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FDA announces new tobacco plan, postpones deeming rule

July 28, 2017

By Jennifer Garvin

Silver Spring, Md. — The Food and Drug Administration said July 28 it is developing a comprehensive plan to "alter cigarette addiction" as well as delaying the 2016 final rule expanding the agency's regulation of tobacco products.

"As a physician who cared for hospitalized cancer patients, and as a cancer survivor myself, I saw firsthand the impact of tobacco," said FDA Commissioner Scott Gottlieb, M.D., in prepared remarks. "And I know all too well that it's cigarettes that are the primary cause of tobacco-related disease and death. What's now clear is that FDA is at a unique moment in history, with profound new tools to address this devastating impact."

In delaying implementation of the 2016 final rule requiring cigar and e-cigarette manufacturers to receive FDA approval for any products marketed after February 2007, the agency said it needed "time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive."

The final rule, which the ADA supported, was expected to go into effect Aug. 8. It will now be delayed until 2021 for "newly-regulated combustible products" such as cigars, pipe tobacco and hookah tobacco" and 2022 for noncombustible products such as e-cigarettes.

The ADA was disappointed at the delay of the final rule.

"We're not convinced that swapping one cancer-causing product for another is in the public's best interest," ADA President Gary L. Roberts said. "You can't say that 'innovative' tobacco products are 'less dangerous' than cigarettes without knowing their immediate and long-term effects on oral health. The FDA has mostly focused on lung cancer, but oral cancer can be just as deadly.
 
"We asked FDA not to go down this path. But if they do, the agency should at least require these companies to furnish data showing how their 'innovative' products impact oral health."

The Association has long advocated for tighter federal regulations on all forms of tobacco. In August 2014, ADA wrote a letter urging FDA to expand its regulation of products it deemed to be covered by the Family Smoking Prevention and Tobacco Control Act.

For more information on the ADA's advocacy efforts on tobacco visit ADA.org/tobacco.