FDA announces decisions on substantial equivalence applications

Today the FDA Center for Tobacco Products announced its first decisions on substantial equivalence applications filed by tobacco manufacturers. It permitted the marketing of two products, denied the marketing of four products and announced that companies had withdrawn applications for 136 products.

Here is a link to the FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM358421

Here is the link to the relevant section of the CTP website: http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm#2

FOR IMMEDIATE RELEASE: June 25, 2013

CONTACT: Peter Hamm, 202-296-5469

It’ll Take Time to Judge Today’s FDA Actions on Tobacco,

But Government’s Role Certainly Signifies a New Day

Statement of Matthew L. Myers

President, Campaign for Tobacco-Free Kids

WASHINGTON, DC – The U.S. Food and Drug Administration made history today. The federal agency issued an order permitting the marketing of two new cigarette products, denied four requests to market new tobacco products, and announced that tobacco companies had withdrawn requests to market 136 other tobacco products. It is the first time any federal agency has ever denied permission to a tobacco company to market a new or modified tobacco product because of the threat it poses to public health.

This activity came about because of the 2009 Family Smoking Prevention and Tobacco Control Act, the landmark law that required tobacco manufacturers to notify the federal government when it modified a tobacco product or introduced a new tobacco product, and to present evidence that the product is either "appropriate for the protection of the public health” or at the very least "does not pose different questions of public health” than other products already on the market.

Significantly, FDA’s actions today indicate that in reviewing new or modified products, the FDA will not only look at the danger posed by the product but also require manufacturers to prove that the new product will not lead to more kids starting to smoke, and that it will not discourage adult smokers from quitting.

Today’s actions are a start: They involved a small number of the applications that have been filed by the tobacco industry. And the FDA didn’t disclose what type of evidence the tobacco companies were required to provide. We would urge FDA to go further in providing the public more detailed information about the type of information tobacco companies must provide and the specific criteria FDA is using to assess the public health impact of each product. So it’s not yet possible to assess the long term impact of FDA’s actions today.

But today, the federal government was able to rule on some products tobacco companies wanted to sell – and that is no small new reality.