U.S. FDA Regulation of Tobacco

A Critical Step Forward Domestically, and a Stepping Stone Toward U.S. Ratification of Global Tobacco Treaty

In June 2009, U.S. President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act, landmark legislation giving the Food and Drug Administration (FDA) authority to regulate tobacco products. This is a critical step toward regulating what has historically been one of the least-regulated products in commerce, and reversing an epidemic that continues to be the leading preventable cause of death in the United States.

The Act also lays the groundwork for U.S. ratification of the global tobacco treaty. Formally known as the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), it has been ratified by more than 160 countries and protects 85 percent of the world’s people. As a Senator, President Obama was a leader in calling for then-President Bush to submit the treaty to the Senate. And as he signed the FDA bill into law, President Obama stressed the importance of working with the WHO and other nations to fight the tobacco epidemic.

Below is an overview of how this legislation stacks up against the WHO FCTC.

• The FDA tobacco law strengthens warning labels on tobacco products, requiring graphic warnings on 50 percent of the front and back of tobacco product packaging. As this measure is implemented, it will bring the U.S. into compliance with Article 11 of the global tobacco treaty.
• The Act restricts tobacco advertising and promotion, prohibiting youth-oriented tactics. However, it falls short of the comprehensive ban on tobacco advertising, promotion and sponsorship prescribed by Article 13 of the global tobacco treaty. For instance, it does not tackle so-called “corporate social responsibility” schemes used by Big Tobacco to buy goodwill and thwart effective public policies. According to the Federal Trade Commission’s most recent report, U.S. consumers are still being bombarded by tobacco promotions: tobacco giants reported spending nearly $13 billion to advertise and market cigarettes and smokeless tobacco products in 2006.
• The most dangerous loophole in the new law is allowing the tobacco industry a seat at the table on an FDA advisory committee. Because Big Tobacco has a fundamental and irreconcilable conflict of interest with public health and a track record of undermining public policy, Article 5.3 of the treaty explicitly safeguards health policy against tobacco industry interference. Including tobacco industry representatives on the FDA Tobacco Products Scientific Advisory Committee is inconsistent with treaty obligations, and runs counter to implementation guidelines that were unanimously adopted by ratifying countries in Durban, South Africa, in November 2008. According to Recommendation 4.8 of those guidelines, “Parties should not allow any person employed by the tobacco industry or any entity working to further its interests to be a member of any government body, committee or advisory group that sets or implements tobacco control or public health policy.”

FDA Commissioner Margaret Hamburg and other U.S. public officials must now resist attempts by Big Tobacco to delay and thwart the Family Smoking Prevention and Tobacco Control Act.

• Altria (Philip Morris USA) claimed to support the legislation, though it played a central role in challenging FDA regulation of tobacco throughout the 1990s. For more information, read “Pulling Out All the Stops: Philip Morris's Fight to Block FDA Regulation of Tobacco.”
• Philip Morris International (PMI), which no longer manufactures or markets tobacco in the U.S., nonetheless has a lobbying presence in Washington, DC. PMI CEO Louis Camilleri told shareholders in May 2009 that “We are a U.S. company. . . . We need politicians’ help.”
• The Association of National Advertisers has already stated its intention to fight the Act’s limits on tobacco marketing and promotion, and expects a tobacco corporation to take a lead on the suit.