Word: fda
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Dates: during 1990-1999
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Smoking opponents have been petitioning the FDA to regulate cigarettes as a drug ever since 1988, when the Surgeon General confirmed that the nicotine contained in tobacco is an addictive drug, creating a dependence similar to those caused by heroin and cocaine. After considering the issue for years, the FDA finally responded late last month. In a letter to the Coalition on Smoking or Health, an alliance of groups that oppose smoking, FDA Commissioner David Kessler acknowledged that there was ample reason to apply drug laws to cigarettes. Wrote Kessler: "Although technology was developed years ago to remove nicotine from...
Shortly after the FDA letter became public, the ABC newsmagazine Day One ; broadcast an investigative report suggesting that the cigarette companies cynically manipulate nicotine levels to keep their customers hooked. For example, the report cited a 1972 internal memo by a Philip Morris scientist noting that "no one has ever become a cigarette smoker by smoking cigarettes without nicotine" and advising the company to "think of the cigarette as a dispenser for a dose unit of nicotine." In their defense, cigarette makers say it is no secret that they control the amount of nicotine in cigarettes. "How do you think...
...list of 700 ingredients in various brands of cigarettes, as reported to the U.S. government, is kept secret, but officials say it contains five substances classified as "hazardous," including some carcinogens. So if the FDA treats cigarettes as a drug, then the agency's duty under the Food, Drug and Cosmetic Act is clear. The fda must make sure that drugs are "safe" -- something certainly not true of cigarettes, which have been linked to everything from lung cancer to premature menopause. The FDA would have two choices: ignore the law or ban cigarettes...
...avoid that dilemma, the fda is asking that tobacco's fate be decided on Capitol Hill. "We recognize that the regulation of cigarettes raises societal issues of great complexity and magnitude," wrote Kessler in his letter. "It is vital in this context that Congress provide clear direction to this agency...
According to this recent letter, the FDA hasdetermined "it is in the best interest of thepublic health that [BRI's] studies be conducted inaccordance with the full requirements of theInvestigational Device Exemptions regulation," asopposed to less thorough pre-market approvalprocess...