Summit stresses importance of identity testing and industry cooperation.
By Janet Poveromo
The United Natural Products Alliance (UNPA) Dietary Supplement Analytical Summit, held November 5-6 in Salt Lake City, UT, kicked off with a warning from UNPA President Loren Israelsen: actions by attorneys general (AG) are not going away. He described a recent NAAG (National Association of Attorneys General) conference, which featured a panel discussion that included Maia Kats from Center for Science in the Public Interest, as well as Harvard MD and perennial supplement critic Pieter Cohen. The Council for Responsible Nutrition (CRN) was represented by the organization’s regulatory counsel, Rend Al-Mondhiry, Israelsen said. “Their meeting was a very painful 60 minutes,” he noted, adding that AGs are arguing that herbal products are not supplements, but drugs.
GNC’s AG Settlement
During the summit, Jim Sander, GNC’s senior vice president, chief legal officer, and Guru Ramanathan, PhD, GNC’s senior vice president and chief innovation officer, explained the company’s settlement with the New York AG.
According to Sander, the company first received news of the AG’s letter regarding the “impure marketing” of five products from a New York Times reporter on deadline. They received the call at 4 o’clock and were given one hour to respond. Regarding the testing on finished goods, Sander said, “We knew it was inappropriate right away.”
The company submitted to an information request. “We gave them everything,” he said, noting that the company supplied 70,000 pages of information. Ultimately, the AGs findings were that GNCs products were consistent with GMPs (good manufacturing practices), and labeling laws.
So why did they settle? GNC said they agreed to a settlement because the alternative was tedious litigation, and concerns regarding consumer confidence. “The perception was that consumer protection laws are inadequate,” Sanders explained. “A drawn-out investigation would keep these erroneous statements on people’s mind.”
The company agreed to DNA-based testing to authenticate plants, where it’s feasible, in addition to standard testing techniques. They also agreed to test for the eight common allergens, and offer consumer education in store and on website, about raw material and finished product testing.
The two suggested an outline for an industry stakeholder groups to elevate standards. The plan includes a coordinated media approach to define a strategy and roadmap to change the narrative of erroneous stories. They also suggested a raw material GMP action group that would require suppliers meet industry standards based on U.S. GMP regulations, Australia’s Therapeutic Goods Administration, Health Canada, among other examples. Lastly, the two suggested a finished product notification database.
“We want to consider as a group, a product notification database. We want to test sample database for ease of notification and effectiveness of data collection, identify third-party providers and costs per product,” they noted.
DNA Testing Exchange
Susan Murch, PhD, professor and Canada research chair, natural product chemistry, University of British Columbia, said DNA barcoding is “easy, cheap, fast technology,” adding that “these tests have been made much faster. The capacity is now massive.”
She added, “we don’t have a grip on diversity. There are sources of error; the same primers don’t work for all species.” She added that small amounts of DNA can be amplified, small difference in DNA cause negative results, and that the degree of certainty in the method is 53 to 85 percent. “Failure to detect DNA does not mean it doesn’t exist.” She stressed that DNA barcoding must be fit for purpose. “DNA isn’t magic, it’s just another chemical test.”
Danica T. Harbaugh Reynaud, PhD, CEO of AuthenTechnologies, LLS, and a botanical geneticist, clarified that DNA barcoding is not DNA sequencing. “It’s a process, not a technology.” She argued that such testing “works, is accurate and can be used on old things.” She noted that false negative results and detection of cross-contaminants can occur if used on degraded DNA, such as extracts, or if not tested under well-controlled conditions. “There are numerous ways to conduct DNA-based authentication. Each method must be validated.” Currently, AuthenTechnologies is the only full-servcie DNA contract testing laboratory for natural products industries.
She explained that when the NY AG targeted supplements in February, she called the test scientist. “They did not call me back,” she said. Afterward she co-authored a white paper refuting the AG’s findings.
Expert Guidance
Offering his advice, Ikhlas Khan, PhD, associate director, National Center for Natural Products Research, University of Mississippi, noted that the industry is 21 now (since the passage of DSHEA) and has grown. “Post NY AG, what are we dealing with?” he said. “Small companies, probably don’t need to do DNA testing since they are not being watch-ed,” he said. “The bigger players do.
“We have to know what we are dealing with before we take an approach,” he noted, adding, “media bashing is an excuse.”
His suggestions for industry solutions:
• Create Institution/s for the dietary supplement industry
• Create a public reference library of authentic reference material
• Compounds/reference markers (specific)
• Clearinghouse for methods of analysis and reference method
• Represent the current status of science
• Be the liaison for scientific issues
