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How to Spot Health Fraud

by Paula Kurtzweil

You don't have to look far to find a health product that's totally bogus--or a consumer who's totally unsuspecting. Promotions for fraudulent products show up daily in newspaper and magazine ads and TV "infomercials." They accompany products sold in stores, on the Internet, and through mail-order catalogs. They're passed along by word-of-mouth.

And consumers respond, spending billions of dollars a year on fraudulent health products, according to Stephen Barrett, M.D., head of Quackwatch Inc., a nonprofit corporation that combats health fraud. Hoping to find a cure for what ails them, improve their well-being, or just look better, consumers often fall victim to products and devices that do nothing more than cheat them out of their money, steer them away from useful, proven treatments, and possibly do more bodily harm than good.

"There's a lot of money to be made," says Bob Gatling, director of the program operations staff in the Food and Drug Administration's Center for Devices and Radiological Health. "People want to believe there's something that can cure them."

FDA describes health fraud as "articles of unproven effectiveness that are promoted to improve health, well being or appearance." The articles can be drugs, devices, foods, or cosmetics for human or animal use.

FDA shares federal oversight of health fraud products with the Federal Trade Commission. FDA regulates safety, manufacturing and product labeling, including claims in labeling, such as package inserts and accompanying literature. FTC regulates advertising of these products.

Because of limited resources, says Joel Aronson, team leader for the nontraditional drug compliance team in FDA's Center for Drug Evaluation and Research, the agency's regulation of health fraud products is based on a priority system that depends on whether a fraudulent product poses a direct or indirect risk.

When the use of a fraudulent product results in injuries or adverse reactions, it's a direct risk. When the product itself does not cause harm but its use may keep someone away from proven, sometimes essential, medical treatment, the risk is indirect. For example, a fraudulent product touted as a cure for diabetes might lead someone to delay or discontinue insulin injections or other proven treatments.

While FDA remains vigilant against health fraud, many fraudulent products may escape regulatory scrutiny, maintaining their hold in the marketplace for some time to lure increasing numbers of consumers into their web of deceit.

How can you avoid being scammed by a worthless product? Though health fraud marketers have become more sophisticated about selling their products, Aronson says, these charlatans often use the same old phrases and gimmicks to gain consumers' attention--and trust. You can protect yourself by learning some of their techniques.

The following products typify three fraudulent products whose claims prompted FDA to issue warning letters to the products' marketers, notifying them that their products violated federal law. Two of the products also were added to FDA's import alert list of unapproved new drugs promoted in the United States. Products under import alert are barred from entry onto the U.S. market.

Take a look at these products' promotions. They are rife with the kind of red flags to look out for when deciding whether to try a health product unknown to you.

Paula Kurtzweil is a member of FDA's public affairs staff.

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Tip-Offs to Rip-Offs
Product No. 1: Pure emu oil
FDA determined that a pure emu oil product marketed to treat or cure a wide range of diseases was an unapproved drug. Its marketer had never submitted to FDA data to support the product's safe and effective use.

One Product Does It All
" ... extremely beneficial in the treatment of rheumatism, arthritis ... infections ... prostate problems, ulcers ... cancer, heart trouble, hardening of the arteries, diabetes and more. ... "
"completely eliminating the gangrene ...
"... antibiotic, pain reliever ... ."

Be suspicious of products that claim to cure a wide range of unrelated diseases--particularly serious diseases, such as cancer and diabetes. No product can treat every disease and condition, and for many serious diseases, there are no cures, only therapies to help manage them.

Cancer, AIDS, diabetes, and other serious diseases are big draws because people with these diseases are often desperate for a cure and willing to try just about anything.

Personal Testimonials
"Alzheimer's Disease!!! My husband has Alzheimer. On September 2, 1998 he began eating 1 teaspoon full of ... Pure Emu Oil each day. ... Now (in just 22 days) he mowed the grass, cleaned out the garage, weeded the flower beds, and we take our morning walk again. It hasn't helped his memory much yet, but he is more like himself again!!!"

Personal testimonies can tip you off to health fraud because they are difficult to prove. Often, says Reynaldo Rodriguez, a compliance officer and health fraud coordinator for FDA's Dallas district office, testimonials are personal case histories that have been passed on from person to person. Or, the testimony can be completely made up.

"This is the weakest form of scientific validity," Rodriguez says. "It's just compounded hearsay."

Some patients' favorable experiences with a fraudulent product may be due more to a remission in their disease or from earlier or concurrent use of approved medical treatments, rather than use of the fraudulent product itself.