FDA Gives Vaping Industry Breathing Room on Costly Product Reviewsadmin
FDA Gives Vaping Industry Breathing Room on Costly Product Reviews was written by Steve Birr and published on The Daily Vaper on July 28, 2017.
Officials with the U.S. Food and Drug Administration announced Friday they are pushing off the deadline requiring vaping retailers to submit costly product applications that threaten their businesses.
FDA Commissioner Scott Gottlieb outlined the administration’s plans for future tobacco regulations, with the stated goal of reducing nicotine levels in products and ultimately cutting smoking rates. As part of the plan, Gottlieb rescheduled the deadline for companies to complywith the FDA’s contentious “deeming rule” from Aug. 8 2018 to Aug. 8 2022, giving the vaping industry some much needed breathing room.
“This is a wise decision and a much-needed delay,” Patricia Kovacevic, general counsel and chief compliance officer of Nicopure Labs LLC, told The Daily Caller News Foundation. “However, the deeming rule as a whole still does not change and it still does not take into consideration the harm reduction potential of e-cigarettes. The grandfather date stays the same, and we still cannot launch new products or improve on existing ones to keep up with advances in technology. So, while grateful, much more needs to be done and the entire regulatory framework needs to be reevaluated and changed.”
The FDA “deeming rule” requires businesses to retroactively submit each individual product to the FDA for approval before it can be sold. Businesses will have to file applications for nearly every product they currently sell. Many are anticipating closure under the FDA rule, due to the application costs, which range from $100,000 to $400,000 dollars each. Vaping advocates are working to exempt products already on the market from the rule to avoid upending the the entire industry.
“Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use,” Gottlieb said in a statement Friday. “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.”
The announcement is a noted break from the alarmist rhetoric typically heard from public health officials on e-cigarettes. The Centers for Disease Control and Prevention regularly harps on the alleged dangers of using the devices and former Surgeon General Vivek Murthy said in December e-cigarettes are threatening to cause a public health crisis among the nation’s youth.
The report still makes it clear the FDA plans to greatly scrutinize the vaping industry, along with other nicotine and tobacco products. Officials will investigate the effects flavored vaping products have on children and young adults to see if they are creating unnecessary risks. Former smokers note flavored vaping products are key to quitting, because they help the user disassociate from the taste of tobacco.
The FDA also plans to reduce the levels of nicotine allowed in traditional cigarette products to reduce general addiction over time.
Gottlieb stressed Friday the FDA aims to strike an “appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.”
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