Four large retailers were ordered yesterday () by the New York State Attorney General’s Office to immediately stop selling their store brands of herbal dietary supplements due to allegedly mislabeled or adulterated product content.
But herbal trade and education organizations immediately criticized the AG’s actions as premature, calling the testing flawed, scientifically-inappropriate, and inconsistent with the FDA’s requirements of Dietary Supplement Current Good Manufacturing Practices (cGMP) for herbal product quality control.
Attorney General Eric T. Schneiderman and Executive Deputy Attorney General Martin J. Mack issued cease-and-desist orders to GNC Holdings, Inc., Target Corporation, Walgreens, Wal-Mart Stores, Inc., regarding the marketing of up to seven herbal supplements: Gingko [sic] biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, Saw Palmetto, and Valerian root. (Valerian was only tested from Target, in place of Ginseng.)
The office states that products from three or four New York state retail stores were tested up to five times each by a DNA barcoding technique developed at the University of Guelph, Ontario and published last year in the journal, BMC Medicine.
The actions have nothing to do with the clinical effectiveness of the products, another issue entirely and one that is not required under the 1994 Dietary Supplement Health and Education Act (DSHEA).
According the formal documents, an attorney general’s researcher, Dr. James A. Schulte II of Clarkson University in Potsdam, NY, determined that only 4 percent to 41 percent of products contained DNA from the plant species indicated on the product label.
While some samples had absolutely no DNA in them, some had DNA from other plants entirely. Some Ginkgo and saw palmetto products contained garlic whereas some garlic products contained no garlic at all.
When contacted for scientific details on the analyses, Dr. Schulte wrote that our request would be forwarded to the attorney general’s office for a response.
Corporate responses, questions for their suppliers
GNC manufactures their own products but Target, Walgreens, and Wal-Mart employ contract herbal manufacturers to provide their store label products: Target’s Up & Up brand, Walgreens’ Finest Nutrition brand, and Walmart’s Spring Valley brand.
In response to the testing results, the AG’s office is requiring the companies to provide by next Monday, February 9, the names and locations of the manufacturers of each product, any evidence of analytical testing for product content and quality, detailed cGMP procedures, and any adverse events reports received for each product.
Two of the four companies cited in this action responded to requests for comment on the issue.
Walmart’s director of national media relations, Brian Nick, wrote,
“At Walmart, we want our customers to have complete trust in the products they buy from our stores. It is our expectation that all suppliers conduct their business and produce products that are in full compliance with the law. Based on this notice, we are immediately reaching out to the suppliers of these products to learn more information and will take appropriate action.”
GNC provided a response through Marketcom PR’s director of client services, Laura Brophy, that contained additional technical details:
“In response to your inquiry, GNC states the following:
- We stand behind the quality, purity and potency of all ingredients listed on the labels of our private label products, including our GNC Herbal Plus line of products.
- The methodology employed by the University of Guelph in testing our products has not been approved by the United States Pharmacopeia and may not be appropriate for the testing of these herbal products.
- GNC tests all of its products using validated and widely used testing methods, including those approved by governing bodies like the United States Pharmacopeia and the British Pharmacopeia.
- While we firmly stand by the quality, purity and potency of all GNC products, we will remove the product lots named in the Attorney General’s letter from our stores in New York State to comply with the binding legal authority of this order, not because we agree with the testing methods used to support it.”
Anne D. Bell of the independent United States Pharmacopeial Convention (USP) added that the organization has long issued standardized methods to verify the content of dietary supplements. She said that the Children’s Hospital of Philadelphia recently banned all dietary supplements from the hospital except for those that carried the “USP Verified” mark.
Scientific methods unclear, possibly faulty
My own laboratory focused on the study of herbal dietary supplements for much of the 20 years I was funded to do so by the National Institutes of Health and American Cancer Society. And I’ve been a vocal critic of the dietary supplement industry, particularly as it relates to chemical standardization of products and their potential for interactions with other drugs a person might be taking, particularly for cancer or HIV/AIDS.
But my first scientific response to the Attorney General’s investigation is that their results on product content may be premature. Whole plant products, for example, would certainly be expected to have the appropriate DNA.
But few herbal supplements are sold this way anymore. Instead, manufacturers prepare standardized extracts of concentrated chemicals made by the plant, using some manner of organic solvent like an alcohol, whereby the plant DNA would be long gone by the time the final, finished product was produced. So, finding no DNA in many of these products would actually be expected.
For that very reason, the USP dietary supplement verification methods require the demonstration of known active chemicals from the herbal products, not DNA (sample, illustrative PDF of two methods here).
And while it’s true that the FDA has an entirely different and far less stringent set of rules for dietary supplements relative to prescription or over-the-counter drugs, manufacturers are now required by law to follow detailed Good Manufacturing Practices for composition and purity that would be expected of a food company.
Nevertheless, some unscrupulous manufacturers slip though the cracks and are often found to have adulterated their products with drugs, particularly in weight loss supplements, male sexual enhancement products, and bodybuilding products.
To combat this problem, the Austin-Texas-based, nonprofit American Botanical Council recently began the Botanical Adulterants Program together with the University of Mississippi’s National Center for Natural Product Research and the American Herbal Pharmacopeia to educate and develop methods to assure authenticity in plant-based dietary supplement products.
(Disclosure: I sometimes still review herbal education clips published by the ABC for scientific content and, as a result, am listed as an unpaid scientific advisor to the organization. ABC counts among its supporters herbal companies, academic educators and researchers, traditional herbalists, and average consumers from over 70 countries.)
ABC director, Mark Blumenthal, and chief science officer, Stefan Gafner, PhD, provided detailed responses earlier this morning that expand upon my own methodological concerns of the AG’s approach to product authenticity.
Blumenthal declined to comment on the specific retailers and their contract manufacturers but wrote,
“There were apparently no controls in the tests, e.g., microscopy for herbal powders, as well as validated chemical methods. All the herbs have been monographed in official pharmacopeias and validated analytical methods are available. At the very least these methods should have been used as a control, especially if the possibility exists that some of the preparations might be extracts, especially ginkgo and possibly SJW [St. John’s wort], where DNA methods are usually unable to detect DNA, which is usually not transferred from the biomass into the extract.”
Gafner, who also serves as technical director for the ABC-AHPA-NCNPR Botanical Adulterants Program, expressed surprise that the AG would issue such aggressive actions against major U.S. companies with just one round of research results from one investigator’s laboratory. More detailed and published investigations by other researchers particularly with ginkgo products, seem to diverge from the results with the chain store product brands in New York.
“At this moment, we have not seen any of the methodology details, so we can’t really comment on how well the tests were carried out, but the high percentage of supplements that did not contain the material indicated on the label definitely should make the investigators wonder just how accurate this approach is,” wrote Gafner.
He added, “It does also not fit within two recent publications on ginkgo (see attached), where chemical analysis confirmed the presence of ginkgo in all the 21 commercial supplements analyzed by Wang et al., and in 31 out of 37 supplements (Little), while for the other 6, the DNA barcoding approach wasn’t able to detect gingko DNA, but that does not mean that the supplements did not contain ginkgo according to the author.”
“They can’t even spell ginkgo correctly”
Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association, a trade organization, also questioned the scientific aspects of the AG’s approach. Fabricant is a natural products researcher who trained in an NIH-supported botanical research center at the University of Illinois at Chicago with the late Norman R. Farnsworth, PhD. He was most recently director of the FDA’s Division of Dietary Supplement Programs.
“I really like the peer-review process. I like knowing what the samples were, what the chain of custody was, what reference materials were used. We have none of that information here,” said Fabricant.
“It’s no different than me calling The New York Times and saying, hey, John Doe used a screwdriver to hammer nails into a bunch of houses on the south shore of Long Island, so the lumber is bad.”
But not all of the issues cited by the AG’s report relate to alleged product misidentification. In other cases, DNA was detected from rice, wheat, palm, and even the tropical houseplant, Dracaena spp.
Fabricant was also not surprised that components such as rice flour would be in some of the products. Pharmaceutically, these inactive ingredients are used as “free flow” agents to facilitate encapsulation or for dissolution of the plant extract after taken by the consumer.
Regarding other component claims made in the AG’s report, Fabricant said that he “wasn’t going to get too excited” until the full methodology is made available. But the atypical excipients certainly raise suspicion that the manufacturers added filler material for whatever reason.
(Fabricant also pointed out that the genus name of the plant, Ginkgo biloba, was misspelled in every case in the AG’s letters and report.)
“In terms of this being a broad GMP problem, as the attorney general seems to suggest, I take a little bit of umbrage. Certainly GMP was a priority during my time in the agency,” said Fabricant. “Only one test has been done here and I think we’ve established that it [DNA barcoding] isn’t even the appropriate one. So the attorney general isn’t even using GMP.”
“Outrageous degree of adulteration”
But others were not as forgiving of the industry. In the AG’s public statement, other experts offered statements in support of the state’s demand to cease sale of these products.
“The evidence for these herbs’ effectiveness is sketchy to begin with,” said David Schardt, Senior Nutritionist of the Center for Science in the Public Interest. ”But when the advertised herbs aren’t even in many of the products, it’s a sign that this loosely regulated industry is urgently in need of reform. Until then, and perhaps even after then, consumers should stop wasting their money. Attorney General Schneiderman has done what federal regulators should have done a long time ago.”
Longtime dietary supplement critic, Arthur P. Grollman, MD, Professor of Pharmaceutical Sciences at Stony Brook University was quoted in the AG’s statement as saying, “This study undertaken by Attorney General Schneiderman’s office is a well-controlled, scientifically-based documentation of the outrageous degree of adulteration in the herbal supplement industry.”
“I applaud the New York Attorney General for taking the additional step of seeking to remove these products from the marketplace as they can cause serious harm to consumers unaware of the actual ingredients in the pills and capsules they ingest.”
Grollman hoped that the New York action would prompt a reform of federal dietary supplement laws that are inadequate to protect the public.
I’m fully aware that the dietary supplement industry has its problems. But if anyone wants to act on products masquerading as medicine that contain absolutely nothing, attention should be turned to homeopathic products.