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.
NGOs File Motion for Summary Judgment in Lawsuit Challenging FDA’s Guidance Extending Deeming Rule Compliance Policy Deadlines
On March 27, 2018, a coalition of public health organizations including the Campaign for Tobacco-Free Kids, the Truth Initiative, the American Cancer Societyand the American Academy of Pediatrics, among others, as well as several individual physicians (collectively the “NGOs”) filed a lawsuit in the United States District Court for the District of Maryland challenging the Food and Drug…Read More
FDA Commissioner Dr. Scott Gottlieb’s Recent Remarks on Vapor Products and the Continuum of Risk; Update on Deeming Rule Appeal
On June 18, 2018, U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb delivered remarks on “FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science” at the Tobacco Regulatory Science Program Meeting. While addressing the importance of regulatory science to inform FDA’s Center for Tobacco Products (CTP) regulatory efforts, Commissioner Gottlieb focused…Read More