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.
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