NEW YORK, NY –Attorney General Eric T. Schneiderman announced today that his office issued letters demanding that 13 dietary supplement manufacturers cease and desist from the sale, distribution, or marketing of adulterated or misbranded “devil’s claw” supplements. The letters, sent Wednesday, are based on a study from the New York Botanical Garden that used an advanced DNA barcoding technique to conclude that the devil’s claw supplements from these manufacturers contained a cheaper related species that is considered less desirable. Attorney General 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.
Attorney General Schneiderman also announced that his office has reached an accord with a 14th manufacturer, Nature’s Way, to improve the manufacturing and marketing of its devil’s claw supplements. Nature’s Way committed to ensure that its devil claw’s supplements solely contain the proper plant species and are labeled accordingly. As more fully explained below, Nature’s Way will also 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—one of the first companies in the supplements industry to do so.
“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 Attorney General Schneiderman. “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.”
Devil’s claw is the commercial name in the United States for the plant Harpagophytum procumbens, which is marketed by the dietary supplement industry as a treatment for arthritis and other forms of joint pain. The purported therapeutic benefits of devil’s claw are not generally accepted in the medical community or approved by the FDA. Native to the Kalahari Desert, there have long been reports of suppliers mixing or substituting devil’s claw with a related plant, Harpagophytum zeyheri, which contains some—but not all—of the same chemicals. Some of the most sought-after chemicals tend to naturally occur in different ratios and in lower concentrations in zeyheri, which is the cheaper of the two plants.
A 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. 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.
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%).
Attorney General Schneiderman’s cease-and-desist letters target 13 manufacturers, which produced 15 of the test products. These companies include:
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.
In a letter responding to an inquiry from the Office of the Attorney General (OAG), Nature’s Way committed to a series of reforms related to the manufacturing and labeling of its devil’s claw products. These commitments are as follows:
Nature’s Way will continue efforts already underway to employ DNA barcode testing across its entire “Green” and “Purple” herbal product lines, which constitute most of the company’s herbal products with one or two ingredients;
When scientifically valid DNA barcodes are identified and available, Nature’s Way will employ this technique as an additional method for ensuring that their Devil’s Claw products do not contain Harpagophytum zeyheri.
Nature’s Way Devil’s Claw products shall contain Harpagophytum procumbens only, and not Harpagophytum zeyheri.
Devil’s Claw Finished Product labels will identify Harpagophytum procumbens as the sole species contained in the Products.
Nature’s Way has also represented that it will refund the suggested retail price to any New York resident who purchased the company’s devil’s claw supplements between January 1, 2012 and the present and, within three months of the date of the letter, submits a sworn complaint to OAG using the form linked here. Refunds will be available one per household, with total refunds not to exceed New York sales of devil’s claw during the period.
The Attorney General opened an investigation into the supplements industry after a study conducted by the University of Guelph in 2013 that found contamination and substitution in herbal products in most of the products tested. That same study also noted that more than half of all FDA Class I drug recalls between 2004 and 2012 were for dietary supplements. Class I recalls are reserved for drugs or supplements for which there is a “reasonable probability that [their use] will cause serious adverse health consequences or death.”
In February 2015, Attorney General Schneiderman directed four major retailers—GNC, Walmart, Target, and Walgreens—to halt the sale of certain herbal supplements following DNA barcode tests that failed to detect plant materials listed on the labels of the majority of products tested and also detected DNA associated with ingredients or contaminants not listed on the label.
In March 2015, Attorney General Schneiderman announced a historic agreement with GNC to implement landmark reforms for herbal supplements. Under the agreement, GNC, one of the nation’s largest supplement retailers, will 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.
This case is being handled by Senior Adviser and Special Counsel Simon Brandler, Executive Deputy Attorney General Marty Mack, and Assistant Attorney General Deanna Nelson.