Health Products Compliance Guidance

Executive summary

This is the document that determines what any seller of wellness equipment - IMPERVITA included - may lawfully claim, and it is a genuinely useful tool for a buyer.

FTC staff prepared it to update and replace the 1998 guide, Dietary Supplements: An Advertising Guide for Industry. Like the 1998 guide, it provides guidance on how to ensure that claims about the benefits and safety of health-related products are truthful, not misleading, and supported by science.

Its evidentiary base is the enforcement record. Since 1998 the FTC has settled or adjudicated more than 200 cases involving false or misleading advertising claims about the benefits or safety of dietary supplements or other health-related products - including foods, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests and health-related apps. The update draws on the issues raised in those cases to illustrate how the FTC identifies express and implied claims and how it evaluates the scientific support for them.

The explicit inclusion of health equipment matters. Although most examples in the document concern dietary supplements, the guidance states that the same legal principles apply to the marketing of any health-related product.

It is intended as business guidance only, interprets FTC advertising law rather than creating it, does not have the force or effect of law, and does not provide a safe harbour from potential liability.

Why this research matters

Buyers rarely realise there is a legal standard governing the claims they are shown. There is, and it is public.

Its most useful concept for a reader is the implied claim. The FTC assesses not only what an advertisement says but what it conveys - so a product page that surrounds a wellness product with disease imagery and clinical language may be making a claim it never states outright.

What the researchers found

The guidance updates and replaces the 1998 Dietary Supplements advertising guide, providing guidance on ensuring that claims about the benefits and safety of health-related products are truthful, not misleading, and supported by science.

It records that since 1998 the FTC has settled or adjudicated more than 200 cases involving false or misleading advertising claims about the benefits or safety of dietary supplements or other health-related products, including foods, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests and health-related apps.

It draws on those cases to illustrate how the FTC identifies the express and implied claims conveyed in advertising and how the agency evaluates the scientific support for those claims.

It states that while most examples involve dietary supplement advertising, the same legal principles apply to the marketing of any health-related product, and that the document is business guidance only which does not have the force or effect of law and does not provide a safe harbour from potential liability.

No study data, effect sizes, or statistical measures exist in this document, and none are reproduced here.

What the results mean

Two ideas from this guidance are directly usable by a buyer.

The first is implied claims. The FTC looks at the net impression an advertisement creates, not just its literal words. A wellness device page that cites clinical trials of a different device class, or juxtaposes general wellbeing language with disease imagery, may be conveying a claim it never states.

The second is substantiation. Health claims require competent and reliable scientific evidence, and the level required scales with the strength and specificity of the claim. A specific, strong claim needs strong, specific evidence about the product.

Applied as a reading test: if a claim would not survive a demand to produce the evidence behind it, treat it as marketing.

Strengths and limitations

Strengths

• Primary source from the agency that enforces advertising law.
• Grounded in more than 200 settled or adjudicated cases rather than theory.
• Explicitly covers health equipment, not just supplements.
• Addresses implied as well as express claims.
• Publicly accessible and written to be applied.
• Recent, at December 2022.

Limitations

• Business guidance without the force of law.
• Most illustrative examples concern dietary supplements rather than equipment.
• Addresses advertising substantiation, not clinical effectiveness.
• Does not evaluate any specific technology or product.
• Enforcement is necessarily selective; absence of action is not endorsement.

Evidence in context

This guidance operates alongside the FDA's general wellness policy. FDA determines whether a product is a regulated medical device; FTC determines whether the advertising claims are adequately substantiated. A product can be a lawful general wellness device and still be advertised unlawfully.

Its principles are directly relevant to the recurring pattern documented elsewhere in this library: clinical-device evidence being cited for consumer wellness products, in PEMF particularly, and traditional sauna research being applied to infrared cabins.

No superseding guidance has been issued as far as we are aware.

Related research

1. General wellness: policy for low risk devices - guidance for industry and FDA staff U.S. FDA, Center for Devices and Radiological Health. Docket FDA-2014-N-1039. 2019. CDRH guidance.The FDA classification framework that operates alongside this advertising standard.
2. Effectiveness of pulsed electromagnetic fields on bone healing: a systematic review and meta-analysis of randomized controlled trials Peng L, Fu C, Xiong F, et al. Bioelectromagnetics 41(5):323-337. 2020. PMID 32495506; doi:10.1002/bem.22271.Clinical PEMF evidence frequently cited in consumer wellness marketing - a live example of the substantiation question.
3. Association between sauna bathing and fatal cardiovascular and all-cause mortality events Laukkanen T, Khan H, Zaccardi F, Laukkanen JA. JAMA Internal Medicine 175(4):542-8. 2015. PMID 25705824; doi:10.1001/jamainternmed.2014.8187.Traditional sauna research frequently applied to infrared cabins, another common substantiation issue.
4. Photobiomodulation: a review of the molecular evidence for low level light therapy Glass GE. Journal of Plastic, Reconstructive & Aesthetic Surgery 74(5):1050-1060. 2021. PMID 33436333; doi:10.1016/j.bjps.2020.12.059.Documents the absence of regulatory standards in photobiomodulation, which complicates substantiation in that category.