Recently some friends asked me whether to do zero nicotine e-cigarette PMTA, FDA will regulate them?
After careful study and communication with FDA, the following analysis and answers are given.
First of all, it is important to know that only “tobacco products” fall under the jurisdiction of CTP. Therefore, it is critical that zero-nicotine e-cigarettes are recognized as “tobacco products”. What is the definition of tobacco products in PMTA?
According to the FDA regulation Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, issued in June 2019 and updated in March 2023, Tobacco products are defined as:
Tobacco products are products made directly from tobacco or made from tobacco derivatives or containing nicotine from any source, natural or synthetic, and intended for human consumption, including all components or accessories of tobacco products (note that raw materials other than tobacco used in the manufacture of components and accessories of tobacco products do not count as tobacco products).
The term “tobacco product” does not imply that an article is a drug, or a device, or a combination product, or a food product if it does not contain nicotine, or contains trace amounts of nicotine that do not occur naturally.
The definition of tobacco products is not limited to those products containing nicotine, tobacco or tobacco derivatives, but also includes parts or accessories of tobacco products, whether for further manufacturing or direct delivery to consumers. For example, vaping oil used in e-cigarettes, vaping with unfilled vaping oil, empty atomizers, and stand-alone batteries are tobacco products that fall under FDA jurisdiction, whether they are sold to consumers for direct use or processed into another product for resold to consumers.
For the purposes of the above definition, tobacco products must be made from tobacco or from tobacco derivatives, which are substances extracted from tobacco or reprocessed from tobacco. If not, then if the product contains nicotine, regardless of the source of the nicotine, it is considered a tobacco product. But the FDA also stressed that even if a product does not contain nicotine, it does not necessarily mean that the product is not a tobacco product. Therefore, it is not immediately clear from this definition whether zero-nicotine e-cigarettes are tobacco products or not.
So, let’s take a look at the definition of “vape.” Again, in this guideline, the definition of vape is as follows:
For the purposes of this guidance, e-liquids (e-vapers) include liquid nicotine, or liquids containing nicotine (i.e. liquid nicotine in combination with colorants, flavorings and/or other ingredients), and liquids that do not contain nicotine or materials made from tobacco or tobacco derivatives, but which can be expected or reasonably expected to be used for human consumption of tobacco products.
E-liquids containing nicotine (including any source) or materials made from or derived from tobacco meet the definition of tobacco products and are, without a doubt, tobacco products. Liquids that do not contain nicotine or materials made from or derived from tobacco, but are intended or reasonably expected to be used with tobacco products (or components of tobacco products groups) or intended for human consumption, are also tobacco products and are subject to the U.S. CTP. For example, if a “zero nicotine” flavored e-liquid could be or could reasonably be expected to be mixed with liquid nicotine, then the “zero nicotine” e-liquid could be considered a component of the tobacco product and, therefore, would also be subject to the CTP. Even if sold separately from e-cigarettes, the e-liquid is a tobacco product. If e-liquids containing zero nicotine are not made from or derived from tobacco and are not intended or reasonably expected to be mixed with liquid nicotine or materials made from or derived from tobacco, then such e-liquids are not tobacco products and are not subject to the jurisdiction of the CTP.
The definition is clear. There are two key factors that determine whether a zero-nicotine e-cigarette is considered a tobacco product:
First, in addition to being completely nicotine free, the product cannot contain tobacco extracts or derivatives.
Second, there is no way the product can be mixed with nicotine to form an e-cigarette.
We also spoke with the CTP and their response was basically the same as our analysis, except that the CTP emphasized that they would judge whether a product is a tobacco product on a case-by-case basis based on the overall situation. That is to say, after all, the products are very different, they will make the final decision based on the actual situation.
With that in mind, let’s look at the “disposable, zero-nicotine e-cigarette.” First, if the e-liquid in your product’s atomizer is completely free of nicotine or any tobacco-related substance, and the customer can’t subjectively add any other substance. Then, your product is not considered as an e-cigarette, not under the management of CTP, and you do not need to apply for PMTA.
However, you need to be able to prove that all e-liquid components are completely unrelated to tobacco and tobacco derivatives. That’s one thing; Second, you need to prove that your product does not artificially add nicotine to the atomizer. This is crucial. In theory, we know that you can’t artificially fill a closed bomb or a disposable product with soot, otherwise it would be called open! But according to some professional players or industry insiders who are familiar with the structure, they can inject the closed product with soot or nicotine. Of course, if it was disruptive oiling, I’m sure the CTP wouldn’t consider it a reasonably expected addition of nicotine, so it certainly wouldn’t count. But if it’s non-destructive, skilful oiling, or the product itself has this loophole, chances are, the CTPS will consider your single-use, zero-nicotine product a “tobacco product.” On this point, the manufacturers will have to evaluate themselves.
On the other hand, nicotine-free products cannot be addictive and lose their tobacco properties. Such products will completely become “toys”. The main audience is teenagers who are not addicted to smoking, and customers can stop using or change products at any time. This is a market risk for nicotine-free products. Moreover, even if there is no nicotine in this kind of product, but a variety of spices and chemical solvents still exist. After soaking the atomizing core and parts, the toxic and harmful substances released under high temperature conditions are actually not less than the electronic cigarettes containing nicotine, aldehydes and heavy metals still exist. Therefore, the potential harm of the product still exists even if the CTPS are not regulated. Therefore, the FDA may not regulate the product as a tobacco product, but as a device or a combination product in consideration of the health protection of its audience.
Therefore, it is not recommended that domestic e-cigarette companies take advantage of this loophole. You know, the FDA is programmed to do what it does best: close loopholes. If you want to make zero-nicotine e-cigarettes for a long time, you should put zero-nicotine products and nicotine-containing products together in a series of products to declare PMTA. At present, known American local tobacco oil manufacturers declare PMTA in this way, almost every flavor of tobacco oil, its nicotine concentration is from 0, the gradient is amplified. Only by doing so, is the safest and the most long-term choice.