Manufacturers

NPA's Fabricant: 'There have to be prosecutions'

20-May-2014 - By Hank Schultz
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Daniel Fabricant, PhD, has seen the clouds that beset the dietary supplements industry from both sides.  The newly minted CEO of the Natural Products Association has been both an industry advocate and one of the industry’s fiercest watchdogs in his recent role at the Food and Drug Administration.

Fabricant had a prior stint with NPA, too, during a period in which the organization experienced significant tumult in the executive ranks.  Fabricant acted as CEO for a period of months after David Seckman, who had held the post for nine years, resigned.  NPA then hired John Gay, who had been with the National Restaurant Association, to fill the role.  Gay’s relatively brief tenure was followed by the hiring of John Shaw, late of the Portland Cement Association.  Fabricant replaced Shaw in early April.

“NPA has always been successful. Any organization may have some turnover and upheavel. But we have a great story to tell and we are going to tell it,” Fabricant told NutraIngredients-USA.

“Our GMP programs were the first out of the gate. We were able to get the AER (Adverse Events Reports) legislation passed,” he said.

Long industry experience

 In the case of both Gay and Shaw, these executves brought lobbying saavy to the role, but neither had prior natural products experience. Fabricant, however, brings a weath of such experience to the role, having put in more than five years previously with NPA and more than three at FDA, as well as doing his doctorate in pharmacognosy at the University of Illinois Chicago under renowned professor Norman Farnsworth.

One of Fabricant’s first tasks at FDA, where he was the head of the Division of Dietary Supplement Programs, was to elucidate and defend the then newly-issued draft guidance on New Dietary Ingredients.  It was a baptism by fire. But he always maintained that the NDI issue was window dressing compared with the industry’s most pressing concern, which was GMP compliance.  The Good Manufacturing Practices rule of DHSEA was rolled out in stages, with the final stage for the smallest companies coming in 2010.  As of that date, all companies were supposed to be in full compliance, which, Fabricant asserted in his time at FDA, was hardly the case.  He frequently made the statement that 70% of companies were not in compliance.

“I think this is the most pressing compliance issue. That 70% figure was based on the inspections that we saw at the agency.  I think GMP compliance still is a challenge, but in any challenge lies an opportunity, and I think at NPA we are uniquely positioned to help.  We are unmatched in our knowledge of how FDA conducts and understands inspections, and I think there are folks who are clamoring for that knowledge,” he said.

Commitment to enforcement

Many credited Fabricant for bringing a renewed emphasis on enforcement to FDA during his tenure there.  The agency had had a mixed record on that score;  some have alleged that agency shoved any enforcement on DSHEA to the back burner for some years after the law was passed in 1994, a period in which weeds may have grown in the garden. That picture started to change with the advent of the GMP rules.  Fabricant says his position on the issue hasn’t changed now that he’s on the other side of the fence, and in particular he advocates for a more muscular approach to catching fly-by-night companies pushing deliberately tainted products.

“If you are talking about getting to the source of the problem there has to be a clear deterrent in place. There have to be prosecutions. A warning letter in those cases is not going to be enough.

“You also have to look at where the problems are coming from, and I can tell you from my time at the agency the bulk of the tainted products are coming from international mail facilities,” he said.

Multiple voices

One observation of the natural products and dietary supplements businesses is that there are simply too many trade organizations, leading to a cacophony of voices in Washington. Does Fabricant see a winnowing of those organizational voices in the future?

“We would have meetings during my time at the agency at which a lot of organizations were present and at the end, we would get together and say, OK, who are we going to listen to? I don’t that’s very good for the industry,” Fabricant said.

“As companies in the industry go through mergers and acquisitions it is only natural, organic if you will, to talk about mergers or acquisitions in the trade organizations.  As those discussions crop up, we will engage in them, if that’s what will serve the industry best. NPA has been around for 78 years and these other organizations, in a lot of ways, were born out of NPA,” he said.

Founded in 1936, the NPA now has more than 1,900 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. 

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