United States Government Accountability Office

GAO Testimony 

Before the Special Committee on Aging, 

U.S. Senate

NUTRIGENETIC TESTING

Tests Purchased from Four 

Web Sites Mislead 

Consumers 

Statement of Gregory Kutz, Managing Director 

Forensic Audits and Special Investigations 

For Release on Delivery

Expected at 10:00 a.m. EST 

Thursday, July 27, 2006

 

GAO-06-977T 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

July 27, 2006

NUTRIGENETIC TESTING 

Tests Purchased from Four Web Sites 

Highlights of GAO-06-977T, testimony Mislead Consumers 

before the Special Committee on Aging, 

U.S. Senate 

Scientists increasingly believe that

most, if not all, diseases have a

genetic component. Consequently,

genetic testing is becoming an

integral part of health care with

great potential for future test 

development and use. Some

genetic tests are sold directly to the 

consumer via the Internet or retail

stores, and purport to use genetic 

information to deliver personalized 

nutrition and lifestyle guidance. 

These tests require consumers to 

self-collect a sample of genetic

material, usually from a cheek 

swab, and then forward the sample

to a laboratory for analysis.

Companies that market this type of

test claim to provide consumers

with the information needed to

tailor their diet and exercise 

programs to address their

genetically determined health risks. 

GAO was asked to investigate the 

“legitimacy” of these claims. This

testimony reflects the findings of

GAO’s investigation of a 

nonrepresentative selection of

genetic tests. Specifically, GAO

purchased tests from four Web sites 

and created “fictitious consumers”

by submitting for analysis 12 DNA

samples from a female and 2 

samples from an unrelated male, 

and describing this DNA as coming

from adults of various ages, 

weights, and lifestyle descriptions. 

GAO also consulted with experts in

genetics and nutrition. 

The results from all the tests GAO purchased mislead consumers by making 

predictions that are medically unproven and so ambiguous that they do not 

provide meaningful information to consumers. Although there are numerous 

disclaimers indicating that the tests are not intended to diagnose disease, all 

14 results predict that the fictitious consumers are at risk for developing a 

range of conditions, as shown in the figure below. However, although some 

types of diseases, such as cystic fibrosis, can be definitively diagnosed by 

looking at certain genes, the experts GAO spoke with said that the medical 

predictions in the tests results can not be medically proven at this time. 

Medical Conditions Predicted for 14 Fictitious Consumers 

Even if the predictions could be medically proven, the way the results are 

presented renders them meaningless. For example, many people “may” be 

“at increased risk” for developing heart disease, so such an ambiguous 

statement could relate to any human that submitted DNA. 

Results from the tests that GAO purchased from Web sites 1 and 4 further 

mislead the consumer by recommending costly dietary supplements. The 

results from the tests from Web site 1 suggested “personalized” supplements 

costing approximately $1, 200 per year. However, after examining the list of 

ingredients, GAO found that they were substantially the same as typical 

vitamins and antioxidants that can be found in any grocery store for about 

$35 per year. Results from the tests from Web site 4 suggested expensive 

products that claimed to repair damaged DNA. However, the experts GAO 

spoke with stated that there is no “pill” currently available that has been 

proven to do so. The experts also told us that, in some circumstances, taking

supplements such as those recommended may be harmful. 

In addition, results from the tests that GAO purchased from Web sites 1, 2, 

and 3 do not provide recommendations based on a unique genetic profile as 

promised, but instead provide a number of common sense health 

recommendations. If the recommendations were truly based on genetic 

analysis, then the 9 fictitious consumers that GAO created for these sites

using the female DNA should have received the same recommendations 

because their DNA came from the same source. Instead, they received a 

variety of different recommendations, depending on their fictitious lifestyles. 

For example, when GAO created lifestyle descriptions stating that the 

consumers smoked, they received recommendations to stop smoking. In 

contrast, if GAO said the consumers never smoked, they received 

recommendations to continue to avoid smoking. 

www.gao.gov/cgi-bin/getrpt?GAO-06-977T.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Greg Kutz at 

202-512-7455 or kutzg@gao.gov.
Mr. Chairman and Members of the Committee: 

Thank you for the opportunity to discuss our investigation of genetic tests 

that are sold directly to the consumer via the Internet, retail stores, or 

pharmacies. Recent advances in science have shown that the human 

genome is made up of about 20,000 to 25,000 genes, which are in turn 

made up of DNA.1

 These genes play a critical role in normal biological 

function, and scientists increasingly believe that most, if not all, diseases 

have a genetic component. Variants in these genes may increase an 

individual’s risk for various common, complex medical disorders. 

Consequently, genetic testing is becoming an integral part of health care. 

There are now genetic tests available for close to 1,000 diseases or 

conditions, including hereditary breast cancer and cystic fibrosis, and 

there is great potential for future test development and use. 

However, only about a dozen2

 genetic tests have been reviewed and 

approved by the Food and Drug Administration (FDA) to ensure their 

safety and effectiveness. A major reason is that the FDA regulates the 

safety and effectiveness of medical devices, meaning products intended to

diagnose, treat, mitigate, or prevent disease.3

 A genetic test is considered 

by the FDA to be a medical device only if it is manufactured as a 

freestanding “kit” and sold to a laboratory.4

 Presently, though, most 

genetic tests are not sold as kits but are manufactured in-house by clinical 

laboratories.5

 In these cases, the laboratory itself decides whether a test 

has sufficient “clinical validity” (i.e., is sufficiently effective at measuring 

what it purports to measure). Although all clinical laboratories must be 

approved under the Clinical Laboratory Improvement Amendments of 

1988 (CLIA) and meet general standards applicable to all laboratories, 

there is no genetic testing specialty under CLIA. This means that there are

 1

DNA stands for deoxyribonucleic acid. 

2

These include tests for cystic fibrosis; factor II and factor V Leiden, which affect blood 

clotting; cytochrome P450 genotyping, which affects the rate at which drugs are 

metabolized and thus can help in determining dosage; and Her-2 neu, which is used to

determine whether a woman will benefit from a breast cancer drug called Herceptin. 

3

See 21 U.S.C. §§ 360c(f)(1), 360e(c)(1) and 21 C.F.R. pt. 809. 

4

21 U.S.C. § 321(h). 

5

See 61 Fed. Reg. 10, 484.

Page 1 GAO-06-977T 
no specific requirements or unique standards for laboratories that perform 

genetic tests.6

This minimal oversight makes it difficult for consumers to determine 

whether a genetic test provides meaningful, scientifically based 

information. In fact, some companies are directly marketing to consumers 

DNA tests that provide health-related information without the advice of a 

physician, including so-called “nutrigenetic” tests. Nutrigenetic tests 

purport to analyze a limited number of genes to provide personalized 

nutritional and lifestyle recommendations. These tests, which have not

been approved by the FDA and are sometimes performed in laboratories 

that have not been approved under CLIA, range in cost from under $100 to

over $1,000. The tests require consumers to self-collect a sample of genetic 

material, usually from a cheek swab, and then forward the sample to a 

laboratory for analysis. Demand for this type of service appears to be on 

the rise; one company estimates that it has sold over 35,000 nutrigenetic 

tests to consumers since it began selling the tests in the United States in 

2003. 

Although the companies that market nutrigenetic tests typically stress that 

the results and information they provide are not intended to diagnose or 

treat any disease or disorder, they do claim that their tests will provide 

consumers with the information needed to tailor their diet and exercise 

programs to address their genetically determined health risks. Because of 

your concerns that the companies marketing this type of test may be 

misleading consumers by providing inaccurate information, you requested 

that we investigate the “legitimacy” of these claims. 

To complete our work, we investigated a nonrepresentative selection of 

four Web sites selling nutrigenetic tests. We chose these Web sites because 

they all claimed that their tests would analyze a limited number of genes, 

between 4 and 19, to create personalized dietary and other lifestyle-related

recommendations; they also stated that their products would not test for 

disease or predisposition to disease. These tests ranged in price from $89 

to $395. We purchased several similar types of tests from each site—14 in

total—so that we could compare a variety of results. To create a testing 

scenario, we developed a series of “fictitious consumers.” To do this, we 

ultimately submitted 12 DNA samples taken by cheek swab from a 9- 

month-old female, with consent from her parents. For comparison 

 6

See Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263(a).

Page 2 GAO-06-977T 
purposes, we also submitted 2 DNA samples taken from an unrelated 48-

year-old male. We had originally submitted DNA samples taken from a 

dog, a cat, and “blank” samples containing no DNA information, but these 

submissions were returned to us because they could not be processed by 

the laboratories. 

On questionnaires that were included with each of the tests, we described 

the DNA from the female and the DNA from the male as coming from adult 

men and women of various ages, weights, and lifestyle descriptions. Each

questionnaire asked for the same type of information about exercise, 

smoking, vitamin consumption, and intake of a variety of foods, but did 

not ask for information about current medical conditions or prescribed 

medications being taken. Figure 1 provides the basis for the 14 fictitious 

consumers we created.

Page 3 GAO-06-977T 
Figure 1: DNA and Lifestyle Descriptions Used to Create 14 Fictitious Consumers 

Source: GAO.

Male

DNA

Female

DNA

Kit from:

Gender:

Age:

Height:

Weight:

Web site 4

Female

72

4’9”

100

Regular exercise - never 

smoked - diet high in 

protein, fried foods - no 

caffeine - takes vitamins 

daily

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Female

71

5’7”

183

No exercise - smoker - diet 

high in grains, dairy, fats - 

high caffeine intake, does 

not take vitamins

Kit from:

Gender:

Age:

Height:

Weight:

Web site 1

Male

59

5’7”

140

Regular exercise - never 

smoked - diet high in 

protein, fried foods - no 

caffeine - takes vitamins 

daily

Kit from:

Gender:

Age:

Height:

Weight:

Web site 2

Male

40

5’8”

140

Regular exercise - never 

smoked - diet high in 

protein, fried foods - no 

caffeine - takes vitamins 

daily

Kit from:

Gender:

Age:

Height:

Weight:

Web site 1

Female

33

5’5”

175

No exercise - smoker -

diet high in grains, dairy, 

fats - high caffeine intake - 

does not take vitamins

Kit from:

Gender:

Age:

Height:

Weight:

Web site 2

Female

34

5’4”

120

Little or no exercise - 

former smoker - varied diet 

- moderate caffeine intake 

- takes vitamins 

occasionally

Kit from:

Gender:

Age:

Height:

Weight:

Web site 4

Male

45

6’0”

210

No exercise - smoker - diet 

high in grains, dairy, fats, 

high caffeine intake - does 

not take vitamins

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Female

46

5’6”

130

Little or no exercise - 

former smoker - varied diet 

- moderate caffeine intake 

- takes vitamins 

occasionally

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Male

68

5’6”

135

Regular exercise - never 

smoked - diet high in 

protein, fried foods - no 

caffeine - takes vitamins 

daily

Kit from:

Gender:

Age:

Height:

Weight:

Web site 2

Male

68

5’6”

185

No exercise - smoker - diet 

high in grains, dairy, fats - 

high caffeine intake - does 

not take vitamins

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Male

45

5’7”

180

No exercise - smoker - diet 

high in grains, dairy, fats - 

high caffeine intake - does 

not take vitamins

Kit from:

Gender:

Age:

Height:

Weight:

Web site 4

Male

65

5’6”

145

Little or no exercise - 

former smoker - varied 

diet - moderate caffeine 

intake - takes vitamins 

occasionally

Kit from:

Gender:

Age:

Height:

Weight:

Web site 1

Male

32

5’9”

150

Little or no exercise - 

former smoker - varied diet 

- moderate caffeine intake 

- takes vitamins 

occasionally

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Male

63

5’10”

200

No exercise - smoker - diet 

high in grains, dairy, fats - 

high caffeine intake - does 

not take vitamins

To assess whether the 14 results and related recommendations we 

eventually received provided any scientifically-based information, we 

consulted with outside experts in the fields of genetics and nutrition. 

Page 4 GAO-06-977T 
These experts have background in a variety of areas related to both fields, 

including genetic technology, genetic discrimination, legal and public 

policy issues pertaining to genetics and human research, pediatrics, 

prevention of communicable diseases and diseases associated with poor 

nutrition, and defining global nutrient requirements. We also reviewed 

recent studies on genetic links to specific diseases and on the efficacy of

nutritional supplements. In addition, we interviewed representatives from

the Web sites marketing the tests and the laboratories processing the 

results. We conducted our investigation from August 2005 through June 

2006 in accordance with quality standards for investigations as set forth by 

the President’s Council on Integrity and Efficiency. 

The results we received from all the tests we purchased mislead the 

consumer by making health-related predictions that are medically 

unproven and so ambiguous that they do not provide meaningful 

information to consumers. Although the results contain statements 

indicating that the information provided is not intended to diagnose 

disease or predisposition to disease, all of the 14 results we received do 

contain predictions that a consumer may interpret as diagnoses. For 

example, the 14 results indicate that our fictitious consumers are at risk 

for developing a range of conditions, including osteoporosis, high blood 

pressure, type 2 diabetes, heart disease, a reduced ability to clear toxins, 

brain aging, and cancer. The 3 results we received from the tests we 

purchased from Web site 4 also stated that our fictitious consumers were 

at below average risk for developing certain medical conditions. Experts 

informed us that although some types of diseases, such as cystic fibrosis, 

can be definitively diagnosed by looking at specific genes, the kinds of 

predictions we received cannot be proven given the level of scientific 

evidence available today. Even if the predictions could be medically

proven, the way the results are presented renders them meaningless. For 

example, many people “may” be “at increased risk” for developing heart 

disease because of a variety of factors, so such an ambiguous statement 

could apply to any human that submitted DNA. 

Summary 

Results from the tests that we purchased from Web sites 1 and 4 further 

mislead the consumer by recommending costly supplements that they 

claim are developed according to an individual’s unique DNA. In reality, 

the pills are not unique in any way, make unproven medical claims, and 

are potentially harmful. For example, the 3 results we received from the 

tests from Web site 1 encourage the purchase of “personalized” dietary 

supplements, supposedly formulated based on our fictitious consumers’ 

DNA and lifestyle profiles, and costing approximately $1,200 per year. 

Page 5 GAO-06-977T 
However, when we examined the lists of ingredients, we found that the 

pills do not appear to be customized because the 3 fictitious consumers we 

created for this Web site received recommendations to purchase the same 

product, despite the fact that there were 2 different DNA donors and each

had a different lifestyle profile. Moreover, experts confirmed that these 

supplements are substantially the same as typical multivitamins that can 

be found in any grocery store for about $35 per year. In addition, the 3 

results we received from the tests we purchased from Web site 4 claimed 

that for over $1,880 per year, its “unique” and “personalized” products 

could repair damaged DNA. The experts we spoke with stated that there is 

no “pill” currently available that has been proven to do so. Again, these 

supplements do not appear to be personalized because the 3 fictitious 

consumers we created for this site received the same recommendation. 

Finally, the experts we spoke with told us that in some circumstances, 

taking supplements such as those that were recommended to us can be 

harmful. For example, taking levels of some vitamins and nutrients that 

exceed the recommended daily allowance may promote cancers and 

chronic diseases. 

Furthermore, results from the tests that we purchased from Web sites 1, 2, 

and 3 do not provide dietary and lifestyle recommendations based on a 

unique genetic profile as promised. Instead, the recommendations we 

received simply provide generally accepted health advice directly linked to 

information we submitted via the questionnaires included with the tests. If

the recommendations were truly based on a consumer’s unique genetic 

profile, then the 9 fictitious consumers that we created for Web sites 1, 2, 

and 3 using the female DNA should have received the same 

recommendations. Instead, these 9 consumers received a variety of 

different recommendations, depending on the fictitious lifestyles we 

provided for them. For example, if we said the consumers smoked, we 

received recommendations to stop smoking. In contrast, if we said that the 

consumers never smoked, we received recommendations to continue to 

avoid smoking. These results lead us to conclude that we could have

invented any type of lifestyle description for the DNA we submitted and 

the recommendations would simply echo this information. Although these 

recommendations may be beneficial to consumers in that they constitute 

common sense health and dietary guidance, DNA analysis is not needed to 

generate this advice. 

During the course of our investigation, we found other information that 

raises concerns for consumers purchasing these tests. For example, we 

discovered that Web sites 1, 2, and 3 were in fact selling the same genetic

test developed by the same company, and that this company was 

Page 6 GAO-06-977T 
pressured by consumer groups in the United Kingdom to stop selling the 

test in that country. The company now sells the same type of test in the 

United States. In addition, we found evidence suggesting a lack of quality 

control by the laboratory actually conducting the DNA analysis for Web 

sites 1, 2, and 3. For example, even though all of the genetic information 

contained in the test results based on a single source should be identical,

we received disparate results for a sample from the same source from the 

tests we purchased from Web site 1. We also found that a laboratory used 

by Web site 4 is not approved under CLIA. 

Although there are numerous disclaimers indicating that the tests we 

purchased do not diagnose disease, the 14 results we received predicted 

that our fictitious consumers were at risk of developing a myriad of 

medical conditions. These predictions were similar for all of our fictitious 

consumers, no matter which DNA or lifestyle description we used. Results 

from the tests we purchased from Web site 4 also stated that our fictitious

consumers were at below average risk for developing certain diseases. 

However, after consulting with outside experts, we determined that these 

predictions cannot be medically proven at this time. Even if the 

predictions could be medically proven, the results use ambiguous 

language to describe the supposed health risks, rendering them 

meaningless. 

Results Contain 

Health-related 

Predictions That Are 

Both Medically 

Unproven and 

Meaningless 

Claims That Test Results 

Will Not Diagnose Disease 

As shown in table 1, the results we received from the tests we purchased 

from all four Web sites contain statements indicating that the information 

they provide is not intended to diagnose disease or predisposition to 

disease. The results also contain language stressing that the tests do not 

screen for genetic disorders and advising consumers to consult with a 

physician if they feel that they might be ill. 

Page 7 GAO-06-977T 
Table 1: Claims That Test Results Are Not Intended to Diagnose Disease 

Tests purchased

from Selected disclaimers

Web site 1 [This is] not a genetic test for disease or predisposition to 

disease, nor does it determine a medical condition. 

If you think you may be ill, consult your doctor. 

Web site 2 Please note that this screening is not a test for inherited 

disorders. 

Web site 3 [This is] not a genetic test for disease or predisposition to 

disease, nor does it determine a medical condition. 

If you think you may be ill, consult your doctor. 

Web site 4 [Our] products are not intended to diagnose or treat any 

disease or disorder; only your doctor can do so. 

Source: GAO. 

Predictions of Medical 

Conditions Received 

Despite these statements, the results we received from the tests we 

purchased from all four Web sites do contain medical predictions that a 

consumer may interpret as diagnoses. The overriding impression from all 

the results is that the 14 fictitious consumers we created are at risk for 

developing a variety of medical conditions, as shown in figure 2. 

Figure 2: Medical Conditions Predicted for 14 Fictitious Consumers 

Furthermore, the results from the tests we purchased from Web site 4 

even suggested that our fictitious consumers with the female DNA were at

below average risk for developing certain conditions. As comparison, the 2 

results we received from Web sites 1 and 3 for the fictitious consumers 

with the male DNA contained similar predictions, despite having different 

DNA variants from the female sample. Specific predictions from each test 

are discussed in further detail below.

With regard to the tests we purchased from Web site 1, the 3 results we 

received stated that the DNA sample from the female displayed an 

“increased risk of reduced calcium and Vitamin D absorption,” meaning 

Page 8 GAO-06-977T 
that she “may be at increased risk of developing osteoporosis.” Results 

from the same tests contained similar predictions with regard to risks for 

developing high blood pressure, type 2 diabetes, and heart disease. The 

DNA sample from the male that we submitted for this test showed the 

exact same risks, despite having different DNA variants from the female, 

as shown in figure 3. 

Figure 3: Predictions Received from the Tests Purchased from Web Site 1 

Source: GAO.

Kit from:

Gender:

Age:

Height:

Weight:

Web site 1

Male

32

5’9”

150

Male DNA

Submitted

DNA

Fictitious

profile

Medical

predictions

Increased risk of:

Osteoporosis

High blood pressure

Type 2 diabetes

Heart disease

Kit from:

Gender:

Age:

Height:

Weight:

Web site 1

Female

33

5’5”

175

Female DNA

Kit from:

Gender:

Age:

Height:

Weight:

Web site 1

Male

59

5’7”

140

Female DNA

As shown in figure 4, the 3 results from the tests we purchased from Web 

site 2 stated that the DNA sample from the female showed “gene variations 

that may alter the body’s ability to metabolize cholesterol” and variations 

that may affect “mineral absorption and bone metabolism.” These results 

also suggested that “certain protective systems” in the body “may have 

altered activity.” 

Page 9 GAO-06-977T 
Figure 4: Predictions Received from the Tests Purchased from Web Site 2 

Source: GAO.

Kit from:

Gender:

Age:

Height:

Weight:

Web site 2

Male

40

5’8”

140

Female DNA

Submitted

DNA

Fictitious

profile

Medical

predictions

Kit from:

Gender:

Age:

Height:

Weight:

Web site 2

Male

68

5’6”

185

Female DNA

Kit from:

Gender:

Age:

Height:

Weight:

Web site 2

Female

34

5’4”

120

Female DNA

Gene variations that may alter the body’s

 ability to metabolize cholesterol

Gene variations that may affect mineral

 absorption and bone metalbolism

Certain protective systems in the body

 may have altered activity

Of the 5 tests we purchased from Web site 3, 3 focused on detoxification, 1 

focused on heart health, and 1 focused on bone health. The 5 results thus 

showed a range of predictions, including that the DNA from the female 

contained gene variations that “may lead to a reduced ability to clear 

toxins” and that her “natural antioxidant defenses are less efficient at the 

removal of free radical damage.” The results also showed increased risk of 

high blood pressure and osteoporosis. The DNA we submitted from the 

male showed similar risks with regard to toxins and removal of free 

radicals, despite having different DNA variants from the female sample. 

See figure 5.

Page 10 GAO-06-977T 
Figure 5: Predictions Received from the Tests Purchased from Web Site 3

Source: GAO.

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Male

45

5’7”

180

Female DNA

Submitted

DNA

Fictitious

profile

Medical

predictions

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Female

71

5’7”

183

Female DNA

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Female

46

5’6”

130

Female DNA

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Male

63

5’10”

200

Male DNA

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Male

68

5’6”

135

Female DNA

Gene variations that may lead to a

 reduced ability to clear toxins

Natural antioxidant defenses are less

 efficient at the removal of free radical

 damage

Increased risk of:

Osteoporosis

High blood pressure

Note: Of the five tests we purchased from Web site 3, three focused on detoxification, one focused on 

heart health, and one focused on bone health. 

Page 11 GAO-06-977T 
As shown in figure 6, the 3 results from the tests we purchased from Web 

site 4 showed that the DNA sample from the female revealed “faulty 

methylation patterns” which may lead to “an above average risk for 

developing cardiac aging, brain aging, and cancer” and “sub-optimal 

glycation,” which can lead to diabetes and increased body fat. These same 

results also stated that the DNA displayed a “significant risk of developing

the age related conditions associated with elevated levels of DNA 

damage.” Results from the tests we purchased from Web site 4 also 

contain predictions that the DNA sample from the female shows relatively 

low risk for developing some diseases. For example, all the results from 

these tests note that the DNA displayed a “below average risk” of 

developing “the age related” conditions associated with “oxidation” and 

“inflammation.” According to the results, oxidation can lead to diabetes, 

heart disorders, and Alzheimer’s disease and inflammation can lead to 

diabetes, heart failure, and fragile bones. 

Figure 6: Predictions Received from the Tests Purchased from Web Site 4 

Source: GAO.

Kit from:

Gender:

Age:

Height:

Weight:

Web site 4

Female

72

4’9”

100

Female DNA

Submitted

DNA

Fictitious

profile

Medical

predictions

Kit from:

Gender:

Age:

Height:

Weight:

Web site 4

Male

45

6’0”

210

Female DNA

Kit from:

Gender:

Age:

Height:

Weight:

Web site 4

Male

65

5’6”

145

Female DNA

Faulty methylation patterns which may

 lead to an above average risk for

 developing cardiac aging, brain aging,

 and cancer

Sub-optimal glycation which can lead to

 diabetes and increased body fat

Significant risk of developing the age

 related conditions associated with

 elevated levels of DNA damage

Below average risk of developing the

 age related conditons associated with

 oxidation and inflammation

Page 12 GAO-06-977T 
Predictions of Medical 

Conditions Cannot Be 

Medically Proven 

Despite the implication that these predictions are based on the DNA 

submitted, none of the results we received contained scientific support to 

assist the consumer in evaluating their credibility, and there is no evidence 

to suggest that the tests have been evaluated by independent experts. 

Furthermore, the genetic experts we spoke with informed us that even 

though it is possible to make a definitive diagnosis of disease by looking at 

certain genes, none of the predictions contained in any of the results we 

received can be medically proven at this time. According to the experts, 

cystic fibrosis and Huntington’s disease are examples of illnesses that can 

be diagnosed based on an analysis of only one gene.7

 In contrast, the 

diseases and conditions identified in the test results we received involve 

complex bodily processes. According to the experts we spoke with, 

although genes are known to be associated with these processes, 

scientists have very limited understanding about the functional 

significance of any particular gene, how it interacts with other genes, and 

the role of environmental factors in causing disease. 

With regard to the specific predictions of heart disease, diabetes, 

osteoporosis, cancer, altered ability to metabolize cholesterol, and 

reduced ability to clear toxins, the experts informed us that research 

proving a genetic connection to the development of these conditions is at 

a very early stage and there are many issues yet to be resolved. 

In addition, the experts we spoke with also stated that the types of tests 

we purchased cannot be used to confirm that an individual has a reduced 

risk of developing these types of diseases. Therefore, the claims that a 

person may be at “below average risk” of developing certain “age related 

conditions” based on the analysis of a few genetic variants is misleading. 

There could be other genetic variants not tested for that confer risk or 

other environmental factors not assessed. 

Medical Predictions Are 

Also Meaningless 

Even if the predictions could be medically proven, the way the results are 

presented—using ambiguous language—renders them meaningless. For 

example, it is unclear what is meant by a “damaged” gene. According to 

the experts we spoke with, although a specific gene can be “damaged” in 

that it contains a variation that causes a loss of function or impaired 

 7

Cystic fibrosis is an incurable disease that causes mucus to build up in the body. People 

who have cystic fibrosis can have serious breathing problems and lung disease. 

Huntington’s disease is a rare condition that causes parts of the brain to break down, or

degenerate, causing rapid, jerky movements and dementia. 

Page 13 GAO-06-977T 
function, the results do not clearly explain what this means. The experts 

also told us that informing someone that they may be at increased risk for 

heart disease or that they have “high levels of DNA damage,” “faulty 

methylation patterns,” or “altered activity” in certain genes are all 

statements that are so ambiguous as to be meaningless. In fact, these types 

of predictions could apply to any human that submitted DNA. For 

example, according to the experts, many people “may” be “at increased 

risk” for developing heart disease because of known and unknown genetic

risk factors; environmental and behavioral risk factors such as obesity, 

smoking, and high cholesterol; and the interaction between these genetic, 

environmental, and behavioral factors. 

Results from the tests that we purchased from Web sites 1 and 4 further 

mislead the consumer by recommending expensive supplements. The 3 

results we received from the tests we purchased from Web site 1 

recommend a supplement that is supposedly based on an individual’s 

unique DNA; in reality, the supplements are not unique and are simply a 

grossly overpriced version of a typical multivitamin. The 3 results we 

received from the tests we purchased from Web site 4 similarly 

recommend expensive supplements that are supposedly unique to the 

consumer; these results also contain medical claims about the 

supplements that cannot be proven at this time. Finally, the experts we 

consulted informed us that, in some instances, taking certain supplements 

may be harmful. 

Results Encourage 

the Purchase of 

Supplements That Are 

Overpriced, Make 

Unproven Medical 

Claims, and May Even 

Be Harmful 

Supplements 

Recommended by the 

Tests Purchased from Web 

Site 1 

The results from the tests we purchased from Web site 1 recommended a 

90-day supply of a “personalized, custom” nutritional formula for $295, or 

approximately $1,200 per year. According to the product information, this 

formula is based on “what your genetic profile reveals as areas in your 

body that may need special support.” Despite this claim, when we 

examined the listed ingredients, we found that we were recommended the 

same product for all 3 of the fictitious consumers we created for this 

test—2 of these consumers actually had the DNA from the female, 1 had

the DNA from the male, and all 3 had different lifestyle descriptions, as 

previously shown in figure 1. However, when we compared the contents of

the supplements recommended for the 2 fictitious consumers with DNA 

from the female with the supplement recommended for the fictitious 

consumer with DNA from the male, we found that the ingredients were the 

same. 

Page 14 GAO-06-977T 
Moreover, the experts we spoke with confirmed that the supplements 

themselves are not unique; they contain vitamins that can be found in any 

pharmacy or grocery store. To find a comparable product, we went to a 

local drug store and found a generic multivitamin with the same 

ingredients, though with different amounts, as those in the recommended 

supplement. In contrast to the exorbitant price requested for the 

supplement, we paid just under $10 for a 100-day supply of this

multivitamin—or about $35 per year, as shown below. 

Figure 7: Comparison of Recommended Supplement from Web Site 1 with Generic

Multivitamin 

Source: GAO.

Niacin

Vitamin B-6

Folic Acid

Vitamin B-12

Biotin

Pantothenic Acid

Vitamin A

Vitamin C

Vitamin D

Vitamin E

Thiamin

Riboflavin

Calcium

Iron

Iodine

Magnesium

Zinc

Selenium

Copper

Manganese

Chromium

Molybdenum

Potassium

Both products contain:

Supplement from Web site 1 Generic multivitamin

$3.28 $0.10

$1,200 $35

Cost per day

Cost per year

Multivitamin

Multivitamin Multivitamin

Supplement

Supplement Supplement

Although these products are not identical, the experts we spoke with said 

that both the supplement and the generic vitamin would probably provide 

the same nutritional benefits for most people. However, they also 

cautioned that the elevated amounts of certain vitamins in the supplement 

may be harmful, as discussed later in this testimony. 

Supplements 

Recommended by the 

Tests Purchased from Web 

Site 4 

The results from the tests we purchased from Web site 4 recommended a 

“personalized” supplement “regimen” costing over $1,880 per year. 

According to the results, these supplements are personalized based on the 

DNA submitted and lifestyle descriptions provided on the questionnaires, 

and they are supposed to help “compensate” for “genetic deficiencies.” 

Specifically, the product information accompanying the test results claims 

that the regimen will repair damaged DNA through the consumption of 7 

pills per day, including 

Page 15 GAO-06-977T 
• 4 tablets per day of a supplement containing over “70 vitamins, 

minerals, and enzymes combined with “CAEs”, a proprietary extract 

from the Tropical Rainforest botanical Uncaria tomentosa, known as 

Cat’s Claw, which has been clinically shown to promote DNA repair in 

the body.” A 60-day supply costs $160. 

• 1 tablet per day of a supplement designed to “enhance the body’s ability 

to repair damaged DNA.” A 60-day supply costs $50. 

• 1 tablet per day of a supplement to control blood sugar and body fat. A 

60-day supply costs $50.

• 1 tablet per day of a supplement designed to manage the process 

“whereby certain genes are activated and deactivated.” A 60-day supply 

costs $50. 

As with the other products we were recommended, these supplements are 

not unique to the consumer. Although the 3 fictitious consumers we 

created for this site in reality all had the female DNA, they all had varying

lifestyle descriptions, as previously shown in figure 1. However, we 

received the same product recommendation for all 3 consumers. For 

example, our fictitious 72-year-old female nonsmoker with a diet high in

protein was recommended the same supplement regimen as our fictitious 

45-year-old male smoker with a diet high in fats, which seems illogical 

given that the supplements are supposedly developed based in part on the 

submitted lifestyle information. 

Furthermore, although the regimen touts “Cat’s Claw” as being the 

ingredient primarily responsible for DNA repair, the experts we spoke 

with told us that these claims are not medically proven at this time. 

According to the experts, Cat’s Claw is a plant whose pharmacological 

properties are being studied for a wide variety of biological effects, but the 

experts were aware of no reports in peer-reviewed scientific literature that 

have demonstrated the ability of Cat’s Claw to repair DNA. Furthermore, 

although there is some research indicating that taking antioxidants may 

help with DNA repair, no pill has yet been proven to repair damaged DNA. 

In fact, manufacturers of supplements are prohibited from claiming that 

their products can treat, cure, or prevent disease; products that make 

these claims are considered drugs and must be approved by the FDA 

before they can be sold. The FDA has already sent Warning Letters to 

several dietary supplement manufacturers who explicitly claimed that 

Cat’s Claw could help treat cancer and arthritis. However, we do not know 

whether the FDA would consider a claim of “DNA repair” to render Cat’s 

Claw an unapproved drug. 

Page 16 GAO-06-977T 
Regarding safety, the nutritionists we spoke with said that it is possible 

that improper use of dietary supplements can be harmful. For example, 

the nutritionists said that taking levels of some vitamins and nutrients that 

far exceed the recommended daily allowance8

 may promote cancers and 

chronic diseases. A recent statement issued by the National Institutes of 

Health9

 also notes that taking more than the recommended daily intake of

certain vitamins and minerals may cause adverse health effects. For 

example, smokers who consume excessive amounts of beta-carotene may 

be at increased risk for developing lung cancer, while consumption of 

excessive amounts of vitamin D and calcium may increase the risk of 

kidney stones. Furthermore, we were told that all nutrients or “food 

components” can be toxic if provided in sufficient quantities, but the 

susceptibility to toxicity varies among the population. For example, there 

is evidence that some people may be at risk because of excessive intakes 

of vitamin E, folic acid, calcium, or selenium. 

Nutritional Supplements 

May Also Be Harmful 

When we asked the nutritionists about the safety of specific ingredients in

the supplements recommended for our fictitious consumers, they 

generally believed that the supplements were comparable to typical 

multivitamins, as previously stated. However, they also expressed a variety

of concerns. For example, one of the nutritionists we consulted 

characterized the levels of vitamin B-6 in both products as “disturbing.” 

Another felt that the levels of Vitamin A in both were “high,” and that the 

supplements from Web site 1 contained excessive amounts of iron, 

because iron stays in the blood and could become toxic. Other experts 

told us that the supplements could be harmful if taken in combination with 

certain medications. For example, Cat’s Claw may have an adverse 

interaction with a medication prescribed for people who are at increased 

risk for forming blood clots, and individuals taking this medication are 

advised to avoid all supplements unless a physician approves.

 8

See http://dietary-supplements.info.nih.gov for detailed information on recommended daily 

allowances. 

9

National Institutes of Health, State-of-the-science Conference Statement: 

Multivitamin/Mineral Supplements and Chronic Disease Prevention, May 15–17, 2006.

Page 17 GAO-06-977T 
Results Do Not 

Provide 

Recommendations 

Based on a Unique 

Genetic Profile 

Results from the tests that we purchased from Web sites 1, 2, and 3 

promise recommendations based on the consumer’s unique genetic 

profile. However, the 11 results we received from these three sites suggest 

that the DNA submitted was not a factor in determining the 

recommendations. Rather, the results simply provide a number of 

common sense health recommendations based on information we 

submitted on the lifestyle questionnaires. 

Although Web sites 1, 2, and 3 acknowledge that information submitted on 

the questionnaires is taken into consideration when determining diet and 

lifestyle recommendations, the overall implication to the consumer is that 

the information derived from the DNA analysis is the most important 

factor, as shown in table 2. 

Table 2: Statements Promising Recommendations Based on Consumers’ Unique

Genetic Information 

Tests purchased

from Product Claims

Web site 1 • “Recommendations are based on your own DNA.” 

• By “adjusting your diet and lifestyle to your genetic profile, 

you can make sure that your body functions at an optimum 

level.” 

Web site 2 • “Recommendations are based on the unique combination of 

your genetic makeup” because it is important to “make 

lifestyle choices” that match your genes. 

Web site 3 • “Recommendations are based on your own DNA.” 

• Recommendations will “focus on gene variations, the 

potential of which may be offset by eating certain foods, 

increasing the intake of specific micronutrients, or making 

lifestyle changes.” 

Source: GAO. 

Tests Promise Unique 

Recommendations

Results Instead Provide 

Recommendations Based 

on Information Submitted 

on Questionnaires 

Despite these claims, the recommendations we received are simply 

common sense regimens directly linked to the information we submitted 

on the questionnaires included with each test. For example, 9 of the 11 

consumers we created for Web sites 1, 2, and 3 had the female DNA. If the 

recommendations were truly based on the consumer’s unique genetic 

profile, then these 9 consumers should have received the same

recommendations because their DNA came from the same source. Instead, 

they received a variety of different recommendations, depending on the 

fictitious lifestyles we provided for them. For example, when we said that

Page 18 GAO-06-977T 
a fictitious consumer with the female DNA smoked and ate a lot of fatty 

foods, we received recommendations to stop smoking and eat fewer fatty 

foods. In contrast, when we said that another fictitious consumer with the

female DNA never smoked and did not eat a lot of fatty foods, we received

recommendations to continue to avoid both smoking and eating foods 

high in fat. Similarly, when we said that fictitious consumers with the 

female DNA did not eat a lot of fruits and vegetables, we received 

recommendations to eat more of these foods. However, if we said that the 

consumer had a diet rich in fruits and vegetables, we were told to continue

this high level of consumption. 

We received similar recommendations with regard to the 2 remaining 

consumers we created using the male DNA. For example, for one of the

fictitious consumers with this DNA, we provided a lifestyle description 

stating that the consumer ate only moderate levels of leafy green 

vegetables, cantaloupe, and eggs—foods that are rich in antioxidants. In 

this case, the consumer was told to eat more foods rich in antioxidants. In

contrast, we said that the other consumer with the male DNA ate a lot of

antioxidant-rich foods. This time, we received recommendations to 

continue high consumption of these foods. Figure 8 provides further 

examples of the relationship between the lifestyle information we 

submitted on the questionnaires and the recommendations we received.

Page 19 GAO-06-977T 
Figure 8: Lifestyle Descriptions Directly Linked to Diet and Health

Recommendations

Source: GAO.

Kit from:

Gender:

Age:

Height:

Weight:

Web site 3

Female

71

5’7”

183

No exercise

Smoker

Diet high in carbohydrates

Diet high in fats

Kit from:

Gender:

Age:

Height:

Weight:

Web site 2

Male

40

5’8”

140

Regular exercise

Never smoked

Diet high in cruciferous 

vegetables (broccoli, 

cauliflower, turnips)

Diet high in fried foods

Kit from:

Gender:

Age:

Height:

Weight:

Web site 1

Male

32

5’9”

150

Female DNA

Female DNA

Male DNA

Little or no exercise

Former smoker

Diet low in food containing 

Omega-3 fatty acids

and calcium 

Moderate caffeine intake

Increase exercise

Stop smoking

Reduce intake of refined 

carbohydrates

Reduce saturated fats

Continue to exercise

Continue to avoid smoking

Continue consumption of 

cruciferous vegetables

Decrease total fat intake

Increase exercise

Continue to avoid smoking

Increase intake of Omega-3

fatty acids

Increase calcium intake

Decrease caffeine consumption

Submitted

DNA

Fictitious

profile

Submitted

lifestyle information

Lifestyle

recommendations

These results lead us to conclude that we could have invented any type of

lifestyle description for the DNA we submitted and the recommendations 

would simply echo this information. Although these recommendations 

may be beneficial to consumers in that they constitute common sense 

health and dietary guidance, DNA analysis is not needed to generate this 

advice. 

During the course of our investigation, we found other information that 

raises concerns for consumers purchasing these tests. For example, we 

discovered that Web sites 1, 2, and 3 were in fact selling the same genetic

test developed by the same company and that this company was pressured 

by consumer groups in the United Kingdom to stop selling the test in that

country. The company now sells the same type of test in the United States.

In addition, we found evidence suggesting a lack of quality control by the 

Other Investigative 

Findings Raise 

Concerns 

Page 20 GAO-06-977T 
laboratory actually conducting the DNA analysis for Web sites 1, 2, and 3. 

For example, even though all of the genetic information contained in the 

test results based on a single source should be identical, we received 

disparate results from the tests we purchased from Web site 1. We also 

found that the laboratory used by Web site 4 is not approved under CLIA. 

Nutrigentic Testing in the United Kingdom: The company that 

manufactures the tests used by Web sites 1, 2, and 3 used to sell the same 

type of test in the United Kingdom—consumers provided DNA samples 

and filled out a lifestyle questionnaire, and the company provided advice 

on what consumers should do to improve their health with diet and 

lifestyle changes. The Human Genetics Commission, the U.K.’s strategic 

advisory body on developments in human genetics, and GeneWatch UK, a 

consumer protection group, alleged that the company’s tests were 

misleading because no scientific evidence validated their clinical claims. 

Other scientists and consumer protection groups also cited numerous 

problems with the tests, including that the claims were exaggerated, the

service should not be offered without adequate counseling, and that they 

provided advice which differed little from standard guidance on diet and

exercise. 

Eventually, the tests were subjected to assessment by a team of three 

experts—a clinical geneticist, a scientist leading a program of research in 

nutritional genomics, and the chief dietitian of a leading teaching hospital.

They published the findings in a detailed report that concluded that there 

was no value in the genetic tests being offered. Subsequently, GeneWatch 

U.K. raised these concerns with major retail chains and pharmacies 

carrying the tests and urged them to stop selling the tests. By July 2002, 

the company was no longer attempting to sell their test directly to the 

consumer in the United Kingdom, either over the Internet or through 

retailers. In 2003, the company moved its operations from the United 

Kingdom to the United States. Despite the findings of the British experts, 

the company now sells the same type of test to American consumers. 

Contradictory DNA Analysis: The results we received from the tests 

we purchased from Web site 1 appear to be contradictory and reflect 

inaccurate lab results. Specifically, the results we received from these 

tests contained a listing of the genes being analyzed and any “variations” 

found in those genes. When we compared the two results we received

based on the DNA from the female, we found that the gene variations 

listed were not exactly the same: one result said that the DNA showed a 

variation in the “eNOS” gene, but the other result said that there was no 

variation in this gene. According to the experts we spoke with, because 

Page 21 GAO-06-977T 
the DNA sample was taken from the same individual, any gene variations 

should be identical. The experts also stated that a competent laboratory 

should reliably be able to detect the presence or absence of a particular 

gene variant. Consequently, concerns exist about whether this laboratory 

has basic quality control procedures in place to identify and prevent 

mistakes. 

Lack of CLIA Approval: As noted in the introduction to our testimony, 

laboratories performing genetic tests for medical purposes must be 

approved under the Clinical Laboratory Improvement Amendments of 

1988 (CLIA). In general, CLIA regulations address personnel qualifications, 

quality control and assurance, recordkeeping requirements, and also 

require laboratories to conduct proficiency testing. All laboratory tests 

performed to provide information about an individual’s health must be 

conducted by law in approved laboratories. During the course of our work, 

when we interviewed a representative from a laboratory conducting tests

for Web site 4, we were told that this lab is not approved under CLIA. 

The current regulatory environment provides only limited oversight to 

those developing and marketing new types of genetic tests. Consequently,

companies that sell nutrigenetic tests like the ones we purchased may 

mislead consumers by promising results they cannot deliver. Further, the 

unproven medical predictions these companies can include in their test 

results may needlessly alarm consumers into thinking that they have an

illness or that they need to buy a costly supplement in order to prevent an 

illness. Perhaps even more troubling, the test results may falsely assure 

consumers that they are healthy when this may not be the case. 

With further advances in science, nutrigenetic tests like those we 

purchased may in the future be valid, allowing consumers to use DNAbased analysis to make diet and lifestyle changes that will actually prevent 

the development of disease. However, as demand for these new tests 

continues to rise, it will become increasingly important for consumers to 

have reliable information in order to determine which tests are accurate

and useful. 

Mr. Chairman and Members of the Committee, 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. 

For further information about this testimony, please contact Gregory D. 

Kutz at (202) 512-7455 or kutzg@gao.gov. Contact points for our Offices of 

Conclusion 

Contact 

Page 22 GAO-06-977T 
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of this testimony. 

Page 23 GAO-06-977T (192190) 
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