Citizen Petition: Guidance/Regulations for PMTA Premarket Submissions

Discussion in 'Advocacy and Legislation' started by 100%VG, May 26, 2017.

  1. 100%VG

    100%VG Did something go Blip?

    I received an email from CASAA today

    A Citizen Petition has been submitted
    to the Food and Drug Administration (FDA) requesting that the agency issue "final guidance or regulations describing the recommended or required contents of premarket submissions." .In addition to requesting this final guidance, petitioners (NJOY et. al.) are requesting that the compliance period be extended by 24 months from the time the guidance is published. Such a delay is necessary in order for manufacturers to complete the required premarket tobacco application (PMTA) process.

    (If you are writing on behalf of a business, please use the industry engagement here)

    Currently, there is no clear-cut path through the PMTA process; it is an expensive hit-or-miss process. Manufacturers submitting PMTA's must rely on the successes or failures of previous applications for guidance and make assumptions about what the agency will consider as supporting evidence. As it stands, less than 1% of the vapor industry can afford to try, and the overwhelming majority of the industry will not even make an attempt.

    21 CFR §10.30 establishes the Citizen Petition as a legitimate pathway to affect changes in regulations after the official public comment period has closed. CASAA is asking our members to post comments in support of this petition on the official docket at Comments must be submitted by November 8th, 2017, 11:59 PM (EST).

    Take Action - Post Your Comment!

    Choose some of the points below to discuss in your comment:
    (See our writing tips if you need help personalizing your message.)
    • Share your experience with vaping.
    • How long did you smoke?
      • How many times did you try to quit smoking?
      • Were you able to quit or significantly reduce your smoking?
      • How long have you been smoke-free?
    • What is your preferred flavor of e-liquid?
      • Do you use a variety of flavored e-liquid and why is access to
        this variety important to you?
    • Have you noticed changes in your ability to purchase vapor
      products as a result of the FDA deeming rule?
      • Are shops and/or manufacturers that you purchase from shutting down?
    Take Action - Post Your Comment!

    (Writing Tip #1)
    If you have a lot to say, please craft your message in a separate word doc and then copy/paste it into the field provided. If you take too long, the system will time out and you will lose your work.

    (Writing Tip #2)
    Although we've provided a prewritten message with compelling talking points, we would strongly encourage you to edit them, because personalized communications to legislators are far more persuasive than form letters. At a minimum, PLEASE INCLUDE YOUR PERSONAL STORY (just a few sentences) in the text of your message.