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Dispatches from SupplySide West

Three chiefs, GMPs, AERs and industry's ‘pretty choir’

By Shane Starling , 03-Nov-2010

In part two of this special interview with the heads of the major US dietary supplement trade groups, the three chiefs unpack the state of play for Good Manufacturing Practices (GMPs) along with adverse event reporting (AERs).

Steve Mister, the CEO and president of the Council for Responsible Nutrition (CRN); John Gay, president and executive director at the Natural Products Association (NPA) and Michael McGuffin, president of the American Herbal Products Association (AHPA) also ponder why it may be that two thirds of the dietary supplements industry are not members of a single trade group.

The three begin with the now fully implemented GMP regulations.

“It’s a little early to declare victory because the early reports from the FDA indicate that almost a third of the inspections so far have not gone as well as we would have liked and have generated some significant violations,” said Mister.

“That tells us we still have a lot of work ahead of us. We gotta keep working on creative ways to address the requirements that are in the regulation and make sure that companies are getting their house in order so that when FDA comes knocking they are ready for those inspections.”

Implementation

On the implementation of the regulation Gay praised the FDA approach but said small to medium-sized required further guidance.

“I think they have been fair – they recognized that smaller firms would take longer to adjust than larger firms which is why they just came under the regulation in June,” he said.

‘A criticism would be that they have promised a small business compliance guide but have not yet delivered on it.”

483s

McGuffin highlighted the fact the FDA ‘483 inspection reports’ were not turning up problems of compliance with the regulation’s new requirements rather than basic quality issues.

“The focus of the inspection is not on the things we have been doing for years. It wasn’t whether the floors were clean, whether the rodents were controlled and the hair nets were on – it was on the meaty new part of the regulation – on meeting new specifications for ingredients and products.”

He said the FDA could be more transparent on the issue and that of identity testing.

AERs

The three chiefs said AER transparency could be improved.

“They don’t have the information up on supplement AERs that they do on pharmaceuticals or OTCs,” reasoned Gay.

McGuffin agreed it an ideal world would contain a system where AERs for all AERs would be available to everybody, but acknowledged there was no schedule on when such a scheme might be put in place.

Mister warned making AERs too accessible could be problematic as it could provide seed to opportunistic attorneys seeking gain from class actions.

Advocacy

On the subject of industry representation being split among different groups, Mister noted that each had something to bring to the table. “I think each of our organizations has a slightly different culture, a slightly different reason for being, but the bigger concern in my mind is not the multiple trade associations but the majority of the industry that is not a member of any of them.”

“The fact there are multiple trade organizations is not an excuse to sit on the sidelines and not join anybody.”

Gay added: “It’s not just this industry. The problem of free riders is true in all organizations.”

McGuffin noted two thirds were not a member of any group, but paid tribute to the unity among the groups. “We do have a unified voice – we are not soloists. We are a really pretty choir.”

To see part one of this interview click here.

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