In today’s video, we discuss disease claims for dietary supplements, and the major enforcement risk that would get raised if you made them for your supplement product.

Many of our clients in the dietary supplement business have asked us questions related to this issue, and so today we’re going to illustrate the potential dangers of these claims with reference to the real case of two dietary supplement companies that saw some heavy FTC enforcement action. By the end of this video, you’ll have a direct example of how the regulators can bring the hammer down on supplement companies for unsubstantiated disease claims. And there we’re taking about not only FDA but FTC.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised over a thousand healthcare industry clients on healthcare and FDA and FTC legal issues. So, we’re here in Encinitas and by permission of the owner, let’s jump into today’s topic:

As of December 2019, the Federal Trade Commission (the FTC) is seeking a civil contempt order against two companies that market dietary supplements, alleging they have continued to promote their products using unproven claims that they can treat and cure diseases, in violation of a 2018 FTC settlement order.

The contempt motion states that Health Research Laboratories and Whole Body Supplements, two companies that both have the same owner, violated the settlement of their previous enforcement action in 2018 by claiming—without the requisite scientific evidence—that some of their supplements could treat, cure, or mitigate cardiovascular disease, atherosclerosis, and hypertension.

The companies also mailed advertisements claiming that another of their supplements cures, treats, or mitigates diabetic neuropathy and diabetes, also without the required supporting scientific evidence. Their mailers touted these supplements as a “miraculous natural solution” for life-threatening diseases.

The director of the FTC’s Bureau of Consumer Protection stated that the companies and their owner “have a troubling history of making unproven claims that their products can treat serious diseases.” He went on to say that they were very happy to hold the defendants accountable and enforce their 2018 order. I’m sure there were very happy about that.

So FTC alleges that the companies were in violation of the 2018 order at least two different ways. As you might have guessed, the 2018 order itself came about as the result of similar unsupported disease claims in the companies’ advertising, and according to the FTC which had required the companies to have at least one randomized, double-blind, placebo-controlled trial to support any claim they make in the future. As the two alleged violations show, however, they have not met this standard.

The lesson here, it’s always best to err on the side of caution when making claims, and don’t make disease claims for supplements because you don’t want to catch a regulator’s eye for advertising that’s unsupported by the scientific evidence. An experienced healthcare and FDA/FTC lawyer can review your business plan and your product marketing and recommend some of the ways you can mitigate your legal risk.

Thanks for watching. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.