In 1980, an Albuquerque teen-ager died after drinking several shots of bourbon at a Christmas party and swallowing two capsules he had been told were amphetamines. Police discovered that the capsules were not amphetamines, but non-prescription drugs made to look like them.
Since then, imitation amphetamines and barbiturates have been linked to 11 other teen-age deaths, according to the Food and Drug Administration.
The federal government faces an unusual jurisdictional problem in trying to control the so-called look-alike drugs. Because their ingredients can be obtained without a prescription, the Drug Enforcement Administration said it doesn't have jurisdiction. The FDA maintains it can play only a limited role because it has certified the ingredients as safe.
While the agencies say they are taking what steps they can, they are somewhat reluctant to take on new enforcement tasks in times of tight budgets.
Fake amphetamines contain large amounts of caffeine, phenylpropanolamine (a nasal decongestant and appetite suppressant) and the decongestant ephedrine. Imitation barbiturates contain acetaminophen, salicylamide, chlorpheniramine or other sedatives and hypnotic agents.
When the ingredients are taken separately and in small doses, they are considered safe, an FDA spokesman said. But they can cause nervousness, insomnia, temporary psychotic episodes, cerebral hemorrhage, drowsiness or death if mixed together in large amounts or taken with alcohol.
Many young people take them that way, a DEA spokesman said, because they believe that will help simulate the "high" caused by controlled substances. In mid-1981, DEA estimated that 30 million doses of fake narcotics were being manufactured each week and distributed through a network of 200 dealers.
Since 1980, FDA has filed administrative complaints against 45 companies that it claims violated counterfeit provisions of the Food, Drug and Cosmetic Act by making imitation drugs. Over the same period, the U.S. Postal Service has filed 20 complaints that accused drug makers of false advertising because they did not disclose that their products could cause illness or death.
Last week, FDA unveiled what it believes is its toughest tactic to date. It informed 15 small companies that they must submit any products that contain combinations of caffeine, ephedrine and phenylpropanolamine for certification as new drugs. "We have researched this extensively and can find no precedent for the three-drug combination. It would be hard to believe that anyone can show a medical purpose or need for these drugs," said Bill Grigg, an FDA spokesman. In effect, Grigg said, FDA's action will force many of the stimulants off the market.
Last year, DEA drafted a model law for states to ban look-alike drugs. So far, 30 states have enacted legislation. DEA also convinced three companies that make drug capsules to voluntarily refuse orders from suspected imitation drug makers.
While federal officials are confident that their tactics have driven many imitation drug makers out of business, Gene Haislip, a deputy assistant administrator at DEA, recently told Congress that "there remains a significant core of manufacturers and distributors who find the profits lucrative enough to be willing to change tactics and fight to remain in business."
For example, once the FDA began filing counterfeit charges, the imitation pill makers stopped making their pills in the same shape and size as controlled substances.
Some manufacturers have started to put warning labels on their products to avoid charges of false advertising claims. Others accept only telephone orders, Haislip explained, to avoid possible prosecution by postal authorities.
Sen. Gordon J. Humphrey (R-N.H.) said such maneuvering has convinced him that the only way to eliminate the imitation drugs is by giving the DEA, FDA and the Postal Service jurisdiction. He has introduced legislation that would prohibit the manufacture of drugs that "look like or are represented to be controlled substances." Products that promote drug abuse would be barred from the mails and FDA counterfeit laws would be expanded.
But at a recent hearing, Haislip urged Congress to delay passing new legislation. "We are trying to solve this problem through leadership. If we can't solve the problem through state laws then we might need to do it at a federal level, but that's not yet clear," he said.
Illinois Attorney General Tyrone Fahner disagreed with Haislip. Fahner told Congress that although his state has moved against dealers, it still has problems. "Some companies we have sued and closed have popped up again under a new name and location. Just because we stop a look-a-like distributor in Illinois doesn't mean we have solved the national problem."