Opening the dialogue
The joint statement from Schneiderman and NPA CEO Daniel Fabricant, PhD signifies a significant shift in the NYAG’s policy in responding to requests from industry stakeholders about the office’s investigation of herbal supplements sold at four major retailers doing business in New York state. Key to the investigation was the sole reliance on DNA barcoding technology, which Schneiderman seems to have held up as gold standard of proving identity and purity. Industry experts have excoriated Schneiderman for using this testing methodology, an approach they say is incapable of adequately characterizing herbal extracts, which formed the bulk of products tested in the investigation. Schneiderman has repeatedly rebuffed calls for more details on the testing procedure, which was overseen by a university researcher with no known expertise in the testing of botanical materials.
Many natural products chemists contacted by NutraIngredients-USA as the NYAG affair has unfolded since early February have said that DNA barcoding technology holds promise for verifying the identity of incoming raw materials. It has serious limitations, though, among these that few authenticated reference barcodes are available and that verifying the DNA of the sample makes only a basic statement about the identity of plant material and says nothing about its potency or about relevant plant parts, all questions of crucial importance in the formulation of herbal extracts.
No one-size-fits-all approach
Chemists familiar with the testing of botanical materials have emphasized that a variety of tools are needed to adequately assess the identity, purity and potency of incoming raw materials, These include organoleptic tests, microscopy and various chemical approaches. There is no valid one-size-fits-all approach, however attractive that idea might be from a media sound bite standpoint.
Today’s statement is the first from Schneiderman that admits to a chink in the DNA armor. The statement says that “no single test or technology alone can provide complete confidence to consumers , we support the application of DNA barcoding technology as part of a multi-faceted approach to assuring authenticity and identifying substitution.” The statement goes on to say that this approach should be used “prior to extraction,” which could be interpreted as a backhand admission on Schneiderman’s part that the technology was inappropriately applied in his initial round of testing on finished herbal dietary supplements.
While all of the trade organizations in the industry have weighed in on the affair and have brought pressure to bear behind the scenes, NPA has taken the most public route in urging its membership to contact the NYAG office directly. NPA has the largest and most diverse membership of all of the trade organizations in the dietary supplement industry, and the group had organized a grassroots pressure campaign urging members to contact Schneiderman directly to ask for transparency on how his investigation was conducted. Whether today’s announcement is a response to that pressure campaign is as yet unclear.
“Each individual who has participated in the grassroots campaign has made a significant contribution in holding officials accountable; making it known that acting without transparency is simply unacceptable,” Fabricant said back in mid February at the inception of the campaign.
Who’s in charge?
Rick Collins is an attorney with Collins, McDonald & Gann, a New York-based law firm that represents a number of dietary supplement companies. Collins said the announcement of the NYAG-NPA collaboration is a welcome development, but doesn’t untangle the thorny issue of Schneiderman’s appropriation of regulatory authority that up to now has been part of the federal government’s purview.
“This collaboration ensures industry has a potential voice in the NYAG’s future efforts. But where is the FDA in this? The federal agency actually tasked with the job of regulating this industry isn’t sitting at this table. Whether the continued initiatives of state authorities will provoke a more aggressive regulatory approach by FDA remains to be seen,” Collins said.
Full statement
The full text today’s joint statement reads as follows:
“We share a common objective of ensuring herbal products bought by consumers are authentic, pure, and sold in full compliance with consumer protection laws. Anyone who buys an herbal supplement should be able to do so with full knowledge of what is in the product and have complete confidence that every precaution was taken to ensure its authenticity and purity. While no single test or technology alone can provide complete confidence to consumers, we support the application of DNA barcoding technology as part of a multi-faceted approach to assuring authenticity and identifying substitution. This includes testing herbal/botanical ingredients prior to extraction in circumstances where DNA Barcode is available for the relevant species. Together, we look forward to jointly working with major manufacturers and retailers of herbal supplements to promote a model for product safety, authenticity, and transparency in this industry. We view this dialogue as a positive step in resolving our differences and we are hopeful that we can work in collaboration to enhance confidence and safe access for consumers."