BETHESDA, Md--Many people believe that the law under which the FDA regulates foods, drugs, devices, and cosmetics contains an exception for tobacco, but FDA Commissioner David A. Kessler, MD, told a symposium on tobacco addiction that this is not so, and that his agency plans to forge ahead with its proposed regulations.
"If you go back to the 1906 Act and its successor act, the 1938 FD&C [Food, Drug and Cosmetic] Act, you will find that the Act in no way limits the agency's ability to regulate cigarettes," Dr. Kessler said at the conference, sponsored by the American Society of Clinical Oncology and the National Cancer Institute.
Other laws, such as the Consumer Product Safety statute and the federal Hazardous Substances laws, do exclude tobacco, Dr. Kessler said. But the FD&C Act defines a drug as "an article (except for food) intended to affect the structure and function of the body," he said.
The key word, Dr. Kessler stressed, is "intended," since nicotine(Drug information on nicotine), the addictive ingredient in tobacco, undeniably affects the body's structure and function.
By ferreting out documents showing that tobacco companies indeed had intended to manipulate the nicotine content of cigarettes, the FDA has made the case that tobacco products fall squarely within the meaning of the law, he said.
"Many people have asked me why it took so long for FDA to act," Dr. Kessler said. Although by the early 1990s there was almost universal agreement within the scientific and medical community that nicotine is an addictive drug, the FDA did not consider this knowledge sufficient by itself.
"In order to oversee tobacco products," he said, "FDA believed it needed to demonstrate that tobacco companies intend for their product to produce nicotine's pharmacological effects."