Senate scrutinizes supplements – hazards found

January 11, 2011

in Health News

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When you shop for a good supplement you expect a clean product right?  Think again.  In a recent study completed by the Government Accountability Office (GAO) on 40 major herbal dietary supplement products tested showed 37 contained trace amounts of at least 1 potentially hazardous contaminant (such as lead, mercury, or arsenic), although none of them in amounts considered to pose an “acute toxicity hazard”.

The report was requested by Sen Herb Kohl (D, Wis), chairman of the Senate’s Special Committee on Aging,  and was presented May 26,2010.

How the Study Was Run

“To determine whether sellers of herbal dietary supplements are using deceptive or questionable marketing practices to encourage the use of these products, we investigated a nonrepresentative selection of 22 storefront and mail-order retailers. We identified these retailers by searching online using search terms likely to be used by actual consumers and by observing newspaper advertisements. Posing as elderly potential consumers, we asked sales staff at each retailer a series of questions regarding the potential health benefits of herbal dietary supplements as well as potential interactions with other common over-the-counter and prescription drugs. We also reviewed written marketing language used on approximately 30 retail Web sites.6 We evaluated the accuracy of product marketing claims against health benefit evaluations published through the National Institutes of Health (NIH) and Food and Drug Administration (FDA). While our work focused on herbal dietary supplements, we also evaluated claims made regarding nonherbal supplement products recommended to us during undercover storefront visits and telephone calls.”

“To determine whether selected herbal dietary supplements are contaminated with harmful substances, we purchased 40 unique single-ingredient herbal supplement products from 40 different manufacturers and submitted them to an accredited laboratory for analysis.”

Why the GAO did this study

Recent studies have shown that use of herbal dietary supplements—chamomile, echinacea, garlic, ginkgo biloba, and ginseng—by the elderly within the United States has increased substantially. Sellers,such as retail stores, Web sites, and distributors, often claim these supplements help improvememory, circulation, and otherbodily functions. GAO was asked to determine (1) whether sellers of herbal dietary supplements areusing deceptive or questionable marketing practices and (2)whether selected herbal dietarysupplements are contaminatedwith harmful substances.

To conduct this investigation, GAO investigated a nonrepresentative selection of 22 storefront and mailorder retailers of herbal dietary supplements. Posing as elderly consumers, GAO investigators asked sales staff (by phone and in person) at each retailer a series of questions regarding herbal dietary supplements. GAO also reviewed written marketing language used on approximately 30 retail Web sites. Claims were evaluated against recognized scientific research published by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). GAO also had an accredited lab test 40 unique popular singleingredient herbal dietary supplements for the presence of lead, arsenic, mercury, cadmium, organichlorine pesticides, and organophosphorous pesticides.

Deceptive Marketing Claims for Herbal Supplements Found by GAO Investigators

Claim

Comments

Garlic prevents obesity and diabetes and cures cardiovascular disease.

NIH does not recognize this herbal supplement as a treatment for obesity, diabetes, or cardiovascular disease.

Ginseng cures diseases, including cancer.

NIH specifically recommends that breast and uterine cancer patients avoid this product, as it may have an adverse interaction with some cancer drugs.

Garlic can be taken in lieu of prescribed high blood pressure medication.

Evidence that this product reduces high blood pressure is unclear, and both NIH and FDA state that no dietary supplement can take the place of prescribed medicines.

Ginkgo biloba can be taken with a daily aspirin prescription.

Taking this product with aspirin may increase the risk of bleeding.

Ginkgo biloba treats Alzheimer’s disease, depression, and impotence.

No clear scientific evidence supports any of these treatment claims.

GAO also found trace amounts of at least one potentially hazardous contaminant in 37 of the 40 herbal dietary supplement products tested, though none in amounts considered to pose an acute toxicity hazard. All 37 supplements tested positive for trace amounts of lead; of those, 32 also contained mercury, 28 cadmium, 21 arsenic, and 18 residues from at least one pesticide. The levels of heavy metals found do not exceed any FDA or Environmental Protection Agency (EPA) regulations governing dietary supplements or their raw ingredients, and FDA and EPA officials did not express concern regarding any immediate negative health consequences from consuming these 40 supplements. While the manufacturers GAO spoke with were concerned about finding any contaminants in their supplements, they noted that the levels identified were too low to raise any issues internal product testing.

Deceptive Marketing Claims for Herbal Supplements Found by GAO Investigators Claim Comments Garlic prevents obesity and diabetes and cures cardiovascular disease.  NIH does not recognize this herbal supplement as a treatment for obesity, diabetes, or cardiovascular disease.  Ginseng cures diseases, including cancer.  NIH specifically recommends that breast and uterinecancer patients avoid this product, as it may have anadverse interaction with some cancer drugs.Garlic can be taken in lieu of prescribedhigh blood pressure medication.Evidence that this product reduces high blood pressure isunclear, and both NIH and FDA state that no dietarysupplement can take the place of prescribed medicines.Ginkgo biloba can be taken with a dailyaspirin prescription.Taking this product with aspirin may increase the risk ofbleeding.Ginkgo biloba treats Alzheimer’sdisease, depression, and impotence.No clear scientific evidence supports any of thesetreatment claims.Source: GAO.  GAO also found trace amounts of at least one potentially hazardous.

Table 1: Potential Negative Health Effects of Contaminants Tested for in Selected Herbal Dietary Supplements

Contaminant Negative health effects
Arsenic Known to increase risk of lung and skin cancer. Long-term exposure can cause skin pigment changes and a thickening of the skin of the hands and feet.
Cadmium Known to cause increased risk of leukemia and testicular tumors. Long-term exposure to lower levels can lead to kidney disease, lung damage, and fragile bones.
Lead May cause increased risk of lung, stomach, and bladder cancer.
Mercury May cause fever, insomnia, and mood shifts. High levels may cause blindness, deafness, and long-term exposure may cause severe renal damage.
Carbofuran Cholinesterase inhibitor.a
Chlorpyrifos Light exposure may cause headaches, blurred vision, watery eyes, dizziness, confusion, diarrhea, and change in heart rate. Heavy exposure may cause seizures, coma, and death.
p,p-DDEb May increase risk of liver and thyroid tumors.
gamma-HCH May cause liver or kidney problems.
HCB May cause liver, thyroid, and kidney damage; may increase risk of liver, kidney, and thyroid cancer.

Sources: Agency for Toxic Substances and Disease Registry, EPA risk assessments, and National Toxicology Program.
Note: All pesticides sold or distributed in the United States must be registered by EPA, based on scientific studies showing that they can be used without posing unreasonable risks to people or the environment. Because of advances in scientific knowledge, the law requires that pesticides that were first registered before November 1, 1984, be reregistered to ensure that they meet today’s more stringent standards. In evaluating pesticides for reregistration, EPA obtains and reviews a complete set of studies from pesticide producers, describing the human health and environmental effects of each pesticide.
aA cholinesterase inhibitor behaves similarly to a neurotoxin and may cause abdominal cramps, diarrhea, nausea, and vomiting.
bDichlorodiphenyldichloroethylene (p,p-DDE)
Sources: Agency for Toxic Substances and Disease Registry, EPA risk assessments, and National Toxicology Program.Note: All pesticides sold or distributed in the United States must be registered by EPA, based on scientific studies showing that they can be used without posing unreasonable risks to people or the environment. Because of advances in scientific knowledge, the law requires that pesticides that were first registered before November 1, 1984, be reregistered to ensure that they meet today’s more stringent standards. In evaluating pesticides for reregistration, EPA obtains and reviews a complete set of studies from pesticide producers, describing the human health and environmental effects of each pesticide.aA cholinesterase inhibitor behaves similarly to a neurotoxin and may cause abdominal cramps, diarrhea, nausea, and vomiting.bDichlorodiphenyldichloroethylene (p,p-DDE)

Table 3: Cases of Deceptive Marketing and Questionable Practices

Case Product Deceptive or questionable marketing claim/practice Comment
1 Ginkgo biloba Product labeling states it “Effectively treats Alzheimer’s Disease, depression, impotence, memory … and more.” Several NIH studies have shown ginkgo to be ineffective at reducing the risk of Alzheimer’s, or otherwise enhancing memory. Other studies have shown that there may be minor alleviation of depression in elderly patients taking ginkgo, but overall, there is not enough evidence to form a clear conclusion.
2 Garlic Product labeling states that it prevents and/or cures cardiovascular disease, cancer, obesity, and diabetes. Only a drug can claim to cure a disease, according to FDA and NIH. As a treatment for these conditions, experts typically recommend healthy eating, regular physical activity, and in some cases FDA-approved drugs, not this herbal dietary supplement. In addition, no studies suggest that this product can cure or prevent any of these conditions.
3 Ginseng Product labeling states that it possesses a “Powerful Anti-cancer Function” and can prevent diabetes, among other questionable claims. NIH states that there is no clear evidence to support that this supplement can prevent cancer or cardiovascular diseases, and more research is needed. While this supplement may lower blood sugar levels in patients with type 2 diabetes, the long-term effects are not clear, and NIH recommends that patients should instead use more proven therapies.
4 Garlic Product labeling states that “it is extremely helpful in treating any form of flu or colds, from a mild head cold to pneumonia. [It] is useful for bronchial conditions such as inflammatory disease, asthma, tuberculosis …” Some research suggests that this herb may reduce the severity of upper respiratory tract infections. However, according to NIH, better studies need to be performed to confirm this effect in humans.
5 Garlic Product labeling states that “Hundreds of scientific studies have proven [this product] to be number one, working to enhance the body’s immune function, protect cells from free radical damage, and reduce cardiovascular risk factors, including issues with blood pressure, cholesterol …” While this herb may help with certain conditions, enhancement of the body’s immune function is not a recognized benefit. Studies have shown that this herb may lower bad cholesterol and blood pressure by a small amount, but the long-term effects are not known. In addition, the effects on good cholesterol are unclear. Further, the seller does not disclose details about the “hundreds of scientific studies” cited in the product labeling.
6 Chamomile Product labeling states that possible benefits of chamomile include the alleviation of insomnia, diverticular disorder, gum disease, and gingivitis. Dietary supplements are not a recommended course of treatment for any of these conditions, according to FDA. While chamomile has traditionally been used as a sleep aid, there is a lack of scientific evidence supporting its effectiveness in treating insomnia, according to NIH. For the other conditions, recommended treatments often include lifestyle changes, drugs, and surgery.
7 Enzymea Publicity materials for this product include a rebuttal of an FDA disclaimer regarding the product’s claim to guard against memory issues. FDA reviewed the supplement and determined that there is little scientific evidence that it reduces the risk of dementia or cognitive dysfunction in the elderly.
Source

http://www.gao.gov/new.items/d10662t.pdf

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