In a move that impacts its supply chain and could have broader implications for a US$35 billion industry, General Nutrition Corp. (GNC) adopted guidelines governing botanical raw materials as part of a strategy to restore confidence in dietary supplements.
The 58-page document, unveiled last week during a summit that was hosted by the United Natural Products Alliance (UNPA), marks an effort by the broader industry to take proactive measures and change the narrative around dietary supplements following a year in which the sector was bombarded with accusations of fraud and mostly played defense reacting to an avalanche of adverse publicity.
“2016," UNPA President Loren Israelsen observed, “will be the year of real profound change."
GNC is seeking to lead such transformation approximately one year after it found itself the subject of a controversial investigation led by New York Attorney General Eric Schneiderman. The company has adopted certain guidelines or cGMPs (current good manufacturing practices) in an effort to effectively track plant material from the harvesting of plants to testing of the raw material.
“We have announced that we are actually accepting this and implementing it, effective immediately," GNC Chief Executive Mike Archbold said in a Feb. 24 interview with Natural Products INSIDER during the UNPA Raw Materials & Supply Chain Summit in Salt Lake City. “That means that vendors who want to work with us need to do the same. Which means they need to start embracing the GMPs that are embedded in this [document]."
The guidelines are largely rooted in documents that are the fruits of previous work led by various groups, including the American Herbal Products Association (AHPA), World Health Organization (WHO) and Health Canada, among others.
Trade organizations which convened for the two-day summit expressed support for the guidelines and hope that the broader industry would adopt them.
“GNC is just the first to stand behind it and say, ‘We … have committed to these new guidelines, to these new GMPs,’" Archbold said. “It’s not a GNC document. It is one for the industry."
The industry has faced heavy fire since Schneiderman announced an investigation approximately one year ago into herbal supplements. According to Schneiderman, third-party DNA testing revealed that a number of products sold by four national retailers including GNC failed to contain the herbs named on the bottles and were contaminated with undeclared substances.
Archbold, the former CEO at women’s apparel retailer Talbots, had only been on the job six months when The New York Times first notified GNC about the investigation. That was on the evening of Feb. 2, 2015. The news broke the following day. He confirmed GNC had no previous notice that New York authorities were investigating the company or the industry.
GNC immediately reached out to Schneiderman’s office and requested information about the DNA findings. “At that point, they didn’t want to really share much," Archbold said. “We expressed our concern that they were not correct in their findings."
Archbold noted GNC had evidence, even before responding to Schneiderman’s investigation, that the products met specifications.
“Every lot of every product that we manufacture, we do a certificate of analysis (CoA) on the completed product to ensure, based upon the industry acceptable standards, that it meets the requirements, and that what we say is in that bottle is in that bottle," Archbold said.
GNC reviewed the CoAs and confirmed they met specifications, he said. What’s more, the company tested the specific lots that were subject to Schneiderman’s investigation because the company retains samples of every lot of products that it manufactures, Archbold explained.
“And they still met specifications," he declared. “We then turned around and took samples from those retained lots and sent them to an independent third party. And we again confirmed that, based upon all the industry standard testing methods, that those products were fully compliant and what we said was in there was actually in there. They met all label claims [and were] fully compliant, fully cGMP."
Within approximately six weeks of The Times publishing its article, GNC reached an agreement with Schneiderman’s office. New York authorities, the agreement acknowledged, found no evidence that GNC deviated from federal manufacturing regulations, or FDA’s cGMPs. GNC even returned the products to store shelves. Months later, dozens of putative class-action lawsuits that were filed against the company, in reliance on Schneiderman’s investigation, were voluntarily dismissed.
By that time, though, GNC had already suffered harm to its reputation. “We lost," Archbold acknowledged in a Feb. 23 speech during the UNPA summit, “because we lost consumer confidence in our products, and that’s the worst thing of all that can happen."
Tracing Botanicals from ‘Seed to Shelf’
Regaining consumers’ trust this year in dietary supplements is a major undertaking for the industry. Israelsen, UNPA’s leader who has been in the industry for decades, expressed the sentiment that time is of the essence. National stories like PBS Frontline’s recent segment “Supplements and Safety" are likely to continue to question the effectiveness and safety of dietary supplements, while marketers of dietary supplements remain in the crosshairs of state attorneys general. GNC, for example, is currently defending itself in a lawsuit brought by Oregon Attorney General Ellen Rosenblum. Meanwhile, Sens. Richard Blumenthal (D-Connecticut) and Dick Durbin (D-Illinois) are expected to introduce legislation as early as March that would further regulate the industry.
The guidelines announced by GNC reflect an effort to ensure the traceability, quality and sustainability of botanical products from “seed to shelf," or from the time the plants are selected and grown in the fields, to testing and packaging of the finished products. Although GNC is adopting the botanical raw material quality guidelines immediately, the 58-page document distributed to attendees at the UNPA summit is titled a “draft" and is expected to evolve.
Whether the document in its current form or in a modified form will be adopted by the broader industry beyond GNC and its supply chain remains to be seen. But AHPA has committed to updating or revising the document through its Botanical Raw Materials Committee and in collaboration with the American Herbal Pharmacopoeia (AHP). The guidelines are rooted in the efforts of various groups over a period of years, including AHPA and AHP.
“We are very interested in this," AHPA President Michael McGuffin said in a phone interview. “We have a lot of understanding of how to bring companies together to come up with consensus positions on quality issues and on standards of practice."
McGuffin lauded GNC for its adoption of the guidelines. “The service that GNC is providing to us is to call greater attention to this," he said. “I think what we’ll find a lot of suppliers will say, ‘this isn’t a problem. We already do this.’"
The botanical guidelines borrow significantly from a document that was published in December 2006 by AHPA, in cooperation with AHP. The document, “Good Agricultural and Collection Practice for Herbal Raw Materials," also has origins in documents published by others such as the WHO and European Medicines Agency, McGuffin explained.
“Our intention at that time was simply to provide guidance on best practices," he said. “We thought it was important to bring a particularly herbal crop perspective … with a U.S.-centric, U.S.-regulated element."
In soliciting feedback from industry on the proposal, AHPA discovered the utility in laying out how such practices would be documented, such as recording that a person obtained permission from a land owner to harvest in accordance with local and state laws.
Such documentation was never developed, said McGuffin, who cited other priorities and limited resources. But AHPA’s Botanical Raw Materials Committee has scheduled a meeting in March (during Natural Products Expo West in Anaheim, California) to discuss the guidelines that were unveiled by GNC.
PLT Health Solutions Inc., an ingredient supplier to GNC that has reviewed the guidelines, previously adopted measures to ensure the traceability of ingredients that are consistent with the document, said Barbara Davis, Ph.D., vice president of medical and scientific affairs. The measures cover such areas as cultivation, harvesting, transport and processing, explained Davis, whose company is behind a transparency initiative known as PLT360.
Said Davis: “I think when people sit down and go through it [the guidelines], they’ll see it’s a really nice road map to doing things the right way."
Guidelines Adopted on Heels of cGMP Criticisms
Similar to the industry’s efforts to rebuild trust with consumers, the document is expected to be a work in progress. While a number of measures must be implemented within one to three years, other provisions—including one governing sustainable harvesting for cultivated botanicals—specify an implementation deadline of 10 years.
“I think we got to figure out a way to shorten that," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN). “It shouldn’t take 10 years to implement this."
The guidelines were adopted following criticisms that current regulations governing dietary supplements are inadequate. Nine months ago, Schneiderman and Indiana Attorney General Greg Zoeller called for improvements in the cGMPs. Ingredient suppliers are not subject to the manufacturing regulations, they pointed out in a letter to FDA.
“There’s no need to wait for Congressional action to drastically improve federal oversight of the dietary supplement industry," Schneiderman said in a statement at the time. “The FDA has the authority to rewrite the rules that govern the multibillion-dollar dietary supplement industry today. The health and safety of the tens of millions of Americans who take supplements every single day will continue to be jeopardized until these lax regulations are improved."
If FDA one day adopts GMP regulations that bind suppliers of botanical ingredients, it’s conceivable the regulations will reflect the principles contained in the botanical raw material guidelines.
“It’s not a mandatory GMP unlike [21 C.F.R. 111], which is mandatory," Mister pointed out in an interview during the UNPA summit. “But like so many things in the industry, if you want to make them mandatory, it’s always better to start developing them within the industry and then once they’re fully formed, then you can take them to the agency."
Mister expressed hope that large companies in the industry would voluntarily adopt the guidelines. “If the big companies adopt these things, that goes a long way toward giving … mainstream consumers … some assurance that the products are well made," he said.
Archbold was asked if GNC’s motive for adopting the guidelines was to fend off legislation to further regulate the industry. While he acknowledged the guidelines could “address the FDA’s needs," he reiterated GNC is focused on earning consumers’ trust and that was the impetus for the guidelines.
“If there is a continual drumbeat of investigations or allegations, etc., that serves to undermine the confidence of consumers in their supplements," Archbold said. “What we’re trying to do is make sure that we can restore that confidence and build that confidence."