FDA Marks First Anniversary Of Tobacco Control Act

Main Category: Smoking / Quit Smoking
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Jun 2010 - 0:00 PDT

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One year ago, President Obama signed the historic Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

Under the Tobacco Control Act, the U.S. Food and Drug Administration obtained authority to regulate tobacco products, with a special emphasis on preventing their use by children and youth and reducing the impact of tobacco on public health. The Act authorizes the FDA, among other things, to set tobacco product standards, require product listing and registration, revise health warning labels, create manufacturing standards, and review products intended to modify the risk of tobacco use.

Since the law's passage, the FDA has taken several important steps in a coordinated effort to prevent our children from becoming the next generation of Americans to die prematurely from tobacco use and ultimately reducing death and disease associated with tobacco use.

"The past year has seen the initiation of the scientific and regulatory foundation for the regulation of tobacco products," said Health and Human Services Secretary Kathleen Sebelius. "The Department of Health and Human Services will continue to work deliberately toward our goals for a healthier America."

The first anniversary of the Act marks a new phase in the federal government's efforts to address a problem that kills 400,000 Americans a year. The FDA is implementing several important requirements that significantly expand the FDA's role in protecting the public from tobacco products. "The country must leverage this historic moment to end tobacco-related death and disease," said HHS Assistant Secretary for Health Howard K. Koh, M.D., M.P.H.

The following provisions of the Act become effective on June 22, 2010:

- FDA rules that limit the sale, distribution, and marketing of cigarettes and smokeless tobacco to protect the health of children and adolescents become legally enforceable

- Provisions that prohibit the advertising or labeling of tobacco products with the descriptors "light," "mild," or "low" or similar descriptors without an FDA order

- Requirements that new, larger health warning labels for smokeless tobacco products begin to rotate on labels, labeling, and advertising and begin to be displayed on smokeless tobacco packaging

"As we complete our first year executing this important new responsibility, FDA has much to be proud of and much yet to do to improve public health through effective tobacco regulation," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.

During the past year, the FDA has:

- Established the Center for Tobacco Products

- Established the tobacco user fee program, which provides funding for FDA tobacco regulation support activities

- Begun to enforce the Act's prohibition on manufacturing, distributing or selling certain flavored cigarettes, such as spice-, fruit-, and candy-flavored cigarettes

- Implemented new statutory authorities, under which tobacco product manufactures have registered their establishments and listed their products with the FDA, provided detailed information about product ingredients and their own research into the health effects of their products

- Convened a Tobacco Products Scientific Advisory Committee, which began to study the impact of the use of menthol in cigarettes on the public health

"As FDA continues implementation of the Tobacco Control Act, we are committed to assuring that the actions we are taking are grounded in science and are open and transparent with participation by various stakeholders," said Lawrence R. Deyton, M.S.P.H., M.D., director of the FDA's Center for Tobacco Products. "It is crucial that the tobacco industry, retailers, state and local officials, public health advocates, and the public understand this law, the FDA's actions, and how they are intended to protect the public health."

Source:
U.S. Food and Drug Administration

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