In June 2019, the FDA released the final PMTA guidelines. Following this, a Maryland District Court ruling ordered a revised submission deadline of 9th September 2020.
All companies involved with the manufacturing, importation, and retail of ENDS in the USA need to submit a PMTA by this date. Failure to comply will be damaging for business, jeopardizing continued participation in the market.
As a full PMTA submission requires significant time and investment, companies are advised to implement their strategies ASAP.
Hall Analytical have developed and validated methods for all of the analytes listed in the guidelines. With a view towards “other constituents, as appropriate”, we have added extra analytes that we deem may be of toxicological concern.
Although independent, we can work in partnership with leading toxicology and regulatory consultants in the interest of product security. We also offer a full TPD notification solution.
Keep your ENDS franchise ahead of regulation and request a consultation today.