Use caution buying medical products online

FDA Consumer, Jan-Feb, 2005 by Michelle Meadows

* Claims regarding a benefit related to a classical nutrient deficiency disease, such as vitamin C and scurvy.

* Claims that a dietary supplement has an effect on the structure or function of the body, when such claims are supported by scientific evidence. An example of such a claim is "calcium builds strong bones" for a supplement that contains calcium.

* Claims that describe general well-being from consumption of the product.

The FDA recommends that consumers contact their health care providers before using dietary supplements. This is especially important for people who are pregnant or breast-feeding, chronically ill, elderly, under 18, or taking prescription or over-the-counter medicines.

Medical Devices

What are they? Medical devices are pieces of equipment, apparatus, machines, implants, test kits, or other similar articles intended to diagnose, heal, manage, or prevent diseases or conditions.

Problem sites: Examples of unlawful device sales include selling contact lenses or other prescription devices without a prescription or fitting by a qualified health care professional. Or a site may be selling an unapproved device and making fraudulent claims about it, such as promoting magnets to treat carpal tunnel syndrome and arthritis pain.

Some over-the-counter tests, such as pregnancy tests, are approved for consumer use, but most tests should be used by health professionals only, says Harold Pellerite, assistant to the director of the Office of Compliance in the FDA's Center for Devices and Radiological Health (CDRH). "And some companies claim you can rely on in-home results when results should be confirmed in a doctor's office."

Other Web sites advertise services on the Internet that entice consumers to come into a storefront to have questionable procedures. "It could be that the use of the device is unapproved or the device itself is unapproved," Pellerite says. For example, some companies promote full-body computed tomography (CT) scans as a way to detect early disease in people who have no symptoms of a problem. But the FDA has approved them only as a tool to diagnose disease when someone is experiencing symptoms or there is some reason for testing.

Risks: Consumers risk missing out on necessary medical treatment or being harmed if they use devices illegally marketed or sold through the Internet. The FDA has received reports of sight-threatening corneal ulcers from using non-corrective decorative contact lenses that were distributed without a prescription.

Joyce Iliya, an attorney in the Texas Office of the Attorney General in Austin, recently worked on several lawsuits involving one death and four serious injuries in patients who developed perforated colons as a result era procedure advertised through the Internet. The companies in the suits were performing what they called "colonic hydrotherapy" without physician involvement.

"They claimed to be able to use a device to clean the colon as a way to prevent serious diseases," Iliya says. "In Internet ads, they claimed to 'cure disease' and 're-energize life,' and people came in to get the procedure." According to the FDA, prescription colonic cleansing systems can be used only for medical purposes such as before a radiological examination.