NY Attorney General to Wipe Herbal
Supplements from Shelves
February 18, 2015
Story at-a-glance
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The New York’s Attorney General has recalled up to seven
popular herbal supplements from four major retailers
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The investigation was based on DNA barcoding, which found up
to 41 percent of the products tested did not contain DNA
from the plant species listed on the label
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DNA barcoding has serious limitations when it comes to
testing herbal supplements because many contain herbal
extracts, which have a loss or denaturation of DNA during
processing
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The DNA barcoding test cannot identify the ingredients in
all herbal supplements accurately
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.
Copyright 1997- 2015 Dr. Joseph Mercola. All Rights Reserved.
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