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DELAY the FDA – Sign the Citizen Petition TODAY

It has been one year since the FDA announced their deeming regulations for the vapor industry. One of the requirements is that all companies must register their e-liquids and vaping devices with the federal government by completing the required premarket tobacco application (PMTA) process. Failure to do so will result in your business no longer operating beyond 2018.

A Citizen Petition has been submitted to the Food and Drug Administration (FDA) requesting the agency issue “final guidance or regulations describing the recommended or required contents of the premarket submissions…” In addition to the final guidance, the petitioners are requesting that the compliance period be extended by 24 months from the time the guidance is published. The delay is necessary for manufacturers to complete the required PMTA process.

Why is guidance needed?

There is no clear-cut path through the PMTA process. It is costly and the only thing applicants have to guide them through the process is the success or failures of previous applications. The manufacturers are being forced to make assumptions about what the regulating body will consider as support evidence.

LESS THAN 1% OF THE VAPOR INDUSTRY CAN AFFORD THE PMTA PROCESS AND THE MAJORITY WILL NOT EVEN MAKE AN ATTEMPT.

This means that the majority of the brands and flavors you have grown to love will disappear. Thousands will be left without jobs and many vapers will be forced to go back to smoking tobacco cigarettes.

What can you do?

You can be heard. A Citizen Petition is a legitimate pathway to affect changes in regulation. If you are a business, please use the industry engagement form. Consumers can comment here.

What topics should be discussed in your comments?

 

  • 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 your purchase from shutting down?

 

If you love vaping and want to see it continue to operate beyond 2018 you must be heard!

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