New York Attorney General (NY AG) Eric Schneiderman has issued letters demanding that 13 dietary supplement manufacturers cease and desist from the sale, distribution or marketing of devil’s claw supplements, which his office claimed are adulterated or misbranded based on DNA barcode analysis conducted by the New York Botanical Garden.

That analysis concluded the devil’s claw supplements from these manufacturers contained a cheaper related species that is considered “less desirable” than what was listed on labels.

Mr. Schneiderman requested that the companies furnish proposals, where appropriate, for recalling any adulterated devil’s claw supplements, compensating consumers who purchased the mislabeled products, and reforming their approach to quality control. 

However, the non-profit American Botanical Council (ABC), Austin, TX, said the NY AG’s investigation has reached an incorrect conclusion based on its “too-narrow interpretation of botanical classifications.”



Devil’s Claw 101
In botanical classification and nomenclature, devil’s claw is usually known scientifically by its Latin name, Harpagophytum procumbens, where Harpagophytum is the genus of the plant and procumbens refers to the species of the plant, ABC explained. The DNA-barcoding tests commissioned by the NY AG showed that some herbal supplements actually contain Harpagophytum zeyheri, a slightly different form of devil’s claw (i.e., a different, but very closely related species). In effect, they are like two siblings, ABC noted.

“Both species of devil’s claw have a similar chemical profile,” said Thomas Brendler, a medicinal plant expert and editor of the African Herbal Pharmacopeia, a compilation of technical information of various African medicinal plants, including their botany, growing conditions, range of habitat, chemistry, and traditional and modern medicinal activities and uses.
 


“While both species differ marginally in shape and chemical composition, both are considered equally effective,” he added. 



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. 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.



Mr. Brendler added that many, possibly most, devil’s claw extracts in the world market are based on mixtures of the two species, as are devil’s claw herbal teas and dried powdered root materials used in supplements and other products. Both species of devil’s claw have been on the market in the U.S. since the 1980s, he noted.


Devil’s claw, the vernacular name for the two species Harpagophytum procumbens and H. zeyheri, occurs in the desert regions of southern Africa (Namibia, Botswana, and South Africa). Its bitter root has historically been used to treat a wide range of ailments and, prominently, as an anti-inflammatory and digestive. Major clinical uses in modern phytotherapy (herbal medicine) focus on its anti-inflammatory effects in the treatment of joint diseases and back pain. The suggested mechanism of action is through COX-2 inhibition. Some 20 human clinical trials conducted over the last 30 years have confirmed its safety and efficacy in the treatment and alleviation of degenerative joint disease, osteoarthritis, and lower back pain.

According to data ABC used for its annual herb market report, devil’s claw is a relatively low-selling herb in the U.S. In 2014, devil’s claw ranked 162nd in sales in the U.S. mainstream retail market and 150th in the natural and health foods channel. Total estimated sales of devil’s claw dietary supplements in the U.S. range from approximately $250,000 to up to $500,000.
 


Mr. Schneiderman contended that federal regulation requires manufacturers to identify plant species using the common name standardized in the trade publication, Herbs of Commerce. That publication defines the common name “devil’s claw” as procumbens, he said. While use of the common name is all that is required by law, most product labels for the supplements tested by the New York Botanical Garden also explicitly referred to the ingredient by its scientific name, procumbens.

Testing Controversy Continues …
The New York Botanical Garden tested 18 devil’s claw supplements labeled for U.S. sale. The study found that for the 16 supplements for which DNA could be identified, all contained zeyheri, either by itself (81%) or mixed with procumbens (19%).

“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,” said Mr. Schneiderman. “This is yet another sign that weaknesses in the supplements industry’s approach to quality control are having real-world consequences for consumers.

Loren Israelsen, president, United Natural Products Alliance, Salt Lake City, UT, noted that DNA barcoding (DNAB) is a new science. “And like all new technologies, its role and utility in the dietary supplement industry is only now evolving. Scientific organizations that set quality standards and establish analytical methods are investigating the potential of DNAB as an additional tool to improve quality and plant identification. And, while the New York attorney general thinks DNAB is a useful enforcement tool, we hope the proper role of DNAB doesn’t become a weapon before it becomes a generally accepted analytical tool for botanical products.”

“Supply chain integrity is of the utmost importance to the dietary supplement industry,” said Steve Mister, president and CEO, Council for Responsible Nutrition, Washington, D.C. “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.”

Federal law for dietary supplements requires that what’s in the bottle is on the label, Mr. Mister added. “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.”

Mr. Schneiderman’s investigation into the supplement industry began in February, when he directed four major retailers—GNC, Walmart, Target, and Walgreens—to halt the sale of certain herbal supplements following controversial DNA barcode tests that Mr. Schneiderman claimed failed to detect plant materials listed on the labels.

In March, GNC reached an agreement with the NY AG, agreeing to use DNA barcoding to authenticate plants used in supplements and adopt new testing standards to prevent contamination. The agreement also imposed reforms to improve transparency for consumers and to promote consumer safety.

Daniel Fabricant, PhD, executive director and CEO of the Natural Products Association, Washington, D.C. noted that more than six months have passed since the NY AG 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.”

“We sincerely appreciate Attorney General Schneiderman’s interest in the quality of herbal materials sold in dietary supplements and his apparent desire to help consumers maintain access to high-quality, safe, and effective herbal products,” said Mark Blumenthal, founder and executive director of ABC.

“We here at ABC have a similar mission, as evidenced by our long-time efforts in the ABC-AHP-NCNPR Botanical Adulterants Program in which we have been working on educating industry and all relevant stakeholders about quality issues in the global herbal market,” he continued. “However, 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.”



This distinction is not a legal or regulatory matter, he added, since authoritative sources recognize both species as being “devil’s claw.”

Nature’s Way’s Commitment 
In connction with its devil’s claw testing, Mr. Schneiderman’s office reached an accord with a 14th manufacturer, Nature’s Way, “to improve the manufacturing and marketing of its devil’s claw supplements.”

According to the AG’s office, Nature’s Way committed to ensuring that its devil claw’s supplements solely contain the proper plant species and are labeled accordingly. Nature’s Way also said it would refund New York consumers who purchased devil’s claw supplements and continue to extend DNA barcode testing across its herbal product lines with one or two ingredients.

“The manufacturers receiving letters from my office should follow the lead of Nature’s Way and address these gaps immediately.”

Mr. Schneiderman’s cease-and-desist letters were sent to the following manufacturers:

Nutraceutical International Corporation (Soloray);
Alternative Remedies Health & Herbs;
The Kroger Co., as parent of Vitacost.com;
FoodScience Corporation (Food Science of Vermont & DaVinci Labs);
Biopower Nutrition;
Thorne Research Inc.;
NBTY, Inc. (Puritan’s Pride);
Olympian Labs, Inc. (Prescribed Choice);
Now Foods;
Nature’s Sunshine Products, Inc.;
RHG & Company Inc. (Vital Nutrients);
The Natural Healing Room & End Time Essentials; and
Shine Supplements

The Office of the Attorney General has not sent a letter to Shine Supplements because the company could not be located through conventional means and is not registered with the Secretary of State to do business in New York.

An additional supplement identified genetically in the New York Botanical Garden’s study was produced by Nature’s Way, which (unlike the other manufacturers) marketed its devil’s claw products as a combination of procumbens and zeyheri.