To all our valued customers,
Huntington Beach, CA (April 25, 2022) – Streamline has reached new milestones related to our synthetic nicotine PMTA. With assistance from Accorto and Thompson Hine Law Firm, we have an on-time and scheduled submission of all necessary information for our PMTA ready to go for May 15th. Our team has developed a comprehensive PMTA strategy thoroughly addressing the Agency’s primary guideline for approval: whether our Juice Head and NIIN synthetic nicotine products are appropriate protection of public health (APPH). This strategy includes not just meeting the requirements published in the guidance but far exceeding them. Accorto will be partnering with one of the world’s leading Consumer Research Organizations to conduct a prospective comparative efficacy study examining the value Streamline’s flavor selection and device style provides to adult smokers in their journey away from traditional tobacco. They will also be developing a marketing plan showing that strict distribution controls, such as the protocols used here at Streamline, are a key factor in the protection of vulnerable populations.
On another note, a couple of weeks ago, Streamline and the Vapor Technology Association’s Board of Directors and members met with the FDA Center for Tobacco Products (CTP). As was reported by VTA in its recent press release: “In attendance was a large group of FDA personnel (35+), including senior leaders, representing seven different offices inside CTP dedicated to addressing the issue of synthetic nicotine. Our team included presentations by three PhDs in Organic Chemistry and Physical Analytical Chemistry, enabling us to frame critical scientific and public policy issues that we believe had not previously been presented to or considered by the FDA.” We felt the meeting was a success and are encouraged by the level of engagement by the FDA. We feel strongly that the strategy we have developed as a Board Member of VTA is already yielding results and we anticipate that strategy will lead to continued positive engagement with the FDA as this process unfolds.
As part of our commitment to all our distributors, retailers, and consumers, we will continue our goal to provide transparency and any updates as we move through this regulatory process.
Thank you for your continued support.
Warm regards,
Patrick Mulcahy
CEO/Co-Founder
Streamline Group is an industry-leading manufacturer and distributor of popular, customer-favorite alternative products, including Juice Head, NIIN, Galaxy Treats, Bam’s Cannoli, Khali Vapors, Party Brands, Hello Kanna, and more.
For more information about Streamline Group products, contact our sales team via email ([email protected]) or telephone (714-823-3750)
Media Contact
Contact: Patrick Mulcahy | Streamline Group
Phone: 714-823-3750
Email: [email protected]
