Last month in Washington, the National Association of Attorneys General (NAAG) conveyed for its winter meeting. State authorities from around the United States converged at the nation’s capital to discuss key legal issues ranging from marijuana regulation to antitrust matters to treating the mentally ill.
Dietary supplement regulation wasn’t on the agenda.
That didn’t stop the Council for Responsible Nutrition (CRN) from arranging meetings with law-enforcement officials in various states just weeks after New York Attorney General Eric Schneiderman announced test results that revealed a number of products sold by national retailers failed to contain the labeled herbs and were contaminated.
“That was one step in a multistep process to try to get information out to the other 49 states," said Steve Mister, president and CEO of the supplement trade organization CRN, in a phone interview.
“The more we demonstrate to the group that supplements are in fact adequately regulated at the federal level and they can trust FDA to inspect facilities, I think the narrower the scope of this investigation will be," Mister added.
The meetings underscored that an industry selling natural products to 150 million Americans is moving beyond the science of supplements—namely whether Schneiderman’s DNA testing methodology was adequate—to politics, seeking to influence state officials who have the clout to not only take enforcement actions against an industry currently under assault but severely damage its credibility.
Through the NAAG gathering and other meetings, Mister said he and his colleagues have conversed with officials in nearly 20 states, discussing Schneiderman’s investigation and other related matters such as testing requirements in the dietary supplement industry. He declined to identify the attorneys general with whom CRN representatives have met, but Mister said his organization is targeting law-enforcement officials based on a number of criteria including interest in Schneiderman’s investigation.
“We have found the meetings to be very enlightening from our side as well," said Mister, who explained the state officials were initially focused on Schneiderman’s findings and a New York Times article that broke the story. “They are very interested in the issue of DNA testing and why it may not be appropriate. I have found they have been very open about being educated on the issue."
It’s not clear whether such meetings helped narrow the pool of attorneys general who have formed a coalition to investigate supplements. Earlier this month, Schneiderman announced that attorneys general from Connecticut, Indiana and Puerto Rico had joined him to investigate whether the herbal supplement industry is validating marketing claims. According to a March 10 press release from his office, the coalition “seeks to enhance transparency and ensure that the herbal supplements industry is taking the steps necessary to validate their marketing claims, including as to authenticity and purity."
Schneiderman’s “initial charges were pretty dramatic, and if I were the AG and tried to put together a coalition of like-minded officials, and I had such a damning accusation, I’d be embarrassed to have so few colleagues join me," said Jeff Stier, a senior fellow at the Washington-based National Center for Public Policy Research, in a phone interview. “It’s a pretty pathetic coalition. He has access to all the AGs, and I imagine he asked all of the AGs or at least most of them, and apparently, most of them turned him down."
Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), a nonprofit formed in 1936, pointed out a number of states that are known for taking action to protect consumers didn’t join the coalition. He cited, for instance, Illinois, Texas and California. None of the three offices responded to requests for comment on whether Schneiderman reached out to them. Liz DeBold, a spokeswoman for Schneiderman’s office, declined to comment about whether Schneiderman reached out to other attorneys general.
“You figure he [Schneiderman] floated it to those attorney generals and they took a pass," Fabricant said in a phone interview. “If someone who is used to flexing their muscle and chooses not to, it may mean that’s not as great a case as" Schneiderman thinks.
Greater forces may be at work. Anthony Young, a veteran food and drug lawyer who is a partner with Kleinfeld, Kaplan & Becker LLP, said an attorney general’s decision to focus its resources on an area is often a political decision. He distinguished the supplement investigation from one in which an attorney general is suing to recover monies that a state had expended, such as investigating health care providers that are accused of defrauding the state’s Medicaid program.
Ironically, Schneiderman’s preliminary findings have met skepticism from some unlikely characters: critics of the supplement industry.
Enter Stier, who worked in the office of the Mayor and in Corporation Counsel's office in the Rudy Giuliani administration in New York. He said he is actually skeptical about supplements and doubts the validity of many efficacy claims. Still, Stier criticized Schneiderman’s science. He is among the naysayers inside and outside the supplement industry who contend New York authorities used the wrong testing—DNA barcoding—or should have validated their findings with additional tests since DNA may be degraded during the manufacturing of botanical extracts.
“There are multiple steps in the manufacture of botanical dietary supplements between farming and final processing which degrade DNA," representatives of NPA who previously worked at FDA’s dietary supplement division wrote in a recent white paper. “These treatments can cause the DNA strains to break and be unrecognizable in barcoding tests."
In a March 18 letter to Sens. Orrin Hatch (R-Utah) and Martin Heinrich (D-New Mexico), FDA’s Thomas Kraus indicated the agency doesn’t use DNA sequencing to identify plants, although the agency is researching the use of the technology for botanical materials.
“Currently, if FDA were to use DNA methods on botanical extracts, we would use them in combination with established chemical or other acceptable methods historically used to verify the identity of these products," Kraus, FDA’s Associate Commissioner for Legislation, wrote.
Molly Johnson, a spokeswoman for the Indiana Attorney General’s Office, declined to answer questions regarding New York’s testing and whether the supplement industry has communicated with her office. She referenced Attorney General Greg Zoeller’s previous statement that “[t]he significant issues recently raised about herbal supplements are a concern that must be taken seriously so as not to further jeopardize the health and safety of people ingesting these products."
Jaclyn Falkowski, a spokeswoman for the Connecticut Office of the Attorney General, said her office joined the coalition based on Schneiderman’s preliminary findings.
“The investigation seeks to ensure that Connecticut consumers have not been exposed to mislabeled products in the manner suggested by New York's investigation," she said in an emailed statement.
“The investigation, which is in the early stages of fact gathering, is not intended to ban dietary supplements," Falkowski added. “We have not drawn broad conclusions about the conduct of this industry as a whole or, indeed, any final conclusions about any particular supplier."
Young said he doesn’t believe Schneiderman’s DNA testing results will drive any resolution that stems from the coalition’s investigation.
Outreach to Attorneys General and Congress
Meanwhile, industry trade groups are reaching out to regulators, lawmakers and consumers to neutralize New York’s probe. Fabricant referenced plans to convey information to consumers through email lists, possibly limited advertisements, and conversations with attorneys general and lawmakers on Capitol Hill.
Fabricant and Mister both said their organizations have been in touch with Schneiderman’s office, and Mister expressed optimism that CRN representatives would have a sit-down meeting within the next month.
The trade groups also are getting in touch with lawmakers. Just this week, NPA announced that it met with more than half the freshmen in the 114th Congress to educate them on industry issues and discuss the benefits of natural products. The association plans to get together with more greenhorns in the next month.
“You have to be active politically if you are in business, and this is exactly why," Fabricant said.
Soon after Schneiderman announced his findings, CRN met with Sens. Dick Durbin (D-Illinois) and Richard Blumenthal (D-Connecticut), a former state attorney general. Durbin and Blumenthal have frequently called for additional oversight over the supplement industry and initially reacted strongly to Schneiderman’s investigation, calling on FDA to investigate the products that were tested.
Said Mister: “We wanted to make sure they understand that investigation was flawed."
Editor’s Note: For information on adulteration in botanicals, attend Ingredient Marketplace, a SupplySide event held April 7 to 9. The event will feature the panel discussion “Adulteration & Your Role in Delivering Value to Consumers" on Wednesday, April 9 just before the show floor opens. This panel will help brands examine business practices and how to align them so they can truly offer valuable finished goods to shoppers. So far, speakers include American Botanical Council (ABC) founder Mark Blumenthal, Council for Responsible Nutrition (CRN) CEO Steve Mister, and Kleinfeld, Kaplan and Becker partner Dan Dwyer.