MEL PMTA Accepted
Mister-E-Liquid, LLC is pleased to announce that we have received the Pre-Market Tobacco Authorization acceptance letter from the FDA. While this does not yet mean our PMTA submission has received a marketing order, often referred to as “approval”, we are thrilled that it has been accepted, and that we are moving into the next step of the review process.
Our PMTA submission consists of applications for each product in the MEL Brand Collection line of vape juice for use in electronic nicotine delivery systems (ENDS). The MEL line of e-liquid consists of our 13 most popular flavors, available in a 30 ml unicorn bottle, with 50% VG and six nicotine options. We at Mister-E-Liquid used our 10 years of data and experience in the electronic cigarette industry to strategically select this line for submission, looking toward the future of vaping.
“I am very humbled by the response from all of you throughout the years as well as the dedication of our amazing staff” stated Mister-E-Liquid’s Chief Executive Officer Ron Pease. “Mister-E-Liquid would not be here without all of you. I am excited about the future of Mister-E-Liquid and the ability to continue to get our product to all of you for years to come.”
In the Acceptance Review stage, Mister-E-Liquid’s PMTA submission was determined to successfully fall under the Center for Tobacco Products jurisdiction and embody the statutory and regulatory requirements set forth by the FDA, resulting in an acceptance letter.
“Mister-E-Liquid would not be here without all of you. I am excited about the future of Mister-E-Liquid and the ability to continue to get our product to all of you for years to come.”
From here, our PMTA submission moves onto the Filing Review stage, a preliminary scientific review to determine if the application consists of products or items defined under Section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act – Application for Review of Certain Tobacco Products. The FDA then sends a filing letter, moving our submission on to a Substantive Review, or a refuse to file (RTF) letter.
In the Substantive Review stage, the FDA will conduct an in-depth analysis of all scientific data submitted with our application. This also includes an evaluation of recommendations that may be suggested by the Tobacco Product Scientific Advisory Committee (TSPAC), a 12-member cabinet of knowledgeable experts in medicine, medical ethics, science, and technology involved in tobacco product manufacturing, evaluation, or use. TSPAC may provide regulatory recommendations associated with safety, dependence, and health matters relevant to tobacco products or recommendations in relation to any topics presented in the Family Smoking Prevention and Tobacco Control Act. Depending on the situation, the FDA may release an environmental information request letter or a deficiency letter.
The final step in the FDA’s PMTA process is determining approval of our application with the release of a marketing order letter, or denial with a no marketing order letter.
The PMTA process is far from over for Mister-E-Liquid, but this achievement is a significant milestone for us. Our submission of the MEL line of vapor products is one of many examples that we’re committed to following regulatory compliance, ensuring the highest quality in our products, and going beyond industry standards, innovating the future of vaping.