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The Impending Doom of Vaping by the FDA

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FDA's regulation authority over vaping

For a few years now, the FDA (Food and Drug Administration) has been in charge of regulation of vaping products. Once they took control of this, they deemed that vaping products were now classified as tobacco products. This includes any and all things that could possibly be considered vaping related. Devices, batteries, liquids, etc.

In 2016, the FDA finalized regulations for vaping that would take effect in the coming years. Initial dates for all vaping products to be FDA approved were set and then later extended to 2022 by FDA Commissioner Scott Gottlieb. When Scott Gottlieb stepped down as FDA commissioner, the date was pushed up to 2021 for FDA approval.

In the past year, the federal courts demanded that the FDA push forward their timeline and require vape companies to complete their registration for approval by May 2020. Currently this is where we stand.

What is required by the FDA?

This is where things turn from sensible to nonsense. The FDA requires all vaping manufacturers to submit a "PMTA" which is a "Pre-Market Tobacco Product Application".

A PMTA is an application which is submitted to the FDA which is to contain a full report of each products health risks, components, additives, how they're prouced, marketed, packaged, etc.

Doesn't sound too crazy, until you see this quote from the FDA website:

"a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others"

This is the estimated cost for a single PMTA, which is necessary for each SKU. What qualifies as a SKU for any vape liquid on the market? Well to give you an idea we have over 800 SKUs. Many companies have thousands of SKUs.

Each SKU is identified as any one flavor, in each nicotine level available and in each bottle size available.

Lets give an example.

1. Example Flavor

This flavor has nicotine options of 0mg, 3mg, 6mg, 12mg

It is available in 15ml, 30ml and 60ml in glass and plastic botles.

That's 6 bottle options and 4 nicotine options. 24 different SKUs for one flavor, if you were to cover all of your options. 

Estimated costs in realistic cases would be millions and millions of dollars, without any guarantee for approval.

Funds required for the PMTA application and submission do not guarantee an approval for your products by the FDA.

Who has FDA approved vape products?

Currently since the release of the PMTA guidelines for standard E-Liquid, no vape manufacturer has submitted a PMTA for any standard E Liquid product.

What can we expect come May?

As things seem right now, many many vape companies will go out of business and there won't be many, if any, vape companies left on the market. This includes online companies or local stores in your area if you are in the United States.

What can we do?

What we would recommend doing is keeping up with http://www.casaa.org/ for the latest updates on vape news and taking part of their call to actions to try and change legislation to be more fair towards vaping.

Otherwise, we recommend you stock up as the deadline gets closer.

Vaping products come with an expiration date of 1 year as a standard.

Generally the only part that can go bad in E-Liquid is the nicotine. Nicotine degrades with heat and exposure to air and sunlight. If these factors are handled, your liquid can last much longer and be just fine.

  • Store your liquid in well-sealed bottles
  • Make sure your liquids are not exposed to sunlight and heat

The easiest way to store your liquids long term are to keep them in their original bottles fully sealed and completely filled. The less extra air in the bottle, the better. You can then store them long-term in the refrigerator which will slow down the degradation of the nicotine. When you are ready to consume your product, just store them in your room the day before and they will be good to go the next day.

Updates

As the deadline approaches and pressure is put on the FDA and the US government, we are hoping some changes happen. As things progress we will have more updates via email and our blog to better inform you of the current scene.

The Impending Doom of Vaping by the FDA

The Clean Vape