August 27, 2020 2 min read
This notice is made to update our partners, distributors, e-tailers, and retailers regarding our status with the FDA's Premarket Tobacco Authorization submission. BLVK is fully committed to submitting our PMTA by the due date of September 9, 2020. In fact, we were ready to submit it by the earlier deadline of May 12, 2020 but since it was extended, we added even more data for a better submission. We have been working on the PMTAs for our products for a year now and have contracted Kalsang Dorji and Thomas Nguyen of Elixa Health Associates to assist us in this process.
As you may know, there is no guarantee that our PMTA submission will be granted a marketing order, but we are utilizing all the resources we have to ensure a better chance.
We wanted to announce this for two reasons: 1) We are a full-blown e-cigarette company that was founded on the basis of providing current, adult smokers an alternative to tobacco products. 2) We are in this for the long haul. Much like our first point, we didn't enter this industry for the sake of making a quick buck. We, like many other companies, exist to provide our team and our customers with a sustainable brand that will last; complete with a product line that can withstand the test of time as we navigate through uncertainty with confidence.
With that, we are here to stay, for as long as possible but we still need your help! The FDA has opened an open comment platform to voice your grievances with the agency and how they've handled regulating our industry. We urge you to speak out and represent an activity that we all know is a better alternative to cigarettes. Your voice matters and we look forward to your support!