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Testimony: 

Before the Special Committee on Aging, U.S. Senate: 

United States Government Accountability Office: 
GAO: 

For Release on Delivery: 
Expected at 2:00 p.m. EDT:
Wednesday, May 26, 2010: 

Herbal Dietary Supplements: 

Examples of Deceptive or Questionable Marketing Practices and 
Potentially Dangerous Advice: 

Statement of Gregory D. Kutz, Managing Director: 
Forensic Audits and Special Investigations: 

GAO-10-662T: 

GAO Highlights: 

Highlights of GAO-10-662T, a testimony before the Special Committee on 
Aging, U.S. Senate. 

Why 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 improve memory, circulation, and other bodily 
functions. GAO was asked to determine (1) whether sellers of herbal 
dietary supplements are using deceptive or questionable marketing 
practices and (2) whether selected herbal dietary supplements are 
contaminated with harmful substances. 

To conduct this investigation, GAO investigated a nonrepresentative 
selection of 22 storefront and mail-order 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 single-ingredient herbal dietary supplements for the presence 
of lead, arsenic, mercury, cadmium, organichlorine pesticides, and 
organophosphorous pesticides. 

What GAO Found: 

Certain dietary supplements commonly used by the elderly were 
deceptively or questionably marketed. FDA statutes and regulations do 
not permit sellers to make claims that their products can treat, 
prevent, or cure specific diseases. However, in several cases, written 
sales materials for products sold through online retailers claimed 
that herbal dietary supplements could treat, prevent, or cure 
conditions such as diabetes, cancer, or cardiovascular disease. When 
GAO shared these claims with FDA and the Federal Trade Commission 
(FTC), both agreed that the claims were improper and likely in 
violation of statutes and regulations. In addition, while posing as 
elderly customers, GAO investigators were often told by sales staff 
that a given supplement would prevent or cure conditions such as high 
cholesterol or Alzheimer’s disease. To hear clips of undercover calls, 
see [hyperlink, http://www.gao.gov/products/GAO-10-662T]. Perhaps more 
dangerously, GAO investigators were given potentially harmful medical 
advice. For example, a seller stated it was not a problem to take 
ginkgo biloba with aspirin to improve memory; however, FDA warns that 
combining aspirin and ginkgo biloba can increase a person’s risk of 
bleeding. In another case, a seller stated that an herbal dietary 
supplement could be taken instead of a medication prescribed by a 
doctor. GAO referred these sellers to FDA and FTC for appropriate 
action. The table below includes several deceptive claims made by 
sellers. 

Table: Deceptive Marketing Claims for Herbal Supplements Found by GAO 
Investigators: 

Claim: Garlic prevents obesity and diabetes and cures cardiovascular 
disease. 
Comments: NIH does not recognize this herbal supplement as a treatment 
for obesity, diabetes, or cardiovascular disease. 

Claim: Ginseng cures diseases, including cancer. 
Comments: NIH specifically recommends that breast and uterine cancer 
patients avoid this product, as it may have an adverse interaction 
with some cancer drugs. 

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

Claim: Ginkgo biloba can be taken with a daily aspirin prescription. 
Comments: Taking this product with aspirin may increase the risk of 
bleeding. 

Claim: Ginkgo biloba treats Alzheimer’s disease, depression, and 
impotence. 
Comments: No clear scientific evidence supports any of these treatment 
claims. 

Source: GAO. 

[End of table] 

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. 

View [hyperlink, http://www.gao.gov/products/GAO-10-662T] or key 
components. For more information, contact Gregory D. Kutz at (202) 512-
6722 or kutzg@gao.gov. 

[End of section] 

Mr. Chairman and Members of the Committee: 

Thank you for the opportunity to discuss findings from our 
investigation into the manufacture and marketing of selected herbal 
dietary supplements commonly used by the elderly.[Footnote 1] The 
Dietary Supplement Health and Education Act of 1994 (DSHEA) defines 
dietary supplements as products that, among other things, are intended 
for ingestion to supplement the diet, labeled as dietary supplements, 
and not represented as conventional foods or as a sole items of a meal 
or diet.[Footnote 2] Recent studies have shown that use of herbal 
dietary supplements, such as chamomile, echinacea, garlic, ginkgo 
biloba, and ginseng, by the elderly in the United States has increased 
substantially.[Footnote 3] 

In 2000, we reported that consumers did not consistently receive 
clear, scientifically supported information concerning products' 
health benefits so they could make informed dietary choices. Further, 
we have reported that consumers faced health risks because federal 
laws and agencies' efforts did not effectively and consistently ensure 
that dietary supplements were safe.[Footnote 4] Most recently, we 
expressed concern that weaknesses in the regulatory system may 
increase the likelihood of unsafe products reaching the market, and a 
lack of consumer knowledge increases the potential health risks 
associated with uninformed consumption.[Footnote 5] At your request, 
we determined (1) whether sellers of herbal dietary supplements are 
using deceptive or questionable marketing practices to encourage the 
use of these products and (2) whether selected herbal dietary 
supplements are contaminated with harmful substances. 

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.[Footnote 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. We 
selected the types of herbs to purchase based on recent surveys about 
the supplements usage of the elderly. These surveys identified the 
most commonly used herbs among the elderly as chamomile, echinacea, 
garlic, ginkgo biloba, ginseng, peppermint, saw palmetto, and St. 
John's wort. We purchased these 40 unique products from a combination 
of retail chain storefronts and online or mail-order retailers; these 
retailers were selected independently from those selected for 
evaluation of marketing practices. For each online retailer, we 
selected brands based primarily on relative popularity according to 
the site's list of top sellers. One unopened, manufacturer-sealed 
bottle of each of these 40 products was submitted to an accredited 
laboratory where they were screened for the presence of common 
hazardous contaminants: lead, arsenic, mercury, cadmium, and residues 
from organichlorine and organophosphorous pesticides. These 
contaminants were selected based on prevalence and the likelihood of 
negative health consequences as a result of consumption. We did not 
independently validate the results received with another lab, or 
through any other mechanism. The likely negative health consequences 
from consumption of these contaminants were determined based on a 
review of relevant health standards and discussions with FDA and 
Environmental Protection Agency (EPA) experts. For a complete 
discussion of our scope and methodology, see appendix I. See appendix 
II for the complete list of contaminants we reviewed. 

Our investigative work, conducted from September 2009 through March 
2010, was performed in accordance with standards prescribed by the 
Council of the Inspectors General on Integrity and Efficiency. 

Background: 

Herbal dietary supplements are traditionally used to alleviate certain 
medical conditions, such as anxiety, digestive problems, and 
depression, and to improve general quality of life. However, for many 
traditional uses, there is not clear scientific evidence to show that 
they prevent or treat underlying diseases or conditions. Further, some 
herbal dietary supplements may interact in a potentially harmful 
manner with some prescription drugs. For example, according to NIH, 
St. John's wort can negatively affect the efficacy of antidepressants, 
HIV treatments, cancer drugs, and anticoagulants, though this is not 
always noted on product labels. The possibility of adverse drug 
interactions is one of the reasons that FDA recommends that consumers 
check with their health practitioners before beginning any supplement 
regimen. The elderly are particularly at risk from these interactions 
since recent studies have found that approximately 85 percent of the 
elderly take at least one prescription drug over the course of a year 
and 58 percent take three or more. Many herbal supplements have not 
been exhaustively tested for hazardous interactions with prescription 
drugs, other supplements, or foods.[Footnote 7] 

Under DSHEA, dietary supplements are broadly presumed safe, and FDA 
does not have the authority to require them to be approved for safety 
and efficacy before they enter the market, as it does for drugs. 
However, a dietary supplement manufacturer or distributor of a 
supplement with a "new dietary ingredient"--an ingredient that was not 
marketed in the United States before October 15, 1994--may be required 
to notify FDA at least 75 days before marketing the product, depending 
on the history of use of the ingredient.[Footnote 8] Also, all 
domestic and foreign companies that manufacture, package, label, or 
hold dietary supplements must follow FDA's current good manufacturing 
practice regulations, which outline procedures for ensuring the 
quality of supplements intended for sale.[Footnote 9] 

Marketing Claims: 

Under DSHEA, a firm, not FDA, is responsible for determining that any 
representation or claims made about the dietary supplements it 
manufactures or distributes are substantiated by adequate evidence to 
show that they are not false or misleading. Except in the case of a 
new dietary ingredient, where premarket review for safety data and 
other information is required by law, a firm does not have to provide 
FDA with the evidence it relies on to substantiate effectiveness 
before or after it markets its products. For the most part, FDA relies 
on postmarket surveillance efforts--such as monitoring adverse event 
reports it receives from companies, health care practitioners, and 
individuals; reviewing consumer complaints; and conducting facility 
inspections--to identify potential safety concerns related to dietary 
supplements.[Footnote 10] Once a safety concern is identified, FDA 
must demonstrate that the dietary supplement presents a significant or 
unreasonable risk, or is otherwise adulterated, before it can be 
removed from the market. 

A product sold as a dietary supplement cannot suggest on its label or 
in labeling that it treats, prevents, or cures a specific disease or 
condition without specific approval from FDA.[Footnote 11] Under FDA 
regulations, a manufacturer may submit a health claim petition in 
order to use a claim on its product labeling that characterizes a 
relationship between the product and risk of a disease, and FDA may 
authorize it provided the claims meet certain criteria and are 
authorized by FDA regulations[Footnote 12] (e.g., diets high in 
calcium may reduce the risk of osteoporosis).[Footnote 13] However, 
manufacturers may make "qualified health claims" when there is 
emerging evidence for a relationship between a dietary supplement and 
reduced risk of a disease or condition, subject to FDA's enforcement 
discretion. The claim must include specific qualifying language to 
indicate that the supporting evidence is limited.[Footnote 14], 
[Footnote 15] 

Dietary supplement labeling may include other claims describing how a 
dietary ingredient is intended to affect the normal structure or 
function of the body (e.g. fiber maintains bowel regularity). The 
manufacturer is responsible for ensuring the accuracy and truthfulness 
of such claims, but must submit a claim to FDA for review no later 
than 30 days after marketing it.[Footnote 16] Because FDA does not 
confirm the claim--a lack of objection allows the manufacturer to use 
it--the following disclaimer must be included: "This statement has not 
been evaluated by the FDA. This product is not intended to diagnose, 
treat, cure, or prevent any disease." The manufacturer does not need 
to provide FDA with documentation, and FDA does not test to determine 
if the claim is true. 

In addition, these claims generally may not state that a product is 
intended to diagnose, mitigate, treat, cure, or prevent a disease or 
the adverse effects associated with a therapy for a disease, either by 
naming or describing a specific disease.[Footnote 17] A claim also 
cannot suggest an effect on an abnormal condition associated with a 
natural state or process, such as aging.[Footnote 18] Context is a 
consideration; a product's name and labeling cannot imply such an 
effect by use of pictures or scientific or lay terminology. Finally, a 
product cannot claim to be a substitute for a product that is a 
therapy for a disease, or claim to augment a therapy or drug. To make 
any of these claims, a manufacturer must submit and receive 
authorization of a health claim petition. 

The Federal Trade Commission (FTC) regulates advertising for dietary 
supplements and other products sold to consumers. FTC receives 
thousands of consumer complaints each year related to dietary 
supplements and herbal remedies. FTC has, in the past, taken action 
against supplement sellers and manufacturers whose advertising was 
deemed to pose harm to the general public. FDA works with FTC in this 
area, but FTC's work is directed by different laws. 

Harmful Substance Contamination: 

Consuming high levels of the contaminants for which we tested the 40 
products can lead to severe health consequences, such as increased 
risk of cancer, as noted in table 1. The negative health effects 
described are, unless otherwise noted, for the acute toxicity in the 
human body. However, the exact effects of these contaminants on an 
individual are based on an individual's specific characteristics. For 
instance, since lead can build up in the human body, the effect of 
consuming a potentially dangerous level of lead by a 55-year-old man 
depends on the amount of lead that man has consumed during his 
lifetime, among other factors. 

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

Contaminant: Arsenic; 
Negative health effects: 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. 

Contaminant: Cadmium; 
Negative health effects: 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. 

Contaminant: Lead; 
Negative health effects: May cause increased risk of lung, stomach, 
and bladder cancer. 

Contaminant: Mercury; 
Negative health effects: May cause fever, insomnia, and mood shifts. 
High levels may cause blindness, deafness, and long-term exposure may 
cause severe renal damage. 

Contaminant: Carbofuran; 
Negative health effects: Cholinesterase inhibitor.[A]. 

Contaminant: Chlorpyrifos; 
Negative health effects: 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. 

Contaminant: p,p-DDE[B]; 
Negative health effects: May increase risk of liver and thyroid tumors. 

Contaminant: gamma-HCH; 
Negative health effects: May cause liver or kidney problems. 

Contaminant: HCB; 
Negative health effects: 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. 

[A] A cholinesterase inhibitor behaves similarly to a neurotoxin and 
may cause abdominal cramps, diarrhea, nausea, and vomiting. 

[B] Dichlorodiphenyldichloroethylene (p,p-DDE) is a breakdown product 
of the pesticide dichlorodiphenyltrichloroethane (DDT). 

[End of table] 

FDA has not issued any regulations addressing safe or unsafe levels of 
contaminants in dietary supplements, but both FDA and EPA have set 
certain advisory levels for contaminants in other foods. The human 
body's absorption of many contaminants is governed by intake method, 
so advisory levels for other foods (e.g., drinking water) cannot be 
strictly applied to dietary supplements. In addition, EPA sets limits 
on how much pesticide residue can remain on food and feed products. 
These pesticide residue limits are known as tolerances and are 
enforced by FDA. If no residue tolerance has been set for a particular 
pesticide, any product containing that pesticide residue is considered 
adulterated and its sale is prohibited by law. See table 2 for a 
summary of the regulations issued by FDA or EPA regarding some of the 
contaminants we tested for. 

Table 2: Regulatory Information for Selected Contaminants: 

Contaminant: Arsenic; 
Regulatory information: FDA has limited arsenic in bottled drinking 
water to .010 parts per million (ppm).[A]. 

Contaminant: Cadmium; 
Regulatory information: FDA has limited cadmium in bottled drinking 
water to .005 ppm. 

Contaminant: Lead; 
Regulatory information: FDA has limited lead in bottled drinking water 
to .005 ppm. 

Contaminant: Mercury; 
Regulatory information: FDA has limited mercury in bottled drinking 
water to .002 ppm. 

Contaminant: Carbofuran; 
Regulatory information: Carbofuran's use is restricted in the United 
States due to ecological and health risks. FDA has limited carbofuran 
in bottled drinking water to .04 ppm. 

Contaminant: Chlorpyrifos; 
Regulatory information: EPA residue tolerances for chlorpyrifos in 
food commodities range from .01 to 20.0 ppm. 

Contaminant: p,p-DDE; 
Regulatory information: The use of the parent chemical for this 
breakdown product has been banned in the United States since 1972. 

Contaminant: gamma-HCH; 
Regulatory information: EPA National Primary Drinking Water 
Regulations limit the level of this pesticide in tap water to .0002 
ppm. EPA residue tolerances for gamma-HCH in food commodities range 
from 4.0 to 7.0 ppm. 

Contaminant: HCB[B]; 
Regulatory information: EPA National Primary Drinking Water 
Regulations limit the level of this pesticide in tap water to .001 ppm. 

Source: GAO analysis of FDA and EPA regulations. 

[A] Parts per million is a measure equivalent to milligrams of 
contaminant per kilogram of carrier material or milligrams of 
contaminant per liter of carrier material. 

[B] Hexachlorobenzene (HCB) is subject to a voluntary usage ban by 
U.S. companies. It is not currently used commercially in the United 
States, though it was previously used to make fireworks, ammunition, 
and synthetic rubber. 

[End of table] 

Deceptive or Questionable Marketing Claims May Lead to Harm for 
Elderly Consumers of Herbal Supplements: 

Our investigation found examples of deceptive or questionable 
marketing and sales practices for dietary supplements popular among 
the elderly (see table 3). The most egregious practices included 
suspect marketing claims that a dietary supplement prevented or cured 
extremely serious diseases, such as cancer and cardiovascular disease. 
Other dietary supplements were claimed to mitigate age-related medical 
conditions, such as Alzheimer's disease and diverticular disorder. We 
also found some claims that followed FDA's labeling regulations and 
guidelines, but could still be considered deceptive or questionable 
and provide consumers with inaccurate information. In addition, while 
conducting in-person and telephone conversations with dietary 
supplements sellers, our investigators, posing as elderly consumers, 
were given potentially harmful medical advice by sales staff, 
including that they could take supplements in lieu of prescription 
medication. In making these claims, sellers put the health of 
consumers at risk. A link to selected audio clips from these calls is 
available at: [hyperlink, http://www.gao.gov/products/GAO-10-662T]. 

Table 3: Cases of Deceptive Marketing and Questionable Practices: 

Case: 1; 
Product: Ginkgo biloba; 
Deceptive or questionable marketing claim/practice: Product labeling 
states it "Effectively treats Alzheimer's Disease, depression, 
impotence, memory...and more"; 
Comment: 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. 

Case: 2; 
Product: Garlic; 
Deceptive or questionable marketing claim/practice: Product labeling 
states that it prevents and/or cures cardiovascular disease, cancer, 
obesity, and diabetes; 
Comment: 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. 

Case: 3; 
Product: Ginseng; 
Deceptive or questionable marketing claim/practice: Product labeling 
states that it possesses a "Powerful Anti-cancer Function" and can 
prevent diabetes, among other questionable claims; 
Comment: 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. 

Case: 4; 
Product: Garlic; 
Deceptive or questionable marketing claim/practice: 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..."; 
Comment: 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. 

Case: 5; 
Product: Garlic; 
Deceptive or questionable marketing claim/practice: 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..."; 
Comment: 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. 

Case: 6; 
Product: Chamomile; 
Deceptive or questionable marketing claim/practice: Product labeling 
states that possible benefits of chamomile include the alleviation of 
insomnia, diverticular disorder, gum disease, and gingivitis; 
Comment: 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. 

Case: 7; 
Product: Enzyme[A]; 
Deceptive or questionable marketing claim/practice: Publicity 
materials for this product include a rebuttal of an FDA disclaimer 
regarding the product's claim to guard against memory issues; 
Comment: 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. 

Case: 8; 
Product: Garlic; 
Deceptive or questionable marketing claim/practice: Sales staff 
informed us that this herbal dietary supplement could be taken in lieu 
of high blood pressure medicine; 
Comment: While this herb may lower blood pressure, better studies are 
needed to confirm this benefit, and NIH does not recommend it as a 
treatment for high blood pressure. 

Case: 9; 
Product: Ginkgo biloba; 
Deceptive or questionable marketing claim/practice: Sales staff 
informed us that there are no side effects to taking the product with 
aspirin; 
Comment: FDA warns that if this product is taken with certain drugs 
(including aspirin), it can increase the potential for internal 
bleeding. 

Case: 10; 
Product: Ginkgo biloba; 
Deceptive or questionable marketing claim/practice: Sales staff 
informed us that by using this supplement, the use of aspirin is no 
longer needed; 
Comment: NIH advises consumers to talk to their health care providers 
before taking any herbal medicines or supplements and before starting 
or ending any drug regimen. 

Source: GAO. 

[A] The product described here is not an herbal dietary supplement, 
but was recommended by sales staff at several retailers to help with 
memory issues. 

[End of table] 

Below are details on several cases in which herbal supplement 
marketing practices were deceptive or questionable and sometimes posed 
health risks to consumers. All cases of deceptive or questionable 
marketing and inappropriate medical advice have been referred to FDA 
and FTC for appropriate action. 

Case 2: In online materials, this garlic supplement included claims 
that it would (1) prevent and cure cardiovascular disease, (2) prevent 
and cure tumors and cancer, (3) prevent obesity, and (4) reduce 
glycemia to prevent diabetes. According to NIH, all these claims are 
unproven, and garlic is not recommended for treating these conditions. 
In fact, for several of these conditions, garlic may interact 
adversely with common FDA-approved drug treatments. Nowhere in this 
product's marketing materials does the seller suggest that consumers 
should consult their health care providers prior to taking its 
supplement. While NIH recognizes that garlic may have some anticancer 
properties, the agency notes that additional clinical trials are 
needed to conclude whether these properties are strong enough to 
prevent or treat cancer. Further, studies have shown that garlic may 
alter the levels of some cancer drugs in the human body, lessening 
their effectiveness. For diabetes, there are no studies that confirm 
that garlic lowers blood sugar or increases the release of insulin in 
humans. In fact, NIH recommends caution when combining garlic with 
medications that lower blood sugar, and further suggests that patients 
taking insulin or oral drugs for diabetes be monitored closely by 
qualified health care professionals. 

Case 3: According to its labeling, this ginseng supplement--which 
costs $500 for a 90-day supply--cures diseases, effectively prevents 
diabetes and cardiovascular disease, and prevents cancer or halts its 
progression. These claims are unproven--no studies confirm that 
ginseng can prevent or cure any disease. In fact, NIH recommends that 
breast and uterine cancer patients avoid ginseng. In addition, ginseng 
may adversely interact with cancer drugs. The product labeling claims 
do not differentiate between type 1 and type 2 diabetes. According to 
NIH, ginseng's effect on patients with type 1 diabetes is not well 
studied. While ginseng may lower blood sugar levels in patients with 
type 2 diabetes, the long-term effects of such a treatment program are 
unclear, and it is not known what doses are safe or effective. NIH 
specifically recommends that consumers with type 2 diabetes use proven 
therapies instead of this supplement. 

Case 7: While our investigators posed as consumers purchasing dietary 
supplements, sales staff provided them with an informational booklet 
regarding an enzyme that claims to "[defend] us against dementia and 
Alzheimer's, exhibiting a truly miraculous capacity to optimize mental 
performance and fight off cognitive decline." In fact, FDA reviewed 
the scientific evidence for the active ingredient of this supplement 
and found that it was not adequate to make such a claim. Because the 
agency considered such a health claim potentially misleading, FDA 
provided for the use of a qualified health claim that contains a 
disclaimer that must accompany the health claim in all labeling in 
which these claims appear. While the booklet we received does state 
the FDA disclaimer on the first page, the manufacturer follows it with 
a rejoinder: "The very cautious language of these claims, which FDA 
mandates can only be stated word for word, is at best a grudging 
concession to the extensive clinical research done with [this 
supplement]. Considering this agency's legendary toughness against 
dietary supplements, FDA's willingness to go this far with the 
[disclaimer] suggests that the FDA must be sure it is safe to take and 
also that the FDA is unable to deny [this supplement] can improve 
human brain function." 

Case 8: One of our fictitious consumers visited a supplement specialty 
store looking for a product that would help with high blood pressure. 
The sales representative recommended a garlic supplement and stated 
that the product could be taken in lieu of prescribed blood pressure 
medication. According to NIH, while this herb may lower blood pressure 
by a small amount, the scientific evidence is unclear. NIH does not 
recommend this supplement as a treatment for high blood pressure and 
warns patients to use caution while taking this product with other 
drugs or supplements that can lower blood pressure. Further, it is not 
recommended that a consumer start or stop a course of treatment 
without consulting with his or her health care provider. Even if a 
sales representative is licensed to dispense medical advice, he or she 
still does not know the consumer's patient history, including other 
drug programs, allergies, and medical conditions, making it 
potentially dangerous for the sales representative to provide medical 
advice. 

Case 9: At a supplement specialty store, one of our investigators 
posed as an elderly consumer who was having difficulty remembering 
things. A sales representative recommended one of the store's ginkgo 
biloba supplements. The consumer told the representative that he takes 
aspirin everyday and asked if it was safe to take aspirin and ginkgo 
biloba together. The sales representative told him that it is 
completely safe to take the two together. However, according to FDA, 
if aspirin is taken with the recommended product, it can increase the 
potential for internal bleeding. 

We spoke to FDA and FTC regarding these 10 claims, and they agreed 
that the statements made in product labeling for cases 1 through 6 are 
largely improper, as the labeling suggests that each product has an 
effect on a specific disease. For case 7, FDA stated that while the 
specific claims discussed here are allowable, depending on the context 
in which they were made, FDA might consider the totality of marketing 
materials to be improper. FDA also agreed that the claims made to our 
undercover investigators in cases 8 and 10 were questionable or likely 
constituted improper disease claims, but that to take action, 
additional information as to the prevalence and context of the claims 
would be necessary. For case 9, FDA noted that, since the statement 
made by sales staff was safe usage information, not a claim about the 
product's effects, it would not violate FDA regulations, unless the 
agency could develop other evidence to show that the claim was false 
or misleading or constituted an implied disease claim. In addition, 
FDA and NIH both noted that by definition, no dietary supplement can 
treat, prevent, or cure any disease. 

Trace Contaminants Found in Selected Herbal Dietary Supplements, but 
None Pose an Acute Toxicity Hazard to Humans: 

We found trace amounts of at least one potentially hazardous 
contaminant in 37 of the 40 herbal dietary supplement products we 
tested, though none of the contaminants were found in amounts 
considered to pose an acute toxicity hazard to humans.[Footnote 19] 
Specifically, all 37 supplements tested positive for trace amounts of 
lead. Thirty-two also contained mercury, 28 contained cadmium, 21 
contained arsenic, and 18 contained residues from at least one 
pesticide.[Footnote 20] See appendixes III and IV for the complete 
results of these tests. 

The levels of contaminants found do not exceed any FDA or 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. However, because EPA has not set pesticide tolerance 
limits for the main ingredients of the herbal dietary supplements we 
tested, the pesticide contaminants exceed FDA advisory levels. FDA 
agreed that 16 of the 40 supplements we tested would be considered in 
violation of U.S. pesticide tolerances if FDA, using prescribed 
testing procedures, confirmed our results. We note that 4 of the 
residues detected are from pesticides that currently have no 
registered use in the United States.[Footnote 21] According to FDA, 
scientific research has not been done on the long-term health effects 
from consumption of such low levels of many of these specific 
contaminants, as current technology cannot detect these trace 
contaminants when they are diluted in human bloodstreams. We have 
referred these products to FDA for its review. 

After reviewing test results with EPA and FDA officials, we also spoke 
with several of the manufacturers of supplements that had trace 
amounts of contaminants.[Footnote 22] The manufacturers we spoke with 
stated that they ensure that their products are tested for 
contamination, and that these tests have shown that their products do 
not contain contaminants in excess of regulatory standards. 
Manufacturers also stated that they comply with all FDA regulations 
and follow good manufacturing practices as defined by the agency. 
While the manufacturers we spoke with were concerned about finding any 
contaminants in their supplements, they noted that the levels 
identified were too low to raise any issues during their own internal 
product testing processes. 

Mr. Chairman, this concludes my statement. I would be pleased to 
answer any questions that you or other members of the committee may 
have at this time. 

Contacts and Acknowledgments: 

For further information about this testimony, please contact Gregory 
D. Kutz at (202) 512-6722 or kutzg@gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this testimony. Individuals who made major 
contributions to this testimony were Jonathan Meyer and Andrew 
O'Connell, Assistant Directors; John Ahern; Dennis Fauber; Robert 
Graves; Cristian Ion; Elizabeth Isom; Leslie Kirsch; Barbara Lewis; 
Flavio Martinez; James Murphy; Ramon Rodriguez; Tim Walker; and John 
Wilbur. 

[End of section] 

Appendix I: Scope and Methodology: 

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 selling herbal dietary 
supplements. 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 customers, we asked sales 
staff at each company 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.[Footnote 23] While our work focused on herbal dietary 
supplements, we also evaluated claims made regarding nonherbal 
supplement products during undercover storefront visits and telephone 
calls. We also reviewed written marketing language used on 
approximately 30 retail Web sites. We evaluated the accuracy of 
product marketing claims against health benefit evaluations published 
through the National Institutes of Health and Food and Drug 
Administration (FDA). 

To determine whether selected herbal dietary supplements were 
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. We 
selected the types of herbs to purchase based on recent surveys about 
the supplements usage of the elderly, defined for this report as 
individuals over the age of 65. These surveys identified the most 
commonly used herbs among the elderly as chamomile, echinacea, garlic, 
ginkgo biloba, ginseng, peppermint, saw palmetto, and St. John's wort. 

We purchased these 40 unique products from a combination of retail 
chain storefronts and online or mail-order retailers. For each online 
retailer, we selected products based primarily on relative popularity 
according to the site's list of top sellers. At each retail chain 
storefront, because of limited selection, we selected only items that 
would be expected to be sold at all chain locations. All 40 products 
were submitted to an accredited laboratory where they were screened 
for the presence of lead, arsenic, mercury, cadmium, and residues from 
organichlorine and organophosphorous pesticides. These contaminants 
were selected based on prevalence and the likelihood of negative 
health consequences due to consumption. The recommended daily intake 
levels of these contaminants and the likely negative health 
consequences because of consumption were determined based on a review 
of relevant health standards and discussions with FDA and 
Environmental Protection Agency experts. 

For each herbal dietary supplement product, we submitted one unopened, 
manufacturer-sealed bottle to the laboratory for analysis. To identify 
levels of arsenic, cadmium, lead, and mercury, products were analyzed 
using inductively coupled plasma mass spectrometry according to method 
AOAC 993.14. Detection limits for these contaminants were .075 
milligrams/kilogram, .010 milligrams/kilogram, .005 milligrams/ 
kilogram, and .050 nanograms/gram, respectively. To identify levels of 
pesticide residues, products were analyzed using a variety of residue- 
specific methods, including those methods published in the FDA 
Pesticide Analytical Manual. We did not independently validate the 
results received with another lab or through any other mechanism. See 
appendix II for a complete list of analytes and their related 
detection levels. 

[End of section] 

Appendix II: Full List of Analytes and Detection Limits: 

Analyte: (2-Ethylhexyl)-Diphenylphosphate; 
Detection limit (ppm)[A]: 0.01; 

Analyte: Acrinathrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Aldrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Allethrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: alpha-BHC; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Ametryn; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Aminocarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Amitraz; 
Detection limit (ppm)[A]: 0.05. 

Analyte: Aniten/Flurecol Butyl Ester; 
Detection limit (ppm)[A]: 0.05. 

Analyte: Arsenic; 
Detection limit (ppm)[A]: 0.075. 

Analyte: Atrazine; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Azinphos-methyl; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Azoxystrobin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Benalaxyl; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Bendiocarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Benfluralin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: beta-BHC; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Bifenthrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Biphenyl; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Bromopropylate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Bufencarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Bupirimate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Buprofezin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Butylate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Cadmium; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Carbaryl; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Carbofuran; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Carbofuran 3-OH; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Carbosulfan; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Carboxin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Chlordene, beta; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Chlordene, gamma; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Chlordimeform (CDF); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Chlorfenvinphos (Total Isomers E, Z); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Chlorobenzilate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Chloroneb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Chloropropylate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Chlorothalonil; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Chlorpyrifos (Dursban); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Chlorpyrifos-methyl; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Chlorpyrifos-O-analogue; 
Detection limit (ppm)[A]: 0.01. 

Analyte: cis-Chlordane; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Clomazone; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Coumaphos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Cyanazine; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Cyanophos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Cycloate/Ro Neet; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Cycluron; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Cyhalothrin lambda; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Cymiazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Cypermethrin; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Cyproconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Cyprodinil; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Dacthal (DCPA); 
Detection limit (ppm)[A]: 0.01. 

Analyte: DEF; 
Detection limit (ppm)[A]: 0.02. 

Analyte: delta-BHC; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Deltamethrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Desmedipham; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Desmetryn; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Di-allate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Diazinon; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Diazinon (O Analog); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Dichlobenil; 
Detection limit (ppm)[A]: 0.05. 

Analyte: Dicloran; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Dieldrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Diethofencarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Difenoconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Dimethachlor; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Dimethoate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Diniconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Dioxacarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Dioxathion; 
Detection limit (ppm)[A]: 0.05. 

Analyte: Diphenamid; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Disulfoton; 
Detection limit (ppm)[A]: 0.01. 

Analyte: d-Phenothrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Edifenphos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Endosulfan I (alpha-endosulfan); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Endosulfan II (beta-Endosulfan); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Endosulfan sulphate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Endrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: EPN; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Epoxiconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: EPTC/Eptam; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Esfenvalerate-2; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Etaconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Ethafluralin; 
Detection limit (ppm)[A]: 0.03. 

Analyte: Ethiofencarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Ethiolate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Ethion; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Ethofumesate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Ethoprop (Ethoprophos); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Ethoxyquin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Etobenzanid; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Etofenprox; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Etridiazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenamiphos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenarimol; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenazaquin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenbuconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenchlorphos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenitrothion; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Fenobucarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenoxycarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenpropimorph; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenthion; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fenvalerate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: flopet; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fluchloralin; 
Detection limit (ppm)[A]: 0.04. 

Analyte: Flucythrinate (Total Isomers); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fludioxonil; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Flusilazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Flutolanil; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Fluvalinate; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Fonofos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Gamma-cyhalothrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: gamma-HCH (Lindane); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Heptachlor; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Heptachlor Epoxide (cis, trans); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Heptenophos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Hexachlorobenzene (HCB); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Hexaconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Hexazinone; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Iprodione; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Isocarbamid; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Isofenphos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Isoprocarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Isopropalin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Isoprothiolane; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Isoproturon; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Kresoxim-methyl; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Lead; 
Detection limit (ppm)[A]: 0.005. 

Analyte: Lenacil; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Linuron; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Malathion; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Malathion OA (Malaoxon); 
Detection limit (ppm)[A]: 0.01. 

Analyte: Mercury; 
Detection limit (ppm)[A]: 0.05[B]. 

Analyte: Metalaxyl; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Methidathion; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Methiocarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Methoprotryne; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Methoxychlor, o,o'; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Methoxychlor, p,p'; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Methyl Parathion; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Metolachlor; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Metolcarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Metribuzin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Mevinphos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Mexacarbate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: MGK-264; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Mirex; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Molinate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Monocrotophos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Monolinuron; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Myclobutanil; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Naphthalene Acetamide; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Napropamide; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Nitralin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Nitrofen; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Nitrothal-isopropyl; 
Detection limit (ppm)[A]: 0.02. 

Analyte: nonachlor cis-; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Nonachlor trans-; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Norea; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Nuarimol; 
Detection limit (ppm)[A]: 0.01. 

Analyte: o,p-DDT; 
Detection limit (ppm)[A]: 0.01. 

Analyte: o,p-DDE; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Oxydemeton Methyl Sulfone; 
Detection limit (ppm)[A]: 0.05. 

Analyte: p,p-DDE; 
Detection limit (ppm)[A]: 0.01. 

Analyte: p,p-DDT; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Parathion-ethyl; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Penconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pendimethalin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pentachloroaniline; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pentachlorobenzene; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pentachlorobenzonitrile; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pentachlorothioanisole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Permethrin-cis; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Permethrin-trans; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Phenmedipham; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Phorate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Phorate-sulfone; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Phorate-sulfoxide; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Phosalone; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Phosmet; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pirimicarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pirimifos-methyl; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Prochloraz; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Procymidon; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Profenofos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Profluralin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Promecarb; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Prometon; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Prometryn; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Propachlor; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Propanil; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Propargite; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Propham; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Propiconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Prothiofos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pyracarbolid; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pyrazophos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pyridaphenthion; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pyrimethanil; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Pyriproxyfen; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Quinalphos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Quinoxyfen; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Quintozene (PCNB); 
Detection limit (ppm)[A]: 0.02. 

Analyte: Resmethrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: S 421 (Octachlordipropylether); 
Detection limit (ppm)[A]: 0.02. 

Analyte: Sethoxydim; 
Detection limit (ppm)[A]: 0.02. 

Analyte: Simazine; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Simetryn; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Sulfotep; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Sulprofos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tebuconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tebufenpyrad; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tebutam; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tebuthiuron; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tecnazene; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Terbufos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Terbumeton; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Terbuthylazine; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Terbutryn; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tetrachloroaniline, 2,3,4,6-; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tetrachlorvinphos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tetraconazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tetradifon; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tetramethrin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Thiabendazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tolclofos-methyl; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tolylfluanid; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tralkoxydim; 
Detection limit (ppm)[A]: 0.05. 

Analyte: trans-Chlordane; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Triadimefon; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Triadimenol; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Triallate; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Triazophos; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Tricyclazol; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Trifloxystrobin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Triflumizole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Trifluralin; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Trimethacarb 2.3.5-; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Trimethacarb 3.4.5-; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Triticonazole; 
Detection limit (ppm)[A]: 0.01. 

Analyte: Vinclozolin; 
Detection limit (ppm)[A]: 0.02. 

Source: GAO, based on laboratory methodology. 

[A] Parts per million is a measure equivalent to milligrams per 
kilogram or milligrams per liter. 

[B] Mercury results appear as parts per billion. 

[End of table] 

[End of section] 

Appendix III: Contaminants Found in Selected Herbal Dietary 
Supplements (in Parts per Million): 

Sample: 1; 
Herb: Saw palmetto; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: 0.011; 
Lead[A,B]: 0.024; 
Mercury[B,C]: 1.210; 
Number of pesticides[D]: 0. 

Sample: 2; 
Herb: Echinacea; 
Arsenic[A,B]: 0.090; 
Cadmium[A,B]: 0.348; 
Lead[A,B]: 0.106; 
Mercury[B,C]: 1.170; 
Number of pesticides[D]: 0. 

Sample: 3; 
Herb: Echinacea; 
Arsenic[A,B]: 0.093; 
Cadmium[A,B]: 0.030; 
Lead[A,B]: 0.043; 
Mercury[B,C]: nd; 
Number of pesticides[D]: 0. 

Sample: 4; 
Herb: Echinacea; 
Arsenic[A,B]: 0.226; 
Cadmium[A,B]: 0.069; 
Lead[A,B]: 1.290; 
Mercury[B,C]: 6.960; 
Number of pesticides[D]: 1. 

Sample: 5; 
Herb: St. John's wort; 
Arsenic[A,B]: 0.391; 
Cadmium[A,B]: 0.090; 
Lead[A,B]: 0.353; 
Mercury[B,C]: 0.980; 
Number of pesticides[D]: 2. 

Sample: 6; 
Herb: St. John's wort; 
Arsenic[A,B]: 0.153; 
Cadmium[A,B]: 0.033; 
Lead[A,B]: 0.587; 
Mercury[B,C]: 2.330; 
Number of pesticides[D]: 0. 

Sample: 7; 
Herb: Ginkgo biloba; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: 0.564; 
Mercury[B,C]: 1.340; 
Number of pesticides[D]: 1. 

Sample: 8; 
Herb: Garlic; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: 0.046; 
Mercury[B,C]: 0.810; 
Number of pesticides[D]: 1. 

Sample: 9; 
Herb: Ginkgo biloba; 
Arsenic[A,B]: 0.151; 
Cadmium[A,B]: nd; 
Lead[A,B]: 0.036; 
Mercury[B,C]: 1.480; 
Number of pesticides[D]: 2. 

Sample: 10; 
Herb: Ginkgo biloba; 
Arsenic[A,B]: 0.162; 
Cadmium[A,B]: 0.017; 
Lead[A,B]: 0.037; 
Mercury[B,C]: 3.420; 
Number of pesticides[D]: 1. 

Sample: 11; 
Herb: Garlic; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: 0.026; 
Lead[A,B]: 0.026; 
Mercury[B,C]: 0.620; 
Number of pesticides[D]: 2. 

Sample: 12; 
Herb: Ginseng; 
Arsenic[A,B]: 0.123; 
Cadmium[A,B]: 0.057; 
Lead[A,B]: 0.126; 
Mercury[B,C]: 10.700; 
Number of pesticides[D]: 5. 

Sample: 13; 
Herb: Peppermint; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: 0.007; 
Mercury[B,C]: 2.170; 
Number of pesticides[D]: 1. 

Sample: 14; 
Herb: Saw palmetto; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: 0.011; 
Mercury[B,C]: nd; 
Number of pesticides[D]: 0. 

Sample: 15; 
Herb: Echinacea; 
Arsenic[A,B]: 0.116; 
Cadmium[A,B]: 0.016; 
Lead[A,B]: 0.109; 
Mercury[B,C]: 4.110; 
Number of pesticides[D]: 0. 

Sample: 16; 
Herb: Ginkgo biloba; 
Arsenic[A,B]: 0.222; 
Cadmium[A,B]: 0.030; 
Lead[A,B]: 0.112; 
Mercury[B,C]: 6.090; 
Number of pesticides[D]: 0. 

Sample: 17; 
Herb: Garlic; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: 0.040; 
Lead[A,B]: 0.029; 
Mercury[B,C]: 1.090; 
Number of pesticides[D]: 0. 

Sample: 18; 
Herb: Saw palmetto; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: 0.026; 
Mercury[B,C]: nd; 
Number of pesticides[D]: 0. 

Sample: 19; 
Herb: St. John's wort; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: 0.011; 
Lead[A,B]: 0.026; 
Mercury[B,C]: 0.860; 
Number of pesticides[D]: 3. 

Sample: 20; 
Herb: Ginseng; 
Arsenic[A,B]: 0.078; 
Cadmium[A,B]: 0.127; 
Lead[A,B]: 0.439; 
Mercury[B,C]: 1.510; 
Number of pesticides[D]: 0. 

Sample: 21; 
Herb: Garlic; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: 0.062; 
Lead[A,B]: 0.030; 
Mercury[B,C]: 0.640; 
Number of pesticides[D]: 0. 

Sample: 22; 
Herb: Chamomile; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: 0.375; 
Lead[A,B]: 0.049; 
Mercury[B,C]: 2.900; 
Number of pesticides[D]: 0. 

Sample: 23; 
Herb: Chamomile; 
Arsenic[A,B]: 0.094; 
Cadmium[A,B]: 0.146; 
Lead[A,B]: 0.375; 
Mercury[B,C]: 2.420; 
Number of pesticides[D]: 4. 

Sample: 24; 
Herb: Peppermint; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: nd; 
Mercury[B,C]: nd; 
Number of pesticides[D]: 0. 

Sample: 25; 
Herb: Chamomile; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: nd; 
Mercury[B,C]: nd; 
Number of pesticides[D]: 0. 

Sample: 26; 
Herb: Chamomile; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: nd; 
Mercury[B,C]: nd; 
Number of pesticides[D]: 0. 

Sample: 27; 
Herb: St. John's wort; 
Arsenic[A,B]: 0.155; 
Cadmium[A,B]: 0.054; 
Lead[A,B]: 0.111; 
Mercury[B,C]: 0.530; 
Number of pesticides[D]: 0. 

Sample: 28; 
Herb: Garlic; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: 0.050; 
Lead[A,B]: 0.305; 
Mercury[B,C]: 0.780; 
Number of pesticides[D]: 0. 

Sample: 29; 
Herb: St. John's wort; 
Arsenic[A,B]: 0.180; 
Cadmium[A,B]: 0.062; 
Lead[A,B]: 0.148; 
Mercury[B,C]: 0.760; 
Number of pesticides[D]: 2. 

Sample: 30; 
Herb: Peppermint; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: 0.023; 
Mercury[B,C]: nd; 
Number of pesticides[D]: 1. 

Sample: 31; 
Herb: Chamomile; 
Arsenic[A,B]: 0.286; 
Cadmium[A,B]: 0.058; 
Lead[A,B]: 0.802; 
Mercury[B,C]: 4.260; 
Number of pesticides[D]: 0. 

Sample: 32; 
Herb: Ginkgo biloba; 
Arsenic[A,B]: 0.524; 
Cadmium[A,B]: 0.054; 
Lead[A,B]: 0.487; 
Mercury[B,C]: 77.800; 
Number of pesticides[D]: 2. 

Sample: 33; 
Herb: Ginseng; 
Arsenic[A,B]: 0.229; 
Cadmium[A,B]: 0.105; 
Lead[A,B]: 1.290; 
Mercury[B,C]: 32.900; 
Number of pesticides[D]: 6. 

Sample: 34; 
Herb: Ginseng; 
Arsenic[A,B]: 0.172; 
Cadmium[A,B]: nd; 
Lead[A,B]: 0.032; 
Mercury[B,C]: 2.110; 
Number of pesticides[D]: 2. 

Sample: 35; 
Herb: Ginseng; 
Arsenic[A,B]: 0.154; 
Cadmium[A,B]: 0.156; 
Lead[A,B]: 0.408; 
Mercury[B,C]: 5.990; 
Number of pesticides[D]: 3. 

Sample: 36; 
Herb: Saw palmetto; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: nd; 
Lead[A,B]: 0.008; 
Mercury[B,C]: 1.100; 
Number of pesticides[D]: 0. 

Sample: 37; 
Herb: Saw palmetto; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: 0.012; 
Lead[A,B]: 0.125; 
Mercury[B,C]: 1.710; 
Number of pesticides[D]: 0. 

Sample: 38; 
Herb: St. John's wort; 
Arsenic[A,B]: nd; 
Cadmium[A,B]: 1.150; 
Lead[A,B]: 0.138; 
Mercury[B,C]: 3.000; 
Number of pesticides[D]: 0. 

Sample: 39; 
Herb: Echinacea; 
Arsenic[A,B]: 0.152; 
Cadmium[A,B]: 0.032; 
Lead[A,B]: 0.649; 
Mercury[B,C]: 6.930; 
Number of pesticides[D]: 0. 

Sample: 40; 
Herb: Ginkgo biloba; 
Arsenic[A,B]: 0.115; 
Cadmium[A,B]: 0.025; 
Lead[A,B]: 0.061; 
Mercury[B,C]: nd; 
Number of pesticides[D]: 2. 

Source: GAO, based on laboratory analysis. 

[A] Parts per million is a measure equivalent to milligrams per 
kilogram or milligrams per liter. 

[B] Results marked as "nd" indicate that the contaminant was not 
detected in excess of the underlying tests' detection limit (.075 
mg/kg for arsenic, .010 mg/kg for cadmium, .005 mg/kg for lead, and 
.050 ng/g for mercury). A result of "nd" does not mean that a 
contaminant does not exist in a sample. It means that if a contaminant 
is in the product, it appears at a level below the detection limit for 
that particular test method. 

[C] Mercury results appear as parts per billion, a measure equivalent 
to nanograms per gram or nanograms per milliliter. 

[D] For additional details on pesticide residues found, see appendix 
IV. 

[End of table] 

[End of section] 

Appendix IV: Pesticide Residues Identified in Selected Herbal Dietary 
Supplements (in Parts per Million): 

Sample no.: 4[A]; 
Herb: Echinacea; 
Pesticide residue: Chlorpyrifos (Dursban); 
Detected level: 0.01. 

Sample no.: 5[A]; 
Herb: St. John's wort; 
Pesticide residue: Amitraz; 
Detected level: 0.05. 

Sample no.: 5[A]; 
Herb: St. John's wort; 
Pesticide residue: Propargite; 
Detected level: 0.04. 

Sample no.: 7[A]; 
Herb: Ginkgo biloba; 
Pesticide residue: Phorate-sulfoxide; 
Detected level: 0.06. 

Sample no.: 8[A]; 
Herb: Garlic; 
Pesticide residue: Triadimenol; 
Detected level: 0.03. 

Sample no.: 9[A]; 
Herb: Ginkgo biloba; 
Pesticide residue: Phorate-sulfoxide; 
Detected level: 0.10. 

Sample no.: 9[A]; 
Herb: Ginkgo biloba; 
Pesticide residue: Triadimenol; 
Detected level: 0.26. 

Sample no.: 10[A]; 
Herb: Ginkgo biloba; 
Pesticide residue: Phorate-sulfoxide; 
Detected level: 0.06. 

Sample no.: 11[A]; 
Herb: Garlic; 
Pesticide residue: Carbofuran; 
Detected level: 0.04. 

Sample no.: 11[A]; 
Herb: Garlic; 
Pesticide residue: gamma-HCH (Lindane); 
Detected level: 0.08. 

Sample no.: 12[A]; 
Herb: Ginseng; 
Pesticide residue: Azoxystrobin[B]; 
Detected level: 0.02. 

Sample no.: 12[A]; 
Herb: Ginseng; 
Pesticide residue: Difenoconazole; 
Detected level: 0.02. 

Sample no.: 12[A]; 
Herb: Ginseng; 
Pesticide residue: Flutolanil; 
Detected level: 0.03. 

Sample no.: 12[A]; 
Herb: Ginseng; 
Pesticide residue: Tebuconazole; 
Detected level: 0.02. 

Sample no.: 12[A]; 
Herb: Ginseng; 
Pesticide residue: Tolclofos-methyl; 
Detected level: 0.05. 

Sample no.: 13; 
Herb: Peppermint; 
Pesticide residue: Propargite[B]; 
Detected level: 0.16. 

Sample no.: 19[A]; 
Herb: St. John's wort; 
Pesticide residue: Azoxystrobin; 
Detected level: 0.01. 

Sample no.: 19[A]; 
Herb: St. John's wort; 
Pesticide residue: Chlorpyrifos (Dursban); 
Detected level: 0.01. 

Sample no.: 19[A]; 
Herb: St. John's wort; 
Pesticide residue: Hexazinone; 
Detected level: 0.06. 

Sample no.: 23[A]; 
Herb: Chamomile; 
Pesticide residue: Flusilazole; 
Detected level: 0.01. 

Sample no.: 23[A]; 
Herb: Chamomile; 
Pesticide residue: Metolachlor; 
Detected level: 0.02. 

Sample no.: 23[A]; 
Herb: Chamomile; 
Pesticide residue: Tebuconazole; 
Detected level: 0.04. 

Sample no.: 23[A]; 
Herb: Chamomile; 
Pesticide residue: Trifloxystrobin; 
Detected level: 0.01. 

Sample no.: 29[A]; 
Herb: St. John's wort; 
Pesticide residue: Amitraz; 
Detected level: 0.06. 

Sample no.: 29[A]; 
Herb: St. John's wort; 
Pesticide residue: Triadimefon; 
Detected level: 0.02. 

Sample no.: 30; 
Herb: Peppermint; 
Pesticide residue: Propargite[B]; 
Detected level: 0.62. 

Sample no.: 32[A]; 
Herb: Ginkgo biloba; 
Pesticide residue: Phorate-sulfoxide; 
Detected level: 0.01. 

Sample no.: 32[A]; 
Herb: Ginkgo biloba; 
Pesticide residue: Triadimenol; 
Detected level: 0.06. 

Sample no.: 33[A]; 
Herb: Ginseng; 
Pesticide residue: Hexachlorobenzene (HCB); 
Detected level: 0.02. 

Sample no.: 33[A]; 
Herb: Ginseng; 
Pesticide residue: Metalaxyl[B]; 
Detected level: 0.01. 

Sample no.: 33[A]; 
Herb: Ginseng; 
Pesticide residue: p,p-DDE; 
Detected level: 0.02. 

Sample no.: 33[A]; 
Herb: Ginseng; 
Pesticide residue: Pentachloroaniline; 
Detected level: 0.28. 

Sample no.: 33[A]; 
Herb: Ginseng; 
Pesticide residue: Pentachlorothioanisole; 
Detected level: 0.05. 

Sample no.: 33[A]; 
Herb: Ginseng; 
Pesticide residue: Pyrimethanil; 
Detected level: 0.03. 

Sample no.: 34[A]; 
Herb: Ginseng; 
Pesticide residue: Metalaxyl[B]; 
Detected level: 0.03. 

Sample no.: 34[A]; 
Herb: Ginseng; 
Pesticide residue: Propiconazole; 
Detected level: 0.02. 

Sample no.: 35[A]; 
Herb: Ginseng; 
Pesticide residue: Azoxystrobin[B]; 
Detected level: 0.03. 

Sample no.: 35[A]; 
Herb: Ginseng; 
Pesticide residue: Dacthal (DCPA)[B]; 
Detected level: 0.07. 

Sample no.: 35[A]; 
Herb: Ginseng; 
Pesticide residue: Pyrimethanil; 
Detected level: 0.11. 

Sample no.: 40[A]; 
Herb: Ginkgo biloba; 
Pesticide residue: Phorate-sulfoxide; 
Detected level: 0.01. 

Sample no.: 40[A]; 
Herb: Ginkgo biloba; 
Pesticide residue: Triadimenol; 
Detected level: 0.10. 

Source: GAO, based on laboratory analysis. 

[A] Product would be considered in violation of U.S. pesticide 
tolerances, should these results be confirmed. 

[B] Pesticide residue detected is not considered, by the Food and Drug 
Administration, to be of regulatory significance. 

[End of table] 

[End of section] 

Footnotes: 

[1] For purposes of this testimony, we defined elderly as people 65 
years of age and older. 

[2] Pub. L. No. 103-417, § 3, 108 Stat. 4325, 4327 (codified at 21 
U.S.C. § 321(ff)). 

[3] Herbal supplements are one type of dietary supplement. An herb is 
a plant or plant part (such as leaves, flowers, or seeds) that is used 
for its flavor, scent, therapeutic properties, or a combination of 
these. "Botanical" is often used as a synonym for "herb." An herbal 
supplement may contain a single herb or mixtures of herbs. 

[4] GAO, Food Safety: Improvements Needed in Overseeing the Safety of 
Dietary Supplements and "Functional Foods," [hyperlink, 
http://www.gao.gov/products/GAO/RCED-00-156] (Washington, D.C.: July 
11, 2000). 

[5] GAO, Dietary Supplements: FDA Should Take Further Actions to 
Improve Oversight and Consumer Understanding, [hyperlink, 
http://www.gao.gov/products/GAO-09-250] (Washington, D.C.: Jan. 29, 
2009). 

[6] Our findings are limited to the individual retailers and sales 
staff we investigated. Our findings cannot be projected to any other 
retailers or sales representatives. 

[7] FDA does not require that herbal supplement manufacturers conduct 
such testing. 

[8] For the products reviewed as part of this testimony, most of the 
dietary ingredients involved were marketed prior to October 15, 1994, 
and therefore were not subject to the "new dietary ingredient" 
approval requirement. 

[9] 21 U.S.C. § 342(g) and 21 C.F.R. §§ 111.1 - .610 

[10] As of December 22, 2007, dietary supplement companies are 
required to submit any report received about a serious adverse event 
to FDA, as mandated by the Dietary Supplement and Nonprescription Drug 
Consumer Protection Act. (Pub. L. No. 109-462, § 3(a),120 Stat. 3469, 
3472 (codified at 21 U.S.C. § 379aa-1)). In addition, companies can 
voluntarily submit reports about moderate and mild adverse events. 
Others, such as consumers and health care practitioners, can submit 
reports of serious, moderate, and mild adverse events on a voluntary 
basis to FDA. 

[11] Labeling refers to the label as well as accompanying material 
that is used by a manufacturer to promote and market a specific 
product. 

[12] FDA authorizes these types of health claims under the Nutrition 
Labeling and Education Act of 1990 (Pub. L. No. 101-535, § 3(a), 104 
Stat. 2353, 2357-60 (codified at 21 U.S.C. § 321(r))) based on 
extensive review of the scientific literature, generally as a result 
of the submission of a health claim petition, using the significant 
scientific agreement standard to determine that the nutrient/disease 
relationship is well established. 

[13] A manufacturer may, alternately, obtain FDA approval to market 
its product as a drug intended for the treatment, prevention, cure, 
mitigation, or diagnosis of a specific disease. 

[14] Dietary supplement labeling may contain nutrient content claims, 
which describe the level of a nutrient or dietary substance in the 
product using terms such as "free," "high," and "low," or compare the 
level of a nutrient in a food to that of another food, using terms 
such as "more," "reduced," and "lite." 

[15] The constitutionality of some of FDA's health claim regulations 
for dietary supplements have been successfully challenged in court. In 
Pearson v. Shalala, 164 F.3d 650 (DC Cir. 1999), the United States 
Court of Appeals for the District of Columbia Circuit held that while 
inherently or actually misleading information could be absolutely 
prohibited, the First Amendment did not permit such a restriction on 
information that is only potentially misleading. The determination of 
whether regulation of potentially misleading information is 
permissible instead requires an analysis of the level of government 
interest, the potential advancement of the government interest by the 
regulation, and the reasonableness of the means chosen to accomplish 
the government's goals. 

[16] FDA receives approximately 4,000 such claims submissions per year 
for one or more claims for one or more products. 

[17] FDA defines a disease as "damage to an organ, part, structure, or 
system of the body such that it does not function properly (e.g., 
cardiovascular disease), or a state of health leading to such 
dysfunctioning (e.g., hypertension); except that diseases resulting 
from essential nutrient deficiencies (e.g., scurvy, pellagra) are not 
included in this definition." 

[18] Some natural states or processes such as aging, menopause, and 
the menstrual cycle, are not themselves diseases but can be associated 
with abnormal conditions that are diseases. Two criteria determine if 
such a condition will be considered a disease: (1) if the condition is 
uncommon or (2) if the condition can cause significant or permanent 
harm. 

[19] Our results are limited by the tests performed. Since we only 
tested a single bottle of each sample, our results cannot be projected 
beyond the single bottle tested. Our results also cannot be projected 
to any other products from the same manufacturers. 

[20] Different forms of mercury have distinctly different adverse 
effects. The tests we performed to identify mercury levels in 
supplements do not differentiate between these different forms of 
mercury. 

[21] EPA canceled all registrations of carbofuran, gamma-HCH 
(Lindane), and dichlorodiphenyltrichloroethane (DDT), the parent 
chemical of p,p-DDE. As of December 31, 2009, all related residue 
tolerances had been revoked. Tolclofos-methyl has never had a U.S. 
registration, but it is approved for use in other countries. 

[22] Discussions with these manufacturers were limited to their 
manufacturing and quality control processes. We did not question these 
manufacturers regarding the marketing of their products. 

[23] Our findings are limited to the individual retailers and sales 
staff we investigated. Our findings cannot be projected to any other 
retailers or sales representatives. 

[End of section] 

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