FDA gives cigar, e-cig makers more time to get products approved

FDA gives cigar, e-cig makers more time to get products approved
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The Food and Drug Administration (FDA) wants to give cigar and electronic cigarette manufacturers more time to comply with new costly product reviews required by rules finalized under former President Obama.

FDA Commissioner Scott Gottlieb announced Friday that manufacturers of electronic nicotine delivery systems (ENDS), including e-cigarettes, will have until August 2022 to submit pre-market applications for products that were on the market before the new rules took effect on Aug. 8, 2016.

Manufacturers of newly regulated combustible products, including cigars, pipe tobacco and hookah tobacco will have until Aug. 8, 2021, to submit applications for market approval.

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The FDA finalized rules in May 2016 to give the agency the authority to regulate cigars and e-cigarettes for the first time under the 2009 Family Smoking Prevention and Tobacco Control Act. The rules forced manufactures to put health warnings on product packaging and on advertisements and prohibited sales to anyone under the age of 18. The rules also required the product approval reviews, all of which are still in effect, Gottlieb said. 

He said the FDA is delaying the deadline for applications to give the agency time to lay the foundation for regulating these products. Under the proposed delay, products would be able to remain on the market while the FDA determines whether to green light the products for sale to consumers.  

The FDA claimed nicotine is most harmful when delivered through smoke particles in combustible cigarettes and that less harmful products like e-cigarettes should be explored.

“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts — and we believe it’s vital that we pursue this common ground,” Gottlieb said.

Gottlieb said Friday that the FDA is also planning to develop new rules to reduce nicotine levels in combustible cigarettes to non-addictive levels and to ask for public input on flavors in e-cigarettes and cigars. Critics say many of those flavors are intended to be appealing to children.