E-Alternative Solutions (EAS) recently announced the submission of its Premarket Tobacco Product Applications (PMTAs) to the Food and Drug Administration (FDA) for its Leap and Leap Go vapor products.
These submissions are a testament to the high standards at EAS, as well as its commitment to follow ethical marketing practices. EAS also remains dedicated to continuing communication with its trade partners as it moves forward in the PMTA process.
Shortly after submitting our PMTAs, EAS received Acceptance and Filing Letters for its Leap and Leap Go vapor products from FDA. This moves these products into the Substantive Review Phase of the PMTA process. These letters demonstrate that the PMTAs met FDA’s baseline criteria for review. All vapor companies participating in the PMTA process should receive letters from FDA similar to these communications if their products obtain acceptance to move to the Substantive Review Phase of the process.
Please click the links below to view EAS’s Letters of Acceptance and Filing for Leap and Leap Go vapor products:
- Leap Letter of Acceptance
- Leap Letter of Filing
- Leap Go Letter of Acceptance
- Leap Go Letter of Filing
In accordance with FDA’s directive, EAS’s Leap Device Kit, Leap Tobacco and Menthol Pods and Leap Go Disposable e-cigarettes will continue to remain available for sale while FDA conducts its substantive review of our applications. In the event FDA concludes that these Leap and Leap Go products are appropriate for the protection of public health, it will issue Marketing Orders authorizing the continued marketing and sale of these products. Furthermore, EAS will reintroduce our Leap flavored pods in the event FDA issues marketing orders for these as well. The Substantive Review Phase is where our months of hard work assembling more than 100,000 pages of evidence will pay off in supporting the company’s proposition that Leap and Leap Go products are appropriate for the protection of public health.
For more detailed information regarding FDA’s PMTA process, you can find it here on its website.
EAS believes that transparency throughout this process with its valued wholesale and retail partners will help it better navigate a new era of regulations. The company is committed to leadership in the vapor industry and remains dedicated to assisting its partners with any questions or concerns they may have as they move forward together.
