FDA Set to Take Control of Tobacco Regulation

Still More Marketing Restrictions Expected for Industry

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NEW YORK (AdAge.com) -- In a landmark vote that was 14 years in the making, the U.S. Senate today passed a tobacco-control bill that gives the Food and Drug Administration sweeping new powers over the packaging, manufacturing and marketing of tobacco products.

Heavy advertising and marketing restrictions are expected for an industry whose top three companies spent a combined $44 million on measured media last year.
Heavy advertising and marketing restrictions are expected for an industry whose top three companies spent a combined $44 million on measured media last year. Credit: AP
After a return to the House for final passage, the Family Smoking Prevention and Tobacco Control Act will head to the White House, and all indications are that President Barack Obama will sign it into law. Mr. Obama was a co-sponsor of the bill when he was still in the Senate.

The FDA would then have regulatory control over the $150 billion tobacco industry, which would not only be forced to reveal, for the first time, the ingredients in its products -- much like food and drug companies must do -- but would also have its advertising and marketing curtailed even more than it already is.

And heavy advertising and marketing restrictions are expected for an industry whose top three companies -- Philip Morris, R.J. Reynolds and Lorillard -- spent a combined $44 million on measured media last year, according to TNS Media Intelligence.

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The bill calls for:

  • Restrictions on marketing and sales to youth, including a ban on all outdoor tobacco advertising within 1,000 feet of schools and playgrounds; a ban on all remaining tobacco-brand sponsorships of sports and entertainment events; a ban on free giveaways of non-tobacco products with the purchase of a tobacco product; a limit on advertising in publications with significant teen readership as well as outdoor and point-of-sale advertising, except in adult-only facilities, to black-and-white text only; and a restriction on vending machines and self-service displays to adult-only facilities.

  • Granting the FDA specific authority to restrict tobacco marketing.

  • Requiring detailed disclosure of ingredients, nicotine and harmful smoke constituents.

  • Requiring bigger and better health warnings on packaging.

  • Funding FDA activity through a user fee on manufacturers of cigarettes, cigarette tobacco and smokeless tobacco, allocated by market share, much like the user fee pharmaceutical companies pay.

  • Strict regulation of "reduced harm" products, which would prohibit the use of descriptions such as "light," "mild" and "low" to characterize a product on labels or in advertising. A manufacturer must file an application and receive an order before it markets any tobacco product as presenting a "modified risk."
The bill was backed by nearly 100 public-health organizations, including the Campaign for Tobacco-Free Kids, the American Cancer Society, the American Heart Association, the American Lung Association and the American Medical Association, all of which have said the legislation will help significantly curtail the estimated 3,500 people who try cigarettes each day and cut down on health-care costs.

In a statement, Sen. Edward Kennedy, D-Mass., the main sponsor of the legislation, said: "This long-overdue grant of authority to FDA to regulate tobacco products means that the agency can finally take the actions needed to protect our people from the most deadly of all consumer products. ... It is a life-saving act for the millions of Americans, especially the young, who will be spared a lifetime of addiction and premature death."

But not everyone was pleased. North Carolina Sens. Kay Hagan, a Democrat, and Richard Burr, a Republican, opposed the bill. Their state produces more tobacco than any other in the country, and the industry is responsible for more than 60,000 jobs there.

"The bill ... would severely impede the FDA's core mission," Mr. Burr wrote on his Senate blog. "Right now, the agency is responsible for ensuring food, drugs, medical devices and cosmetics are safe, effective and properly labeled. Adding tobacco to the list would stretch the FDA even more than it already is. In order to achieve effective regulation of tobacco, the FDA is not our best option. This is why I proposed regulation under an agency in the Department of Health and Human Services responsible solely for tobacco and nothing else."

North Carolina-based R.J. Reynolds and Lorillard aren't happy either. The Nos. 2 and 3 tobacco companies in the U.S. said the bill aids market leader Philip Morris, which is owned by Altria Group and markets the country's best-selling cigarette, Marlboro. The bill was crafted, in part, with the help of Richmond, Va.-based Philip Morris, which earned $25 billion in revenue in 2008 -- almost triple that of RJR ($8.8 billion) and more than quadruple the $4.2 billion of Lorillard.

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