Add a Dose of Skepticism
Produced in cooperation with the
Food and Drug Administration [FDA]
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
health-related 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
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.
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.
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/.
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
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.
Consumers spend an estimated $2 billion a year on unproven arthritis
remedies - thousands of dietary and 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
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 such claims must follow the FDA's pre-market
testing and review process required for new drugs.
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
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
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 not take any product containing comfrey
either orally or as a suppository and should not apply comfrey products to
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
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
- 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."
- 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
- 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
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 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.
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.
How to Report a Potential
To report a health product that you believe is being advertised falsely,
- the FTC by phone, toll-free, at 1-877-FTC-HELP (1-877-382-4357); TDD:
1-866-653-4261; 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
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