The Denunciation
February 3, 2015: With great fanfare, New York State Attorney General Eric Schneiderman revealed the results of his testing of six of the most popular supplements. Only 21% actually had DNA from the plant species listed on the labels, and he alleged many were contaminated. He demanded their removal from the marketplace, and issued cease and desist orders to that effect. Media kits with photos of the offending products were distributed throughout the state. He told us:
Mislabeled Consumer Products Pose Unacceptable Health Hazards ... investigation is focused on what appears to be the practice of substituting contaminants and fillers in the place of authentic product.
This appeared to be quite damning. How could he possibly have been wrong? The supplements tested were ginkgo, St. John's wort, echinacea, valerian root, garlic and ginseng. Samples were purchased from each of four major retailers: GNC, Target, Walgreen's and Walmart, for 24 distinct products in all. In 19 of the 24 cases. the testing did not find the DNA of the herb listed on the label. Numerous independent third parties have tested such supplements. As we shall see, in the vast majority of cases, supplements have been found to contain the listed active ingredient. How can this be? It turns out that the failed supplements were either extracts or deodorized garlic. Detailed documentation of this is set forth in footnote[1]. Can an extract, or deodorized garlic, contain the active ingredient but not the DNA? Let's find out...
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Why He Got It Wrong
Extracts are made by immersing an herb in solvent. The solvent may vary - water, ethanol, vinegar, and citric acid have all been used for this purpose. This mixture may or may not be heated depending on the process. After enough time has elapsed, the solvent containing the extract is filtered off and the solids are discarded. Does the DNA end up in the discarded solids or the extract? As a first step in DNA extraction (ppt file), the plant material is very finely ground up to break up the cell walls. DNA is a large molecule and cannot exit an intact cell wall. So when making an extract from intact leaves, one might not get any DNA. If the plant material is broken up, traces of DNA may then find its way into the extract. If heat was used in the extraction process, the DNA may be degraded and rendered undetectable. So the presence or absence of DNA in an extract is irrelevant. To properly test an extract you must test for the active ingredient. Before moving on we may ask, how is it that the active ingredients can be extracted without the grinding step? Plant cell walls have pores to allow movement of nutrients in and out. Those pores are around 35-50 angstroms in size. A check on molecule size of the extracts shows the active ingredients of all six are small enough to easily pass through these pores[2]. So the active ingredients will be extracted through the cell wall, but not the DNA. Two of the 19 supplements that failed to contain the correct DNA were deodorized garlic. Garlic is commonly deodorized by heating . So as a result the garlic DNA is likely rendered undetectable as well.
Test results
One recent study used gas chromatography to check for the presence of the active ingredients in 21 ginkgo supplements. All 21 were found to contain the active ingredients expected in ginkgo extract. Ginkgo extracts have also been tested for DNA, using PCR (polymerase chain reaction) to amplify traces of DNA to detectable amounts. In this test Ginkgo DNA was found in 31 of 37 samples. Here is what the investigator had to say about the remainder:
The ... barcode assay cannot distinguish between samples that do not contain any G. biloba and samples that contain G. biloba processed in a way that rendered the G. biloba DNA incompatible with PCR (e.g., prolonged high temperature treatment). Thus, the assay cannot determine if the six samples (16.2%) without trace of G. biloba DNA do not in fact contain any G. biloba.
How about the testing performed for Attorney General Schneiderman? He says:
An expert in DNA barcoding technology, Dr. James A. Schulte II of Clarkson University... was hired by the Attorney General’s office to perform the testing.
A list of Dr. Schulte's publications shows that he has published 49 papers. Every single one is on the evolutionary biology of animals, mostly lizards. A few of these also involve DNA. Lizard DNA. Did he use PCR? Was he aware of the extract issue? This was not disclosed. *Why did Schneiderman hire a lizard expert instead of an expert in the testing of supplements? Did credentialed experts recognize these tests were inappropriate and refuse to get involved?* In performing this test Schneiderman and Schulte apparently relied upon a widely reported study performed at University of Guelph entitled "DNA barcoding detects contamination and substitution in North American herbal products". The abstract of this study tells us:
Product substitution occurred in 30/44 of the products tested.
That would be 68%. Contrary to the abstract, we find in the text:
Our barcoding analysis... identified product substitution in 32% of the samples
The actual data, from Table 2 of the study, shows that of 44 supplements, they failed to find the right DNA in 15 cases. So the "headline" number in the abstract is incorrect and extremely misleading. What of these 15 cases? Included were 2 or 3 cases each of cohosh, celery, ginkgo, and St. John's wort, all of which are commonly supplied as extracts[3]. There were apparently only 6 instances, out of 44 tests, were whole herb was tested and DNA was missing. How about the specific supplements that failed the Attorney General's testing? ConsumerLab tests supplements on behalf of subscribers. The standard to which they test each supplement is publicly available. They test that the active ingredients are present in the stated amount. They test for contamination by pesticides and heavy metals. They will fail a product for not disintegrating within a specified period of time, or for not including therapeutic amounts, even if it measures up to the label. Not every product tested by the Attorney General was tested by ConsumerLab. However, of those products that were tested, every single product that was failed by the Attorney General passed according to ConsumerLab (subscription required). This includes all four ginkgo brands, two each of the ginseng and St. John's wort products, and a saw palmetto product. In sum, nine of the products failed by the Attorney General were found by ConsumerLab to contain the stated amount of active ingredient.
The Alleged Contamination
The Attorney General purchased each retailer's supplement from 3 or 4 different locations and then tested each individual sample 5 times, for a total of 15 or 20 tests per product. On the average the Attorney General detected DNA of what was referred to as contamination about 1/3 of the time. For example, for GNC ginseng, he found rice, dracaena, pine, wheat, and citrus once each after 5 tests were run on each of 4 different samples. In no case was any contaminant found consistently in any product, as would be the case if it were used as a filler. The most frequent contaminant was rice, found 6 times out of 15 tests, on three occasions. No quantitative information was provided. If PCR was used for DNA amplification (which Scheiderman has refused to disclose), positive results would have been obtained from just tiny traces of DNA. Such contamination could have come from traces of product dust in a facility that also processed other products. So quantitative information is crucial - are we dealing with parts per billion, or grams? We have no idea because that information was not provided. The same problem affects the Guelph study cited above. They alleged contamination in 24 of 44 cases. They used PCR to amplify the DNA, so we have no idea whether the alleged contamination is present in significant amounts.
GNC's comments
What do the accused have to say about all this? Three of the accused retailers sell a broad array of products and are not supplement experts. GNC, however, is in the supplement business. Let's see what they had to say:
GNC tests all of its products using [methods] approved by governing bodies like the United States Pharmacopeia and the British Pharmacopeia. ...The DNA barcoding technology ...has not been approved by the United States Pharmacopeia and may not be appropriate for the testing of these herbal products. The Attorney General's office has refused to provide the test data to GNC.... Dr. Pieter Cohen, a consistent supplement industry critic and Harvard Medical School assistant professor, [said] the Attorney General's test results were so extreme that he found them hard to accept. He said it was possible that the tests had failed to detect some plants even when they were present because the manufacturing process had destroyed their DNA... Natural Products Association Executive Director Daniel Fabricant, Ph.D., who headed the Food and Drug Administration's Division of Dietary Supplements until last spring,... notes that the products tested were extracts and the testing results were unsurprising, given the refining processes used. "You can't even start to draw any conclusions or learn anything from it"
After retesting their products GNC went on to say:
The retesting results clearly and conclusively demonstrate that the Company’s products are pure, properly labeled and in full compliance with all regulatory requirements... GNC’s test results were reviewed by Robert Fish, a noted expert on FDA good manufacturing. ... Mr. Fish concluded that "the products at issue were each manufactured in compliance with federal FDA requirements, that the products contain the ingredients stated on the labels at the levels indicated on the labels, that the products are not contaminated" ... Frank S. Davis, PhD and Director of Regulatory Affairs for Regulatory Compliance Associates ... said, "In my expert opinion, the allegations in the NY AG Letter regarding the results of DNA-based testing are not the product of reliable scientific principles and methods and therefore do not form a reliable basis for allegations of adulteration, mislabeling, or contamination of the GNC products identified in the NY AG Letter." ... [T]he USP published the following statement in its April 2014 Pharmacopeial Forum: "Some of the botanical preparations, such as extracts used as ingredients for dietary supplement dosage forms, are subjected to conditions that would eliminate the DNA content rendering the DNA-based methods unusable for these types of ingredients."
Nevermind: Schneiderman Admits Supplements Were Good All Along, Ends Investigation.
March 30, 2015. Text of agreement between GNC and AG Schneiderman (pdf):
NY AG found no evidence in the course of its investigation that GNC deviated from the federal Food and Drug Administration ("FDA") "Current Good Manufacturing Practices" ("cGMPs") rules or standard industry practice in the production of the Tested Supplements. GNC also provided documentation of the scientific testing protocols and quality control methods that GNC employed on the Tested Supplements during production and as finished goods and of subsequent retesting by GNC and an independent laboratory. The results of this testing likewise indicate that the Tested Supplements were manufactured consistent with FDA cGMP requirements.
What exactly are "cGMPs"? FDA defines them as:
Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products
So if you adhere to the cGMP regulations, that assures your product has the ingredients claimed, in the strength stated, and is not contaminated. Schneiderman found no evidence to the contrary. As to the investigation:
This agreement constitutes an assurance of discontinuance for purposes of Executive Law § 63(15) that will discontinue NY A G's investigation of GNC Herbal Plus brand products
GNC's comment:
The agreement affirms that the relevant GNC products were in full compliance with the federal Food and Drug Administration “Current Good Manufacturing Practices” ..., and as highlighted in the agreement, GNC provided the results of *rigorous tests conducted both internally and by independent third parties*. These tests provided conclusive evidence that GNC’s products are safe, *pure, properly labeled* and in full compliance with all regulatory requirements. The *testing also demonstrated that the Company’s products contain all herbal extracts listed on their respective labels*. As part of its commitment to industry leadership, GNC will expand its testing processes deeper into its supply chain by leading ongoing industry efforts to integrate source material traceability standards including DNA barcoding where appropriate (prior to extraction processes) and enhance certain other aspects of its operations to provide consumers even greater confidence in its products.
What is Scheiderman's side of the story?
Where NY AG and GNC disagree, however, is on the sufficiency of federal rules and testing requirements ...Given the existence of chemically-similar natural or synthetic substitutes, NY AG is concerned that standard chemical approaches provide inadequate assurance of the authenticity of herbal supplements
In other words, he is now concerned that even though an extract may contain what it is supposed to, it might be synthetic. This is a far cry from his highly publicized annoucement at the outset:
Mislabeled Consumer Products Pose Unacceptable Health Hazards ... investigation is focused on what appears to be the practice of substituting contaminants and fillers in the place of authentic product.
To the general public, who have no idea of the details, he makes himself out to be a hero:
Attorney General Eric T. Schneiderman today announced a landmark agreement with Pennsylvania-based retail giant GNC to implement new standards in authenticating herbal supplements, ensuring their purity, and educating consumers about their chemical content. Under today’s agreement, GNC will perform DNA barcoding on the “active” plant ingredients used in its products; implement testing for contamination with allergens, both before and after production; and post prominent signage advising consumers of the processed, chemical nature of extracts.
What Did Schneiderman Know and When Did He Know It?
Let us revisit the original February 3rd annnouncement:
*Just 21%* Of Supplement Tests *Identified DNA From Plant Species Listed* On Labels
[emphasis added] So Schneiderman scrupulously told us the exact truth. What he failed to tell us, of course, was that this fact was irrelevant. Would he have been so careful with his wording had he believed these supplements actually lacked their active ingredients? -------------------------------- *Footnotes:
[1]The AG designated these products as not containing DNA of the active ingredient: GNC: echinacea, ginkgo, ginseng, St. John's wort, saw palmetto Target: ginkgo, ginseng, St. John's wort, saw palmetto Walgreen's: garlic, ginkgo, ginseng, St. John's wort Walmart: echinacea, garlic, ginkgo, ginseng, St. John's wort, saw palmetto Manufacturer's specifications of the products were verified at gnc.com and walmart.com. All were extract except: Walmart echinacea, and Walmart garlic which is deodorized. GNC and Walmart offer saw palmetto as either extract or whole herb. An image given to media by the AG for Walmart/ Spring Valley shows he tested the extract: https://tribwpix.files.wordpress.com/2015/02/supps.jpg?w=1200 An image given to media by the AG for GNC shows he tested two samples of extract, one of the whole herb and one unknown: http://wnyt.com/wnytimages/repository/2015-02/gnc---photo.jpg According to the AG, two samples failed, one passed, and one had mixed results. The other products and their descriptions were removed from the manufacturers' websites as a result of the AG's action. For Walgreens, an image provided by the AG shows the ginkgo marked as "extract" and the garlic as "odorless": http://wnyt.com/wnytimages/repository/2015-02/walgreens-photo-crop.jpg Ginseng is shown as extract here: http://27bzcmukscr11z1wycuem83o5.wpengine.netdna-cdn.com/files/2015/02/CAM00418.jpg St John's wort as extract here: http://pics.drugstore.com/prodimg/446354/155.jpg For the Target products that are extracts, ginkgo is shown here: http://scene7.targetimg1.com/is/image/Target/14509713?wid=410&hei=410 st, john's wort here: http://graphics8.nytimes.com/images/2015/02/03/science/03supplementsgarlic/03supplementsgarlic-thumbLarge-v4.jpg ginseng here: https://consumeraffairs.global.ssl.fastly.net/files/cache/news/walgreens-ginseng_small.jpg The Target saw palmetto is whole herb. So the Target saw palmetto and the Walmart echinacea were the only unprocessed whole herb products known to have failed the AG's DNA test.
[2]Vitamin B12 will pass through a 15 angstrom pore. The sizes of the molecules of the active ingredients of all 6 extracts are comparable to the size of B12: ginkgolides and ginsenoside for ginkgo extract, hypericin and hyperforin for St Johns Wort extract, ginsenoside for ginseng, sesquiterpenes for valerian root, six for echinacea of which cicoric acid is the largest, and allicin for garlic.
[3]Supplements supplied as extracts are usually marked the front of the bottle. Whether a particular supplement is supplied as an extract may be surveyed by doing an internet image search for the supplement in question. For example, https://www.google.com/search?lr=&safe=images&hl=en&biw=944&bih=428&tbm=isch&sa=1&q=celery+supplement&oq=celery+supplement&gs_l=img.3..0i24l4.174706.175890.0.176783.6.6.0.0.0.0.238.486.0j2j1.3.0.msedr...0...1c.1.61.img..5.1.228.75CQoQGjTI8 In cases where the herb is supplied mostly as extract but occasionally as whole herb, as for cohosh, no indication is given by the investigators which version was tested.