In recent years, the dietary supplements industry has boomed. This is evident  in the number of new products emerging, as well as in the increased scrutiny from regulatory bodies like the FTC. As an example of this scrutiny, the FTC recently released the revised Health Products Compliance Guidance. This provides guidance for companies in the natural supplements industry. As a company that champions science-backed products, Radicle Science is keenly interested in helping our peers understand and comply with these guidelines. Here, we provide an overview of what industry leaders need to know about the updated guidance. 

  1. Be Specific and Back Up Claims: Both Explicit and Implied 

The FTC has a particular focus on companies that make claims about their products without backing them up with science. One important thing to bear in mind is that the FTC expects that any claim made about a product is backed by rigorous scientific evidence. “As a general matter, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing to meet the competent and reliable scientific standard,” the FTC Health Products Compliance Guidance details.

This means avoiding claims that are too general or sweeping, as well as ones that cannot be backed up by scientific research. When marketing your health products, make sure you rely on rigorous clinical data before making any claims. 

Also of note, the FTC  says that science supporting individual ingredients may not be adequate to substantiate a claim on your product if it contains a combination of ingredients and your product hasn’t been studied in its entirety in rigorous clinical trials. 

  1. Don’t Mislead About Safety 

One of the core principles of the FTC Health Products Compliance Guidance is to ensure that companies don’t mislead the public about the safety or efficacy of their products. It’s important to emphasize that products marketed in the dietary supplements industry are not immune to FDA and FTC regulations. As such, any claims made about safety, efficacy and potential adverse effects need to be substantiated with scientific research. 

It’s imperative your company takes any safety concern seriously and the appropriate steps to substantiate your claims. Never risk consumer safety, and take every opportunity to build trust with both consumers and the regulatory agencies responsible for protecting consumers. 

  1. Ensuring Your Data is Relevant to Your Audience

Another area of focus for the FTC is ensuring that when companies use clinical trials to substantiate a claim, the trial participants are representative of your target customers. Many clinical trials are conducted overseas, especially in India, but the biological makeup and environmental differences between Indians and Americans are great.  The FTC wants to ensure that products sold in America work for Americans.  

The pharmaceutical industry has also been under increased scrutiny of late because of the lack of diversity in clinical trials:  middle-aged white men are the primary participants in clinical trials. This issue has the potential to compromise the overarching goal of research in the first place: to  improve the health and well-being of the entire U.S. population.

If your product is being marketed toward women over the age of 50, does your clinical trial pass muster and align with this same demographic? When considering the supporting documentation for your label claims, make sure your study population is relevant to the population you are looking to serve. 

  1.   The FTC is Watching You 

The final point to bear in mind is that the FTC is highly aware of the dietary supplements industry and is monitoring compliance on a regular basis to ensure that companies are adhering to the guidelines laid out in the Health Products Compliance Guidance. In fact, warning letters go out to companies on a frequent basis. And, that’s when companies are lucky enough to receive just a warning letter. Sometimes it goes straight to a lawsuit or the Department of Justice. (Our recent webinar discussed this in-depth)

The FTC may consider examining your company’s website regularly to monitor completeness of all clinical studies. As a leader in the natural supplements industry, it’s important that you understand how the FTC is going to watch your company carefully. Being transparent and consistent with your marketing should minimize the risk of an FTC investigation. 

The FTC guidelines serve a greater purpose because they are designed to further promote transparency and credibility within the supplements industry. By understanding and complying with these guidelines, you can help to create a culture of trust and dependability that will benefit your company and consumers alike. 


As a B-corp, we democratized clinical trials to make them easily accessible and affordable for the supplement industry.  Our large-scale, diverse, gold-standard clinical trials generate the evidence required by the FTC to make claims — and ensure science-backed natural supplements are brought to the consumer market.. By adhering to the guidelines outlined in the FTC Health Products Compliance Guidance, dietary supplements can help people live healthier, happier lives – with clinical proof that will help manufacturers be healthier too.  

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