FDA Exercises Tobacco Regulation for First Time—Rejects Four Products, Approves Two

Thursday, June 27, 2013

For the first time, the federal government has exercised its authority to approve and reject tobacco products, which it had been granted under a 2009 law.


The Food and Drug Administration (FDA) announced this week that it had authorized the sale of two new makes of cigarettes, both of them by the Lorillard Tobacco Company.


The FDA also rejected four other new tobacco products, but was prevented from releasing any information about them due to the law’s guidelines.


Under the law, the agency is allowed to reject tobacco products that experts say pose public health risks above and beyond comparable products already on the market. It can also limit ingredients, like nicotine, in cigarettes and other products.


Signed into law four years ago by President Barack Obama, the Family Smoking Prevention and Tobacco Control Act imposed new warning labels on tobacco ads and packaging, limited advertising to minors, and banned flavored cigarettes. It also required tobacco companies to seek FDA approval for its new products. However, the FDA had not exercised its regulatory authority until now.


The two new products receiving approval were Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box.


Some observers noted the fact that the products approved were both non-menthol may have been instrumental in the FDA’s decision. The banning of the menthol additive is something that the agency is reportedly considering.


News of the FDA’s actions caused Lorillard’s shares to rise as much as 4.9% before dropping back, according to Reuters.


The FDA pointed out that there is no other agency in the world that holds such power over tobacco products. Advocates of its use of the regulation described the news as a historic milestone.


“This is the first time in history that a federal agency has told tobacco companies that they could not market a new or modified cigarette because of the public health problems they pose,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, told The New York Times.


The FDA is currently reviewing about 4,000 applications for approval to market new tobacco products. Of those, only 500 are not yet in stores. The other 3,500 are already on the market, as the FDA has allowed them to be sold to the public on a provisional basis, pending the agency’s review.

-Danny Biederman, Noel Brinkerhoff


To Learn More:

In First, F.D.A. Rejects Tobacco Products (by Sabrina Tavernise, New York Times)

U.S. Approves Two New Newport Cigarettes in First Use of New Powers (by Toni Clarke, Reuters)

Judge Tells Big Tobacco Oversight by Courts and FDA Isn’t Either/Or (by Noel Brinkerhoff, AllGov)

Big Tobacco Claims FDA Members are Drug Industry Supporters (by Noel Brinkerhoff, AllGov)    

Small Cigarette Brands Accuse FDA of Passing Regulation that Favors Big Three (by Noel Brinkerhoff, AllGov)  

Landmark Bill to Regulate Tobacco (by Noel Brinkerhoff, AllGov)         


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