FDA Regs on Ecigs

A Deeming Rule 101

You’ve probably read or heard something about recent FDA regulation applicable to the vaping industry — also known as the Deeming Rule. If you’re not aware how you’ll be affected as a vaper, you should know the full story. It starts with an overview of the implications of the FDA’s Deeming Rule.

To be sure, the rule includes some common sense provisions that most people can agree on, e.g., keeping vaping products out of the hands of minors by setting a minimum age for purchase, and registering manufacturing facilities with the FDA.

But what’s also included in the Deeming Rule may surprise you, and will ultimately impact your choices and your lasting enjoyment of the vaping experience.

What the Deeming Rule Does

The Tobacco Control Act (TCA) of 2009 retroactively established February 15, 2007 as the market date after which all “new tobacco products” (quotes added) must be put through a burdensome authorization process with the FDA.

This is a real head-scratcher with regard to vaping products in particular, for a couple of reasons.

What were you vaping in early 2007? You probably hadn’t even heard of it then. Few vaping products were being sold at that time. So all vaping products are “new” and not exempted from premarket authorization by the FDA.

The Deeming Rule got its name when the FDA “deemed” vaping products to be tobacco products, even though they do not contain any tobacco.

These inexplicable aspects of the Deeming Rule have led to considerable action in Washington, D.C. More about that below.

What the Deeming Rule means for manufacturers is a number of requirements, including a lengthy, expensive testing, human studies, and authorization process for every single e-liquid flavor and vaping device they offer.

The FDA itself estimates that the cost for this may top $300,000 PER PRODUCT. New flavor? $300,000. A nicotine-free version of the same flavor? $300,000. New device? $300,000. And that’s just for testing and research. The industry believes it will cost much more per product than the FDA’s estimate. Whatever the amount, paying it doesn’t guarantee that the product will be approved.

Getting just one new flavor approved could cost more than some smaller manufacturers generate in a year. Keeping current products on the market after August 8, 2018 requires the same lengthy application, and many millions of dollars.

What Will Change for You

So, what’s the upshot of all of this for you as a vaper? The most significant implication is the loss of your freedom.

Want new flavors? Few to none will be available. Looking for new devices? The same.

The prohibitive cost of authorization for manufacturers means new flavors and devices could cease, and with them, your buying choices become sharply limited.

We hope you like your current vape.

Of course, since many existing products will disappear by August 2017 at the latest, there’s no guarantee you’ll get to continue enjoying them, either.

With the pre-market authorization deadline set for late summer 2018, however, you will likely see other less impactful changes first.

There are no more free samples, for example. You may still encounter some sampling opportunities, but the law now requires there to be a cost. The actual amount has not been set by the FDA and is at the discretion of the seller.

You’ll also see fewer vending machines, as these can only be used in locations where the vendor is able to guarantee that no one under the minimum age has access.

Your local vape shop owner may no longer help you assemble a device, replace your coil, or otherwise tamper with the equipment unless you buy it first.

The Deeming Rule broadens the definition of manufacturer to the extent that even your favorite local vape shop may be considered one. If they mix flavors or assemble any devices, or even if they import devices or liquids directly from abroad, they’ll be subject to the same regulations and associated costs as any manufacturer.
Indeed, your local vape shop could become an endangered species.

FDA ecig regulations

What Some Are Doing About It

In the legal space, Nicopure Labs, LLC, maker of Halo and eVo brand e-liquids, was the first to challenge the FDA over the Deeming Rule in federal court. Other parties soon joined the suit. The case has been featured extensively in the press and is ongoing.

On the legislative front, congressional Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) sponsored an amendment to a 2017 Agricultural Appropriations bill that may ease some of the burden on manufacturers. This was voted for inclusion by the House Appropriations Committee in April 2016, though the larger bill has yet to see a vote.

The Cole-Bishop Amendment would change the grandfather date of all unregulated “tobacco products” — including vaping products — from the 2007 date established by the TCA to August 8, 2016, when the Deeming Rule went into effect.

This would allow vaping products that were already being sold on August 8, 2016 to be exempted from the costly and lengthy approval process and, thus, have a chance to remain on the market.

It would also mean that you could keep enjoying your favorite e-liquid flavors and vaping hardware, provided they were available before that date.

What You Can Do

If you’re concerned about where the vaping industry is headed, there are some things that you can do. And the sooner you do them the better.

Contact your congressional representatives and ask them to support the 2017 Agricultural Appropriations bill with the Cole-Bishop Amendment, as it will keep a growing industry working, foster a stronger economy, and preserve your freedom of choice. Also share with them any benefits you may have personally experienced since you began vaping.

You may also want to express your views with your state or local government officials, who might be considering legislation that severely restricts vaping and vaping products if they haven’t already.

There are real threats to the future of vaping, but you don’t have to take them lying down. It’s your government and it’s your choice. There’s no reason why an adult shouldn’t be able to continue enjoying their vaping experience without excessive interference from the government. Let the people who represent you know how you feel.

One comment

Leave a Reply

Your email address will not be published. Required fields are marked *