FDA Unveils Multilingual Health Fraud Protection Initiative for Consumers

En Español

By: Jonca Bull, M.D., and Jason Humbert, R.N.

Jonca Bull

Jonca Bull, M.D., FDA’s Assistant Commissioner, Office of Minority Health

Consumers are constantly bombarded by advertisements for fraudulent medical treatments and cures — dangerous scams that often target the most vulnerable populations. FDA is fighting back with its own enhanced educational initiative. And we’re urging health professionals and community leaders to help.

During National Consumer Protection Week, from March 6-12, FDA is launching a new multimedia and multilingual initiative, including a new video (see below) and a consumer article, all translated into English, Spanish, Simplified Chinese, Korean, Vietnamese, and Tagalog. The purpose of these materials? Alerting consumers of the dangers of imported tainted products falsely marketed as dietary supplements, and providing tips on how to prevent health fraud scams.

We invite you to share this information with your patients and networks. Additionally, please visit www.FDA.gov/SupplementSafety for information in Spanish and some Asian languages on how to prevent health fraud. You also will find tips and advice by visiting the FDA Health Fraud Scams page.

Sellers of tainted medical products are mostly from the United States, but often sell products that originate overseas and target certain ethnic groups. Sometimes the labels are in languages other than English and such products may be sold at flea markets, swap meets, ethnic stores, or from the homes of individuals.

Jason Humbert

Jason Humbert, R.N.,CDR, U.S. Public Health Service, FDA’s National Health Fraud Coordinator, Office of Regulatory Affairs, Office of Enforcement and Import Operations

Companies also recruit friends, family members and co-workers to market products through word-of-mouth. They advertise on TV and radio, in magazines and newspapers, through direct mail and social media channels such as Facebook, Twitter, and Instagram and through e-commerce platforms.

Sellers prey on underserved populations and people with limited English proficiency who are prone to fall victim to health fraud scams due to limited or inadequate access to health care services, language barriers, low health literacy, and cultural beliefs.

Health fraud scams are a multimillion dollar industry involving the marketing of drugs, medical devices, biologics and cosmetics. Bogus products can cause serious or fatal injuries, and can harm consumers further by delaying the proper diagnosis and treatment of health conditions.

Fraudulent products are often offered to prevent, treat, or cure conditions such as obesity, diabetes, arthritis, cancer, and HIV. Some scammers encourage their clients to stop using their prescribed medications and replace them with their products without consulting their physicians first.

FDA has found that many of these products are mislabeled, and in some instances contain active ingredients that shouldn’t be available without health care provider oversight.

Consumers can report adverse reactions to FDA MedWatch by calling 1-800-FDA-1088 (1-800-332-1088) to request a report form, or file a complaint online. Patients’ names and reports are kept confidential. Additionally, consumers can anonymously report fraudulent products marketed on the Internet through FDA’s website. Consumers who don’t speak English can report problems with the help of their local Consumer Complaint Coordinator.

Jonca Bull, M.D., is FDA’s Assistant Commissioner, Office of Minority Health

Jason Humbert, R.N.,CDR, U.S. Public Health Service, is FDA’s National Health Fraud Coordinator, Office of Regulatory Affairs, Office of Enforcement and Import Operations

Don’t Get Scammed: Beware of Health Fraud

National Consumer Protection Week runs March 3–9, 2013. This coordinated campaign by federal, state, county and local government agencies, and non-profit partner organizations encourages consumers nationwide to make better-informed decisions.

In this video, the Commissioner of Food and Drugs Margaret A. Hamburg, M.D., and the FDA National Health Fraud Coordinator Gary Coody, R.Ph., discuss health fraud scams and give tips to consumers.

For More Information:

National Consumer Protection Week and FDA’s Fight Against Health Fraud Scam

By: Margaret Hamburg, M.D.

This week, FDA joins 29 other government agencies and a host of private groups to highlight National Consumer Protection Week, an annual event for consumers to learn how to protect their privacy, manage money and debt, avoid identity theft, and prevent frauds and scams. And, helping protect consumers against health fraud or scams is where the FDA plays a role.

For the FDA, banishing fraudulent remedies has been a top focus since the agency was created—and that was back in the early 1900’s, when consumer protection involved protecting consumers from peddlers of snake oil and “miracle” elixirs.

Margaret Hamburg, M.D.We’re still combating this illegal trade, but it has taken on a modern and much more prolific form. Health fraud scams are now advertised in newspapers, TV and cyberspace, promising sure-fire cure-alls, quick fixes, and “revolutionary remedies” for conditions that range from obesity to cancer. On FDA’s website, we define health fraud scams as the “deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial but scientifically unproven effect on health but that has not been scientifically proven safe and effective for such purposes.”  In other words, something that doesn’t do what it says it’s supposed to do.

Whether bought in a store or ordered by mail or online, products that fit this description—including drugs, dietary supplements, medical devices, biologics and cosmetics, many of which are produced and shipped from abroad—harm the buyers in more ways than one. These products can hurt consumers by delaying the proper diagnosis and treatment, causing serious or fatal injuries, and definitely wasting money.

Unfortunately, the deceit that makes this trade possible takes many forms. Some products—like the recently discovered counterfeit “Avastin”, which contained none of the approved and effective cancer drug—are worthless look-alikes of genuine medicines. Others are billed as “all natural” dietary supplements while containing hidden drugs and other chemicals that can be dangerous to health. Still other bogus products are promoted by statements that are misleading, false or not supported by scientific evidence.

The most common fraudulent products claim to prevent or treat such chronic diseases as cancer, arthritis, diabetes, heart disease, Alzheimer’s disease and multiple sclerosis. But other bogus cure-alls can emerge quickly in the wake of new public health hazards. For example, following the nuclear incident in Japan a year ago, the market was flooded with unapproved drugs claiming to provide protection from harmful radiation.

To keep these latter-day versions of snake oil from harming American consumers, FDA uses every tool in its legal arsenal. Since the start of 2011, our agency has warned more than 90 companies that inadequate or false labeling of ingredients and false or misleading claims of effectiveness violate FDA laws and regulations.

If there is no prompt corrective action, FDA takes additional enforcement measures. Since January 2011, 23 healthcare products—mostly supplements containing unapproved drugs — have been recalled from the market. In addition, at FDA’s request, U.S. marshals seized large quantities of fraudulent medications and dietary supplements. And side-by-side with steps taken in the United States, FDA works closely with authorities abroad to combat drug counterfeiters and to stop the sale of bogus products by foreign-based vendors on the Internet.

Despite these efforts, today’s media and globalized trade provide countless opportunities for purveyors of health fraud scams to victimize consumers. The most effective protection against this corruption is a healthy dose of skepticism. Every consumer can help combat health fraud by following three simple rules:

  • Be smart! If the offer sounds too good to be true, it’s probably a scam.
  • Be aware! Claims such as “Miracle Cure” or “Quick Fix” are red flags—learn to recognize them.
  • Be careful! Before taking an unproven or little known treatment, talk to a doctor or health care professional—especially when taking prescription drugs. And be especially cautious when buying medical products online.

To learn more, I encourage consumers to visit the National Consumer Protection Week website for the location of the events of the National Consumer Protection Week. Some of the programs—for example, in Philadelphia, Pennsylvania, in Tallahasee, Florida, and in Cincinnati, Columbus and Kettering in Ohio—include presentations by FDA staff.

And remember that at all times, there is a wealth of information on how to prevent and report health fraud scams on our website.This web-site contains videos and articles on how to avoid fraudulent schemes, and offers information about products that have been seized, recalled or are the subject of warnings from the agency.

Americans can count on FDA to continue doing its utmost to protect consumers from health fraud. But, the National Consumer Protection Week is a reminder that exposing and avoiding fraudulent products is a public health mission in which every one can, and should, do their part.

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration