Published on July 28th, 2016 | by Jimmy Hafrey
If you thought the FDA was going to clear up its overreaching regulations, think again.
A new article out on Forbes this week showcases that the FDA either doesn’t understand the vaping industry or has a hard time articulating what aspect of it comes under its regulation umbrella. The one thing the agency does know is that vaping is somehow a tobacco product.
How did they arrive at this conclusion? Well, most vapers use an e-liquid that uses nicotine as a way to quit smoking. Nicotine is a substance that naturally occurs in tobacco. So in the FDA’s view, nicotine is a tobacco product.
This is a little concerning, especially since we’ve covered here before the fact that synthetic nicotine is now becoming more commercial. And more importantly, not all vape products on the market contain nicotine, a fact that many vape activists and public health scientists have been raising.
Take, for example, Michael Siegel, a Boston University public health professor. The professor released a correspondence from an unnamed source that showcases that not even the FDA knows what to do about the non-nicotine vape products on the market.
The question posed to the FDA was simple: “Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations? If so, will they also require pre-market approval like products that do contain nicotine?”
This is an important question because, again, not all vape products contain nicotine. One would think that the answer to this question would be a simple no, those products would not fall under these regulations.
The answer is not so simple. In fact, the original full-length reply is over 1,000 words long, which you can read here. The actual question isn’t answered until 10 paragraphs in.
The FDA’s reply comes to the conclusion this way: “As it relates to e-liquids that contain zero nicotine, generally, if your zero-nicotine product is not made or derived from tobacco, it may still be a tobacco product subject to FDA regulation if it is intended or reasonably expected to be used with or for the human consumption of a tobacco product; or intended or reasonably expected to alter the performance, composition, constituents, or characteristics of a tobacco product (with certain exceptions relating to controlling moisture or temperature for storage and initiating external heat source), your product is subject to FDA regulation. These products will be evaluated on a case-by-case basis. This applies to closed and open system devices that contain zero nicotine.”
If you’re shaking your head in confusion, you’re not the only one. Even Siegel states that “I have no clue what the heck the FDA is talking about.”
The truth is, there’s no reason why non-nicotine open or closed vaping systems would be subject to the regulations or the pre-review market process. But it seems that since the FDA believes it would be possible to introduce nicotine to either system, then they must come under the regulations.
And the warning the FDA gives that “these products will be evaluated on a case-by-case basis” prohibits any vape company or small business owner to know whether or not they will have to fork out hundreds of thousands of dollars for a review process for a non-nicotine vape product.
This correspondence goes to prove one thing: vape companies will never know if they’ll be complying with the FDA regulations until the agency decides they’re not. And that’s no way to run a business.
We will continue to update this article if and when the FDA decides to clarify their response to this simple question.