Citizen Petition Regarding FDA Deeming Regulations
The Food and Drug Administration (FDA) announced deeming regulations for the vape industry that require all companies register their e-liquids and vaping devices. Companies and many retailers who mix their own eLiquids must complete a premarket tobacco application (PMTA) process that is expected to cost $500,000 per eVapor product.
The majority of Vape industry businesses cannot afford the PMTA process. Many will have to close their doors. Your favorite vape products will be off the market. Jobs will be lost.
A Citizen Petition has been submitted to the 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.
What can you do?
Stop The Vape Ban is asking supporters to make their voices heard by posting comments in support of this petition on the official docket at Regulations.gov. In addition to contacting your Members of Congress, you can comment and sign the Citizen Petition – a pathway to promote changes in regulation.
Review the points below and be sure to personalize your comments on how this virtual vape ban affects you. (Comments are limited to 5,000 characters total)
- Share your experience with vaping.
- 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?
Review the points below and be sure to personalize your comments on how this virtual vape ban affects you.
- Share basic background on your company or business.
- Why complying with the PMTA requirements would be difficult.
- How the PMTA requirements should be altered in order for your company to have an opportunity to comply.
- How it is impossible for your company to comply with the draft guidance in the limited time provided.
- Why can your company not afford to comply with the PMTA requirements.
* Please note - your comments are public. Anyone can view your or others’ comments on the docket at Regulations.gov. The contact information you provide to Stop The Vape Ban in order to post your comment will not appear on Regulations.gov.