The FDA Has Not Yet Clarified The Regulations On The Synthesis Of Nicotine.

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The FDA has not yet clarified the regulations on the synthesis of nicotine.

2019-01-22

It has been more than six months since the issue of synthetic nicotine was first proposed as a challenge to the FDA's presumptive rules. It seems that the unclear position held by the institution will still cause confusion and at least one lawsuit.

The Nicopure v. FDA lawsuit filed in August this year has demonstrated FDA's confusion about the synthesis of nicotine and how it works in vaping control under the Family Prevention of Smoking Act and the Tobacco Control Act of 2009.

Current regulations state that any product that includes tobacco or tobacco-derived products is subject to the Act and is governed by the broad rules set forth by the US FDA. This will include nicotine-containing vaping smoke oils, which are natural ingredients in tobacco.

But synthetic nicotine is created in the laboratory and has nothing to do with any tobacco product. Although this ingredient is still very new to the vaping community, it is expected to become a big player in the vaping world. Consumers can vape nicotine, a tobacco-free way to quit smoking, an idea that is exciting and considered to end the over-the-counter FDA.
But the FDA does not think so. Republican Senator Ron Johnson of Wisconsin sent a letter to the FDA Commissioner to give some truth to the agency's explanation of synthetic nicotine.

In their response to the Nicopure v. FDA lawsuit, the agency explained why synthetic nicotine may not be exempt from the regulations. The FDA stated:

“Not all nicotine-free tobacco oils (NFLs) are subject to presumptive rules. Assuming that the NFL is not made of tobacco or obtained from tobacco, it is governed by rules only if it meets the definition of “component or part”. That is, if it is “intentionally or reasonably expected” or “(1) in order to change or influence [A] the performance, composition, or characteristics of the tobacco product; or (2) in conjunction with or for the consumption of tobacco products Used by people; not an attachment. "... The NFL will be designated as a 'component or part' if it is intentionally or reasonably expected to be mixed with nicotine."

In layman's terms, the FDA means that, according to the law, any product that may contain tobacco, whether used at the time of production or offline, by an independent company or consumer, is regulated by law. Because synthetic nicotine is used as a smoke oil in open systems, such as mods or other e-cigarette devices that use smoke oil, these products may be subject to regulatory controls.

This is meaningless for businesses and consumers, considering that most e-cigarette customers buy smoky oil and use it as it is; few consumers would think of adding tobacco-derived nicotine to products that already contain it. And the vape delivery system, which is not made up of any tobacco derivatives, is considered a tobacco product, and the idea is simply absurd.

However, hope is still there, it comes from Nicopure and the next generation of laboratories. There is also a collaboration with Vapeix that will create a “cloud-connected atomizer-only platform” that ensures that the vape mod can only be used with TFN nicotine. If the launch of this product goes well, then no doubt more companies will follow suit, as long as it can circumvent the FDA regulations that are clearly going to make the industry bankrupt.