The FDA published its final rule to deem e-vapor products to be regulated tobacco products pursuant to the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”). With this final “Deeming Regulation” which will become effective on August 8, 2016, FDA is extending the Agency’s “tobacco product” authorities from cigarettes, smokeless tobacco and roll-your-own tobacco, to all other categories of products that meet the statutory definition of “tobacco product” including, but not limited to, e-liquid products that contain tobacco-derived nicotine.
The adoption of the final rule creates many far-reaching and serious consequences for our industry. Most importantly, FDA failed to amend the February 15, 2007 “Grandfather Date” for deemed e-vapor products, forcing nearly all e-vapor devices, components/parts and e-liquid products on the market now to go through the Premarket Tobacco Application (PMTA), which could costs hundreds of thousands if not millions of dollars per application. Because there were virtually no e-vapor or e-liquid products on the market as of February 15, 2007, there is no way to utilize the less onerous Substantial Equivalence (SE) or SE Exemption pathways that tobacco companies can take advantage of for their harmful cigarette products, for example.
Worse still, the Deeming Regulation freezes the market on the August 8, 2016 effective date. No new products will be able to enter the market after that date without first submitting a PMTA, and obtaining marketing authorization – which could take years. Only products that are on the market as of August 8 will be able to take advantage of the two year “compliance policy” allowing PMTAs to be submitted by August 8, 2018. And then, even if you are able to submit a PMTA that FDA accepts by the deadline, FDA will force you to remove your products from the market if they don’t complete their review of your application within 12 months.
In short, FDA’s Deeming Regulation is tantamount to a ban and will effectively kill the industry – and the products that millions of adult Americans rely on in lieu of combustible tobacco – in less than three years. That is why we must come together now to fight this regulation and force FDA to take a more reasonable approach.
Right To Be Smoke Free Coalition and E-Vapor Industry Trade Associations File Lawsuit Challenging FDA’s Deeming Regulation and the Tobacco Control Act
On behalf of the Right To Be Smoke Free Coalition and the entire e-vapor industry, yesterday Keller and Heckman LLP filed a Complaint in the U.S. District Court for the District of Columbia challenging portions of FDA’s Deeming Regulation and the Tobacco Control Act on various constitutional and administrative grounds. The named Plaintiffs in the…Read More
On Wednesday April 13, 2016, the Right to be Smoke-Free Coalition filed its response to Indiana’s reply to our Motions for Summary Judgment and Permanent Injunction. Our response also addressed arguments raised in an amicus brief filed in support of the law by Indiana Vapor Company and Crown Liquors. In our response we address the…Read More