Speaking with NutraIngredients-USA at SupplySide West 2015, Dr Fabricant said: “We have to stay vigilant; FTC is not going away. People said this was a bad case [for FTC]. The attorneys from Bayer did a fantastic job and in terms of mapping out a strategy for defending yourself, that’s what people ought to look at, but holding it up as this one case is going to solve all of our FTC problems, people have another thing coming.”
Dr Fabricant also spoke about the ongoing investigation into herbal supplements by New York Attorney General Eric Schneiderman.
“I think people were happy with the Devil’s Claw thing because it didn’t get the press burn that the first issue had, but when you look at the letters the firms got it’s very concerning in that they had the issue on the misbranding but they also had an NDI issue: This ingredient has never been notified to the agency, therefore it’s adulterated for failing to file. That’s particularly troubling because we have other NDI cases in the States where people were hurt, like what happened in Hawaii in 2013.
“The AG is certainly working hard for the plaintiff’s bar right now and people ought to be very aware of it.”
GMPs
On the topic of GMP compliance, Dr Fabricant said that the numbers he wants to see from FDA are the re-inspection numbers, which would show how the industry is progressing and improving (or not). “Without the re-inspection numbers the data is still young. They’ve admitted themselves that they haven’t seen everyone in the industry yet, so until you have that complete data set it’s tough to say if there is an improvement.”
Other topics covered in this interview include elevating the Division of Dietary Supplement Programs to an Office and a discussion around pre-market registration.