Supplements retail giant GNC revealed its new initiatives to improve its product quality and bolster all-important consumer confidence in the wake of the New York attorney general sting operation against herbal supplements earlier this year.
At the United Natural Products Alliance conference in Salt Lake City last week, two GNC executives told of six new plans they agreed to with the attorney general’s office. These ranged from using DNA barcodes as a means of identifying certain botanical raw materials when they arrive in GNC's facility to communicating on product labels whether an herbal supplement is an extract or whole herb.
“All of these help improve consumer confidence and change the perception that perhaps there’s something wrong,” said Guru Ramanathan, PhD, GNC’s senior vice president and chief innovation officer. “There was nothing wrong with what we were doing; everything we do is compliant, yet there was this perception, so this addresses that perception.”
The other initiatives include testing for eight common allergens, asking its raw material suppliers to go through some form of independent certification that they are following GMPs and installing signage in stores and information on its website to educate consumers about the difference between whole herbs and extracts.
“We need to elevate ingredient quality standards throughout the industry,” Ramanathan said. “This is not about GNC, this was about our customers and how will our customers perceive our products.”
GNC was one of four national retail chains—the others being Walmart, Target and Walgreens—that were targeted in a February operation by the New York attorney general’s office that used a new test method called DNA barcoding to identify the source botanical ingredients. It has been widely panned throughout the industry and academia because DNA evidence is routinely denatured or destroyed during the extraction process with botanicals.
As part of the agreement with the NYAG, GNC was able to put its products back on store shelves. That’s because GNC, as part of the 70,000 pages of documentation it provided the NYAG, provided evidence of other, more common testing methods that showed its products were in fact compliant with regulations and contained all the ingredients they were supposed to.
The NYAG’s final findings found no evidence that GNC deviated from GMPs and industry standards. All its tested products were found to be manufactured consistent with FDA’s GMP rules, and all tested products were in compliance with label standards. Press releases from the NYAG’s office, however, downplayed that to the point of not even mentioning those elements while playing up the agreement by GNC to use DNA barcoding—the linchpin technology, discredited though it was with extracts.
'This was about consumer confidence'
Many within the industry questioned why GNC would agree to use DNA barcoding when it is seen as not quite ready for prime time. It is certainly not appropriate for botanical extracts, and even with whole herbs, there is a lack of a reference library of validated type specimens that align with commercially available herbs.
“We said we’d help with implementation of DNA-based authentication to identify plants,” said Ramanathan. "But we said we have to do it at the right place. This would be in addition to—critically —all of the standard testing techniques we are currently following. They said can we propose some ideas for when. We said at the time we can collect the DNA, before it’s being transformed. That’s the guidance we’ve given to our raw material suppliers.”
Within 60 days of the original NYAG action, GNC made the agreement for its quality-assurance initiatives. Its stock price had taken a beating, and consumers were seen as beginning to question the quality of its products.
“The negative media attention was harming us and the industry, and keeping an erroneous conversation on top of consumer minds,” said Jim Sander, GNC’s senior vice president and chief legal officer. “So GNC decided we would help lead industry efforts with processes to boost confidence, quiet the media, find a path toward a resolution and move the attorney general off of looking at DNA testing on finished goods and perhaps move them to earlier in the supply chain. Maybe it’s more appropriate there.”
The ingredient supply chain is seen as the weak link in supplement quality—even though responsibility for ingredient quality legally falls upon brand holders. The 2010 Food Safety Modernization Act, regulations of which are still rolling out and will for the next few years, requires ingredient suppliers to “identify hazards like adulterants and contaminants and establish protocols,” said Sander.
Although some in the industry assert that FSMA is the final link in efforts to shore up the competence of the ingredient supply chain, others including GNC saw the need to go beyond FSMA —and faster, because consumer confidence dictated that immediate announcements needed to be made about product quality.
“Consistent with FSMA, which is pending, it made sense that we’ll do some of these things to improve consumer confidence—not to say what we were doing was inadequate,” said Ramanathan. “This was about consumer confidence. That was one of the main driving reasons behind the agreement.”
GNC has internally created four working groups: media strategy, quality seals and facilities certifications, industry product notification database, and numbering codes, and a raw material GMP group. This last one may be the most important one.
“The idea is to look at this all the way from the farm to the factory, but also recognize that changing farming practices is going to take time,” said Ramanathan. “After the harvest and before it comes to our manufacturing facilities, there is something we can do. Our suppliers and farmers want to help, and that’s gratifying to us.”
Ramanathan said GNC has looked at Australia’s Therapeutic Goods Authority regulatory scheme, Health Canada’s regulations and others in sketching out its still-developing plans regarding ingredient suppliers. The idea is being broken out into two parts—good farming and harvesting practices, and the portion of the process after the farmer delivers products to a processor intermediary that processes the material before sending it along to GNC.
GNC has signed an agreement with AuthenTechnologies, to date the only commercial DNA barcoding company in existence in the U.S., to conduct its DNA barcoding tests of raw materials. Its DNA barcoding initiatives will begin in about a year’s time.