FDA Approves New Cigarettes in First Use of New Regulatory Power Over Tobacco

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It’s taken four years, but the U.S. Food and Drug Administration (FDA) has finally exerted its authority to review and regulate cigarettes and certain tobacco products.

Two new Newport non-menthol cigarettes will soon appear on the market, thanks to powers Congress granted to the FDA in 2009 to study the safety of cigarettes, cigarette tobacco and rolled tobacco. The approval does not indicate any endorsement by the FDA that the cigarettes are safe, or safer than currently sold smokes, only that the new products are not any more harmful than the company’s existing cigarettes. The agency also rejected four other new cigarettes from other manufacturers, stating that these makers failed to demonstrate that these cigarettes were similar to already available products.

“Today’s historic announcement marks an important step toward the F.D.A.’s goal of reducing preventable disease and death caused by tobacco,” said Dr. Margaret A. Hamburg, the agency’s commissioner in a statement. “The F.D.A. has unprecedented responsibility to protect public health by not allowing new tobacco products under F.D.A.’s authority to come to market without F.D.A. review.”

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Since receiving the much fought-for regulatory power under the Family Smoking Prevention and Tobacco Control Act, the FDA began scrutinizing the marketing of cigarettes, inaugurating its authority by banning cigarette advertising or sponsorship of entertainment or sporting events, since children are likely to be in attendance. The agency has also forbidden use of terms such as “light” and “low-tar” labels on packaging after a Surgeon General’s report showed that so-called light cigarettes are no less harmful than regular cigarettes. And in an attempt to send a message to the tobacco industry, the FDA also proposed more graphic warnings on cigarette packaging, but is currently modifying its campaign after tobacco companies sued the government, claiming the new labels, which the FDA wanted to mandate, violated free speech.

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For their part, cigarette manufacturers have turned their attention to new markets — as cigarette sales in the U.S. continue to decrease — dropping 33% from 2000 to 2011, some companies have concentrated on overseas markets, in Asia and Africa. New ways to consume tobacco also represent fresh opportunities. Last August, the Centers for Disease Control reported a 123% increase in the consumption of smokeable tobacco products like cigars and pipes in the U.S. The 2009 law did not provide the FDA with regulatory control over cigars, pipe tobacco or e-cigarettes, so it’s likely no coincidence that the largest spike in pipe-tobacco and cigar use occurred between 2008 and 2011, as federal cigarette taxes increased due to the new regulations and pipe tobacco became cheaper than loose tobacco and large cigars also carried lower taxes than small cigars and cigarettes.

The CDC also showed that the new regulations prompted some tobacco makers to relabel roll-your-own tobacco as pipe tobacco to bypass the tax, and boost the size of small, cigarette-like cigars to meet the defined criteria of large cigars, which remained outside of the FDA’s tobacco jurisdiction.

The approvals — and the rejections — send a clear message to tobacco makers about the standards the FDA is applying when evaluating new smoking products. According to Reuters, the agency is reviewing around 4000 applications for tobacco products, 500 of which are new. And the FDA plans to submit a proposal for expanding its authority to include pipes and novel smoking devices such as e-cigarettes. It’s currently the only agency in the world with the authority to greenlight or reject new tobacco products.

6 comments
Ricardospencer
Ricardospencer

The Food and Drug Administration Thursday proposed regulating e-cigarettes for the first time.This is great news. It's always good to see some research supporting e-cigarettes. http://goo.gl/ee0N3m