A panel during the annual Dietary Supplements Regulatory Summit focused on how the product quality picture has changed since then New York AG Eric Schneiderman first sent his cease and desist letters to four major retailers in 2015. The allegation was that DNA testing had revealed that bottles of popular herbal supplements contained little to none of the herb claimed on the label.
NYAG affair
While the retailers involved — including GNC and Walmart — were able to fairly quickly show that the allegation was based on a misapplication of the testing method (something Schneiderman never formally admitted), the industry was put in a position of reacting to events. It proved difficult to get out ahead of the issue, and to counteract the notion that Schneiderman had brought to light what a number of consumers and some mainstream journalists already believed anyway, that being that few dietary supplements were what they said they were.
A panel at the annual event focused on how that picture has changed in the intervening years. The panel, which was moderated by Aaron Secrist, head of quality at NOW Health Group, included Dadrion Gaston of Walmart, Day Gooch of Vitamin Shoppe, Sudipta Veeramacheneni, PhD, of GNC and Guru Ramanathan, PhD, of Global Healthcare Innovation (Ramanathan was head of innovation at GNC at the time of the Schneiderman affair). Also, Glenn Bass of FDA gave a presentation on the Agency’s approach to inspection and enforcement.
Shock to the system
Ramanathan said Schneiderman’s attack was unexpected. GNC and the other retailers were able to deal with the immediate issue and get the named products back on the shelf fairly quickly. But a major concern was that part of the allegations focused on how federal regulations of dietary supplements were insufficient to protect consumers and that the states themselves were forced to act. There was a fear at the time that other state AGs might take up Schneiderman’s banner and start imposing their own restrictions on the sale of supplements.
“This was quite a shock to a number of us,” Ramanathan said. “As industry leaders we felt we done the right things and had appropriate protocols in place.”
“It caused the industry leaders to pause and reflect. While we had guidance from the FDA on the manufacturing of products there were gaps in the guidelines as they pertained to raw materials like botanicals and synthetic ingredients,” he added.
“This overall feeling was that there were so many emerging influencers like state regulators. We had academicians running tests and challenging products. We needed a comprehensive system that could provide end to end transparency for the whole supply chain,” Ramanathan added.
AHPA’s outline a key part of the effort
A collaborative effort was formed, led in part by GNC, to address the issue, Ramanathan said. He credited input from all the trade organizations in helping to direct and inform the effort. That included the American Herbal Products Association, that lent its existing framework of botanical supply practices to the program.
“Fast forward to today. It has become even more important now because you have a number of players who have taken to ecommerce. We don’t know who these people are and what they quality systems are,” he said.
Harmonizing audits
A key part of the effort, said Walmart’s Gaston, was to find a way to harmonize audit activities. In this, the key players (both Ramanathan and Gaston are on SSCI’s Board of Directors) sought to model their initiative after the Global Food Safety Initiative.
“Safety and regulatory compliance should be a ticket to entry to the industry, not a competitive advantage,” Gaston said. “One auditing body could be in a facility and come up with different conclusions to another. That need for harmonization became very apparent.”
SSCI now has three certifying bodies— Eurofins, UL and Intertek — that are participating in the program and whose auditors have been trained to a common set of guidelines.
“It is completely driven by industry experts which gives the ability to truly understand the challenges the industry faces,” said GNC’s Veeramacheneni.
“It helps us shape the narrative around the industry if we are proactive and take a stance in driving quality, so that the whole industry isn’t being painted with a broad brush by some players who may not be doing things the right way. Consumers should never expect anything less,” she added.
The annual event, hosted this year by the Natural Products Association, is a collaborative effort among the five major trade associations representing the dietary supplement industry. The other participating organizations are the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition and the United Natural Products Alliance.
For more information on SSCI, visiting the organization's website.
