Statement: Oral Arguments Before the U.S. Supreme Court On the FDA’s Authority to Regulate Tobacco December 1, 1999

Statement by Matthew L. Myers Executive Vice President and General Counsel, CAMPAIGN FOR TOBACCO-FREE KIDS

Dec. 9 1999

Washington, DC — Today’s arguments underscored two critical points – the U.S. Food and Drug Administration is on sound legal ground in asserting jurisdiction over tobacco products and it is critical to the nation’s public health that the Supreme Court uphold this authority.

The FDA has made a powerful case that tobacco products fall within the definition of “drugs” and “drug delivery devices” as those terms are defined in the Food, Drug and Cosmetic Act. Tobacco clearly meets the statutory definition of a drug and should be covered by the same common sense regulations that govern other consumer products.

The tobacco industry’s arguments boil down to two very dangerous assertions. The first is that the FDA cannot now assert jurisdiction over tobacco products because it has not done so previously. Should the Supreme Court accept this argument, it would be rewarding the industry for conducting a 40-year campaign to conceal the truth about the deadly and addictive nature of its products from the FDA, Congress, and the American public.

The industry’s second argument is that the FDA can regulate a product only if the manufacturer makes a specific claim of a positive therapeutic effect. If the Court were to accept this argument, it would create a huge loophole that would invite manufacturers to shade the claims they make about their products to avoid government oversight. The consequences for public health and safety are potentially disastrous.

The tobacco industry has been a rogue, unregulated industry for decades. The FDA’s assertion of jurisdiction over tobacco products and the Rule it issued in August 1996 represent the most important action ever taken by the federal government to rein in the tobacco industry and reduce tobacco use among our nation’s children. Whether through a ruling of the Supreme Court or an act of Congress, it is vital that the FDA be allowed to move forward with this important initiative to protect the public health.

 

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