Consumers were warned today by the Federal Trade Commission and the U.S. Food and Drug Administration that unapproved Human Immunodeficiency Virus (HIV) test kits can give inaccurate test results. The warning came as the agencies outlined joint law enforcement actions taken to halt the sale of ineffective and unapproved HIV test kits in the United States. The FTC also announced settlement of charges that a company that advertised on the Internet, Cyberlinx Marketing, Inc., falsely represented that its HIV home test kits accurately detected HIV.
"Cyberlinx's egregious conduct threatened the health of those consumers who relied upon the representation that the kits gave accurate results," said Jodie Bernstein, Director of the FTC's Bureau of Consumer Protection.
The FDA has taken law enforcement actions against manufacturers and distributors of unapproved HIV test kits for the illegal sale of these test kits in the United States.
Currently, there is one HIV home collection test system that is approved by the FDA and legally sold in the United States. This test, "Home Access Express HIV-1 Test System," which is manufactured by Home Access Health Corporation, allows consumers to collect a blood sample for testing in the privacy of their home. The sample is then sent to a laboratory for analysis. The results are obtained by calling a toll-free telephone number using an anonymous personal identification number.
"The approved HIV test system has been carefully reviewed by the FDA to ensure that the test system is capable of yielding accurate, dependable results," said Steven Masiello, Director of the Office of Compliance and Biologics Quality at FDA's Center for Biologics Evaluation and Research. "The consumer has no assurance of the reliability or accuracy of the test results from unapproved HIV home test kits."
The unapproved HIV test kits being marketed on the Internet are often referred to as "rapid tests," since they provide test results in the home in 15 minutes or less. These rapid tests use a simple finger prick process for home blood collection or a special sponge device for saliva collection. The sample is applied to a plastic testing device and a developing solution is added to determine if the sample is positive for antibodies to HIV. According to the FDA, these unapproved tests, which lack, among other things, medical laboratory testing and controls, may give inaccurate results.
FTC and FDA Law Enforcement Actions
Cyberlinx and its president, Jeffrey S. Stein, have settled FTC charges that their unapproved HIV home test kits gave erroneous results. The FTC alleged that Cyberlinx and Stein violated federal law when they represented on their Internet site that their "EZ MEDTEST" HIV home test kits detected HIV infection in human blood. In fact, FDA testing of Cyberlinx's HIV home test kits confirmed that the products were not reliable in detecting the presence of HIV.
Under the stipulated final order settling the charges, Cyberlinx and Stein are banned from marketing any HIV home test kits in the future and must pay back the money they received from the sale of their kits.
The complaint outlining the charges against Cyberlinx and Stein alleges that the defendants violated the FTC Act through their false representations that the products they marketed as "EZ MEDTEST HIV Type I & II home test kit" accurately detected HIV infection in humans. As part of the agencies' joint investigation, the FDA tested the "EZ MEDTEST HIV Type I & II home test kit" sold by Cyberlinx using blood serum samples known to contain antibodies to HIV (HIV-positive) and found that the test kits failed to consistently detect the presence of antibodies to HIV. On July 8, 1999, the FDA notified Cyberlinx's customers about the inaccurate test kit results. According to the FDA notification letter, the test kits were labeled "HIV 1/2 STAT-PAK Ultra Fast." (The text of this notification letter can be found at www.fda.gov/medwatch/safety/1999/ezmedt.htm)
The order imposes a lifetime ban on Cyberlinx and Stein from marketing or selling any HIV home test kit. In the event that Cyberlinx or Stein wishes to market or sell any medical device other than HIV home test kits, they are required to post a $500,000 bond, the FTC said. If Cyberlinx and Stein jointly wish to engage in such endeavors, the required bond is $1,000,000.
In addition, within 10 days after entry of the order, Cyberlinx and Stein have to transfer to the Commission the money they received from the sale of their HIV home test kits. The order also prohibits the defendants from transferring, disclosing, or selling information regarding any person who paid any money to either of them at any time prior to entry of the order in connection with the purchase of any HIV home test kit.
The Commission vote to authorize the filing of the complaint and stipulated order was 4-0. It was signed by a federal District Court judge in Las Vegas, Nevada.
NOTE: Stipulated final judgments are for settlement purposes only and do not constitute an admission by the defendant of a law violation. Stipulated final judgments have the force of law when signed by the judge.
Since 1996, the FDA has conducted several investigations of firms selling and promoting unapproved HIV test kits in the U.S. In addition to seizing HIV home-use test kits and criminally prosecuting a California businessman responsible for distributing a fraudulently marketed home-use HIV test system, the FDA also has issued 12 Warning Letters to manufacturers and distributors for the illegal sale of unapproved test kits. In the past year, for instance, the following firms were cited:
- Akers Laboratories (New Jersey - manufacturing and distributing for export "HealthTest HIV 1+2 Rapid Assay Test Kits")
- Chembio Diagnostic Systems, Inc. (New York - manufacturing and distributing "HIV 1/2 STAT-PAK Ultra Fast" test kits)
- Pan Probe Biotech, Inc. (California - manufacturing and distributing "in vitro diagnostic products")
- Sovo Tec Diagnostics, Inc. (California - distributing "HIV 1/2 STAT-PAK Ultra Fast" and "HIV 1/2 Whole Blood" test kits)
The texts of these and the other FDA Warning Letters are available on the FDA's website at: http://www.fda.gov/foi/warning.htm.
Consumers should be aware that unapproved and unreliable HIV rapid test kits may continue to be marketed on the Internet and through magazine and newspaper promotions for use in the home. "The Internet makes it easy for con artists to take advantage of consumers," said Jane Henney, M.D., Commissioner of the FDA. "Therefore, consumers need to be cautious." The FTC and FDA will continue to investigate and prosecute firms and persons involved in the sale and distribution of unapproved HIV rapid test kits.
Copies of the FTC complaint and stipulated final order in the Cyberlinx and Stein case are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580; 877-FTC-HELP (877-382-4357); TDD for the hearing impaired 1-866-653-4261. To find the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
(FTC File No. 992 3226)
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