Ullman breaks down FTC’s recent Health Products Compliance Guidance

22-Mar-2023 - Last updated on 22-Mar-2023 at 13:32 GMT

The details around claims substantiation in the recently released Health Products Compliance Guidance from the Federal Trade Commission (FTC) could be a “huge sea change”, says attorney Marc Ullman.

The guidance, which was published at the end of 2022, updates the Dietary Supplements: An Advertising Guide for Industry, issued in 1998.

Speaking with NutraIngredients-USA, Marc Ullman, Of Counsel for Rivkin Radler, LLP, said that the new guidance finally makes it clear that the new guidance applies to all categories of products making health-related claims.

“Everything from pedometers to OTC devices, OTC drugs, and dietary supplements,” he said. “On the surface, this guidance would appear to be very positive and would put all of these products on an equal playing field.

Ullman added that much of the guidance is common sense, particularly around social media.

“You’re responsible for your social media sites, you’re responsible for things that your influencers do on platforms like TikTok. That’s all good,” he said. “It makes it clear to everybody that these new media platforms are treated like every other media platform. Advertising is advertising. It doesn’t matter where you’re doing it.

“But towards the back part of the document, they [FTC] get into a discussion of what they think you need for substantiation for your claims, and there’s language in that part of the guidance, where the commission states that it believes that if you make any kind of health-related claim, you need a randomized controlled trial, an RCT, and you can’t rely on in vitro studies, you can’t rely on animal models.

“You need a randomized controlled trial and those have to be in people, and that’s a huge sea change if they follow up on that.”

Battle of the experts…

So, what is the commission looking for? “This will be largely dependent on your claim,” said Ullman. “If you say, ‘soy proteins have beneficial effects for cardiovascular health’, you’re looking at soy proteins, generally. If you say, ‘My product does X’, then they are going to say you need evidence based upon your product.”

And how enforceable is all this? “We don’t know. We have to wait and see if the Commission follows up on it. It may be out there as rhetoric designed with the purpose of pushing people to bolster their substantiation. If this was the FDA, I might say it may be possible they may never do anything with this. The FTC tends to be a lot more aggressive.

“The general standard for substantiation is what experts in the field would be satisfied with. If they pursue this, there will be a test case or two and it largely will depend on a battle of the experts who will debate if the commission’s position is reasonable.”

Ullman also discussed the recent Dietary Supplement Ingredient Directory from the FDA, which he described as, "utterly unhelpful and disingenuous". Watch the video for more.