AHPA, CRN, UNPA present unified front on self regulation initiatives

By Hank Schultz contact

- Last updated on GMT

Images: © iStockPhoto / monticelllo
Images: © iStockPhoto / monticelllo

Related tags: Dietary supplement

Three of the trade organizations representing the dietary supplement business came together in Utah this week to lend support to plans to extend the industry’s self regulation capabilities.

The three groups, the American Herbal Products Association, the Council for Responsible Nutrition and the United Natural Products Alliance took the stage together at the Raw Materials and Supply Chain Summit hosted by UNPA in Salt Lake City. The two-day meeting concluded on Wednesday.

A centerpiece of the meeting was the introduction of a set of raw material GMPs by GNC​ which the company said it will institute immediately for its own suppliers.  The company hopes the draft proposal, which is based in large part on earlier work done by AHPA and the American Herbal Pharmacopoeia, will become a blueprint for industry and help extend GMP standards to the supply end of the supplement business, which was excluded when 21 CFR 111 was put into effect. The revision process for the 58-page document will be managed by AHPA.

That wasn’t the only piece of the puzzle, however. A significant portion of the meeting was devoted to discussion of harmonization of documentation practices and the need for standards that could give some uniformity to the certification picture.

Threats continue to mount

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Loren Israelsen, UNPA

Loren Israelsen, president of UNPA, said a unified stance on quality assertions can’t come soon enough. The past year was a rough one for the industry, and he predicted that 2016 will be a year of profound change for the category. The threats to the industry just keep on coming, he said.

“Pieter Cohen (a Harvard Medical School professor who is a strident critic of the industry) has made it very clear that he has more coming down the pipeline,” ​Israelsen told the audience. “The complications in the auditing world and the certification world are real opportunities.”

Israelsen said that the shocks of the past year have opened the door for movement on ideas that were stalled for years. For example, there is a growing consensus around the idea that something has to be done to bolster the notion that the business is completely above board. Resisting the idea of a pre-market notification of products is no longer viable, he said. The fact that dietary supplements can go onto the shelf without anything in the way of notification or approval is often cited with astonishment and alarm in negative mainstream media pieces about the industry. The question has now become what is the best format for such a registry, he said.

“There were industry meetings in the past where people even refused to say the words ‘product registry,’ ”​ Israelsen said.

History of cooperation

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Michael McGuffin, AHPA

AHPA president Michael McGuffin reminded the audience that the trade organizations, while they don’t always agree, have a history of working effectively together.

“We do compete for dollars, even among the people in this room, but we have a tremendous history of working together,” ​McGuffin said. He cited the industry’s unified stance that helped bring about the Proxmire Amendment and the Dietary Supplement Health and Education Act itself.

“We won in ’76 and we won in ’94 and we won by working together,”​ he said. “And we came together in 1996 to propose a cGMP rule for dietary supplements. It took us two years to get a rule. I don’t love 111; I think it’s a flawed rule. But we did get a lot of what we need.

“We do have a single voice, but that’s made up of a chorus, and we’re stronger for that,” ​McGuffin said.

Steve Mister, President and CEO of CRN, said that this year will be an opportunity that industry must seize in order to forestall what could be onerous and cumbersome legislation

Steve Mister Headshot sq
Steve Mister, CRN

“When this industry comes together we are pretty formidable force. There is a real sense that this year is an opportunity to something transformative. This is an industry that is listening to the criticisms and is trying to evolve. For the certifiers, we have to say how can we create some common standards that we can measure against. We think this is the right way to go, and this is a moment that may not come again,”​ he said.

“2016 will be a year of profound change,”​ Israelsen said in closing. “I think we have been treading water, resting on the laurels of DSHEA.  We need to build on this momentum going forward. But whatever we do, it should be done by industry.  We plan it, we design it, we build it.

“There is still the hardest job of all and that is to communicate to consumers what is taking place. Once the consumer’s trust is lost it is hard to regain,”​ he said.

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