On March 28, FDA commissioner Scott Gottlieb sat down with CNBC’s Meg Tirrell to discuss a variety of topics. In the 30-minute interview Dr. Gottlieb touched on just about every aspect of the FDA’s reach, including some topics related to vaping.
For the general consumer, it might not seem like much, but when the head of the FDA speaks about the vaping industry which they’ve been working to regulate in different ways, listening is important.
When it came to the conversation about e-cigarettes, Dr. Gottlieb was quick to talk about the regulations they’ve put in place. He admitted that the initially instated regulations were “foundational” to get the actual regulation where it needs to be, while acknowledging that there are adults who seek, and continue to seek, satisfying levels of nicotine, pointing to the “opportunity” in e-cigarettes.
Dr. Gottlieb recognized several times that the current vape regulations in place were to allow the FDA adequate time to develop the appropriate regulation process moving forward, which is why he opted to delay the deadline for PMTA submissions. The purpose of setting that deadline was, in his words, to “get the proper rules in place.” Up to this point, the consensus in the vaping community was that many regulations in place were a negative for the industry, rather than a potential positive. We can agree, though, that finding the proper way to keep vaping safe is extremely important.
Another comment he made a point of mentioning was that he doesn’t want to sweep the market of “products that could provide an alternative.” This is a good sign coming from a free-form interview about the FDA’s actual views on the vaping industry as a whole.
Dr. Gottlieb revealed that the FDA was planning on putting out two guidance documents “probably during the summer.” These guidance docs would provide information on how to study toxicology with e-cigarettes to bring through new approval pathways as a potential OTC product, rather than a prescription pharmaceutical.
As it stands now, the FDA wants to open the marketplace for more opportunities to sell nicotine, for adults who want nicotine, as a pharmaceutical product in a safe way.
The last thing the commissioner touched on was in regards to marketing. They are currently in the process of researching and addressing flavors and will soon begin enforcement against inappropriate marketing. The clearest plan in place is that they will continue to push very hard against inappropriate marketing material and other offenses of that nature.
Overall, what CNBC got from Dr. Gottlieb was a very honest look at the process of regulation in the vaping industry. Up until this point they’ve been simply laying the foundation for proper regulation by prioritizing areas of concern rather than trying to do everything at once. At times, halting something is best way to find out what is wrong with it on a deep level. It seems the FDA is working hard to figure out exactly what it is that makes vaping tick, and where it could have the potential to go, which is something that we all can agree is an important step in keeping the vape community alive, but also in the safest manner possible.
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