March 1, 2010
Even in a time of widespread distrust of government, most people continue to put their faith in the Food and Drug Administration, says Daniel Carpenter, professor of government at Harvard University and author of the soon-to-be published book "Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA."
"FDA approval is like the Good Housekeeping seal of approval, only much more so," Carpenter says. "Sellers try to take advantage of that reputation."
But as reassuring as they may seem, the words "FDA approved" or "FDA registered" don't mean as much as consumers often assume. "FDA certification of a product is never a guarantee of safety or effectiveness of anything," Carpenter says.
The long list of products flaunting their FDA bona fides includes the Flex Belt, the HairMax laser comb and a supplement called Canditate. The Flex Belt, an electronic exercise device that stimulates the abdominal muscles, is described online as the "only ab belt toning system cleared by the FDA for toning, firming and strengthening stomach muscles." The website for HairMax says the product has "FDA clearance," an honor that supposedly represents "a milestone in hair care, hair growth and hair science." A site touting Canditate, a remedy for yeast infections, calls it "an FDA-approved herbal product."
All products that make health-related claims need some kind of clearance by the FDA. Cosmetics don't – unless they claim to treat specific problems such as dandruff or acne. Consumers trying to sort out marketing claims should understand that the FDA holds different products to different standards, says Dr. William Maisel, an assistant professor of medicine at Harvard Medical School and the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston.
Strictly speaking, he says, the only products that the FDA actually "approves" are drugs and serious high-tech medical devices such as implantable defibrillators. Other products may be "listed" or "registered" with the agency, but that's a big step down from actual approval; determining whether any particular product has actually gone through the right channels can be difficult.
It's important to realize that the FDA doesn't regulate vitamins, herbs or other dietary supplements. "If a company claims that a supplement is FDA approved, you should doubt that altogether," Carpenter says. Some companies openly flout that law, but the FDA has limited resources to stop offenders, he says.
A few herbs really do have approval, but only as an ingredient in FDA-approved drugs. For example, yohimbine, a compound derived from the herb yohimbe, is FDA approved for the treatment of male sexual dysfunction.
Because the FDA doesn't test supplements, companies aren't allowed to claim that their vitamins or herbs can treat or prevent any specific disease, which is why so many products claim to simply "promote" health. "They don't have to come to us to have that claim evaluated," says Dr. Robert Temple, director of the Office of Medical Policy at the FDA's Center for Drug Evaluation and Research. "It can usually be assumed that they don't have good evidence for it."
Prescription drugs, in contrast, have to go through a rigorous testing process to convince the agency that the product has some benefits that outweigh the risks. Over-the-counter drugs, such as cough syrups and pain relievers, are also monitored by the FDA, although the testing process isn't as rigorous, especially if the product is considered likely to be safe.
The agency takes a similar hard-line approach to serious medical devices such as implantable defibrillators. Like drugs, these devices — also called Class 3 devices — are supposed to go through serious testing to establish both safety and effectiveness.
For less-invasive medical equipment, known as Class 2 medical devices, the standards and the scrutiny drop dramatically. This category includes some hospital devices, such as X-ray machines, along with consumer products such as powered wheelchairs and skin lasers.
Exercise equipment can fall into the Class 2 category if the company claims to do something other than promote general fitness, such as rehabilitating injured joints or speeding weight loss. Before they can sell such products, manufacturers have to convince the FDA that devices are "substantially equivalent" to similar products already on the market, regardless of whether those existing products actually work. Passing this test gives them FDA "clearance," but not approval.
In some cases, companies claim to follow in the footsteps of existing products that seem very different from their own. In their application to the FDA, manufacturers of the HairMax laser comb claimed to be on the same level as a laser device intended to kill lice.
Manufacturers of Class 1 devices — gadgets with few or no moving parts, such as tongue depressors, usually have to simply register with the FDA. When the agency allows such devices to go to market, "they aren't passing judgment that one tongue depressor is any better than any other tongue depressor," Maisel says. "They're just saying it's a safe device."
In recent years, experts both within and outside the FDA have expressed concern that the agency has been too quick to approve some devices. The head of the FDA's Center for Devices and Radiological Health resigned last August after the agency approved a nerve stimulator and a device for knee surgeries despite the objections of FDA scientists. "Things were getting through that were not sufficiently tested," Carpenter says.
The FDA recently asked the Institute of Medicine to review the agency's approach to approving medical devices. The final report is scheduled to come out in spring 2011. The Institute of Medicine declined to comment on its findings so far.
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