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.
On May 2, 2018, the U.S. Food and Drug Administration (FDA) filed its brief in response to Appellants Nicopure and Right to be Smoke-Free Coalition’s appeal in the lawsuit challenging aspects of the Tobacco Control Act (TCA) and the Deeming Rule now pending before the U.S. Court of Appeals for the D.C. Circuit. FDA’s brief…Read More
Opening Brief Filed in Deeming Rule Appeal by Nicopure Labs and the Right to be Smoke-Free Coalition
On February 12, 2018, Nicopure Labs, LLCand the Right to be Smoke-Free Coalition[i] (the Appellants) filed their opening brief in the appeal of last year’s decision from the U.S. District Court for the District of Columbia, which ruled in favor of FDA in the first lawsuit challenging aspects of the Tobacco Control Act (TCA) and the Food and Drug Administration’s (FDA’s) Deeming…Read More