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After what appeared like a quiet couple of months, NY AG Eric Schneiderman’s dietary supplements investigation has resurfaced.
After what appeared like a quiet couple of months, New York Attorney General (NY AG) Eric Schneiderman’s dietary supplements investigation has resurfaced-this time issuing cease-and-desist letters to makers of devil’s claw supplements sold in the state of New York.
On September 9, AG Schneiderman’s office sent cease-and-desist letters to 13 devil’s claw supplement manufacturers, including NBTY, Now Foods, Thorne Research, Nutraceutical International Corp., and Nature’s Sunshine Products, alleging that their products contain a plant species that is not in fact the more-expensive devil’s claw species Harpagophytum procumbens. Schneiderman ordered the companies to recall the products and to compensate consumers who purchased them.
To test the devil’s claw products, the NY AG’s office once again employed DNA barcode testing, a method his office has relied on throughout its investigation of the herbal supplements industry, which began in February when his office ordered numerous herbal supplements, including ginseng, Echinacea, and St. John’s wort, off retail shelves. The dietary supplements industry has heavily criticized the use of DNA testing on finished herbal products, explaining that DNA may no longer be intact in finished herbal products to allow for accurate testing.
In its press release announcing the devil’s claw probe, the NY AG’s office says that DNA testing performed by the New York Botanical Garden found that the supplements in question contained a “cheaper related species that is considered less desirable”-namely, related devil’s claw species Harpagophytum zeyheri, “which contains some-but not all-of the same chemicals” as Harpagophytum procumbens. Of the 16 supplements that the New York Botanical Garden was able to detect DNA in, tests allegedly found that all contained Harpagophytum zeyheri, either alone (81%) or in mixture with Harpagophytum procumbens (19%).
But in an American Botanical Council (ABC; Austin, TX) press release, medicinal plant expert Thomas Brendler, editor of the African Herbal Pharmacopeia, says that Harpagophytum procumbens and Harpagophytum zeyheri are equally effective, despite their different chemical makeup.
“Both species of devil’s claw have a similar chemical profile,” Brendler is quoted as saying. “While both species differ marginally in shape and chemical composition, both are considered equally effective.” And, the ABC press release points out, some government pharmacopeias consider the two species interchangeable in terms of anti-inflammatory properties and benefits for osteoarthritis, and that it is not uncommon to find devil’s claw extract in the global market containing both devil’s claw species. (In Canada and Europe, devil’s claw is sold as an arthritis treatment, according to an ABC HerbClip monograph on devil’s claw.)
“According to various government-recognized medicine evaluation bodies and pharmacopeias, the two species of devil’s claw are considered interchangeable for the purpose of their use for their medicinal actions,” the ABC press release states. “These organizations include the European Medicines Agency, the European Pharmacopoeia, and the unofficial ESCOP (European Scientific Cooperative for Phytotherapy), a pan-European consortium of medicinal plant experts. Also listing both species as interchangeable is the proposed monograph ‘Harpagophytum species root’ in the United States Pharmacopeia’s Herbal Medicines Compendium.”â¨â¨
Mark Blumenthal, founder and executive director of ABC, said in the press release that while his group appreciates the NY AG’s interest in herbal supplement quality, “splitting the devil’s claw genus in the very narrow way that they have done in this investigation is akin to splitting hairs-it has no real meaning or value to anyone, particularly the herb consumer.”â¨
“This may be a hair-splitting botanical distinction,” noted Blumenthal in the press release, “but it certainly is not a legal or regulatory one, especially since authoritative sources recognize both species as being ‘devil’s claw.’”
Blumenthal also points out that ABC data show devil’s claw to be a relatively low-selling herb in the United States, with total sales in the country ranging from $250,000–$500,000.
One Company Settles
AG Schneiderman’s office announced that it has so far reached agreement with one devil’s claw supplement manufacturer, Nature’s Way, who, unlike the other manufacturers, did label its product as containing a combination of Harpagophytum zeyheri and Harpagophytum procumbens. According to the AG’s press release, the company has agreed not only to issue refunds to customers but also to employ DNA barcode testing in its operations in order to ensure that devil’s claw products do not contain Harpagophytum zeyheri.
This is the second company to settle with the NY AG’s office in the course of his investigation of the supplements industry. In March, retailer GNC agreed to employ DNA testing at its facilities-a move criticized by many industry members.
Supplements Probe Persists
After this latest move, it appears that AG Schneiderman will not let up on his investigation of the herbal supplements industry. In June, AG Schneiderman and a collation of state attorneys general asked FDA to enact stricter dietary supplement regulations and asked Congress to do the same in April.
In his office’s press release on the devil’s claw investigation, AG Schneiderman said, “When a scientific study tests numerous herbal supplements manufactured by more than a dozen companies and finds the wrong plant in just about every one, it raises more troubling questions about whether people who buy dietary supplements are getting what they pay for. This is yet another sign that weaknesses in the supplements industry’s approach to quality control are having real-world consequences for consumers. The manufacturers receiving letters from my office should follow the lead of Nature’s Way and address these gaps immediately.”
Industry reactions to this latest NY AG probe are largely critical.
Dan Fabricant, PhD, executive director and CEO of the Natural Products Association (Washington, DC), stated: “More than six months have passed since the Attorney General first began this inquiry and two critical issues remain. First, he has yet to make public or subject to peer review the questionable ‘science’ or ‘research’ on which this action is based, and second, he has not pursued prosecutorial actions in either case. We encourage the U.S. Food and Drug Administration and other public health interests to ask the Attorney General to release his findings immediately so they can do the most good for consumer protection in the quickest fashion possible.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), issued this statement: “Supply chain integrity is of the utmost importance to the dietary supplement industry. There are multiple ways to qualify the supply chain, to identify ingredients, and to detect adulterants in products. The companies involved should be permitted to defend their methods of ingredient testing and to justify their use of particular species of botanicals before being declared to be misbranded or adulterated by the New York Attorney General. The federal law for dietary supplements requires that what’s in the bottle is on the label. Proper identification of ingredients is a requirement of federal law and we expect all companies to stand behind the quality of their products. As we have seen before, investigations by the New York Attorney General’s office are rarely as clear-cut as they might seem.”
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