PMTA
UPDATE: 8/13/2021 - Our PMTAs that were filed by the U.S. Food and Drug Administration (FDA) have now entered the SCIENTIFIC REVIEW PHASE as communicated by the FDA. The products that are entering the phase included all the products found on our website such as our Freebase Nicotine E-Liquids as well as our Salt Based Nicotine E-Liquids with the exception of tobacco flavored products.
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UPDATE: 3/2/2021 - Our PMTAs that were accepted by the U.S. Food and Drug Administration (FDA) have now been FILED. We are now moving one step closer to market authorization as we enter the substantive review phase. The products that were filed included all the products found on our website such as our Freebase Nicotine E-Liquids as well as our Salt Based Nicotine E-Liquids. Please see filing letter below.
UPDATE: 12/31/2020 - Our PMTAs that were submitted to the U.S. Food and Drug Administration (FDA) have been ACCEPTED. The products that were accepted include all the products found on our website. It includes all of our Freebase Nicotine E-Liquids as well as our Salt Based Nicotine E-Liquids. We are now awaiting for the review phase of the process which we expect to be able to get through as well. We will continue to update this page with our progress. Please see acceptance letter below.
UPDATE: 9/9/2020 - BLVK has submitted our PMTAs via the CTP Portal to the U.S. Food and Drug Administration (FDA) seeking authorization for the marketing and sale of our wide-range of e-liquid products. This is truly another milestone for us as it puts us one step further through the review process in hopes of receiving a marketing order from the FDA. We have always valued transparency, and our PMTA submission will provide the FDA everything t hey need to deem our vapor products appropriate for the protection of public health. We are confident with the thorough product analysis we've submitted, and we're hoping for a positive review by the FDA to continue providing our products to responsible adults seeking alternatives to traditional combustible tobacco products.