PACKAGED TOBACCO
A Long & Winding Road It has taken 10 years, but the Food and Drug Administration finally gave the regulatory thumbs-up to some vapor products By Melissa Kress
That is the number of vapor products that had received the greenlight to remain on the market in the United States
ONE.
Five years later, in May 2016, the agency released its final deeming rule extending its regulatory authority to e-cigarettes, cigars, hookah tobacco, and pipe tobacco.
In 2011, the FDA announced it would regulate the relatively new electronic cigarette and vapor segment as tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act.
On Aug. 8, 2016, the deeming rule went into effect. Under the rule, tobacco companies were given two years to submit marketing applications to the FDA for products that were not on the market as of Feb. 15, 2007.
as of mid-October. The Food and Drug Administration (FDA) on Oct. 12 authorized the Vuse Solo electronic nicotine delivery system (ENDS) and its accompanying
In the summer of 2017, the agency revealed a new tobacco roadmap and revised some of the timelines spelled out in the deeming rule. Among the changes, applications for newly regulated combustible products would have to be submitted by Aug. 8, 2021, and applications for non-combustible products, such as ENDS and e-cigarettes, would have to be submitted by Aug. 8, 2022.
Two months later, Grimm set a May 12, 2020 deadline for tobacco companies to submit PMTAs to the agency. However, that deadline was pushed back another 90 days to Sept. 9, 2020 after the agency — citing the COVID-19 pandemic — asked for a delay. Grimm also gave the FDA 12 months to act on the PMTA submissions.
Following legal challenges, U.S. Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ruled on May 15, 2019 that the FDA sidestepped its authority when it pushed back the deadlines set by the deeming rule.
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