FDA announces decisions on substantial equivalence applications
Tuesday, June 25, 2013
Posted by: Natalia Gromov
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and announced that companies had withdrawn applications for 136 products.
is a link to the FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM358421
is the link to the relevant section of the CTP website: http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm#2
IMMEDIATE RELEASE: June 25, 2013
Take Time to Judge Today’s FDA Actions on Tobacco,
Government’s Role Certainly Signifies a New Day
of Matthew L. Myers
Campaign for Tobacco-Free Kids
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companies had withdrawn requests to market 136 other tobacco products.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.
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
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.
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.
today, the federal government was able to rule on some products tobacco
companies wanted to sell – and that is no small new reality.
Source Victoria Almquist, Director, Outreach, Campaign for