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Adulterated and Mislabeled Herbal Supplements May Endanger the Health of Pennsylvanians

Results from an investigation spearheaded by the New York Attorney General’s office has caused the New York Attorney General to send cease and desist letters to four national retailers: GNC, Target, Walgreens, and Walmart. The letter demands that each retailer halts their sale of allegedly “adulterated and/or mislabeled herbal dietary supplements.” The letter seems to target several supplements sold at each retailer. The supplements sold by the retailers may include:

  • Gingko Biloba
  • John’s Wort
  • Ginsing
  • Garlic
  • Echinacea
  • Saw Palmetto
  • Valerian Root

According to a summary of the testing procedures set forth in the cease and desist letter, popular store-branded supplements were purchased at a variety of locations in New York state. These supplements were then tested using the generally scientifically accepted DNA barcoding procedure. The tests were repeated 5 times for each and every sample. In the case of the GNC products, 6 products were purchased at four different locations and each sample was tested 5 times – thus leading to 120 results. The tests revealed that 5 of 6 products were not what they claimed to be. In fact, only 22 percent of tests revealed the DNA for the expected herbal substance – 33% of tests produced DNA that did not match what the product purportedly contained.  Nearly half of tests – 45% — did not produce any botanical DNA, whatsoever.

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On the basis of the information provided by the New York Attorney general and contained within the cease and desist letters, test results for the specific herbal supplements tested include:

  • Echinacea – 5 tests of GNC-branded Echinacea detected oryza DNA, which is commonly referred to as rice. 1 test revealed the presence of either pinus or ranunculacae DNA. 14 tests did not reveal the presence of any plant-based DNA. By contrast, 11 of 15 tests of the Target version revealed Echinacea DNA.
  • Garlic – All samples of GNC-branded garlic containedthe expected DNA.Tests of Walgreens branded garlic supplements showed no identifiable amounts of garlic DNA in all but 1 test. 10 of 15 tests of the Walgreens product showed no plant DNA was present.
  • Ginko – Tests of the Walmart branded Ginko allegedly revealed no presence of the expected DNA. Traces of DNA from rice, mustard, wheat, radish and a tropical houseplant were detected. Likewise, the samples for the remaining retailers also contained no trace of Ginko DNA.
  • Ginseng – No samples contained detectable amounts of gingko DNA. Target did not have a ginseng sample tested.
  • John’s Wort – The presence of DNA belonging to St. John’s Wort was not found in any sample. The Walgreen’s-branded St. John ’s Wort was found to contain DNA from garlic, rice and a tropical houseplant.
  • Saw Palmetto – Walgreens was the only retailer to see all of its tested samples contain 100% Palmetto DNA. Target was a close second with 12 of 15 tests revealing the presence of saw palmetto DNA. The expected DNA was present in only a handful of the Walmart and GNC samples tested.

In all, the tests show that results for store-branded versions are rather unpredictable even for the same retailer. Some products did not contain any of the herbal supplement that it was alleged to contain. Others contained some amounts of the supplement but also showed measureable amounts of substances that weren’t supposed to be in the bottle.

Herbal Supplements In Use By 20% of U.S. Adult Population, Risks Remain

A study conducted at the San Francisco Medical Center found that nearly 20% of the adult US population uses at least one herbal supplement. It is possible that an even greater percentage of the population utilizes herbal supplements today as the 2008 study revealed a positive trend in the adoption of a supplement regime. However despite this increasing use and acceptance, there is only limited data that supports the efficacy of these substances. Furthermore, despite perceptions of herbal remedies as being“safe” due to their natural origin, they can still cause medical complications and drug interactions. When herbal supplements contain substances that are not disclosed on the label, the risk of a serious medical issue or death due to an allergy or a drug interaction becomes even more pronounced.

Supplements May Also Contain Banned Pharmaceutical Adulterants

An earlier study reported on by revealed that herbal supplements did not always contain what was purported to be in the bottle in a different respect than found in the previous studies. Discovery of banned pharmaceuticals in herbal supplements resulted in the FDA recalling 274 dietary supplements. A study conducted by Dr. Pieter A. Cohen was, at the time, the first analysis of how well FDA restrictions of pharmaceutical adulterants are being followed by supplement producing companies six months after the initial recall. Of the 274 recalled supplements, 27 met the criteria for the study and had their composition analyzed by the researchers. The researchers’ findings included:

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  • One or more banned pharmaceutical adulterants were present in two-thirds of the samples tested.
  • 2% of products tested contained at least 1 additional banned substance not identified by the FDA.
  • 85 percent of sports performance enhancement supplements contained at least 1 banned substance.
  • 67 percent of herbal weight loss remedies contained one or more banned substance.
  • 20 percent of herbal sexual enhancement products contained a banned ingredient.

The effects of the banned substances allegedly detected by the study themselves are a cause for concern. Sibutramine and analogs of sibutramine, a banned substance known to increase the risk of serious heart complications and associated with reports of psychosis, was detected in weightless supplements. Banned substances phenolphthalein and aromatase inhibitors were detected in supplements despite links to DNA damage, cancer risks, and reports of infertility. Sildenafil, the active ingredient in Viagra, was also detected in supplements. Fluoxetine, the active ingredient in Prozac, was also detected by testing. Other banned substances that appeared in testing results include sildenafil, phenolphthalein, benzyl sibutramine, and a number of anabolic steroids.

Making these findings even more stressing is the fact that they occurred, at least, 6 months following FDA recalls. The study’s authors conclude that “more aggressive enforcement of the law, changes to the law to increase the FDA’s enforcement powers, or both” will be necessary to protect consumers from banned substances in herbal supplements.

In repose to this study finding banned drugs in supplements, the American Herbal Products Association (AHPA) has expressed its disagreement with both the study’s methodology and conclusion. The organization states that “[t]he authors of the letter confuse illegal, adulterated drugs that were marketed as supplements with regulated dietary supplements.” The industry organization calls for the continued enforcement of existing laws and states that passing new laws will not change the behavior of criminal enterprises.

Herbal Supplements Present A Myriad Of Risks

The current regulations, or some would argue, lack of regulation regarding herbal supplements presents a serious risk for health-conscious Pennsylvanians. To begin with, many herbal supplements do not contain the herb that is advertised and thus, even if the particular herb is effective, the expected health benefit will not follow because the substance is not present. Exacerbating matters further is that fillers and other undisclosed substances being used in these supplements that may increase the chances of a life-threatening allergic reaction or drug interactions. Finally, the presence of banned pharmaceuticals in at least some supplements should cause consumers to pause and reconsider their purchase until they perform the research necessary to feel comfortable that they are getting exactly what they pay for when they buy an herbal supplement.

If you’ve suffered an injury from an herbal supplement or another hormonal supplement, call our offices to schedule a free consultation today – (215) 709-6940.


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