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Citizens’ Petition – [Concluded] Keep Synthetic Nicotine Available!
A Citizens’ Petition on behalf of the American Vapor Manufacturers Association (AVM) has been posted to Regulations.gov and is open for comments/support.
The petition is asking FDA to do the following:
- Use its enforcement discretion to allow the continued marketing of open system products that use synthetic nicotine for which a premarket application (PMTA) has been submitted, beyond July 13, 2022, and until FDA completes its scientific review; and,
- Allow for these manufacturers to continue submitting additional data and amendments for their application.
By way of background, In March 2020, FDA was granted the authority to regulate synthetic nicotine when President Biden signed the Omnibus Budget Bill. The language in the new law required manufacturers of synthetic nicotine products to submit PMTAs within 60 days (May 14, 2022) of the law taking effect to keep their products on the market for an additional 60 days (July 13, 2022).
The new law required vapor companies to produce highly technical, expensive, and scientifically rigorous premarket applications within 60 days. Similar to the roll-out of the 2016 deeming rule–which gave manufacturers only two years to submit applications that include studies that can take more than three years to complete–the new regulation of synthetic nicotine is almost entirely about taking products away from people who smoke and/or vape and punishing the industry rather than protecting consumers.
A previous Citizens’ Petition submitted by NJOY in 2017 likely contributed to the FDA’s announcement of comprehensive nicotine regulations that included a delay of the PMTA deadline from 2018 to 2022 for smoke-free products. While the environment has changed since then, FDA’s expanded authority over synthetic nicotine still allows for the agency to exercise its discretion with regard to PMTA enforcement. Neither court order nor act of congress has so far limited FDA’s ability to regulate with the protection of public health at the core of its actions.
- A prewritten message is provided for you, but please edit it to include your experience with switching to smoke-free products like vaping and nicotine pouches that contain synthetic nicotine. Feel free to delete the entire prewritten message and replace it with your own words.
- If the FDA removes synthetic nicotine products from the market, how will that affect your ability to remain smoke-free, or continue reducing the number of cigarettes you smoke?
- Encourage the FDA to authorize more smoke-free products (with or without synthetic nicotine) in flavors other than tobacco.
Take Action Now!
If you prefer or need to send comments via US Mail, here are the mailing instructions:
- Make sure that docket No. FDA-2022-P-1211-0001 is referenced at the beginning of any letters you’re sending.
- Mailing adress:
- Division of Dockets Management Food and Drug Administration
- 5630 Fishers Lane, Room 1061
- Rockville, MD 20852