Legislation That Will Grant FDA Authority To Regulate Tobacco Products

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Main Category: Smoking / Quit Smoking
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 02 Apr 2008 - 15:00 PDT

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Markup legislation that would grant the FDA (Food and Drug Administration) authority over tobacco product regulation has been completed by the Committee on Energy and Commerce. The bill, H.R. 1108, the Family Smoking Prevention and Tobacco Control Act was approved with bipartisan support of 38 to 12.

John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, said "The legislation the Committee approved today will help protect the lives of Americans, particularly our youth, from the harmful effects of tobacco. Cigarette smoking is the leading cause of preventable death in the United States, and this legislation will help address this enormous public health problem."

Rep. Henry Waxman (D-CA) authored the legislation.

Waxman said" Today we have taken an important and long overdue step toward protecting our children and the public health. We passed this legislation with bipartisan support. The adjustments made in the legislation during the mark-up process have addressed many of the concerns that were raised with the bill. We now have a product that can and should move forward expeditiously. Tobacco has never been, and should never be, a partisan issue. I believe most Members of Congress share my desire to pass meaningful and truly effective tobacco legislation to reduce youth smoking and I am optimistic about the chances of the legislation become law this year."

Rep. Frank Pallone, the Chairman of the Subcommittee on Health, said "I commend the full committee for recognizing the need for government to finally regulate tobacco, one of the most dangerous products available to consumers. By passing this landmark legislation that allows the FDA to regulate the sale and the marketing of tobacco products, we are one step closer to keeping cigarettes out of the hands of our nation's children and saving millions of Americans from a lifetime of addiction."

H.R. 1108 would amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services (HHS) through FDA. The legislation provides FDA with resources necessary to fulfill its new responsibilities by requiring manufacturers and importers of tobacco to pay user fees to fund FDA's new regulatory responsibilities under the bill.

Dingel said that the legislation not only would give the FDA the authority to regulate tobacco, but would also give it the resources needed to meet these new responsibilities. He went on to say that the program will be fully funded through fees paid by tobacco companies, and resources will not be diverted away from the FDA's existing obligations.

H.R. 1108 will:
(Quoted verbatim from the Committee on Energy and Commerce website)

-- Subject new tobacco products to pre-market review

-- Allow the Secretary to require prior approval of all label statements

-- Allow the Secretary to restrict the sale or distribution of tobacco products, including advertising and promotion

-- Allow the Secretary to take specified actions, including public notification and recall, against unreasonably harmful products

-- Require the Secretary to establish tobacco product standards to protect the public health

-- Set forth standards for the sale of modified risk tobacco products

-- Prohibit cigarettes from containing any artificial or natural flavor (other than tobacco or menthol)

-- Reinstate FDA's 1996 Rule, which restricted tobacco marketing and sales to youth

-- Require the Secretary to establish a Tobacco Products Scientific Advisory Committee

-- Amend the Federal Cigarette Labeling and Advertising Act to change cigarette warning labels and advertising requirements. The legislation also makes changes to smokeless tobacco warning labels and advertising requirements

According to the Committee on Energy and Commerce website, this measure has the backing of public health groups and industry. Such tobacco companies as Philip Morris and US Smokeless Tobacco Company have backed the measure, as well as the National Association of Convenience Stores.

The legislation will now go to the floor of the House of Representatives.

http://energycommerce.house.gov

Written by - Christian Nordqvist
Copyright: Medical News Today
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