Yesterday, MNB took note of a New York Times report that the New York State Attorney General is accusing GNC, Target, Walgreens and Walmart "of selling fraudulent and potentially dangerous herbal supplements and demanded that they remove the products from their shelves."
The story says that the AG's office says it "conducted tests on top-selling store brands of herbal supplements" at the retailers "and found that four out of five of the products did not contain any of the herbs on their labels. The tests, the story says, "showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies."
Almost immediately, there was a backlash against the New York Times story and the New York AG's test methodology.
The Natural Products Association (NPA) released a statement from its CEO and Executive Director, Daniel Fabricant, Ph.D., who previously was director of the Division of Dietary Supplement Programs at the Food and Drug Administration (FDA):
“The full details and data the New York Attorney General found through the DNA tests have not been made available to the public. We do not know exactly what was tested, and no labels of products have been shared. The Natural Products Association has confirmed with one of the retailers, GNC, that every product tested was a botanical extract, in which DNA is unlikely to be intact, making that test not fit for purpose. Therefore, if the study is using the wrong tool, that hardly seems newsworthy or beneficial for consumers.
In addition, we do not have any insight into how reference materials were selected to compare the products in this study. We also do not know how products were obtained or sampled, nor do we know the chain of custody of said products. What’s interesting is that in keeping with the federal regulations for dietary supplements, ingredient identity testing is a requirement, as are the use of reference materials to establish identity, so it’s peculiar that a study to evaluate quality isn’t consistent with parameters of what’s required by the federal regulations for quality. Also, per these same regulations, manufacturers are given flexibility in testing decisions, and may or may not choose to use DNA barcoding, as it may or may not always be appropriate. Nevertheless, they have requirements on testing for identity that are required by law, and if those requirements aren’t met, the government can and does take action, ensuring consumer protection is in place. Thus, it is unclear as to why the New York Attorney General is making this request.
We encourage the New York Attorney General’s office to release the full study details promptly, and look forward to reviewing them thoroughly. Consumers should know that supplements are a safe part of a balanced approach to a healthy lifestyle that includes good diet and exercise, and they should consult with their doctor or health care professional before making any changes to their health care regimen.”
Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), issued a statement as well:
“These actions today by the New York State Attorney General’s (AG) office smack of a self-serving publicity stunt under the guise of protecting public health. Supposed concerns about the products in question are based on a novel testing method that has been roundly criticized by botanical scientists who question whether DNA barcoding technology is an appropriate or validated test for determining the presence of herbal ingredients in finished botanical products. Processing during manufacturing of botanical supplements can remove or damage DNA; therefore while a DNA testing method can be useful in some cases, this method well may be the wrong test for these kinds of products.
Nor does the DNA testing method provide information on the amounts of food contaminants found in the products. This is important because there are well-established legal thresholds that allow for trace amounts of some ingredients like gluten, and trace amounts of DNA from rice, beans, pine, citrus, etc. are not considered harmful or required on labels. Announcing the detection of minute amounts of these substances unnecessarily alarms consumers without informing them whether the detection of DNA from these substances poses any allergic risk.
Instead of giving companies a reasonable opportunity to respond to these concerns, the AG unfortunately chose to label them guilty without a fair trial. Not only is the testing method itself suspect for these kinds of products, but the scientist who developed the assay and conducted the testing is not a botanical or a food expert. He is an evolutionary biologist who specializes in testing DNA in dinosaurs and lizards."
Maged Sharaf, Ph.D, chief science officer for the American Herbal Products Association (AHPA), said in a prepared statement that "using DNA barcoding as the only method for identifying ingredients in popular herbal dietary supplements and ignoring all other well-established and valid methods of herbal analysis is a suspect analytical process at best, and likely to provide results that are inaccurate."
And Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), told ABC News that "from a scientific perspective, it appears that the NY AG is way out in front of the available scientific evidence to support and substantiate his position. We cannot know this for certain until we know more about the testing protocols, but in general, as we told the New York Times, DNA barcode testing often cannot determine the identity of a botanical material if it’s been extracted, or if the material has been submitted to a prolonged heat treatment,” he continued, “so, if any of the products tested were extracts — e.g., ginkgo, and possibly the St. John’s wort products — then it’s understandable why they got a negative finding. This also may be true for other products tested, i.e., if they were extracts.”
The story says that the AG's office says it "conducted tests on top-selling store brands of herbal supplements" at the retailers "and found that four out of five of the products did not contain any of the herbs on their labels. The tests, the story says, "showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies."
Almost immediately, there was a backlash against the New York Times story and the New York AG's test methodology.
The Natural Products Association (NPA) released a statement from its CEO and Executive Director, Daniel Fabricant, Ph.D., who previously was director of the Division of Dietary Supplement Programs at the Food and Drug Administration (FDA):
“The full details and data the New York Attorney General found through the DNA tests have not been made available to the public. We do not know exactly what was tested, and no labels of products have been shared. The Natural Products Association has confirmed with one of the retailers, GNC, that every product tested was a botanical extract, in which DNA is unlikely to be intact, making that test not fit for purpose. Therefore, if the study is using the wrong tool, that hardly seems newsworthy or beneficial for consumers.
In addition, we do not have any insight into how reference materials were selected to compare the products in this study. We also do not know how products were obtained or sampled, nor do we know the chain of custody of said products. What’s interesting is that in keeping with the federal regulations for dietary supplements, ingredient identity testing is a requirement, as are the use of reference materials to establish identity, so it’s peculiar that a study to evaluate quality isn’t consistent with parameters of what’s required by the federal regulations for quality. Also, per these same regulations, manufacturers are given flexibility in testing decisions, and may or may not choose to use DNA barcoding, as it may or may not always be appropriate. Nevertheless, they have requirements on testing for identity that are required by law, and if those requirements aren’t met, the government can and does take action, ensuring consumer protection is in place. Thus, it is unclear as to why the New York Attorney General is making this request.
We encourage the New York Attorney General’s office to release the full study details promptly, and look forward to reviewing them thoroughly. Consumers should know that supplements are a safe part of a balanced approach to a healthy lifestyle that includes good diet and exercise, and they should consult with their doctor or health care professional before making any changes to their health care regimen.”
Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), issued a statement as well:
“These actions today by the New York State Attorney General’s (AG) office smack of a self-serving publicity stunt under the guise of protecting public health. Supposed concerns about the products in question are based on a novel testing method that has been roundly criticized by botanical scientists who question whether DNA barcoding technology is an appropriate or validated test for determining the presence of herbal ingredients in finished botanical products. Processing during manufacturing of botanical supplements can remove or damage DNA; therefore while a DNA testing method can be useful in some cases, this method well may be the wrong test for these kinds of products.
Nor does the DNA testing method provide information on the amounts of food contaminants found in the products. This is important because there are well-established legal thresholds that allow for trace amounts of some ingredients like gluten, and trace amounts of DNA from rice, beans, pine, citrus, etc. are not considered harmful or required on labels. Announcing the detection of minute amounts of these substances unnecessarily alarms consumers without informing them whether the detection of DNA from these substances poses any allergic risk.
Instead of giving companies a reasonable opportunity to respond to these concerns, the AG unfortunately chose to label them guilty without a fair trial. Not only is the testing method itself suspect for these kinds of products, but the scientist who developed the assay and conducted the testing is not a botanical or a food expert. He is an evolutionary biologist who specializes in testing DNA in dinosaurs and lizards."
Maged Sharaf, Ph.D, chief science officer for the American Herbal Products Association (AHPA), said in a prepared statement that "using DNA barcoding as the only method for identifying ingredients in popular herbal dietary supplements and ignoring all other well-established and valid methods of herbal analysis is a suspect analytical process at best, and likely to provide results that are inaccurate."
And Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), told ABC News that "from a scientific perspective, it appears that the NY AG is way out in front of the available scientific evidence to support and substantiate his position. We cannot know this for certain until we know more about the testing protocols, but in general, as we told the New York Times, DNA barcode testing often cannot determine the identity of a botanical material if it’s been extracted, or if the material has been submitted to a prolonged heat treatment,” he continued, “so, if any of the products tested were extracts — e.g., ginkgo, and possibly the St. John’s wort products — then it’s understandable why they got a negative finding. This also may be true for other products tested, i.e., if they were extracts.”
- KC's View:
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The bulk of my commentary was focused on the fact that I find it fascinating that retailers are being held responsible for what they sell, though I also said that "I've never much believed" in supplements.
In addition to these official responses, and stories, I got a number of emails about the story. The longest was from MNB reader Skye Lininger, who also happens to be the CEO of Aisle 7, which used to be known as Healthnotes, and who has experience with this industry...
First, I’ve never understood the statement “I don’t believe in supplements.” Supplements aren’t something you believe or don’t believe in any more than you believe or don’t believe in gravity. They are well understood chemical compounds that science has demonstrated have biological activity. I make this claim with confidence since for more than twenty years our business has curated the science around supplements and have cataloged over 100,000 studies that have been published over the past 50 years in over 1,000 medical and scientific journals on dietary supplements and are indexed in PubMed (a service of the National Library of Medicine). There have been many thousands of clinical trials, double-blind placebo controlled trials, epidemiological studies, and meta-analysis. Over half of all Americans take supplements on a regular basis.
Second, the four cited retailers are all very large companies. The vendors who supply them are also billion dollar companies. The raw material supply chain in the supplement industry for major players is well established. The NY AG’s testing was only on herbal products. When herbs arrive at a manufacturer’s facility they are quarantined and tested. The plant material is then matched against reference samples. Botanical lab experts do organoleptic and other testing before releasing for manufacture. While the size of a company isn’t a guarantee, it does imply a certain level of process, documentation, care, and expertise. There is, after all, a lot at stake.
Third, you assume at face value that the DNA studies performed by the NY AG’s office were valid without questioning whether or not they knew what they were doing. The AG’s office houses lawyers, not scientists. Experts know that HPLC is the standard for testing herbs and other dietary supplements. Which do you think more likely, that very large supplement manufacturers and retailers all carried products from a variety of vendors that supplied products that contained ZERO Gingko (as in one of the alleged fraudulent products), or that a lab for an attorney general, with no expertise in the field (the AG’s tester is a paleontologist, not a biochemist) blew it?
Fourth, it is not possible to test for some of the items alleged to be in the products. You can’t test for an unknown most of the time. You can test for something you know is there if the item hasn’t been overly processed. In the case of the herbs, some were in tincture form. Tinctures are most often made using alcohol which denatures the protein, destroying the DNA. Think about how in CSI if the perp wipes down an area with alcohol there is no longer any DNA evidence. There is no mention of HPLC testing in the report from the AG.
Fifth, dietary supplements are not exempt from regulation. There is, in fact, an elaborate enforcement structure and plenty of authority for both the FDA and the FTC to act. The FDA has published “Good Manufacturing Practices” that are similar to those required for OTC drugs that the supplement industry is required, by law, to follow. It is the FDA’s job to enforce the GMPs. Companies not following GMPs or other FDA regulations are cited, fined, and sometimes shut down. There are certainly bad actors, but this is true of all industries—e.g. there are counterfeit pharmaceuticals on the market. A big difference between the two (i.e. supplements and drugs), that many people miss, is that drugs are very powerful compounds that, if misused, can kill people. Dietary supplements are much more benign—and while not harmless, do not carry the same risks as pharmaceuticals.
Finally, you say that the supplement industry has spent a ton of money lobbying. All industries lobby. The dietary supplement industry is roughly $32 billion in size. The global pharmaceutical industry is closing in on $400 billion. Who do you think spends the most on lobbying? And what is wrong with lobbying? It is a legal activity designed to educate lawmakers on your industry’s views and positions. The supplement industry has never lobbied against safety or reasonable regulation.
Could the supplement industry do a better job at policing itself? Could the FDA do a better job at regulating the industry? Of course the answer (as with every industry) is “yes.” However, your comments on this issue were disappointing since you perpetuated a lot of misinformation about the supplement industry. On this one, I don’t think you were thorough with your homework and relied instead on a not fully accurate news story from the NY Times without checking with experts in the category. I believe time will show that the AG jumped the gun and that their process was far more political than it was scientific. In the meantime, many will continue to erroneously believe that supplements are not well studied and that they are unregulated; when in fact, the opposite is true.
Points taken.
I'll keep my response short and simple.
You're right that I was overly glib in saying that I've never much believed in supplements. What I should have written is that rightly or wrongly, I've always had a kind of healthy skepticism about the supplement industry ... but then again, I have a fair amount of skepticism about a lot of industries.
I'm happy to stand firm on my criticism of lobbying. I think that all people and all special interests have a right to be heard ... but the outsized amounts of money spent by companies and industry to get their own way and influence legislators always has struck me as a corrupting factor in the way government works. I feel exactly the same way about money spent on elections. Is it all legal? Sure. Does it all hurt democracy? In my view, immeasurably, and perhaps, eventually, fatally.
As for the rest of it ... which has to do with methodology and scientific conclusions ... I'm willing to wait to see how it all turns out. I'll be interested to see if the companies involved - manufacturers and retailers - have anything close to the kind of record-keeping and documentation that the courts will demand of them.
I would point out that the fact that more than 50 percent of all Americans take supplements is not by itself persuasive, since 25 percent of all Americans reportedly believe that the sun revolves around the earth...
