulatory/federal-trade-commission-ftc/

3. US Food and Drug Administration. Dietary Supplement Health and Education Act of 1994. Pub L No. 103-417, 108 Stat 4325.

4. Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013;309(19):2005-2015. doi:10.1001/jama.2013.4997

5. Mori K, Inatomi S, Ouchi K, Azumi Y, Tuchida T. Improving effects of the mushroom Yamabushitake (Hericium erinaceus) on mild cognitive impairment: a double-blind placebo-controlled clinical trial. Phytother Res. 2009;23(3):367-372.

6. Cooley LLP. FTC revises health products compliance guidance. March 2, 2023. Accessed July 23, 2026. https://www.cooley.com/news/insight/2023/2023-03-02-ftc-revises-health-products-compliance-guidance

7. Chilton CH, Crowther GS, Śpiewak K, Brindell M, Singh G, Wilcox MH, Monaghan TM. Potential of lactoferrin to prevent antibiotic-induced Clostridium difficile infection. J Antimicrob Chemother. 2016;71(4):975-985.

8. Langel J. Substantiating Health Claims: Examples of Proof (and Lack Thereof) in Advertising. The Langel Firm. May 26, 2023. Accessed July 23, 2026. https://www.thelangelfirm.com/debt-collection-defense-blog/2023/may/substantiating-health-claims-examples-of-proof-a/