The Food and Drug Administration is signaling that it is ready to assume new regulatory authority over tobacco products. The agency issued guidelines Wednesday putting tobacco marketers on notice that, if they come out with new products or change their ingredients, they need the FDA’s permission.
The FDA got its expanded regulatory muscle from the Family Smoking Prevention and Tobacco Control Act of 2009. As the Associated Press reports, the law gives the agency the ability to regulate marketing, reduce nicotine content and block labels such “low tar” and “light.”
However, the agency can’t apply a general ban on tobacco products. It simply can require that new products aren’t more dangerous than existing ones.
“No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such,” said Lawrence R. Deyton, director of the FDA’s Center for Tobacco Products.
The new guidelines apply to tobacco products that were introduced or changed since Feb. 15, 2007, when the tobacco law was introduced. Companies that have introduced new products since then, or that intend to in the future, must submit an application to the FDA and obtain a marketing order. To pass muster, the new products must be “substantially equivalent” to items that already were commercially available on the Feb. 15, 2007 cutoff date.
“This piece of the Tobacco Control Act protects the health of all Americans,” Health and Human Services Secretary Kathleen Sebelius said in a news release. “It does this by setting a clear deadline for tobacco companies to provide important product information to the FDA so the agency can then begin evaluating tobacco products for any potential new risks to public health.”
According to The Wall Street Journal, one potential immediate applicant is Star Scientific Inc., a Virginia-based company that said this week that it plans to submit a new “moist snuff” tobacco product for approval during the first quarter of 2011.
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