Last week Schneiderman sent a letter to members of Congress asking for an investigation of the herbal supplement industry and for greater enforcement powers for FDA. The letter was signed by AGs from 13 other states, and alleged that a lack of oversight over the industry has resulted in a situation in which the AGs have ‘strong concerns’ about consumer safety.
Lack of dialogue
The letter has spurred a strong reaction from industry groups, all of whom have responded in one form or another. One strain that runs through all the responses is a frustration with Schneiderman’s refusal to engage in a dialogue about the substantive issue in the case, that being the misapplication of DNA testing to allege that the initial suite of herbal products pulled from the shelves in New York state were fraudulent in that they contained little or none of the listed herbal ingredient and that they contained undeclared traces of other plant material. NYAG has refused to release more details about these tests and has declined to engage in a dialogue about how the methodology that was used was unfit for the purpose of testing finished products, especially in the case of extracts, which a majority of these products were.
“The main message is Mr Schneiderman is relentless and he doesn’t need the facts on his side to proceed, because the facts aren’t on his side. He used the wrong analytical method. Period,” Michael McGuffin, president of the American Herbal Products Association, told NutraIngredients-USA.
“It is unfortunate that the New York State Attorney General (NY AG) has spearheaded a request for Congress to spend taxpayers’ money to ‘launch a comprehensive congressional inquiry into the herbal supplements industry’ when the industry is already amply regulated on a federal level by FDA and FTC. In fact, concerns raised in that letter about alleged widespread safety issues are not true, based on government’s post-market surveillance system which demonstrates relatively few safety issues for these products, particularly in comparison to other industries regulated by FDA,” said Steve Mister, president and CEO of the Council for Responsible Nutrition.
Harassment tactics
For the Natural Products Association, Schneiderman’s tactics have devolved to the realm of pure harassment. NPA CEO Daniel Fabricant, PhD, makes the point that Schneiderman, in his recent deal with GNC, has admitted that GMP rules do cover the sector and that GNC is in compliance with these.
“Attorney General Schneiderman has admitted that the federal Good Manufacturing Practices currently in place for dietary supplements are sufficient, and companies such as GNC are in compliance with those, but yet he moves forward in his request to spend federal taxpayer dollars on an investigation into an industry that is fully regulated by the FDA.
The Natural Products Association regards this most recent action by Attorney General Schneiderman as added harassment based on science fiction. For the past two months, the attorney general has continued to escalate his attack on the supplement industry without any legitimate data to back up his arguments,” Fabricant said.
Shortcoming of relying on DNA alone
DNA bardcode testing is a methodology that as yet has not been fully accepted by natural products chemists as fit for purposed for testing botanical materials. While it can identify a plant species before it is processed, it says nothing about the part of the plant from which the sample was taken, something of often key importance in herbal products. Nor does it say anything about the quality of the material, beyond its identity. A botanical could be harvested at the wrong time and stored inappropriately so as to be almost useless for the purposes of making an herbal extract yet still pass a DNA test. So the method, if it is to be used at all, must be used in concert with other test methods, experts say, in order to give an accurate picture of identity, purity and potency. But Schneiderman has based his whole effort on this lone test method, holding it up as some sort of gold standard, and implying the industry has been negligent for not having used it more frequently.
The issue of purity is another area on which Schneiderman and the industry disagree. Schneiderman’s initial report stated that DNA from materials other than the herbs listed on the labels showed up in the tests. Industry responded that the efficacious dosages of many herbal extracts are quite small, and capsules are routinely filled up with inert materials such as rice powder, whose DNA would be recorded in such a test. The issue points out another shortcoming of relying on DNA testing as a gold standard, namely that the test will not usually record the amount of material that is present. So certain stray bits of DNA could show up, but might be from an amount of extraneous material that is well below federal guidelines for purity.
“The NY AG has refused to release the details of the findings from his investigation, demonstrating a disturbing lack of transparency, and making it impossible for scientific experts to answer with certainty—although there are plausible theories—as to why some of the products tested contained allergens and plant species left off the label. What is certain is that the basis of the report—a testing methodology known as DNA Barcoding—is simply an inappropriate methodology for testing herbal supplements made from herbal extracts, thereby making the NY AG’s report misleading,” Mister said.
Question of preemption
Loren Israelsen, president of the United Natural Products Alliance, found it troubling that the AGs appear to be trying to muscle into areas of law already covered by existing federal agencies and statutes. For instance, the agreement NYAG reached with GNC includes certain reporting protocols and mandates certain testing regimens that would seem on the surface to usurp FDA authority.
“What is the motivation here? We have seen that there can be political gain for some,” Israelsen said.
“This area of law has been largely been preempted by the FDA, the FTC, the Food, Drug & Cosmetic Act and DSHEA. Much of what the AGs are looking at clearly falls in the area of current law and regulation. If you read the letter that they sent to Congress, there appears to be a clear lack of understanding and awareness of all of the apparatus that is in place to work on these issues. If it were true that there is a lack of enforcement, what we have said for years is that Congress should adequately fund FDA,” he said.
“We would like to see the whole question turned back to the primary issue of whether there is an underfunded agency. We fear that the current direction they have taken will require a great deal of time and energy to explain to the AGs that what they are going after is not part of their domain,” Israelsen said.
Conflating drug spikers with legitimate manufacturers
Both McGuffin and Mister took issue with the AGs attempt to cite the actions of certain criminals who sell unlicensed drugs disguised as supplements as indicative of quality problems afflicting above-board dietary supplement manufacturers. These products are illegal drugs, and have been acknowledged by FDA as such, they say.
“CRN is a strong and vocal advocate for more resources to FDA for stronger and swifter enforcement of these existing regulations. We acknowledge there are some problems facing our industry, and we wish that the state AGs had focused their efforts on helping solve the serious problem of criminals who spike products with illegal drugs and market them illegally as dietary supplements,” Mister said.
“That’s not something that we do, that’s something that is done to us. We agreed with FDA five years ago to not call them tainted supplements any more, but to call them tainted products. To lump those in with legitimate supplements is at best disingenuous and at worst, dishonest. We admit we’re an imperfect industry, like all the other industries out there,” McGuffin said.