Food and Drug Administration’s newest commissioner stands by science and backs electronic cigarettes as “better way”
Newly confirmed FDA Commissioner, Dr. Scott Gottlieb, gave an interview on CNBC’s business talk show Squawk Box last Thursday. During the interview he continued the recent drastic shift in tone of the Food and Drug Administration toward support for electronic cigarettes, rationalizing “It’s not the nicotine that kills you, it’s all the other carcinogens in lighting tobacco on fire.” He went on to discuss making it easier for businesses to develop and market safer alternatives to smoking tobacco, as well as a proposed “public dialogue” for implementing the mandated changes of nicotine levels in traditional cigarettes.
This is a very different story from the FDA, who just last year passed the controversial deeming rule which caused major ripples throughout the industry. For the unaware, the deeming rule expanded the definition of tobacco products onto electronic cigarettes among other products, allowing the government to exert greater regulations and fines over the proprietors of hard working vape businesses. Whatever the past, Dr. Gottlieb has already proven to be an ally to the vaping community by leading the FDA to extend deadlines of the controversial new PreMarket Tobacco Applications until 2022.
The Pending PMTA
The PreMarket Tobacco Applications, or PMTA is an application required for any new tobacco product (now including electronic cigarettes) before being legally marketable in the United States. Being a policy from just the previous FDA leadership, PMTAs had only been used for one product before the deeming rule, several types of snus for the Swedish Match Company. The deeming rule itself is in part what caused vaping to be regulated under the same rules as tobacco. The original compliance window was supposed to be 36 months, but the FDA decided to give products already on the market a more generous four years.
While the delay doesn’t apply to any products that came onto the market after 2016, everything already out will have until 2022 to meet guidelines. Most critically, they will retain the ability to market their products in the meantime. This was a major win for countless companies who were concerned about the logistics of such a short window to comply.
The other major portion of the new plan released by the FDA alongside the delayed PMTA is a plan to lower the level of nicotine in traditional cigarettes to non-addictive levels over the next several years. Wall Street didn’t take the news very well with tobacco stocks dropping the most they have in almost 20 years. This proposed regulation could further push bigger tobacco companies to delve into, and eventually take over, the electronic cigarette sector.
Those against the deeming rule and the PMTA from the start have argued that these rules unfairly impact smaller business who may be unable to meet standards quickly or pay large penalties when they don’t. This system hands big tobacco a significant advantage, as they are much more able to comply with the new and tougher regulations in a timely manner. Dr. Gottlieb seems to agree that giving these businesses the time they need to get things in order is best, but still stresses that the focus for everyone needs to be on innovation. He was quoted, “We’ve opened up a pathway to new product innovations that we think can potentially provide nicotine to people who still want to enjoy satisfying levels of nicotine.” He concluded, “There could be product innovation… to deliver the nicotine in better ways.” His commitment to vaping as a likely candidate for this innovation could have a significant impact on the future of vaping in America.
With our new FDA commissioner, America may soon catch up to the rest of the vaping world when it comes to vaping as the major smoking cessation tool. The circumstances are changing and the science gets more detailed every day. With continued support from governmental bodies such as the FDA, it’ll only become easier to educate the general smoking public of the numerous advantages to vaping over smoking. Especially for anyone who truly wants to finally kick the habit. The current numbers show us that we have a long ways to go, but with people like Dr. Gottlieb in our corner, it’s only a matter of time.
Check back soon for updates.