Speaking with NutraIngredients during the recent Regulatory, Scientific, and Quality (RSQ) Conference hosted by the Consumer Healthcare Products Association’s (CHPA), Blackwell said companies are launching category-crossing products—from beauty-from-within supplements to novel oral and inhalation formats—that challenge existing FDA definitions and force difficult regulatory pathway decisions.
Blackwell, who is EAS’ senior director of dietary supplement and tobacco consulting services, also discussed enforcement trends, noting the FDA’s attention beyond manufacturers.
“We are seeing a few newer areas of focus from the FDA— they do seem to be focusing more on-own label distributors and brand owners as opposed to just manufacturers,” she said. “We’ve had clients that are literally just a corporate building, a brand owner corporate building, and the FDA has shown up and done an inspection, and so a lot of times, people overlook that requirement. There are GMP requirements for a brand owner, even if you’re not manufacturing. We’ve seen some focus over the past few years on distribution centers as well.”
Companies should also be aware that the FDA is ramping up unannounced inspections of foreign facilities, which historically has not been the case, said Blackwell.
“Foreign manufacturers usually get a notification, usually about a month, sometimes a few weeks before the FDA will arrive for an inspection for many reasons,” she said.
“I mean, logistically, it’s difficult, right? The FDA can’t just fly overseas and show up and then the company is shut down for holiday. But the FDA announced that they will be using unannounced inspections more, and we have evidence that that’s occurred. I actually have two international clients, where the FDA has shown up unannounced.”
Other hot-button issues discussed included the impact of tariffs on the industry and the implications of the recently released MAHA report.
“We do know that RFK, Jr. seems to be a proponent of dietary supplements,” Blackwell said. “There are phrases in some of the documentation around high quality supplements, but we just don’t know what that means yet. What makes a high quality supplement? Does that mean there’s going to be more regulatory focus on those products? Or does it mean there’s going to be less and allow more flexibility for the manufacturers? We’re not really sure.”