FDA Approves First Over-the-Counter Home Drug Testing Kit

DRUG TESTING February 1997

On January 21, the FDA approved the marketing of the first over-the-counter home drug testing kit designed to help parents determine whether their children are using drugs (Marlene Cimons, "FDA Approves First Over-Counter Home Urine Test Kit for Drug Use," Los Angeles Times (Washington Edition), January 22, 1997, p. A5; John Schwartz, "Kit for Home Drug-Testing Is Approved," Washington Post, January 22, 1997, p. A1).

The decision came several months after congressional Republicans criticized the FDA for infringing on parents' rights by refusing to sanction a similar home drug testing kit marketed by Sunny Cloud, a Georgia entrepreneur. Cloud's company, Parents Alert, has sold her drug testing kits by mail order and refused to seek FDA licensing, arguing that the FDA does not have jurisdiction over her product. The FDA claims jurisdiction over the kits, regarding them as "medical devices." The FDA has allowed Cloud to continuing marketing her kit by mail until they develop a policy for considering applications for such kits. For more background information, see "FDA's Regulation of Home Drug Test Attacked," NewsBriefs, November 1996.

The approved kit is marketed as "Dr. Brown's Home Drug Testing System®." The "Dr. Brown" is J. Theodore Brown, a clinical psychologist with a background in substance abuse treatment, who founded Personal Health and Hygiene Inc., that produces the kit. Brown said the kits should be available by the end of March at a cost of about $30. He said users could expect test results from one to three days after the lab receives the sample. (Kathleen Day, "Persistence Comes Up Positive," Washington Post, February 10, 1997, Business Section, p. 13).

Dr. Brown's Home Drug Testing System® includes "a kit for urine collection, storage and mailing; a laboratory testing service; and a results and referral service," according to the Department of Health and Human Services (HHS). The new kit tests urine for the presence of marijuana, PCP, amphetamines, cocaine, heroin, codeine and morphine (U.S. Department of Health and Human Services, "FDA Approves OTC Test System for Drugs of Abuse," HHS News, January 21, 1997).

The designated drug-testing labs have been certified by the Substance Abuse and Mental Health Administration, the College of American Pathologists and the Health Care Financing Administration, the FDA said. The labs perform confirmation tests to minimize the possibility of false positives, which the FDA said can be produced by certain medicines and foods. For results of the test, consumers will call an 800 phone number and identify themselves wih an identification number from their kit. Phone representatives will inform them of the results, and can provide information about the results and referrals to drug abuse counseling and medical services.

Chris Policano, a spokesman for Phoenix House, a national drug abuse treatment and prevention organization, said the kits are a tool, but not a solution to the problem. "The ideal situation is one where parents and teenagers are communicating with each other," said Policano. In a press release on January 21, HHS Secretary Donna E. Shalala agreed, saying, "It is crucial for parents to talk openly with their children about the dangers of drug abuse."

The HHS news release is located at: http://www.fda.gov/bbs/topics/NEWS/NEW00553.html.