April 15, 2023

Supplement Marketers Face New Substantiation Challenges

What are "structure/function" claims?

Continuing with The Dietary Supplement Health and Education Act of 1994, supplement advertisers have attempted to stay within the FDA product labeling boundaries of what is known as "structure/function" claims.

“Structure/function” labeling claims describe the effect the ingredients of the product have on the structure or function of the body of the person taking the product.

Classic example: "Calcium builds stronger bones."

Supplement advertisers have attempted to avoid health claims by generally staying within the “structure/function” boundaries for advertising claims regulated by the FTC.

Substantiation and "reasonable basis"

The general requirement for substantiation for all advertising claims is a "reasonable basis" for all objective claims.

If you'd like additional information regarding substantiation and "reasonable basis," visit The Ultimate Claims Substantiation Guide for Digital Marketers (+ Examples) .

Claims regarding a product's health or safety benefits must be substantiated by “competent and scientific evidence."

In December 2022, the FTC released its Health Products Compliance Guidance updated and replaced its 1998 guidance for dietary supplements.

Penalty notice letters

On April 13, 2023, the FTC issued 670 penalty notice letters (NPOs) to companies regarding advertising claims for health-related claims.

The penalty notice letters put the recipients on notice that subsequent FTC enforcement proceedings will seek civil penalties (fines) against the wrongdoer who breaches the rules set out in the NPOs, which can amount to over $50,000 per violation.

All advertisers of dietary supplements should heed this notice in the NPO: “Failing to have at least one “well-controlled” human clinical trial to support claims that a product is effective in curing, mitigating or treating a serious disease.”

Randomized clinical trials require extensive testing periods for reliable results and are expensive and challenging to complete correctly.

In prior consent orders for settled cases, the FTC has provided detailed information regarding clinical trials and how many clinical trials may be required for appropriate substantiation.

Takeaway

Supplement advertisers should carefully review the Health Products Compliance Guidance linked above for specific information regarding the substantiation of health-related claims.

Supplement claims should be reviewed and revised if they are overstated regarding scope, material disclosures, or the certainty of emerging science.

Understand that if the FTC determines that your claim requires a clinical trial for substantiation, your only option may be to litigate and win the enforcement action to prevail.