WASHINGTON -- The House Committee on Energy & Commerce on Wednesday completed a markup of legislation, authored by Representative Henry Waxman (D-Calif.), that would grant the Food & Drug Administration (FDA) the authority to regulate tobacco products. The committee approved the bill, Family Smoking Prevention & Tobacco Control Act (H.R. 1108), with bipartisan support, by a vote of 38 to 12.
The move comes despite concerns voiced by many lawmakers that the agency cannot handle its current workload, added an Associated Press report.
H.R. 1108 would amend the Federal Food, [image-nocss] Drug & Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health & Human Services (HHS) through the FDA. The legislation provides the FDA with resources necessary to fulfill its new responsibilities by requiring manufacturers and importers of tobacco to pay user fees to fund the new regulatory responsibilities under the bill.
"This legislation not only gives the [FDA] the authority to regulate tobacco, but also provides the agency with resources necessary to meet these new responsibilities," said committee chairman Rep. John Dingell (D-Mich.). "This program will be fully funded through fees paid by tobacco companies, and will not divert resources away from FDA's existing obligations."
The bill would do the following:
Subject new tobacco products to premarket 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 the 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 & Advertising Act to change cigarette warning labels and advertising requirements. The legislation also makes changes to smokeless tobacco warning labels and advertising requirements.Committee Republicans were almost divided on the legislation, with 11 voting for it, said AP. Those who opposed it said the agency has had enough trouble ensuring the safety of the nation's food supply and medicine. "This legislation, if it becomes law, would require the FDA to take on a task that is enormous, complex and completely outside its regulatory experience," said Rep. Joe Barton (R-Texas), and the ranking Republican on the committee. "It will almost necessitate a diversion from its core functions."
Barton said the Federal Trade Commission (FTC) was better suited for the job.
Waxman said the "unfortunate state of affairs" at the FDA did not mean the agency should ignore the harms of tobacco. "It simply means that when we give the agency this additional responsibility, we also must give it the resources necessary to handle the job and to handle it well," he said.
The user fees on tobacco companies could initially generate $90 million in the current fiscal year, according to AP. By 2018, that amount would increase to $755 million. Aides said the fees would be assessed based on market share.
The legislation would ban candy-flavored cigarettes, which attract younger smokers. It would also prohibit terms such as "light" or "mild" which many consumers mistakenly believe means the products are safer.
The Bush administration has voiced qualms about giving the agency responsibility for tobacco regulation because some people could get a false sense of security about the safety of tobacco products, AP said.
For decades, the FDA said it lacked authority to regulate tobacco so long as cigarette makers did not claim that smoking provided health benefits. In 1996, it reversed course and cited new evidence that the industry intended its products to feed the nicotine habits of the roughly 45 million Americans who smoke. Tobacco companies sued, and the case eventually landed in the Supreme Court. In 2000, the court ruled 5-4 that Congress did not authorize the FDA to regulate tobacco.
The current measure enjoys support from public health groups and from industry. Tobacco manufacturers such as Philip Morris USA, Swedish Match, U.S. Smokeless Tobacco Co. and others have voiced support.The National Association of Convenience Stores (NACS) has withdrawn most of its opposition. Others, such as Reynolds American, have voiced opposition.Click hereto read NACS' full letter to the committee.To read PM USA's full letter in support of H.R. 1108, click here.
Click hereto read Reynolds American's full statement in opposition to the legislation, "If FDA is 'Broken,' Why is Congress Focused on Adding Tobacco Regulation to the Agency Rather Than Ensuring the Safety of Food, Drug & Medical Devices in the United States?"
The bill must now go to the floor of the House for consideration. The Senate Health, Education, Labor & Pensions Committee approved similar legislation (S 625) on last August.
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