By Dr. Mercola
New York's Attorney General, Eric Schneiderman, has ordered GNC, Target, Walgreens, and Wal-Mart to immediately stop selling certain herbal supplements. The products include up to seven varieties -- ginkgo biloba, St. John's wort, ginseng, garlic, echinacea, saw palmetto, and valerian root – that reportedly were mislabeled or contained adulterated content.
While the products have already been pulled from shelves amidst what the Attorney General's (AG) office called an "outrageous degree of adulteration," there is a problem.
The test used to deem the herbal products adulterated is considered inadequate and unproven by experts, such that the results cannot be considered valid. I'm all for transparency and truth in labeling, but these supplements have been wrongfully targeted in what appears to be a carefully orchestrated attack or a horribly incompetent attempt to protect consumers.
This goes far beyond just damaging the reputation of businesses and products, class-action lawsuits are already underway, which could leave the NY Attorney General in a very vulnerable position with a lot of explaining to do.
Fewer Than Half of Supplements Tested Contained Ingredients Indicated on the Label, AG Study Claims
The study, which was commissioned by New York's Attorney General, found that only 4 percent to 41 percent of the products tested contained DNA from the plant species listed on the label.
Some of the products contained none of the ingredient while others reportedly contained DNA from other plants.1 The products were tested up to five times each using a DNA barcoding technique, which is at the heart of the controversy over the results.
The AG's office is requiring the companies to provide detailed information about the product manufacturers, evidence of analytical testing, detailed cGMP [current good manufacturing practice] procedures, and any adverse events reported, but to date the details of the AG's study are unclear. The AG's office has not released full study protocols or reports of analytical data.2 As Forbes reported:3
"[American Botanical Council chief science officer, Stefan Gafner, PhD], 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.'"
DNA Testing Is Unable to Identify Ingredients in Many Herbal Supplements
The AG's investigation used DNA testing, which, according to The American Herbal Products Association (AHPA), is an "inadequate and unproven analytical method to test herbal supplement products."
Not only is DNA barcoding an emerging technology that is seen by many in the scientific community as one that might one day play a complementary role in testing, but it has serious limitations when it comes to testing herbal supplements.
Namely, many herbal supplements contain herbal extracts, which have a loss or denaturation of DNA material during processing. The DNA barcoding test cannot, therefore, identify the ingredients accurately. AHPA President Michael McGuffin said:4
"It appears that many, if not all, of the products the New York State Attorney General tested contained herbal extracts and this processing would likely disrupt or destroy the DNA…
If an herbal product manufacturer used this analysis, without any additional confirmation, to prove that an herbal extract is accurately identified, the U.S. Food and Drug Administration (FDA) would almost certainly dismiss this as inadequate to verify identity."
In fact, in 2013, the New York Times5 reported on a similar study using DNA barcoding, which also found a sizable number of products tested did not include the product on the label.6 At that time, the FDA publically called the testing method invalid.7
While the FDA has used DNA barcoding to reveal some cases of fraud, such as that in mislabeled seafood, it does not use it for testing herbal supplements. Apparently, the reporter who wrote the 2013 New York Times story, Anahad O'Connor, was called by an AG prosecutor.
As NewHope360 reported,8 the author noted in a blog that the prosecutor "had read my article in the Times and was outraged that companies selling health products engaged in such large-scale fraud."
Later in the blog, O'Connor writes: 'I had no idea that the article had made an impression on law enforcement officials too – and I'm glad that they used their resources to root out what appeared to be a blatant case of consumer fraud.'
So it appears the New York Attorney General launched an investigation patterned after the one in 2013, even though the FDA already called the data invalid. Adding to the curiosity, NewHope360 reported:9
"[Frank Lampe, vice president for communications at the United Natural Products Alliance] said he wonders why those resources did not include a call to the FDA and why they appear to have used the Times story as a road map in their investigation. 'It's the question for the [New York] Attorney General: What motivated this?' he said."
This appears to be far more a case of politics and policy than one of public protection… the Attorney General even incorporated the views of legislators into his news release!
In response, the United Natural Products Alliance is collecting "large quantities" of the supplements cited in the Attorney General's investigation and submitting them to certified botanical testing labs for analysis.
According to ABC News:10
"'They will perform universally accepted methods and procedures to test the products and will independently report their findings, which will be made public,' said Loren Israelsen, the group's president. 'We feel the most appropriate response to bad science is good science.'"
GNC Tests Show Products are Pure, Properly Labeled
GNC refuted the claims made by the New York State Attorney General and submitted both original test results and results of re-tests as evidence of purity and proper labeling of the supplements in question. It looks like Eric Schneiderman may soon be eating some crow, as the tests came back clean. NewHope360 reported:11
"The retesting results clearly and conclusively demonstrate that the Company's products are pure, properly labeled and in full compliance with all regulatory requirements.
…In performing its tests, GNC used only validated, widely used and generally accepted testing methodologies approved by standard setting bodies, including the United States Pharmacopeia, Association of Agricultural Chemists, British Pharmacopeia and European Pharmacopeia.
These are the non-profit scientific organizations that set standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide."
The re-test results were even reviewed by Robert Fish, who is described as an expert on FDA good manufacturing. He, too, confirmed their authenticity, stating:12
"…the products at issue were each manufactured in compliance with federal FDA requirements … the products contain the ingredients stated on the labels at the levels indicated on the labels … the products are not contaminated, and … the products are therefore not adulterated."
Supplements Are Already Tightly Regulated
Pro-pharmaceutical spokesmen like Dr. Paul Offit and US Senator Dick Durbin have repeatedly stated that dietary supplements are unregulated and need stricter oversight due to the hazards they pose to your health. This is patently false, and you only have to look at the very first sentence on the Food and Drug Administration's (FDA) website to settle that dispute.13 There, it plainly states:
"FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering 'conventional' foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
- The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before it is marketed.
- FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market."
Back in the early 1990s, the FDA threatened the availability of dietary supplements to the point that consumers staged a massive revolt, which resulted in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The law specifically protects your access to dietary supplements by classifying them as foods, not food additives or drugs, and it grandfathered in dietary supplements that were already in use as of 1994. Only novel ingredients introduced after October 15, 1994 are required to seek FDA approval, but the FDA can, and has, shut down supplement makers that do not meet these regulations.
This Isn't a Matter of Safety…
An estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and administered, and two million more suffer serious side effects. How does the safety of supplements compare?
- In 2001, 84.6 percent of all substances implicated in fatal poisonings were pharmaceutical drugs, according to that year's American Association of Poison Control Centers (AAPCC) report. This compares with 0.8 percent for all dietary supplements combined, even including substances such as dinitrophenol, a dangerous (and illegal) substance banned in 1938, as well as the central nervous system stimulant Ma Huang (Ephedra). ONE drug alone, the anti-asthma drug theophylline, which was responsible for 15 deaths that year, amounted to 66 percent more than all the available dietary supplements combined.
- According to CDC mortality data for 2005, prescription drugs killed more than 33,500 people that year, second only to car accidents. That same year, the American Association of Poison Control Centers reported 27 deaths that were associated with dietary supplements (one of which was reportedly due to Ephedra; the herbal supplement banned the year before for being too dangerous. In 2005, low-dose Ephedra was also subsequently banned).
- In 2011, it was reported that there are more than 487 times more adverse event reports for FDA-approved prescription drugs than there are for supplements, and 409 times more serious events for drugs than supplements.14
New York State Has a History of Anti-Supplement Legislation
In 2013, the New York State legislature revealed two bills that showed anti-supplement bias. The first, S3650, would create a system for reporting adverse events related to supplements (even though the FDA already collects them), and give the health commissioner the authority to ban supplements based on any risk they deemed to be "harmful." The Alliance for Natural Health reported:15
"This would undermine the hard-won national regulatory system for supplements under DSHEA, the Dietary Supplement Health and Education Act of 1994—which was enacted to encourage access to nutritional supplements. Creating a 'negative' list of supplements at the state level directly contradicts the process outlined by DSHEA and brings us one step closer to a system of approved vs. non-approved supplements.
Remember, supplements aren't allowed to state their full therapeutic benefits lest they be considered a drug by the FDA. Since it is illegal for producers to cite benefits in any but the most vague terms, the analysis will necessarily be one-sided, and any risk, no matter how tiny, may be deemed sufficient to have the supplement banned. Note that the same rule isn't applied to OTC drugs like acetaminophen, which every year is responsible for 100,000 calls to poison control centers, 56,000 emergency room visits, 26,000 hospitalizations, and more than 450 deaths from liver failure."
The second bill, A.4700, would require sports supplement manufacturers and distributors to hand out pamphlets describing whether the product had been banned by sports leagues and whether there were negative adverse effects or known herb-drug interactions. However, the bill excludes supplements in liquid form and those that contain caffeine, which means those supplements that are sometimes deemed risky, like energy "shots," would not be included.
Perhaps the NY Attorney General will reap what he has sowed, and end up paying the price for putting political motivations ahead of prioritizing real health issues facing citizens of his state. The New Yorker may have shot a fatal blow at his job security in a piece titled, "How Not to Test a Dietary Supplement".
If you'd like to tell New York legislators to oppose these anti-supplement bills and question the lack of basic knowledge displayed by the NY Attorney General, you can do so here.
Transparency Is Important, But Integrity Is Required
Recalls for supplements attract attacks from those who would prefer to eliminate the supplement industry, as it's seen as a threat to pharmaceuticals. But it's not a fair game when the supplements are recalled due to no fault of their own, but rather due to flawed and inadequate testing. Then it's a witch-hunt. The supplement industry would do well to be as transparent as possible in every aspect of their manufacturing.
There are certainly plenty of shady characters in every industry, and illegal acts occur across the board - including the supplement industry. But there is a difference between compliance and enforcement, the fact that illegal supplements exist is not because more regulations are necessary when current regulations are not enforced.
From now on, my own products will have videos explaining the formulation and manufacturing processes used, and include video walk-throughs of the plant where my products are made. Below are two such videos. The first shows the RFI manufacturing facility, where many of my nutritional supplements are made. The second explains the Licaps (liquid capsule) technology, and why I've chosen this particular technology for my liquid supplements.