"The Food and Drug Administration, a powerful yet largely invisible bureaucracy ... is poised at the brink of fundamental, some say dangerous, change," The New York Times reported yesterday.
As the agency "contemplates expanding its vast regulatory repertory to include tobacco, critics and even some supporters are questioning whether it is up to the task," the paper reported.
Some legislators and former government officials believe that the FDA is not up to the challenge of regulating tobacco. Gerald Myer, who retired in 1994 as deputy director of the FDA's Center for Drug Evaluation and Research, said, "This is something that strikes me as just off the wall. It is far afield from the FDA's core responsibilities." Rep. James Greenwood, R-Pa., said, "I don't have confidence that we could toss them this issue of regulating the contents of tobacco products and get a good result."
If the FDA does begin regulating cigarettes, "[t]he workload would be enormous; there are more than 600 ingredients in cigarettes and each one would have to be evaluated for safety," according to the Times.
In April, the paper reported, a federal judge in North Carolina ruled that the FDA had the right to classify nicotine as a drug and cigarettes as drug-delivery devices. According to the Times, David Kessler, former FDA commissioner who resigned earlier, contends that this "victory alone is the proof of the agency's prowess." Kessler said, "The fact is that the agency took on an American Goliath and won. If you have any doubts about the agency's capability, put them to rest."
According to the Times, because some lawmakers question "whether the FDA is ready for tobacco," they may be less willing to provide it with the $300 million a year needed "solely to regulate tobacco." Rep. Greenwood said, "I would not be surprised to see Congress just leave the FDA regulatory piece out of it now."
In 1976, when the agency began to review medical devices, it asked Congress for funds to hire 1,200 new employees, but did not receive the funds.
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