Regulatory Policy

Many Doubt FDA Up to Regulating Tobacco

Critics and even some Food and Drug Administration supporters doubt that the agency is up to the task of regulating nicotine in cigarettes as a drug.

"This is something that strikes me as just off the wall," warns Gerald F. Meyer, a former deputy director of the agency's Center for Drug Evaluation and Research. "It is far afield from the FDA's core responsibilities."

  • The FDA already passes judgment on $1 trillion worth of products each year -- 25 cents out of every consumer dollar spent.

  • One former agency official says "the odds are overwhelming" that taking on tobacco regulation "is going to distort the agency's priorities."

  • It would also require $300 million a year in addition to the agency's current $980 million budget.

  • The agency is already engaged in anti-tobacco regulatory enforcement activities critics think is far from its legitimate role -- for instance, hiring teenage decoys to buy cigarettes in Texas, Washington, Florida and Illinois.

Analysts say the workload of regulating cigarettes would be enormous, since they contain more than 600 ingredients -- each of which would have to be evaluated for safety.

Source: Sheryl Gay Stolberg, "FDA, Taking on Tobacco, Now Faces a Critical Change," New York Times, August 3, 1997.


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