On April 13, 2023, the FTC issued nearly 700 notices of penalty offenses to leading dietary supplement brands sending the industry into a flurry evaluating their marketing and labeling compliance. For those still looking for perspectives on how to evaluate and mitigate risk, here’s a product claim risk assessment. 

1.Product Claim: “Clinically Proven” claim on the product packaging and the claim is backed by high quality, randomized, controlled human clinical trials (RCTs).  

Risk Level: Low

Reason: RCTs are considered best practice by the FTC. The FTC’s “competent and reliable scientific evidence” standard requires 1) Subject matter expert oversight 2) the study is deemed acceptable by the profession utilizing it 3) that the research be robust and based on best practices in the applicable scientific field and 4) have representative populations and participation large enough to show statistical significance. 

Ensuring Compliance: Consider making your RCT transparent and available on your website or independently reviewed and published for additional credibility.

2. Product Claim: “Clinically Proven Ingredient” claim on the product packaging and the claim is backed by high quality, randomized, controlled human clinical trials (RCTs).            

Risk Level: Medium

Reason: Just because one ingredient has been clinically proven, it doesn’t mean the finished formulation has been clinically proven. Depending on the claim made on pack and other marketing romance language, a consumer could perceive that the finished product has been more robustly evaluated than it really has and create regulatory exposure for the brand. From a safety and quality perspective, it’s vital to understand ingredient interactions within a finished product formulation. 

Ensuring Compliance: RCTs are best practice so anything short of that is a potential risk. Until you can conduct an RCT, conduct a thorough review of the product label. Consider how a consumer might perceive claims on the label. An independent analysis and survey of consumers may help a brand understand how their label is being perceived by consumers. Additionally, make sure to understand the role that the clinically proven ingredient plays in the finished product. The potential for interactions of supplements and other ingestables is real, so it’s important to study and minimize any adverse clinical outcomes because of undisclosed dietary supplement and drug interaction.

3. Product Claim: Structure Function claims without any use of RCTs

Risk Level: Elevated

Reason: While RCTs are considered best practices, the FTC does give guidance where RCTs are not practical. In these cases, the FTC accepts high-quality epidemiological evidence so long as they are considered acceptable by subject matter experts.  

Ensuring Compliance: Evaluate the documentation that you have to support label claims. If you don’t have epidemiological evidence or an RCT, consider the brand risk and re-evaluating the marketing and labeling strategy. 

This new FTC guidance should serve as a wake-up call and provide clarity on what brands should be considering best practice when it comes to substantiating claims. Act now to mitigate brand risk. 

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