NJOY Submits a Citizen Petition To The FDA

The United States Foods and Drug Administration has a process that allows individuals and organizations to request that the FDA change their health policies through what’s called a citizen petition.

At any time, someone can file a citizen petition that asks the FDA to “issue, amend, or revoke a regulation or order.” The law also states that the FDA must respond to petitions within 150 days.

On May 17th, NJOY, the Vapor Technology Association, The Smoke-Free Alternatives Trade Association, Turning Point Brands, Nicopure Labs, Five Pans, Johnson Creek, and other businesses submitted a citizens petition asking for the FDA to provide clear guidance for vape manufacturers about how to submit premarket applications and also to extend compliance deadlines by 24 months.

If you read the petition on Regulations.gov, you’ll see the reasoning behind these requests. For example the petition points out that it’s now nearly a year after the FDA released the Draft PMTA Guidance on electronic cigarettes and in that time, we still have not received recommendations from the FDA on completing Pre-Market Tobacco Applications or substantial equivalence reports.

That’s a pretty solid reason if you ask me.

This isn’t your typical everyday online petition that the government brushes off and ignores. The citizen petition process is a formal process that the FDA must follow as defined in the Code of Federal Regulations.

With that said though, the FDA still has final say in whether or not the requests in the petition are granted. There was an empirical study that reviewed every citizen petition filed with the FDA between 2001 and 2010, so nine years of data. What they found is that the FDA granted 19% of petitions and denied 81%.

Also worth noting though is that most petitions are from pharmaceutical companies trying to delay generic brands from coming onto the market. So the success rate or denial rate might not reflect the chances that this new petition from NJOY might have.

So what can you do to help? Go to CASAA.org to find the call to action. You can submit comments on the petition on Regulations.gov until November 8th, 2017. In your comment, you can share your experience with vaping, talk about how long you’ve smoked and how vaping has helped you quit or reduce smoking, what your favorite flavors of e-liquid are and why flavors are important to you, and how the FDA deeming rule has changed your ability to buy vapor products.

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