Letter says investigation raises concerns
As first reported earlier this morning in the New York Daily News, 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, sent Thursday, 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.
“Products falsely identified as black cohosh — an herb commonly taken to reduce menopause symptoms — may have caused severe liver damage in certain women. And media reports have uncovered over-the-counter supplements, including those purporting to build muscle, aid weight loss, and reduce anxiety, that were secretly laced with dangerous prescription medications,” the AGs wrote.
The AGs were seeking the lawmakers’ help because in their view FDA has failed to act.
"The FDA has long been aware of problems in the dietary and herbal supplement supply chain, from dubious ingredient sourcing to a failure to carry out proper testing on finished products," the letter continued.
“This is just harrassment 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?”
“It’s an escalation of an already difficult and frustrating matter in no small part because we can’t get to the truth,” said Loren Israelsen, president of the United Natural Products Alliance. “The letter is a continuation of the mischaracterization by the NYAG of the results of the original DNA barcode tests. That’s troubling because it seems as if he is now impervious to being corrected on the facts. You have to question his motivations.”
Michael McGuffin, president of the American Herbal Products Association, took issue with some of the examples Schneiderman used in the letter to justify his call for greater regulation.
“This industry is ready and able to be subjected to any honest scrutiny,” McGuffin said. "But the letter called out drug spiking. A guy is going to jail over that. We’re happy about that; that is what is supposed to happen. He pleaded guilty to drug misbranding. That's what the government called it. It’s a deliberate red herring."
Turning of the screw
Scheiderman’s probe into the way dietary supplements are manufactured and marketed started at the beginning of February with letters mailed to four major retailers—GNC, Target, Walgreens and Walmart—demanding they pull certain herbal supplements off shelves in New York state, alleging they were fraudulent. The justification for this was DNA barcode testing Schneiderman’s office contracted to have done on samples of the supplements. NYAG said that the test results showed little or no DNA from the parent herbal materials were found in the finished products. The office has refused to release full details of those tests, saying that it is part of an ongoing investigation.
Industry experts have hotly contested the fitness of this testing methodology when used for this purpose, that is, the testing of finished products. Many of the products that were tested are extracts, and the experts—including some strident critics of the dietary supplement industry—have pointed out that properly made herbal extracts by their very nature could be expected to contain little or none of the DNA of the parent material.
Undeterred by this criticism, Schneiderman forged ahead, next demanding the substantiation the original four retailers have for the structure/function claims the companies have made on product labels. The next turn of the pressure dial saw Schneiderman demanding detailed records relating to GMP compliance from dietary supplement manufacturers Nature’s Way, NBTY, Nutraceutical Corp. and Pharmavite.
The first company to seek some sort of rapprochement with Schneiderman was GNC. GNC was the most forward of the first four companies cited in pushing back against Schneiderman’s tactics. The company released the results of its own and third party testing of the product lots in question, testing which the company said showed without exception that the products met label claims for identity and potency.
But GNC was seen also as the company with the most to lose, as dietary supplements form the company’s bread and butter, whereas they are minor business lines for Walgreens and even less so for Target and Walmart.
On Friday GNC signed a deal with Schneiderman in which it agreed to institute a new DNA testing regimen for incoming raw material and to report the test results to Schneiderman’s office every six months. GNC also agreed to place signs in stores explaining to consumers the difference between whole herb products and formulas based on herbal extracts. The company also agreed to a more rigid allergen testing protocol.
Many industry observers have criticized this deal as setting a bad precedent, by lending official credence to the use of DNA barcoding technology as some sort of gold standard for the testing of botanical materials and for Schneiderman's usurpation of some responsibilities they see as more properly resting with FDA.
In the text of the GNC agreement, Schneiderman’s office foreshadowed the letter, which had already been sent at the time the agreement was signed. While admitting that GNC was in compliance with all relevant federal laws, the statement about the agreement went on to say, “Where NYAG and GNC disagree, however, is on the sufficiency of federal rules and testing requirements and their relationship to state consumer protections laws.”
Schneiderman’s letter is co-signed by the attorneys general of Connecticut, District of Columbia, Hawaii, Idaho, Indiana, Iowa, Kentucky, Massachusetts, Mississippi, New Hampshire, Northern Mariana Islands, Pennsylvania, and Rhode Island. While it seems likely that a plea for more regulation will disappear into the currently gridlocked maw of Congress, the supplement industry can’t let down its guard, both Israelsen and Fabricant said.
“It’s a nuisance it gets picked up in the press,” Fabricant said. “I’d love to say definitively that there’s nothing to worry about, but you never know when someone like some junior member of Congress might pick up on this. If not in this term, then maybe in a future term.”
“We need to continue to look for reasonable people who are willing to listen to the science. And if they have legitimate concerns we are always willing to listen and discuss,” Israelsen said.