Our Fight

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FDA

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.

Indiana

The State of Indiana passed, HEA #1434, a law that could wipe out the e-liquid industry in the state and, if not taken off the books permanently, could create dangerous precedent for other states.  Effective July 2016, the law prohibits e-liquid manufacturers, whether or not they are located in the state, from selling products to retailers and distributors in Indiana without a permit which requires compliance with expensive and burdensome manufacturing and security protocols that may be impossible to meet. Indiana vape shops will also be required to obtain a tobacco sales certificate and are prohibited from selling e-liquids where the manufacturer has failed to obtain a permit.  Of most concern, the statute is aimed solely at e-liquids used in “open-system” products, while giving manufacturers of “closed-system” cigalikes a free pass.

Keller and Heckman Partner Eric Gotting Interviewed on the Smoke Free Radio Network

February 13, 2017

Keller and Heckman LLP Partner Eric Gotting was a guest on the Smoke Free Radio Network on February 3, 2017 to discuss the recent decision on the Indiana e-liquid law from the Seventh Circuit Court of Appeals in favor of the e-vapor industry, and to provide an update on the Right To Be Smoke-Free Coalition lawsuit challenging FDA’s Deeming…

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Keller and Heckman LLP Victory for the Right to be Smoke-Free Coalition and E-Vapor Industry in Indiana

February 13, 2017

WASHINGTON, D.C. – On January 30, 2017, the U.S. Court of Appeals for the Seventh Circuit issued its decision in Legato Vapors LLC et al. v. David Cook et al., No. 16-3071, striking as unconstitutional portions of Indiana’s Vapor Pens and E-Liquid Act (the Act) as it applies to out-of-state manufacturers. Among other things, the…

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