FDA Not Clear on Regulating Nicotine-Free eLiquids
In a response brief to the Court dated November 1st 2016, the FDA stated that: “Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’ —that is, if it is ‘intended or reasonably expected’ either…(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory.”
The FDA’s Deeming Rule was designed to extend the agency’s regulatory authority over a variety of tobacco products, which greatly impacts the vape industry. However, the recent clarification from FDA attorneys appears to confirm that the Deeming Rule does not extend to e-liquids that are either nicotine-free, or not made or derived from tobacco, when marketed and sold appropriately. Nicotine-Free eLiquids are what the FDA refers to as NFLs. Vapor business owners in the market knows it well as TFN, short for Tobacco-Free Nicotine.
It’s been over six months since the issue of synthetic nicotine was first raised as a challenge to the FDA’s deeming regulations. Now it seems that the unclear stance the agency is holding in regard to the ingredient is still causing confusion and at least one lawsuit.
Reason is reporting that the recent Nicopure v. FDA lawsuit, which was filed in August of this year and can be read here, has showcased the FDA’s own confusion about synthetic nicotine and how it plays a role in the vaping regulations under the Family Smoking Prevention and Tobacco Control Act of 2009.
The current regulations cite that any product that includes tobacco or a tobacco derivative falls under the act and is subject to the broad rules set forth by the FDA. This would include vaping e-liquids that use nicotine, which is naturally found in tobacco.
But synthetic nicotine is created in a lab, free from any tobacco products. While the ingredient is still quite new to the vaping community, it is poised to become a big player in the world of vaping. The idea that consumers can vape nicotine as a smoking cessation method without tobacco is exciting and was thought to put an end to the overreaching regulations put forth by the FDA.
The FDA, however, does not see it that way. It took Republican Senator Ron Johnson of Wisconsin sending a letter to the FDA commissioner, for the agency to come somewhat clean of their own interpretation of synthetic nicotine. We wrote about Johnson’s letter at length a while back which you can read here.
The agency even went so far as to explain why synthetic nicotine may not be exempt from regulations in their own response to the Nicopure v. FDA suit. The FDA states that:
“Not all nicotine-free e-liquids (NFLs) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a “component or part”—that is, if it is “intended or reasonably expected” either “(1) To alter or affect [a] tobacco product’s performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product; and is not an accessory.”…An NFL that is intended or reasonably expected to be mixed with liquid nicotine would qualify as a ‘component or part.’”
In layman’s terms, the FDA is saying that, by law, any product that may contain tobacco, either at the time of construction or later on down the line by an independent business or consumer, is subject to the regulations. Because synthetic nicotine is found as e-liquids for open systems, such as mods and other vape devices that can use other vape liquids, these products may be subject to the regulations.
This makes very little sense to companies and consumers, considering that most vape customers buy e-liquids and vape them as-is; very few consumers would even think of adding tobacco-derived nicotine to products that already contain the ingredient. And the very idea that vape delivery systems, which are not made up of any tobacco derivatives, are considered tobacco products is ridiculous.
There is hope on the horizon, however, and it’s coming from Nicopure and Next Generation Labs. There is a collaboration in the works with Vapeix to create a “cloud-connected smart vaporizer platform” that basically ensures that the vape mod is only used in conjunction with e-liquids that use TFN nicotine. If this product launch goes well, the vape community can bet that more companies will follow suit, if only to skirt the FDA regulations that are resounding in their apparent intention to bankrupt the industry.
But the question still remains: what is the FDA’s true stance on TFN nicotine? The agency has yet to be concrete in their interpretation of the act that gave them control over the vape industry, but it can only be surmised by this writer that more lawsuits will push the issue out into the open.
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SOURCE: ChurnMag (http://www.churnmag.com/news/fda-unclear-on-regulating-synthetic-nicotine/) | Tobacco On Trial: 11/2016 Nicopure v FDA : R2B Coalition v FDA (http://www.tobacco-on-trial.com/wp-content/uploaded/2016/11/2016-11-01-nicopure-fda.pdf) Next Generation Labs (http://www.nextgenerationlabs.com/)