NutraCast: Navigating pitfalls and exploring opportunities for dietary supplement entrepreneurs

Brian Yam, vice president of regulatory affairs and quality assurance at Blue Ocean Regulatory, said entrepreneurs face a lot of unknowns, and dubious players take advantage of that.

"You don't know what you don't know, right? And many manufacturers are counting on this," he said. "Not all of them—I think there's a lot of good manufacturers out there.

"But there's also a lot of shady manufacturers out there, and the manufacturers that are shady are counting on you not knowing how the industry works. And so it's really hard to tell if a manufacturer is saying something that's legitimate, or are they just giving you the runaround?

"And a lot of the times a start-up just doesn't, they just don't understand the complexities and the regulatory nuances of the dietary supplement space. So it's really important that you arm yourself with the right resources to help you navigate through this."

The right resources can mean everything from attracting the right investors to researchers who have a solid understanding of claims. 

"Researchers themselves need to have a good understanding of what the FDA and FTC expect," Yam said. "And the reason why is when they're doing the research and they're designing the studies, we want to make sure that the findings can meet FDA and FTC expectations.

"Otherwise, ultimately, what's the point of the research? Like, I mean, scientifically, there's value in there, but from a supplement brand standpoint, there isn't. I mean, if it doesn't meet FDA or FTC's expectations, you can't make that claim.”

To hear more on the current regulatory environment in the context of ingredient innovation and why Yam thinks the FDA could use the music industry as a source of inspiration, listen to the NutraCast.

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