FDA Center for Devices and Radiological Health
October 31, 2001
“Sally” was afraid that she had been exposed to HIV. She didn’t want to buy a test in the local pharmacy because someone she knew might see her. She didn’t want to go to a clinic for the same reason. So, like many other consumers, Sally decided to purchase her HIV test from an Internet source. She took the test and was distraught to find that the result was positive. After several agonizing weeks, she went to her doctor who did a confirmatory test with a more sophisticated testing method and the result was negative. Sally did not have HIV. The test she purchased from the Internet had not been approved or cleared by the Food and Drug Administration (FDA), so it did not include the required labeling for a confirmatory test and counseling after a positive result.
Tests such as Sally bought are called in vitro diagnostic (IVD for short) tests. They use a sample of blood, urine, or other specimen taken from the human body. A doctor uses IVD tests along with a physical examination and a medical history to get a picture of a patients health status. Rarely does one IVD test provide a diagnosis.
Although many quality IVD tests are being sold over the Internet, other tests sold on-line may not work or be harmful. Some tests are illegal, that is, being sold without clearance or approval by the FDA. Examples of some types of IVD tests available from the Internet are:
- drugs of abuse
- blood sugar
- antibodies to silicone
While some of the above tests are approved or cleared for sale directly to the consumer (called over-the-counter or OTC), most IVD tests are not. FDA has cleared or approved many tests for use in a doctor’s office or for professional use only, but Internet marketers are selling them OTC or for unapproved uses.
Misleading advertising is another problem. Ads promise in-home results, but most IVD tests should be followed with a second, more sophisticated laboratory test to confirm the results. For example, tests to detect prostate cancer, called PSA (prostate surface antigen) test, are for screening only and should be used in conjunction with a rectal exam performed by a doctor. Elevated PSA test results often are further evaluated using additional tests such free PSAs or complexed PSA.
Internet sources also heavily advertise tests for detecting the presence of drugs such as marijuana, nicotine, amphetamine, and methamphetamine in children and employees. Again, to be sure of their accuracy, the positive results for these tests must be confirmed by additional laboratory tests. Another example of false advertising is claiming that disposable supplies, such as test strips for blood glucose monitors, will work in “any meter.”
So what precautions can a consumer take? If you think that you have a medical condition or disease, see your doctor or healthcare professional. Don’t try to diagnose yourself with questionable products obtained over the Internet. If you still want to buy an IVD test over the Internet, how can you tell if it is a legitimate product? First, ask if FDA has cleared or approved the product for use at home. Second, be wary if you see that the test:
- claims to diagnose more than one illness, e.g., cancer, arthritis, and anemia.
- is made in a country other than the United States. If so, check to see if FDA has cleared or approved the test for use at home.
- is made by only one laboratory and sold directly to the public. This is a “home-brew” test and is not intended for OTC sale.
The following general precautions apply to any healthcare purchase on the Internet:
- Don’t be fooled by a professional-looking website. Anyone can hire a web-page designer to create an appealing site.
- Avoid websites with only a post office number and no telephone number.
- Avoid websites that use the words “new cure” or “miracle cure.”
- Avoid products with impressive-sounding terminology that can hide bad science.
- Avoid products that claim the government, medical profession, or research scientists have conspired to suppress the product.
- Beware of claims that the test complies with all regulatory agencies.
- Beware of tests labeled for export only. This usually means that the test is not cleared or approved for sale in the U.S.
Although FDA’s resources are limited, the agency is taking action against Internet websites with misleading marketing or unsafe products. FDA has sent warning letters that demand the owners of these websites stop selling medical devices until they can prove FDA has cleared or approved the devices for sale. In a warning letter, FDA typically requests that the firm send to FDA (by a certain date) a description of the corrective action that it plans to take. FDA is working with the Federal Trade Commission (FTC) whose laws allow it to quickly regulate practices that are unfair and deceptive (see http://www.ftc.gov ). FDA also sends information about deceptive companies to the National Consumer League’s Fraud Information Center.
If you have questions or complaints about a particular medical device or website, you can call FDA at 1-999-INFO-FDA (1-888-463-6332) or your local FDA district office. They will be able to tell you if FDA has cleared or approved the medical device in question. Finally, if you want to purchase an IVD test promising a diagnosis for treatment of a serious illness, talk to your healthcare provider before using it to find out if additional tests will be needed.
You can report false claims to the Federal Trade Commission (FTC) at 1-877-FTC-HELP (1-382-4357); TDD at 202-32602501; by mail to Consumer Response Center, FTC, Washington, DC 20850. Report to the Food and Drug Administration’s (FDA) MedWatch program at 1-899-FDA-1088 or at www.fda.gov/medwatch.
This article was revised on November 4, 2001.