‘Miracle’ Health Claims:

Add a Dose of

Skepticism

1-877-FTC-HELP

FEDERAL TRADE COMMISSION FOR THE CONSUMER

www.ftc.gov

FTC FACTS for Consumers

Produced in cooperation with the Food and Drug Administration

CURE-ALL

Whether they’re looking for a short cut to losing

weight or a cure for a serious ailment, consumers may be spending billions of dollars a year on

unproven, fraudulently marketed, often useless healthrelated products, devices and treatments. Why? Because health fraud trades on false hope. It promises

quick cures and easy solutions to a variety of problems,

from obesity to cancer and AIDS. But consumers who

fall for fraudulent “cure-all” products don’t find help

or better health. Instead, they find themselves cheated

out of their money, their time, and maybe even their

health. Fraudulently marketed health products can keep

people from seeking and getting treatment from their

own healthcare professional. Some products can cause

serious harm, and many are expensive because health

insurance rarely covers unapproved treatments.

To avoid becoming victims of health fraud, it’s

important for consumers to learn how to assess health

claims and seek the advice of a health professional.

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Common Health Fraud Targets

Officials at the Federal Trade Commission (FTC) and

the Food and Drug Administration (FDA) say health

fraud promoters often target people who are overweight or have serious conditions for which there are

no cures, including multiple sclerosis, diabetes,

Alzheimer’s disease, cancer, HIV and AIDS, and

arthritis.

Cancer

A diagnosis of cancer can bring feelings of fear and

hopelessness. Many people may be tempted to turn to

unproven remedies promoted as cancer cures. But they

and their loved ones should be skeptical of “miracle”

claims because no single device, remedy or treatment

can treat all types of cancer. Cancer is a name given to

a wide range of diseases; each requires different forms

of treatment that are best determined with the advice of

a health professional.

Cancer patients who want to try an experimental

treatment should enroll in a legitimate clinical study.

The FDA reviews clinical study designs to help ensure

that patients are not subjected to unreasonable risks.

For more information about cancer treatments,

contact the American Cancer Society; the nearest local

chapter will be listed in the yellow pages of your phone

book. For free publications on cancer research and

treatment, call the National Cancer Institute’s Cancer

Information Service at 1-800-4-CANCER (1-800-422-

6237) or log on to http://cancernet.nci.nih.gov.

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HIV and AIDS

Although legitimate treatments can extend life and

improve the quality of life for people with AIDS, there

is, so far, no cure for the disease. People diagnosed

with HIV, the virus that causes AIDS, may want to try

untested drugs or treatments. But trying unproven

products or treatments, such as electrical and magnetic

devices and so-called herbal cures, can be dangerous

and may cause HIV-positive individuals to delay

seeking medical care.

An example is the herb St. John’s Wort, which has

been promoted as a safe treatment for HIV. There is no

evidence that this herb is effective in treating HIV, and

in fact, studies have shown that it interferes with

medicines prescribed for HIV.

People who think they may be HIV-positive may

turn to home test kits. But claims for these products

may be misleading and possibly harmful. Safe, reliable

HIV testing can be done only through a medical professional or a clinic, or through the Home Access

Express HIV-1 Test System; it is the only system

approved for home use by the FDA.

The U.S. government has a toll-free HIV-AIDS

Treatment Information Service, 1-800-HIV-0440

(1-800-448-0440), which is staffed by English- and

Spanish-speaking health information specialists. Information also is available at www.hivatis.org.

Arthritis

Consumers spend an estimated $2 billion a year on

unproven arthritis remedies — thousands of dietary and

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so-called natural cures, like mussel extract, desiccated

liver pills, shark cartilage, CMO (cetylmyristoleate),

honey and vinegar mixtures, and magnets and copper

bracelets. But these remedies are not backed by adequate science to show that they offer long-term relief.

For current, accurate information on arthritis treatments and alternative therapies, call the Arthritis

Foundation at 1-800-283-7800 or visit its website at

www.arthritis.org.

Assessing Claims for Dietary

Supplements

The array of dietary supplements — vitamins and

minerals, amino acids, enzymes, herbs, animal extracts

and others — has grown tremendously over the years.

Although the benefits of some of these products have

been documented, the advantages of others are unproven.

For example, claims that a supplement allows you

to eat all you want and lose weight effortlessly are

false. To lose weight, you must lower your calorie

intake or burn more calories — for example, by increasing exercise. Most medical experts recommend

doing both.

Similarly, no supplement can cure arthritis or

cancer in five days. Such claims are false. Consumers

should be wary of any claims for a dietary supplement

that say it can shrink tumors, cure insomnia, cure

impotency, treat Alzheimer’s disease, or prevent severe

memory loss. These kinds of claims deal with the

treatment of diseases, and companies that want to make

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such claims must follow the FDA’s pre-market testing

and review process required for new drugs.

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FDA Regulation of Health Claims

Federal law allows for certain claims to be made in the

labeling of food and supplements. These include claims

approved by the Food and Drug Administration that

show a strong link, based on scientific evidence,

between a food substance and a disease or health

condition. These approved claims can state only that a

food substance reduces the risk of certain health problems — not that it can treat or cure a disease. Two

examples of approved claims are: “The vitamin folic

acid may reduce the risk of neural tube defect-affected

pregnancies,” and “Calcium may reduce the risk of the

bone disease osteoporosis.”

Dietary supplements also may carry claims in their

labeling that describe the effect of a substance in

maintaining the body’s normal structure or function, as

long as the claims don’t imply the product treats or

cures a disease. The FDA does not review or authorize

these claims. An example of such a claim is, “Product

B promotes healthy joints and bones.” When a dietary

supplement is promoted with a claim like this, the

claim must be accompanied with the disclaimer, “This

statement has not been evaluated by the Food and Drug

Administration. This product is not intended to diagnose, treat, cure or prevent disease.”

To learn more about the kinds of labeling claims

that can be made for foods and dietary supplements,

see www.cfsan.fda.gov/~dms/hclaims.html.
Safety Concerns

Prescription drugs must undergo clinical testing and

receive the FDA’s full review for safety and effectiveness before they are sold. Over-the-counter medicines

are subject to the OTC drug review process, which

determines safety and effectiveness of the products.

Dietary supplements are not required to undergo

government testing or review before they are marketed.

Yet, supplements may have drug-like effects that could

present risks for people on certain medicines or with

certain medical conditions. This is true, even if the

product is marketed as “natural.” For example, St.

John’s Wort can have potentially dangerous interactions with a number of prescription drugs, including

anticoagulants, oral contraceptives, antidepressants,

antiseizure medicines, drugs for HIV, and drugs to

prevent transplant rejection.

If you take a prescription medicine, always consult

your healthcare professional before starting a dietary

supplement.

Some dietary supplement substances require further scrutiny and study before they can be considered

safe for all people. Though many supplements have a

history of use, that history does not necessarily guarantee safety in every circumstance.

Some substances for which safety concerns have

been raised are comfrey, chaparral, lobelia, germander, aristolochia, ephedra (ma huang), L-tryptophan,

germanium, magnolia-stephania and stimulant laxative

ingredients, such as those found in dieter’s teas. The

herb comfrey, for example, contains certain alkaloids

that can cause serious liver damage. Consumers should

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not take any product containing comfrey either orally

or as a suppository and should not apply comfrey

products to broken skin.

Even some vitamins and minerals, when consumed

in excessive quantities, can cause problems. For example, high intakes of vitamin A over a long period

can reduce bone mineral density, cause birth defects

and lead to liver damage, according to the National

Academy of Sciences.

To ensure the safe use of any healthcare product,

read the labels and package inserts, follow product

directions and check with your healthcare professional.

How to Spot False Claims

When evaluating health-related claims, be skeptical. If

something sounds too good to be true, it usually is.

Here are some signs of a fraudulent claim:

● Statements that the product is a quick and effective

cure-all or diagnostic tool for a wide variety of

ailments. For example: “Extremely beneficial in

the treatment of rheumatism, arthritis, infections,

prostate problems, ulcers, cancer, heart trouble,

hardening of the arteries and more.”

● Statements that suggest the product can treat or

cure diseases. For example: “shrinks tumors” or

“cures impotency.”

● Promotions that use words like “scientific breakthrough,” “miraculous cure,” “exclusive product,”

“secret ingredient” or “ancient remedy.” For

example: “A revolutionary innovation formulated

by using proven principles of natural health-based

medical science.”

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● Text that uses impressive-sounding terms like these

for a weight-loss product: “hunger stimulation

point” and “thermogenesis.”

● Undocumented case histories or personal testimonials by consumers or doctors claiming amazing

results. For example: “My husband has

Alzheimer[‘s disease]. He began eating a teaspoonful of this product each day. And now in just 22

days he mowed the grass, cleaned out the garage,

weeded the flower beds and we take our morning

walk again.”

● Limited availability and advance payment requirements. For example: “Hurry. This offer will not

last. Send us a check now to reserve your supply.”

● Promises of no-risk “money-back guarantees.” For

example: “If after 30 days you have not lost at least

4 pounds each week, your uncashed check will be

returned to you.”

Avoiding Unscrupulous Dealers

It’s easy to see why some people can be taken in by

promoters’ promises, especially when successful treatments have been elusive. But resist pressure to decide

“on the spot” about trying an untested product or treatment. Ask for more information and consult a knowledgeable doctor, pharmacist or other healthcare professional. Promoters of legitimate healthcare products do

not object to your seeking additional information.

To learn whether the FDA or the FTC have taken

action against the promoter of a product you may be

considering, visit www.fda.gov/oc/enforcement.html

or www.ftc.gov. Visit www.cfsan.fda.gov/~dms/

ds-warn.html for a list of the dietary supplement

ingredients for which the FDA has issued warnings.

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In addition, if you’re considering a clinic that

requires you to travel and stay far from home for

treatment, check it out with your doctor. Although

some clinics offer effective treatments, others prescribe

untested, unapproved, ineffective, and possibly dangerous “cures.” In addition, the healthcare providers who

work in these clinics may be unlicensed or lack other

appropriate credentials.

For information about a particular hospital, clinic

or treatment center, contact the state or local health

authorities where the facility is located. If the facility is

in a foreign country, contact that government’s health

authority to see that the facility is properly licensed and

equipped to handle the procedures involved. For

information about facilities in Mexico, contact the

Secretary of Health (Secretaria De Salud) in the Mexican state where the facility is located.

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Virtual Health “Treatments”

www.ftc.gov/bcp/conline/edcams/miracle

Offers tips on avoiding health fraud online.

Dietary Supplements

www.cfsan.fda.gov/~dms/supplmnt.html

Offers an overview of dietary supplement regulation, including

safety and warning information.

Buying Medicines and Medical Products Online

www.fda.gov/oc/buyonline/default.htm

Offers tips and precautions for buying medical products online.

Online Resources
How to Report a Potential Problem

To report a health product that you believe is being

advertised falsely, contact:

● the FTC by phone, toll-free, at 1-877-FTC-HELP

(1-877-382-4357); TDD: 202-326-2502; by mail to

Consumer Response Center, Federal Trade Commission, Washington, DC 20580; or online at

www.ftc.gov. Click on “File a Complaint Online.”

● your state Attorney General’s office, state department of health, or local consumer protection

agency. These offices are listed in the blue pages of

your telephone book.

To report a product that you believe is fraudulently

labeled, call your local FDA office. The number is

listed in the blue pages of the telephone book.

To report an adverse reaction or illness that you

think is related to the use of a supplement or other

healthcare product, call a doctor or other healthcare

provider immediately. You also may want to report

your reaction or illness to FDA MedWatch. Call

1-800-FDA-1088 (1-800-332-1088) to request a report

form, or file a complaint online at www.fda.gov/

medwatch/report/hcp.htm. Patients’ names are kept

confidential. For more information on how to report a

problem to FDA, see www.fda.gov/opacom/

backgrounders/problem.html.

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Federal Trade Commission

1-877-FTC-HELP (1-877-382-4357)

www.ftc.gov

The FTC works for the consumer to prevent

fraudulent, deceptive and unfair business practices

in the marketplace and to provide information to

help consumers spot, stop and avoid them. To file

a complaint or to get free information on consumer

issues, call toll-free, 1-877-FTC-HELP (1-877-382-

4357), or use the complaint form at www.ftc.gov.

The FTC enters Internet, telemarketing, identity

theft and other fraud-related complaints into

Consumer Sentinel, a secure, online database

available to hundreds of civil and criminal law

enforcement agencies in the U.S. and abroad.

Food and Drug Administration

1-888-INFO-FDA (1-888-463-6332)

www.fda.gov

The FDA regulates over $1 trillion worth of products, which account for 25 cents of every dollar

spent annually by American consumers. It is part of

FDA’s job to see that the food we eat is safe and

wholesome and that the medicines and medical

devices we use are safe and effective. For more

information, call toll-free, 1-888-INFO-FDA (1-888-

463-6332), or visit the FDA website, www.fda.gov.

October 2001

F C EDERAL RADE OMMISSION T FTC OR HE ONSUMER

1-877-FTC-HELP www.ftc.gov