Explanations for this delay begin with the drug's manufacturer, Carter-Glogau Laboratories Inc. of Glendale, Ariz., and the distributor, O'Neal, Jones. Neither had sought F.D.A. approval to market the solution, a process that would have required clinical trials to demonstrate it was safe and effective. The distributor reportedly told callers that approval was unnecessary because the product was not a new drug, but a variation of others long on the market. (Competing companies thought otherwise and were seeking F.D.A. approval for their intravenous vitamin E preparations.)

Dr. Carl J. Bodenstein, a neonatologist at Sacred Heart Hospital, said that in January, when he and his associates told O'Neal, Jones of infant deaths possibly linked to E-Ferol, they were told in turn that the substance had been proved safe, and were threatened with libel or slander charges if they said otherwise. Other doctors also received assurances that the product was safe.

The company did not report the deaths to the F.D.A. Whether it had a legal responsibility to do so is not clear, because of the drug's disputed status. Any company marketing a product that needs Federal approval is obliged to report severe reactions within 15 working days of their discovery, according to William Grigg, an agency spokesman. But any company marketing a drug that does not need approval is under no such obligation. In a case such as E-Ferol, where a company did not seek approval but perhaps should have, the reporting requirement is fuzzy. Representative Weiss said he was asking the Justice Department to determine whether a criminal or civil suit should be brought in the case. The doctors in Spokane did not fill the reporting gap. They called a regional F.D.A. official in January to find out if E-Ferol had been approved, but they did not mention the deaths associated with its use. At the time, Dr. Bodenstein said, he and his colleagues were making ''a very subjective and very risky assumption'' that E-Ferol, and not a nursery infection, was causing the deaths. So they notified the distributor, who they believed had a responsibility to inform the F.D.A., and they told their story to a prominent pediatrician, whose professional standing and closer ties to the F.D.A., they thought, would lead him to inform the agency. 'Working in a Void'We decided to let people who knew how to play the game play it,'' Dr. Bodenstein said. But ''things fell through'' and the pediatrician, whom Dr. Bodenstein would not name, never acted. (Weeks later, doctors in Ohio and Tennessee alerted the Centers for Disease Control in Atlanta to clusters of deaths among infants receiving E-Ferol. The centers investigated and at the end of March told the F.D.A. the vitamin E solution might be dangerous.) The Spokane group also prepared a warning notice and request for information on similar deaths for publication in a professional journal. The material appeared this month. Remarking on the apparent lack of urgency, Dr. Bodenstein said he was afraid of warning doctors off vitamin E, a valuable product that was saving lives, before ruling out other causes of the nursery deaths. ''Keep in mind that we were the first people trying to sort all this out,'' he said. ''We were working in a void.'' The Food and Drug Administration, however, was not. The agency had been told repeatedly that the solution was being marketed without approval, but took no action until it learned of the mounting death toll. Agency officials have offered various explanations as to why they had not mandated a safety review: that vitamin E had been used safely for decades; that the intravenous form did not seem to be very different from other vitamin E products; that the whole class of vitamins was under long-term review, which made action on an individual vitamin premature. An internal agency memorandum noted, too, that the compliance section said it ''does not have the resources to go after all the drugs that are marketed'' and that ''because this is a vitamin, it has low priority.'' The author of the memorandum, Dr. Gloria Troendle, said she ''did not understand that any illness or deaths were thought to be related to the drug.'' Some observers agree this was a reasonable response. ''It's an imperfect world,'' said a former agency official, who asked not to be identified. ''They put vitamins at the bottom of their list of concerns and it blew up in their face. But I don't know any better way to do it.''