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NY--no more herbal supplements from pharmacies?



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Mrs Bissli




 
 
    
 

Post Thu, Feb 05 2015, 6:19 pm
So it looks like they're going to restrict drugstores from selling popular
herbal supplements like Echnachia, St John's Wort, Gingseng in NY?

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NY AG ASKS RETAILERS TO HALT SALES OF SOME HERBAL SUPPLEMENTS
2015-02-03 13:07:22.217 GMT

(The following is a reformatted version of a press release issued by the Office
of New York Attorney General Eric T. Schneiderman and received via electronic
mail. The release was confirmed by the sender.)

A.G. SCHNEIDERMAN ASKS MAJOR RETAILERS TO HALT SALES OF CERTAIN HERBAL
SUPPLEMENTS AS DNA TESTS FAIL TO DETECT PLANT MATERIALS LISTED ON MAJORITY OF
PRODUCTS TESTED

Cease And Desist Letters Sent To GNC, Target, Walgreens And Walmart As Most
Store Brand Supplements Were Found To Contain Contaminants Not Identified On
Ingredient Labels; Just 21% Of Supplement Tests Identified DNA From Plant
Species Listed On Labels

Schneiderman: Mislabeled Consumer Products Pose Unacceptable Health Hazards

NEW YORK -- Attorney General Eric T. Schneiderman today announced that his
office sent letters to four major retailers, GNC, Target, Walmart, and
Walgreens, for allegedly selling store brand herbal supplement products in New
York that either could not be verified to contain the labeled substance, or
which were found to contain ingredients not listed on the labels. The letters,
sent Monday, call for the retailers to immediately stop the sale of certain
popular products, including Echinacea, Ginseng, St. John’s Wort, and others.
Attorney General Schneiderman requested the companies provide detailed
information relating to the production, processing and testing of herbal
supplements sold at their stores, as well as set forth a thorough explanation
of quality control measures in place.

The letters come as DNA testing, performed as part of an ongoing investigation
by the Attorney General’s Office, allegedly shows that, overall, just 21% of
the test results from store brand herbal supplements verified DNA from the
plants listed on the products’ labels — with 79% coming up empty for DNA
related to the labeled content or verifying contamination with other plant
material. The retailer with the poorest showing for DNA matching products
listed on the label was Walmart. Only 4% of the Walmart products tested showed
DNA from the plants listed on the products’ labels.

“This investigation makes one thing abundantly clear: the old adage ‘buyer
beware’ may be especially true for consumers of herbal supplements,” said
Attorney General Schneiderman. "The DNA test results seem to confirm
long-standing questions about the herbal supplement industry. Mislabeling,
contamination, and false advertising are illegal. They also pose unacceptable
risks to New York families—especially those with allergies to hidden
ingredients. At the end of the day, American corporations must step up to the
plate and ensure that their customers are getting what they pay for, especially
when it involves promises of good health.”

“As the sponsor of a measure that would require labeling that states whether a
product has been evaluated by the FDA or not, and legislation to establish a
dietary supplements safety committee, I fully support the Attorney General's
efforts in this area,” said New York State Senator Ken LaValle. “ I will
continue to fight for legislation that will provide adequate labeling
information for the public.”

“Since 2005, I have sponsored legislation to create a dietary food supplements
safety committee,” said New York State Assemblymember Felix Ortiz. “This bill
was crafted for the very same reasons the Attorney General is now targeting
retailers selling generic supplements that may or may not contain the
substances contained on the labels. I support the Attorney General’s efforts
and I will continue to push for the passage of my bill (A3548) to help reduce
this kind of consumer fraud. We need adequate standards and better enforcement
over these dietary supplements so consumers will feel confident knowing what
they are buying.”

“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.”

“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,” said Arthur P. Grollman, M.D.,
Professor of Pharmacological Sciences at Stony Brook University. “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.
Hopefully, this action can prompt other states to follow New York’s example and
lead to the reform of federal laws that, in their current form, are doing
little to protect the public.”

Using DNA barcoding technology to examine the contents of herbal supplements,
the Attorney General’s investigation is focused on what appears to be the
practice of substituting contaminants and fillers in the place of authentic
product. The investigation looked at six different herbal supplements sold at
the four major retail companies in thirteen regions across the state, including
Binghamton, Brooklyn, Buffalo, Harlem, Nassau County, Plattsburgh,
Poughkeepsie, Rochester, Suffolk County, Syracuse, Utica, Watertown, and
Westchester County.

The testing revealed that all of the retailers were selling a large percentage
of supplements for which modern DNA barcode technology could not detect the
labeled botanical substance.

While overall 21% of the product tests confirmed DNA barcodes from the plant
species listed on the labels, 35% of the product tests identified DNA barcodes
from plant species not listed on the labels, representing contaminants and
fillers. A large number of the tests did not reveal any DNA from a botanical
substance of any kind. Some of the contaminants identified include rice, beans,
pine, citrus, asparagus, primrose, wheat, houseplant, wild carrot, and others.
In many cases, unlisted contaminants were the only plant material found in the
product samples.

The U.S. Food and Drug Administration requires companies to verify that their
products are safe and properly labeled for their contents, but unlike drugs,
supplements do not undergo the agency's rigorous evaluation process, which
scrutinizes everything about the drug—from the design of clinical trials to the
severity of side effects to the conditions under which the drug is
manufactured.

If the producers of herbal supplements fail to identify all the ingredients on
a product’s label, a consumer with food allergies, or who is taking medication
for an unrelated illness, is taking a potentially serious health risk every
time a contaminated herbal supplement is ingested. The Attorney General's
investigation is focused on potential violations of New York's General Business
Law and Executive Law, including deceptive practices and deceptive advertising.

An expert in DNA barcoding technology, Dr. James A. Schulte II of Clarkson
University in Potsdam, N.Y., was hired by the Attorney General’s office to
perform the testing. DNA barcodes are short genetic markers in an organism’s
DNA and are used to identify it as belonging to a particular species. Barcodes
provide an unbiased, reproducible method of species identification. Barcodes
can be used to determine the exact plant species being tested.

The DNA tests were performed on three to four samples of each of the six herbal
supplements purchased from the New York stores. Each sample was tested with
five distinct sequence runs, meaning each sample was tested five times. Three
hundred and ninety tests involving 78 samples were performed overall.

GNC:
Six “Herbal Plus” brand herbal supplements per store were purchased and
analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw
Palmetto. Purchased from four locations with representative stores in
Binghamton, Harlem, Plattsburgh & Suffolk.
Only one supplement consistently tested for its labeled contents: Garlic. One
bottle of Saw Palmetto tested positive for containing DNA from the saw palmetto
plant, while three others did not. The remaining four supplement types yielded
mixed results, but none revealed DNA from the labeled herb.
Of 120 DNA tests run on 24 bottles of the herbal products purchased, DNA
matched label identification 22% of the time.
Contaminants identified included asparagus, rice, primrose, alfalfa/clover,
spruce, ranuncula, houseplant, allium, legume, saw palmetto, and Echinacea.

Target:
Six “Up & Up” brand herbal supplements per store were purchased and analyzed:
Gingko Biloba, St. John’s Wort, Valerian Root, Garlic, Echinacea, and Saw
Palmetto. Purchased from three locations with representative stores in Nassau
County, Poughkeepsie, and Syracuse.
Three supplements showed nearly consistent presence of the labeled contents:
Echinacea (with one sample identifying rice), Garlic, and Saw Palmetto. The
remaining three supplements did not revealed DNA from the labeled herb.
Of 90 DNA tests run on 18 bottles of the herbal products purchased, DNA matched
label identification 41% of the time.
Contaminants identified included allium, French bean, asparagus, pea, wild
carrot and saw palmetto.

Walgreens:
Six “Finest Nutrition” brand herbal supplements per store were purchased and
analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw
Palmetto. Purchased from three locations with representative stores in
Brooklyn, Rochester and Watertown.
Only one supplement consistently tested for its labeled contents: Saw Palmetto.
The remaining five supplements yielded mixed results, with one sample of garlic
showing appropriate DNA. The other bottles yielded no DNA from the labeled
herb.
Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched
label representation 18% of the time.
Contaminants identified included allium, rice, wheat, palm, daisy, and dracaena
(houseplant).

Walmart:
Six “Spring Valley” brand herbal supplements per store were purchased and
analyzed: Gingko Biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, and Saw
Palmetto. Purchased from three geographic locations with representative stores
in Buffalo, Utica and Westchester.
None of the supplements tested consistently revealed DNA from the labeled herb.
One bottle of garlic had a minimal showing of garlic DNA, as did one bottle of
Saw Palmetto. All remaining bottles failed to produce DNA verifying the labeled
herb.
Of the 90 DNA test run on 18 bottles of herbal products purchased, DNA matched
label representation 4% of the time.
Contaminants identified included allium, pine, wheat/grass, rice mustard,
citrus, dracaena (houseplant), and cassava (tropical tree root).
The Attorney General’s investigation follows an important study conducted by
the University of Guelph in 2013 that also found contamination and substitution
in herbal products in most of the products tested. As was said at the time by a
spokesperson for the University of Guelph, “The industry suffers from unethical
activities by some manufacturers.”

The market for herbal supplements is significant. The Natural Products
Foundation estimates that the dietary supplement industry contributes $61
billion dollars to the national economy. A 2013 study from the Canadian
Institutes of Health Research estimated there are about 65,000 dietary
supplements on the market consumed by more than 150 million Americans.

That same study also found that more than half of Food and Drug Administration
(FDA) Class I drug recalls between 2004 and 2012 were dietary supplements.
Class I recalls are reserved for drugs or supplements for which there is a
“reasonable probability that [their use] will cause serious adverse health
consequences or death.”

The Attorney General thanks Dr. James A. Schulte II of Clarkson University in
Potsdam, N.Y. for providing his expertise in DNA barcode testing for this
investigation.

The case is being handled by Executive Deputy Attorney General Marty Mack and
Assistant Attorney General Deanna Nelson with the assistance of NYAG’s thirteen
regional offices.
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