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, 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."