ONTARIO, Calif., Jan. 26, 2021 /PRNewswire/ — 7 Daze®, a leading premium e-liquid manufacturer, revealed today the receipt of its Premarket Tobacco Product Application (PMTA) acceptance letter from the U.S. Food and Drug Administration (FDA). 7 Daze submitted its application to the FDA seeking the authorization for the marketing and sale of its Reds Apple™ e-liquid products. The application now moves to substantive review where the FDA will determine if 7 Daze’s products are appropriate for the protection of public health.
“7 Daze has been working with leading consultants, scientists, and laboratories to submit our application to the FDA. Being one of the few companies to have completed the statutory requirements set forth in the PMTA guidelines, including clinical trials, we are very optimistic about the future here at 7 Daze” said John Lau, CEO of 7 Daze. “We look forward to the FDA’s review of our data, scientific research, and manufacturing quality system required to advance our application to the final stage of achieving a marketing order.”
All manufacturers of electronic nicotine delivery systems (ENDS) were required to submit a PMTA to the FDA by the September 9th, 2020 deadline to continue selling ENDS products in the United States. During the substantive review phase, the FDA evaluates the scientific studies and data presented in the applications submitted to ensure that the products are appropriate for the protection of the public health (APPH). 7 Daze will continue working with the FDA until all necessary requirements are met, resulting in the company being granted a marketing order.
About 7 Daze
7 Daze is a leading e-liquid manufacturer based in Southern California. It is committed to providing adult-smokers with an alternative to traditional tobacco products. Since 2013, the company’s products have been trusted by adult smokers in over 100 countries worldwide.
For more information, visit https://7dazemfg.com/
SOURCE 7 Daze