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FDA’s Welch: ‘We are not seeing the drastic jumps in GMP compliance that we would like to see’

By Stephen Daniells+

15-Oct-2015
Last updated on 15-Oct-2015 at 16:04 GMT2015-10-15T16:04:27Z

FDA’s Welch: ‘We are not seeing the drastic jumps in GMP compliance that we would like to see’

With about 50% of the industry's facilities inspected, GMP compliance is largely not where the FDA would want it to be, said the Agency's Dr Cara Welch. 

Speaking with NutraIngredients-USA at the SupplySide West 2015 show in Las Vegas, Dr Welch, Acting Deputy Director of the Division of Dietary Supplement Programs at the FDA, told us: “I wish that I had a great story for GMPs, but we are not seeing the drastic jumps in compliance that we would like to see. Largely, we are not where we want to be.

“We want to inspect all of the firms that we know of, and we want to get through the entire inventory at some point. We’re about halfway through the inventory – that we know of. Our inventory is facilities, and not necessarily companies; some companies have more than one facility.”

The foreign arena is a challenge, she said, because of funding, but FSMA should help on that issue.

“Unfortunately, the top GMP violations are still failure to establish finished product specifications. It’s a big issue. If you don’t know what kind of product you are setting out to make then how do you know it’s compliant in the end? And also to either set a specification for identity or to test.”

NDI Draft Guidance

Another topic up for discussion was the re-issuing for the draft guidance for New Dietary Ingredients (NDI), which was supposed to be delivered by the end of 2014.

“We are absolutely going to see a revised draft NDI guidance,” said Dr Welch. “It’s a high priority the Agency, and really for the Division of Dietary Supplements to get it out. We want to clarify issues for the industry as much as industry wants them clarified.”

The document will again be a draft guidance, meaning that its release will be followed by a period for the industry and relevant stakeholders to comment.

“Comments are very important,” she said. “On this end we are asking very specifically for certain comments because we want to know how to do something better. What type of guidance would be relevant and useful for the stakeholders?”

An ‘Office’ of Dietary Supplement Programs?

As reported by NutraIngredients-USA , four of the five main trade associations for dietary supplements have written to the FDA to express their “interest in and support for” the elevation of the Division of Dietary Supplement Programs (DDSP) to an ‘Office’ within the Center for Food Safety and Applied Nutrition (CFSAN).

Dr Welch said: “We do believe that it would be good for the dietary supplement program to be elevated to an office. But there are certain processes that have to happen: it has to be signed off on by HSS, and then it has to go to Congress.”

Finally, Dr Welch also discussed a willingness by the Agency to publicly acknowledge the dietary supplement industry’s GMP successes as well as chalking up its failures.

“One of the tacks we’re looking at is demonstrating the areas of good players in the industry. For example, we’ve done a GMP compliance history to date, and we’re seeing largely compliance from the large firms. We’d like to see that trickle down into the medium and small players, but that will take some time.” 

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