Regulation
Dispatches from SupplySide West 2013

FDA’s Dr Fabricant: GMP violations are staying the same, and that’s a concern

20-Nov-2013 - By Stephen Daniells
Interview of Dr Daniel Fabricant - Director, Division of Dietary Supplement Programs, FDA
FDA’s Dr Fabricant: GMP violations are staying the same, and that’s a concern
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One year on and 'GMPs' and 'concern' continue to be used together by Dr Daniel Fabricant, Director of the Division of Dietary Supplement Programs at the agency, with many of the compliance issues still basic. 

In a wide-ranging interview with NutraIngredients-USA at last week’s SupplySide West show in Las Vegas, Dr Fabricant addressed the issues of GMPs, carrots, NDIs, and OxyElite Pro.

At last year's show, Dr Fabricant told us that there was not a, "clear indication there will be a drop in non-compliance anytime soon, and that concerns us". One year on and the and message remains the same with the Agency’s inspectors continuing to seeing more of the same problems as previous years, with the main violations still being basic.

“The topic of discussion should move to a more technical basis at this point,” he said. “We want it to. That’s what GMPs are about, and that’s how they move ahead.”

Why are firms continuing to struggle? “I can speculate that it’s about resources, or companies don’t think we’ll get to them, but that’s all speculation. It’s like feeding your children – you’ve got to do it. You have to be a GMP compliant firm.”

“These are products that 180 million Americans use every day and our expectation is that they meet basic quality standards.”

“We are going to take a look at how we do business, too. We have a lot of injunctions that are resource intensive, we do seizures as well. What tools can we use to get the rate down and do it quickly?”

On the topic of a ‘carrot’ to entice companies further to comply with GMPs, Dr Fabricant said that, “If firms want to advertise that they do a good job, then fine, but the issue is when they start talking about an inspection made under 704. That’s a prohibited act. Advertising shouldn’t be violating the law.”

OxyElite Pro

Talking briefly about the OxyElite Pro issue, Dr Fabricant noted that the company, USPLabs, has agreed to a Class 1 recall. “You shouldn’t see liver damage, hepatitis, with a food,” he said.

“The focus should be on the product,” he added, with the aegeline issue being an aside.

“There isn’t safety data establishing that it’s safe for use. There is clearly a temporal relationship between the product and the liver injury,” said Dr Fabricant.

Follow-on NDIs

Another issue addressed by Dr Fabricant during the interview was the subject of ‘follow-on’ NDIs. (For a more in-depth analysis of this issue, please click here for NutraIngredients-USA’s most recent coverage of this issue).

So, can a company with a similar ingredient benefit from another company’s NDI?

“The short answer is no,” he said. “If you spend the resources, investigate the science, and establish that your particular ingredient has a reasonable expectation of safety, and you get an acknowledgement letter from the agency, then I would think at a minimum that firm B through the gate would have to establish they were identical to your product before even thinking about going to market.”

“Our view is that if it’s a unique product, it may be a similar ingredient – we take great pains not to say it’s identical – but we don’t know the specs of that other ingredient, we don’t know if it’s made in an area with a high amount of elemental contamination and there’s lead. There are so many issues that are not known to the agency that our expectation is that someone would submit a separate NDI and not ride on the coat tails of someone else.” 

Related topics: GMPs, QA & QC, Product claims, NDI draft guidance, DMAA, Regulation