The Real Implications of the FDA Deeming Rule

From the UK to Germany, to all the way ‘Down Under’ in Australia, governments worldwide have imposed various rules and regulations on e cigarettes. While that was viewed as an eventuality, many believe some governments have gone over the top to curb electronic cigarette usage. A prime example? None other than the United States of America.

By now, both the pro and anti-vaping communities have heard about the USA FDA’s Deeming Rule on e-cigarettes. Even people with little knowledge about e cigs have become somewhat educated regarding these devices. They’re everywhere, for good or for bad (depending on who you ask).

Whether you were/are for or against vaping, both sides of the spectrum were certain that the Deeming Rule would have large implications on the e-cig market, specifically in the United States. When a decision like this is pushed through, it’s nothing to brush aside. Laws are laws, and they are generally enforced (oftentimes strictly), especially when it comes to products labeled under ATF (alcohol, tobacco, and firearms). But, will this really happen with e cigs?

For starters, the FDA ruling on e-cigarettes was supposed to come into effect on August 8th, 2016. E-cigarette manufacturers had until December 31st, 2016 to register their products with the FDA. This deadline has already been pushed back to June 30st, 2017 likely because the FDA system cannot handle the amount of submissions to their website. However, the vaping industry is bracing for a full enforcement by the FDA. Our question is: how much should US vape businesses be worried?

Everyone remembers the days of Napster, the popular P2P file sharing service that was shutdown mainly due to unauthorised use of (licensed) music/audio files. Yet, while Napster was certainly a big fish, there were hundreds, if not thousands, of other P2P sites that were fully operational. It’s been 15 years since Napster’s shutdown. However, there has been a significantly large increase in P2P, free online streaming, and torrent sites – almost all “illegal” by law. Music/audio/video licensing is a larger business than vaping itself. For years now, governments have been trying to shut down these P2P type sites. But, when one is shut down, ten more pop up.

Now, some may argue that tobacco is very different than internet websites, the latter being much harder to regulate and patrol. Tobacco is a physical product sold (primarily) in physical stores. Internet sites are much more complicated legally and practically speaking. While this is true for tobacco, this isn’t entirely the case with e-cigarettes.

Yes, Big Tobacco will need to go through the FDA process, along with any other vaping business wishing to expand into retail. However, many vape shops are online. It will be difficult for the FDA to impose their will on every one of these sites. At worst, they will (try to) make an example of a few online vape shops. But otherwise, we don’t expect e-cig consumers to be largely affected.

Moreover, there is a large possibility of US vaping customers flocking to UK sites, and shipping their e-cig products internationally. Or, the creation of a black market is very possible as well.

The FDA is already having a hard time coping with the influx of vaping businesses trying to register on their site. It is doubtful the Deeming Rule will have any serious impact on most vaping businesses, especially in the short term.

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