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Will the rest of the dietary supplements industry follow GNC’s lead on GMPs?
Walking the halls of this year’s Natural Products Expo West trade show in Anaheim, CA, it occurred to me that it’s been just over a year since the dietary supplements industry first found out it was being investigated by New York Attorney General Eric Schneiderman. A lot has happened since then.
Lawmakers, attorneys general, and media continue to raise questions about supplement safety and quality. Industryfolk, meanwhile, are having their own discussions, both to acknowledge the fact that there are indeed certain bad players in industry but also to suggest how responsible industry members can strengthen their own QA/QC programs and show that the industry is doing more to address public concern. Based on my conversations during Natural Products Expo West, it was apparent to me that many companies are placing emphasis on increased quality assurance.
But that may not be enough to satisfy naysayers.
While self-driven quality measures are necessary, notable, and commendable, consumers and critics most outspoken against the industry want something bigger. Short of changing the laws governing supplements, critics want to see signs that the industry as a whole is uniting to make change.
Thus, in January, we saw the first signs of such movement when the Council for Responsible Nutrition (CRN) announced that the association’s membership will now be required to submit label information for all U.S. products to the government’s Dietary Supplement Label Database. And now, GNC, the dietary supplement industry’s Goliath, has taken a dramatic step to change its own quality-control structure.
In February at the United Natural Products Alliance’s Raw Materials & Supply Chain Summit, GNC announced a new, sweeping set of GMP standards that are now compulsory for every single one of the raw-material suppliers the company does business with. Why is this such a big deal? One of the biggest topics of conversation in supplement quality is the fact that ingredient suppliers are not directly subject to FDA’s Good Manufacturing Practices regulations for dietary supplements (21 CFR 111) that supplement manufacturers themselves face. So GNC has taken it upon itself to institute its own set of consistent, standardized GMP requirements for its suppliers, which will supersede how suppliers, individually, would go about quality assurance. “We have always held ourselves and our vendors to the highest standards, and those vendors have sometimes interpreted those highest standards differently,” GNC’s CEO Mike Archbold tells Nutritional Outlook.
To create the new, “harmonized” best practices, the company reached internationally and across the industry for input, Archbold says. It took inspiration from more than 10 international guidelines, including those of the American Herbal Products Association’s (AHPA) Good Agricultural Collection Practices, CRN’s Standardized Information on Dietary Ingredients (SIDI) protocol, the World Health Organization, the European Medicines Agency, and so on, as well as input from former FDA auditors and GNC’s own suppliers and processors. As a result, GNC’s GMPs include manufacturing rules from 21 CFR 111…and then some. GNC’s standards reach as far back in the process to cultivation and all the way forward to handling and packaging. “This set of guidelines really is the culmination of all that work from all of those participants,” Archbold says. “The intent was to make sure that we were not missing anything in this process.”
GNC’s hope is that the rest of industry will follow suit in adopting these GMPs. To encourage this, after the company adopted the guidelines, it turned the document over to AHPA. Archbold says AHPA will act as the document’s steward for the rest of the industry, maintaining the document as it is further edited-something Archbold says he fully expects and hopes will happen as industry science, technology, and processes advance.
Archbold says GNC has reason to expect that the “major industry participants” will adopt these supplier GMPs soon based on conversations the company has had. “We’ve actually gathered everyone in the industry, from our competitive retailers to the mass-market players, raw-material providers, multilevel marketers, practitioners, even the pharmaceutical companies,” Archbold says. “So everyone has been involved in the process to make sure that all the voices are being heard.” He says that even competitors were receptive to the initiative. “It’s really been a concerted effort to say, ‘We collectively need to set the standards.’”
“We’re making sure these aren’t just GNC’s standards,” he adds. “It’s why it’s going to be maintained by AHPA on a go-forward basis, because this needs to be something that’s owned by the industry.”
GNC, however, will get credit as the first company that took the initiative to bring about this change. Not long after the company announced the plan, it made the guidelines mandatory for its suppliers, even as it expects future revisions. “We felt that this was so important that the industry needed to embrace it, and embrace it quickly,” Archbold says.
Most importantly, he says, this initiative will enable GNC to communicate to customers about how the company is bolstering safety, purity, potency, and quality of product. And, he says, he doesn’t believe legislative change, including premarket approval, is needed. Instead, an industry-wide supplier-GMP initiative like this, coupled with the general preventative requirements suppliers meet under the Food Safety Modernization Act and the requirements manufacturers meet under 21 CFR 111, as well as other initiatives like CRN’s product registry requirements, are “perfect complements” to ensure product quality.
The dietary supplements industry may not have a thousand miles to go toward building-or rebuilding-public confidence in the market, but a single step towards broad-scale, uniform change, like this industry-wide GMP initiative, is certainly moving in the right direction. Archbold says, “I’m very excited that the industry has really come together to embrace change once again.”
Should FDA’s Dietary Supplement GMPs Include Ingredient Suppliers?
Dietary Supplement Industry in the Crosshairs: Takeaways from the New York Attorney General Investigation
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