No matter how you feel about Donald J. Trump, you can at least grant him this: He may have inadvertently distracted New York State Attorney General Eric T. Schneiderman from further lifting the curtain on how the supplement industry does its business. For as long as Schneiderman and his office are combing through financial records at the Trump Foundation or spearheading lawsuits against Trump University, they aren’t analyzing DNA test results from a market basket of supplements.
Of course, their diverted focus doesn’t consign the state’s investigation—opened after University of Guelph researchers found widespread contamination and substitution in herbal products—to ancient history. Nor does it undo the damage that Schneiderman inflicted in early 2015 when he very publicly directed four major retailers to stop selling some popular herbal supplements after DNA barcoding revealed not only the absence of plant materials listed on labels, but the presence of potential contaminants, to boot.
It does, however, suggest that the Empire State’s chief law-enforcement officer is frying other fish for the present. And it gives those in the supplement industry—not just retailers but suppliers, manufacturers, and marketers alike—a much-deserved time-out in which to take a breath, take stock of the investigation’s fallout, and take a good hard look at how they’ve been operating, and improving, since.
It would be hard to understate just how black an eye the “New York affair” gave the supplement world. As Elan Sudberg, CEO, Alkemist Labs (Costa Mesa, CA), says, “Between the media and the AG, the industry was dished a huge platter of scrutiny last year that changed how it’s viewed universally.” And despite the current lull, that attention hasn’t fully let up.
After all, says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), attorneys general are tenacious creatures, and “once they open an investigation, they want to pull out a win.” But to Schneiderman’s likely consternation, “There may not be a win here for him to have,” Mister surmises.
For that, thank the DNA barcoding, or fingerprinting, from which the attorney general extracted his evidence. As Anurag Pande, PhD, vice president, scientific affairs, Sabinsa (East Windsor, NJ), explains, “While DNA fingerprinting can definitely help in identifying the right species of raw material, this technique has limited application when applied to plant extracts”—like those implicated in the sting—“which may not contain any DNA.” He adds that the method has limitations not only when evaluating finished products, but also when identifying plant parts or the possibility of chemical and inorganic contaminants, as well.
Nevertheless, DNA barcoding was “thrust onto frontstage for show,” Sudberg supposes, because “General Schneiderman found the shiniest ball and made it a requirement when, actually, the technology is barely ready to serve our industry in any meaningful way, particularly when compared to better-established methods that we’ve been using for years.” He believes that companies quick to adopt DNA testing “have done so under misguided pressure or purely to appear ahead of the game to the media and industry.”
FDA itself issued a statement in response to an inquiry from Senators Orrin Hatch (R-UT) and Martin Heinrich (D-NM) noting that the agency neither uses nor requires DNA barcoding and would need to evaluate any methodology aimed at a specific product before determining whether the method was appropriate and scientifically valid for the product. “Even GMP regulations say that you must use at least one appropriate test to verify ingredient identify,” Mister adds, “but don’t say what that test is, because a test that’s appropriate for chondroitin may not be appropriate for ginkgo.”
Yet such arguments may prove too little, too late, in the face of continued attention from states attorneys, the media, regulators, Congress, industry watchdogs and—oh yeah—consumers. Schneiderman’s investigation, Mister says, “emboldened all of them.”
But the upshot isn’t all downside. For despite using “a few bad apples to paint the whole industry as bad” and drawing its conclusions from a “questionable methodology,” Schneiderman’s action, Pande says, “still raised important questions about supply-chain transparency and, in many cases, the authenticity of supplements sold in the market.” And if there’s a silver lining to be mined from this experience, that’s where it lies.
Looking back with the benefit of hindsight, Mister believes the investigation “brought to the surface a concern that lots of people in the industry had, which is, ‘How are we guaranteeing the safety, purity, and identity of these products?’” And how can industry gird itself for the next time an attorney general comes knocking? “We need a better answer to show that we’re protecting our supply chains all the way back to the plant’s harvest so that we have a better story to tell.”
The supplement community is drafting that new narrative right now, Mister says, and their work is playing out in “several major quality initiatives within industry that were already being talked about but needed an impetus and momentum to go forward.”
Principal among them is CRN’s Supplement Online Wellness Library (Supplement OWL), developed and run in conjunction with UL and launched into “beta test” amongst nine companies in mid-September. The registry collects information about supplement products on two tiers, the first of which details basics like product name, ingredients, and allergens, and requires that companies supply manufacturing and packaging facility information for FDA’s exclusive access.
The second tier lets companies, for a nominal fee, reveal more about their products and upload supporting quality documentation, such as sustainability certificates and evidence of GMP compliance. This tier is open to view by retailers and regulators on a permission-only basis that listing companies can grant. And though Mister says that CRN’s board discussed the establishment of such a registry as far back as December 2014, “after New York, there was a lot more enthusiasm for doing it.”
Cheryl Luther, DC, general manager, dietary supplements and functional beverages, NSF International (Ann Arbor, MI), also believes the New York investigation has “driven the industry to become less fragmented and more unified in self-regulating,” and she cites increasing participation in the Global Retailer and Manufacturer Alliance (GRMA) as a “sign of industry unification.”