For e-cigarette and ENDS manufacturers in particular, the FDA issued final guidance this past June to help navigate the PMTA application process but a final rule has yet to be published. The FDA says a final rule, however, isn’t needed for manufacturers to continue submitting PMTAs to the agency. The proposed rule outlines the general process the FDA will take when evaluating PMTAs, including application acceptance, application filing and inspections. It also outlines how amendments to an application can be filed, how an application can be withdrawn, how to address changes in ownership, post-market reporting and maintenance of records, FDA communications with an applicant, FDA’s disclosure procedures and electronic submission requirements. The proposed rule also explains how applicants can submit supplemental PMTA or a resubmission and how to respond and address receiving a “No Marketing Order” from a deficient application.
The proposed rule will open for public comments for 60 days through Nov. 25, 2019.
You can read the proposed rule for premarket tobacco product application and record keeping requirements by clicking here.
 has issued a proposed rule addressing the PMTA requirements and procedures for tobacco products.){kind=link}