Below we have collected links to help manufacturers and retailers. We’ve included links from the FDA’s website that will direct you to specific topics. If you have any questions or comments regarding anything please feel free to contact us directly at firstname.lastname@example.org.
MANUFACTURING – Goes over the different requirements needed from the FDA for vape manufacturers.
LABELING & WARNING REQUIREMENTS – Goes over the what is required on eliquid labels, and rules regarding the Nicotine Warning Statement
ADVERTISING & PROMOTIONAL REQUIREMENTS – Discusses what eliquid manufacturers and retailers can and can not do. For example – Sponsoring Events, Use of Brand Name, Free Sample Restrictions, and the requirements of the Nicotine Warning Statement on advertisements/promotions.
PREMARKET TOBACCO PRODUCT APPLICATIONS – This document explains which products this guidance applies too, when a PMTA is required, General Procedures for review of Electronic Nicotine Delivery Systems (ENDS), What information the FD&C requires you submit, and what information the FDA recommends you submit.
SCIENTIFIC POLICY MEMORANDA – Memoranda to assist reviewers with the evaluation of tobacco product applications. This information adds detail about key areas of regulatory science.
CUMULATIVE NUMBER OF PMTAS RECEIVED SINCE PROGRAM INCEPTION – Reviews the numbers of PMTA’s received, approved or denied, etc.
HPHC COMPLIANCE – Reviews how companies can comply with the requirement to report on the quantities of harmful and potentially harmful constituents (HPHCs) in tobacco products.