August 28, 2020
Via Electronic Submission
RE: Petition for Extension of Premarket Tobacco Product Application Filing Deadline from Keller and Heckman LLP
The American E-liquid Manufacturing Standards Association (AEMSA) appreciates this opportunity to comment on Docket No. Docket: FDA-2020-P-1797
Established in 2012, AEMSA is an all-volunteer 501(c)(6) non-profit organization of American small-business open-system e-liquid manufacturers dedicated to promoting safety and responsibility through self-regulation. AEMSA remains the only vapor industry trade association focused on creating, implementing, and upholding standards for the responsible manufacture and distribution of e-liquids for adult tobacco users. AEMSA has developed facility, ingredient, traceability, delivery, youth-access prevention, and packaging standards that are publicly available for all e-liquid manufacturers, and which have previously been presented to FDA.
AEMSA members are small-businesses committed to complying with, and maintaining compliance to FDA regulations, including premarket review for all new tobacco products. Unfortunately, the COVID-19 pandemic that grips this nation is inhibiting our small-business members from completing robust PMTA submissions, for FDA review, to demonstrate that open-system e-liquid products are appropriate for the protection of public health.
AEMSA has presented to FDA, on numerous occasions, plans that would alleviate the burdens that small-business open-system e-liquid manufacturers face, as well as reduce the burden on FDA in the review of PMTA submissions; all with the goal of protecting public health. Now, given the urgency of both the upcoming PMTA deadline, while dealing with a once in one-hundred year pandemic, FDA should, for the benefit and protection of public health, extend the PMTA deadline by at least 180 days.
To read the entire contents of the comment submission made by AEMSA, please view the document here: