Within a day or two of the Feb. 3 New York Times article that broke news of NY Attorney General Eric Schneiderman’s investigation of herbal supplements, longtime supplement industry critics Sens. Dick Durbin (D-IL) and Richard Blumenthal (D-CT) said they were urging FDA to open its own investigation into herbal supplement fraud. While rumor was they wrote a letter to FDA, the agency told INSIDER, “We are not able to confirm that we have received any correspondence from Senators Durbin and Blumenthal, but you should also know that our general policy is to respond directly to the members when we receive such an inquiry."
Durbin’s staff confirmed to INSIDER no letter was sent: “Senators Durbin and Blumenthal did not write a letter to the FDA; rather, they released a statement calling on the agency to conduct a comprehensive, nationwide investigation into the products identified in the New York Attorney General’s report, and to use its existing authority to ensure that dietary supplements found to be misbranded and dangerous are removed from store shelves. As such, there has been no formal response from the FDA, though the Senators have and will continue to work with the agency on efforts to keep consumers informed about and safe from unregulated dietary supplements."
A letter was sent to FDA from the Senate, but the authors were Sens. Orrin Hatch (R-UT) and Martin Heinrich (D-NM). In the letter, they discuss Schneiderman’s continued lack of transparency and the growing chorus of voices from inside and outside the supplement industry calling the DNA testing method inadequate for finished herbal extract product identification. Further, they asked FDA to clarify federal law on dietary supplements, including GMP (good manufacturing practice) requirements to conduct at least one appropriate test or exam of incoming material and outgoing finished product. They also asked FDA to comment on the validity of DNA barcoding as a standalone test for supplements.
INSIDER had reached out to FDA on these same points, and the agency confirmed dietary supplement GMPs require manufacturers verify identity of dietary ingredients each time they are used. “The GMPs do not specify which test must be used for identity, just that firms must perform identity testing on every dietary ingredient, every time it is used," the agency said. “The firm has the responsibility to use the most appropriate identification method for their dietary ingredients – there is no blanket identification method that works for all dietary ingredients."
On DNA testing, the agency told INSIDER it does not currently use DNA sequencing for dietary supplement ingredient verification, but is actively working toward developing validated methods for plant identification, for use by both industry and the agency. “The agency has been working on building a library of DNA sequences for plants, but this project is not complete," FDA noted. “The agency currently uses chemical markers or fingerprints for ingredient verification." As for opening up its own investigation, FDA held its usual stance on not commenting on current or future investigations or enforcement plans.
Former head of the FDA Dietary Supplement Division and current CEO and executive director of the Natural Products Association (NPA) Dan Fabricant said FDA has a general policy of not getting involved in state matters, but when there are questions about the agency’s jurisdiction and authority, FDA is somewhat obligated to address those questions publicly. “One of the agency’s biggest roles is educate the public," he said, adding that most sides of this NY investigation have asked questions of FDA.
Fabricant said while the investigation does not appear to have much weight on Capitol Hill at this time—Congress has bigger fish to fry and went on recess shortly after the NY AG news hit the news—there is still an educational need. “We have to be mindful and make sure members of Congress are getting the right info about testing and existing supplement regulation," he said. “Members want to hear the facts and figures." He predicted industry champions such as Hatch would go to FDA for public confirmation of regulatory facts.
The Council for Responsible Nutrition (CRN) also reached out to Congress right after the NY AG investigation news hit. “We immediately dispatched to meet with our friends and critics on Capitol Hill, to make sure they heard the other side of the story," said Steve Mister, president and CEO of CRN. In the offices of both industry allies and foes—including Durbin and Blumenthal—CRN talked about the inappropriateness of DNA testing in this case and how Schneiderman likely got this part wrong. CRN also reiterated the federal regulations requiring ID testing of ingredients as well as tests to make sure finished products actually match what is on their labels.
Overall, CRN wanted to reassure allies that this is a one-off case that industry is actively addressing. It also wanted to convey to industry critics in Congress that this NY case might not be the bandwagon they want to jump on, given it appears Schneiderman erred in his testing protocol. “I think they heard the message and were very thoughtful about it on both sides," Mister said, noting his colleagues were well-armed with fact sheets and statements from experts, even those outside of industry, on the testing discrepancies.
So far, there has been no new legislation or even hearings pop up in Congress, indicating lawmakers are still taking it all in and are busy with other federal matters. While Congress may be in a general pattern of wait-and-see on this NY investigation, both CRN and NPA warned the real concern for industry might be the 49 other state AGs. State AGs tend to talk to each other, and industry will need its grassroots prowess, including its newfound social media presence, to ensure the NY AG’s investigation of herbal supplements is not replicated all across the country.
Visit INSIDER’s Supplement Law blog for more coverage of the NY AG investigation.