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Tobacco Regulation: How the FDA Took on Big Tobacco

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A Question of Intent; A Great American Battle with a Deadly Industry

David Kessler, Former Commissioner, U.S. Food & Drug Administration

 

I learned a lot about the FDA and tobacco regulation from this book. I bought it after catching the end of an NPR interview with the author, David Kessler. For me, it read like a thriller. A Question of Intent examines the inner workings of healthcare, science, government, law and politics as told by a former U.S. FDA Commissioner who took on Big Tobacco from 1990 through his resignation in 1997, while working under Presidents George Bush and Bill Clinton.

Family Smoking Prevention and Tobacco Control Act.

A little history……

By 1950, most states had laws prohibiting the sale of tobacco products to minors. In 1964, Surgeon General Luther Terry issued a report on smoking and health saying that tobacco causes lung cancer and is a main contributor to bronchitis.

In 1964, the surgeon general report officially recognized the health risks of tobacco. At the time, about 42 percent of adults in the United States smoked, compared with about 20 percent today.

In 1965, United States Congress passed the Federal Cigarette Labeling and Advertising Act (FCLAA), which required a health warning on all cigarette packs.

In 1970, President Richard Nixon signed the Public Health Cigarette Smoking Act, which banned cigarettes ads on the radio or television. It also required an updated warning on the cigarette packages. “Warning: The Surgeon General has determined that cigarette smoking is dangerous to your health.”

By 1988, smoking was banned on U.S. flights two hours or less, and 10 years later, all U.S. carrier flights became smoke-free.

The industry was hit with a big blow in 1998 when it agreed to a $206 billion master settlement with 46 states, the largest settlement in U.S. history.

In 1992 the federal government required states to set a minimum age of at least 18 years to purchase tobacco.

In 1996, the “FDA Rule” on tobacco regulation was issued to prevent and reduce tobacco use by children. How? By prohibiting non-face-to-face sales of tobacco, prohibiting outdoor advertising of tobacco products near schools or playgrounds, imposing more stringent advertising regulations, and prohibiting brand name sponsorships, among other things.

After tobacco regulation was issued in 1996, tobacco companies sued. In the 2000 Supreme Court case FDA v. Brown & Williamson Tobacco Corp., the court ruled that Congress had not given the FDA authority over tobacco and tobacco marketing. As a result, Congress was forced to provide explicit FDA authority to regulate tobacco. This was finally accomplished via the passage of the Family Smoking Prevention & Tobacco Control Act in 2010.

The Family Smoking Prevention and Tobacco Control Act is a federal statute in the United States. It was signed into law by President Barack Obama on June 22, 2009. The Act gives the Food & Drug Administration the power to regulate the tobacco industry. A signature element of the law imposes new warnings and labels on tobacco packaging and their advertisements. The goal of this is to discourage minors and young adults from smoking. The Act bans flavored cigarettes and places limits on the advertising of tobacco products to minors. It also requires tobacco companies to seek FDA approval for new tobacco products.

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