First shot across the bow
In early February Schneiderman announced the results of an investigation conducted by his office into herbal dietary supplements sold by GNC, Target, Walgreens and Walmart. NYAG hired a academician unfamiliar with herbal products testing to conduct DNA barcode tests on the products, and announced that the tests found little or no DNA of the plant material listed on the label in the bottles. Schneiderman sent cease-and-desist letters to the retailers, demanding the products be pulled off the shelves, alleging they were fraudulent.
Industry experts (and some industry critics, too) were quick to respond. The key point they harped upon (and continue to bring up) is that the testing protocol was not fit for purpose and displayed an alarming ignorace of how herbal products are made. Many of the products tested were extracts, and a properly made herbal extract by its very nature would be expected to contain very little or none of the DNA from the raw material. There is ample information available on how to test herbal dietary supplements, they said, but NYAG inexplicably failed to refer to these national standards, rendering the investigation critically flawed from the outset.
Industry critics weigh in, too
Even some strident industry critics called Schneiderman onto the carpet over this lack of proper oversight of the investigatory process. Dr Tod Cooperman runs a testing service called Consumer Labs that tests products bought on the open market and publicizes the results. Cooperman is a divisive figure within the industry, because many feel he chooses his testing protocols and reports results in such a way as to make the quality picture look as bleak as possible. Nevertheless, Cooperman came to the industry’s defense, saying the DNA test was not fit for purpose to test finished products.
Similarly another prominent industry critic, Dr Pieter Cohen, a physician associated with Harvard Medical School, said the test results “didn’t ring true.”
Another turn of the screw
Schneiderman seemed totally unfazed by the criticism of his investigation, much to the bemusement of industry insiders, who seem to have expected at least some softening of his stance after what they believed to a be a deal breaker in the guise of the misapplication of the DNA test was brought to his attention. Instead, Schneiderman turned up the pressure with subpoenas to the original four retailers seeking their substantiation of the structure/function claims made on product labels.
Schneiderman expanded the scope of his probe even further later in February when he sent letters to NBTY, Pharmavite, Nature’s Way and Nutraceutical Corp. demanding detailed ingredient and quality control information on every herbal dietary supplements they sold in New York state.
GNC knuckles under
Finally GNC agreed to a deal with NYAG for additional testing of its herbal products, including DNA barcode testing, in return for allowing the products back on the shelf. This was an initial surprise, in that GNC was the most forward of the initial four retailers in the testing of the products, tests it conducted both in-house and and at a third-party lab. The company was adamant in saying that the tests showed without exception that the products met label claims. The deal was seen as good for GNC in the short term and a bad precedent for the industry in the long run.
Other AGs join in appeal to Congress
Schneiderman took his assault against the dietary supplement industry up yet another notch with a letter he and 13 other attorneys general sent to members of Congress asking for an investigation of the herbal supplements industry and asking them to consider giving the Food and Drug Administration broadened enforcement powers over the industry.
The letter, sent at the end of March, the letter, signed by the group led by Schneiderman and Indiana AG Eric Zoeller said, “The multi-billion dollar herbal supplements industry is built on the promise that its products will improve the health and well-being of those who use them, yet a current state investigation has raised serious concerns about the marketing and safety of the herbal supplements regularly consumed by millions of Americans.”
The letter was addressed to Sen. Jerry Moran, R-KS, the chairman of the Senate Commerce subcommittee responsible for consumer protection issues, Rep. Joe Pitts, R-PA, chairman of the House Energy and Commerce health subcommittee, and other lawmakers.
“This is just harassment at this point,” Daniel Fabricant, CEO of the Natural Products Association told NutraIngredients-USA. “Two months ago this guy (Schneiderman) was saying there was this huge public health problem. Now he has done a 180 and has allowed those same products back onto the shelf (via the deal with GNC) that he was saying were so dangerous. How much credibility does this guy still have?”
Where does it leave the industry?
While this saga continues, some features of the new landscape are beginning to come clear. The dietary supplement business has been put on the deep defensive, and a new strategy going forward is called for. Industry insiders said a number of opportunities have presented themselves in this otherwise dim picture, including the need to better educate both the public and lawmakers on the value of dietary supplements and their regulatory framework. Another idea that has been floated is to have a panel of experts available to respond in a thoughtful, informed and dispassionate way could go a long way toward defusing future crises such as this, with the attendant mainstream media fallout they create.