GNC lays out initiative for supplement industry meant to recapture quality narrative
GNC officials presented their ideas at the two-day Dietary Supplement Analytical Summit put on by the United Natural Products Alliance. Guru Ramanathan, chief innovation officer and Jim Sander, chief legal officer, represented GNC. The overall aim of the conference was to look at DNA testing methodologies in the wake of the actions of New York Attorney General Eric Schneiderman in an effort to determine which of these is fit for purpose for the testing of dietary supplement raw materials and how they can be integrated into existing identity testing procedures.
Blindsided by NY AG
Ramanathan and Sander first laid out GNC’s recent tussle with Schneiderman and why they came so quickly to the agreement they did. The story broke in early February, and Sander said the first GNC heard of it was a deadline call from a New York Times reporter. (He didn’t identify the reporter by name, but Anahad O’Conner wrote the story that broke in The Times the next day, Feb. 3).
“We first became aware of the AG investigation when we received a phone call from the New York Times reporter who said he was on a deadline for 5 o’clock. We received the call at 4 o’clock and we had an hour to respond,” Sander told the conference attendees.
Ramanathan said that GNC sent a vast amount of material to the NY AG in an effort to cooperate in the investigation.
“It was close to 70,000 pages we submitted. Lots of information,” he said.
Meanwhile, Sander said GNC was soliciting opinions from industry experts on the validity of the AG’s findings. The response was unequivocal.
“The response was immediate and consistent that they had used the DNA barcoding inappropriately. All of the test results that we submitted to them showed that GNC products contained all of the ingredients on the labels,” he said.
Ramanathan and Sander said the company chose to come to an agreement with Schneiderman quickly, the questions about the underpinning of his initial investigation notwithstanding. To drag out a negotiation would only serve to put the company deeper into the red as far as consumer confidence was concerned, he said.
“There was no evidence that GNC deviated from GMPs. The NY AG agreed that our products were indeed labeled in compliance with Federal standards. Many of you said, if your products were compliant, why didn’t you fight?” Ramanathan said.
Sander said GNC could have filed a lawsuit in an effort to force Schneiderman to release all of the details about how those initial tests were done (something which, to date, he still hasn’t done). But the company felt it was better to move forward to try to put the episode behind it quickly and to clear the decks for coming legislation, in particular the Food Safety Modernization Act (FSMA).
“We thought the negative media that came from this fosters erosions of consumer confidence. Long, drawn out lawsuits would keep that story in the media and in consumers’ minds. We wanted to move the AG from a standpoint of applying the DNA test not to finished goods but to where it is earlier in the supply chain where it might be more appropriate. We knew that FSMA was coming down the line and that would require ingredient suppliers to identify potential contaminants and install preventive controls,” Sander said.
“It made sense to us to say we will agree to do some of these things because it will increase consumer confidence,” Ramanathan said.
GNC’s position received some support from the conference organizers. In a later, wrap-up session, UNPA president Loren Israelsen said that GNC’s eventual agreement with Schneiderman, which commits GNC to explore the application of DNA testing in its supply chain where feasible and appropriate, was carefully crafted to give Schneiderman a face-saving result without painting GNC itself into a corner.
“When I read through that agreement with all of the qualifications, the restrictions, the pause points . . . I’m glad it was GNC negotiating that agreement, because they have the skill and the resources to deal with someone like AG Schneiderman,” he said.
Model for the future
Ramanathan and Sander spent the remainder of their 50 minute session detailing a quality control initiative the company has been working on with industry stakeholders. The goal, they said, is to recapture the narrative and to raise the bar industry-wide on quality.
“Our products were compliant, our labeling was compliant, but this was all about perception. The initial days (of presenting this to industry thought leaders) was tough because many of you folks were questioning about why we had to make these changes. But there is so much concerted misinformation about this industry in the press. We came to the conclusion that we need to do more and we need to do more as an industry. This is not just about GNC or the first four companies targeted by the NY AG,” Ramanathan said.
The pair laid out a multi-part strategy for raising the quality bar across the industry and for improving the perception of the industry within the mainstream media. A key part of the strategy is a plan, labeled as Industry Product Notification and Numbering System, would require pre-market registration of products. As matters stand, dietary supplement companies are encouraged to submit label information to the Dietary Supplements Label Database maintained by the National Institutes of Health. But there is no requirement to do so. It’s time to move on from voluntary systems to something more formal, Sander said.
“There are product label databases in existence. We want to test samples of these for ease of application and effectiveness of data collection and to see what this might cost per product. We want to gather recommendations and develop this into something the group and the wider industry could support,” Sander said.
The plan also includes a raw material GMP portion, in which suppliers would be required as part of an industry-wide practice to meet certain standards to be developed by the group. These standards would incorporate existing ideas from FDA GMP regulations and standards gleaned from rules established by Australia’s Therapeutic Goods Administration, Health Canada and possibly other bodies, Ramanathan said.
“We want to have some uniformity to provide a basis for talking about quality standards. The minimum standard is going to be more than what is currently required. How do we create a raw material GMP standard?” Ramanathan said.
Other aspects of the plan include forming an industry-wide media strategy and a policy on how best to certify that industry members are meeting the new standards.
Ramanathan said the plan is sure to be opposed by some (indeed the American Herbal Products Association reiteratied its official position on Friday backing participation in the NIH label database over any mandatory system), but he said that the time has come to change the regulatory basis for the industry.
“History is full of examples of those who failed to adapt,” Ramanathan said, while showing a picture of a dinosaur.