Do Zero-Nicotine E-Cigarettes Need PMTA? Trying to Exploit Loopholes Is Not Advisable

Recently, some friends have asked me whether zero-nicotine e-cigarettes need to undergo PMTA and whether the FDA will regulate them.

In response to this question, after careful research and communication with the FDA, I provide the following analysis and answers.

First, we need to understand that only "tobacco products" fall under the jurisdiction of the CTP, so whether zero-nicotine e-cigarettes are classified as "tobacco products" is crucial. What is the definition of tobacco products in PMTA?

According to the FDA's regulations published in June 2019 and updated in March 2023, the definition of tobacco products is:

Tobacco products are those made directly from tobacco or derived from tobacco, or containing nicotine from any source, whether natural or synthetic, intended for human consumption, including all components or accessories of tobacco products (note that raw materials used to manufacture components or accessories of tobacco products that are not made from tobacco do not count as tobacco products).

The term "tobacco products" does not imply that an item without nicotine, or containing only trace amounts of naturally occurring nicotine, is a drug, device, combination product, or food.

The definition of tobacco products is not limited to those containing nicotine, tobacco, or tobacco-derived substances; it also includes components or accessories of tobacco products, whether used for further manufacturing or directly delivered to consumers. For example, e-liquids for e-cigarettes, unfilled e-cigarettes, empty atomizers, and standalone batteries are all considered tobacco products, regardless of whether they are sold for direct consumer use or processed into another product before being sold to consumers, and are under FDA jurisdiction.

From the above definition, tobacco products must be made from tobacco or derived from tobacco. The so-called tobacco derivatives refer to substances extracted from tobacco or reprocessed from tobacco. If not, then if a product contains nicotine, regardless of the source of that nicotine, it is also considered a tobacco product. However, the FDA emphasizes that even if a product does not contain nicotine, it cannot be assumed that the product is not a tobacco product. Therefore, from this definition, we still cannot intuitively determine whether zero-nicotine e-cigarettes are tobacco products.

So, let's take a look at the definition of "e-liquid". Similarly, in the guidelines, the definition of e-liquid is as follows:

For the purposes of this guidance document, e-liquid (e-juice) includes liquid nicotine or nicotine-containing liquids (i.e., liquid nicotine combined with colorants, flavorings, and/or other ingredients), as well as liquids that do not contain nicotine or materials made from or derived from tobacco, but are expected or reasonably expected to be used for human consumption of tobacco products.

E-liquids containing nicotine (from any source) or made from or derived from tobacco materials meet the definition of tobacco products and are undoubtedly considered tobacco products. Liquids that do not contain nicotine or materials made from or derived from tobacco, but are expected or reasonably expected to be used with tobacco products (or components of tobacco products) are also considered tobacco products and fall under CTP jurisdiction. For example, a "zero-nicotine" flavored e-liquid may be expected or reasonably expected to be mixed with liquid nicotine, so this "zero-nicotine" e-liquid could be viewed as a component of a tobacco product and thus would also be subject to CTP regulation. Even if sold separately from e-cigarettes, such e-liquids are still tobacco products. If a zero-nicotine e-liquid is not made from or derived from tobacco and is not intended or reasonably expected to be mixed with liquid nicotine or tobacco-derived materials, then these e-liquids are not tobacco products and are not under CTP jurisdiction.

This definition clarifies that whether zero-nicotine e-cigarettes are classified as tobacco products hinges on two key factors:

First, the product's ingredients must not only be completely nicotine-free but also not contain tobacco extracts or derivatives.

Second, the product must not be capable of being mixed with nicotine to form an e-cigarette.

We also communicated with the CTP, and their response was generally consistent with our analysis, with the additional emphasis that they will make determinations on a case-by-case basis based on the overall situation to judge whether a product is a tobacco product. In other words, given the significant variability in products, they will make the final determination based on actual circumstances.

With this information in mind, let’s look at "disposable zero-nicotine e-cigarettes." First, if the e-liquid in your atomizer contains no nicotine and no tobacco-related substances, and customers cannot subjectively add any other substances, then your product is not considered an e-cigarette, is not under CTP management, and does not require PMTA.

However, you must have sufficient proof that all the components of the e-liquid are completely unrelated to tobacco and tobacco derivatives. This is one aspect; secondly, you must also provide sufficient proof that your product cannot be artificially filled with nicotine. This point is crucial. Theoretically, we know that closed-system pods or disposable products cannot be manually filled with e-liquid; otherwise, they would be classified as open systems! However, some professional users or industry insiders familiar with the structure claim they can inject e-liquid or nicotine into closed products. Of course, if it’s a destructive filling method, I believe the CTP would not consider this a reasonable expectation for nicotine addition, so it certainly wouldn’t count. But if it’s a non-destructive, skillful filling method, or if this product has a loophole, then it’s very likely that the CTP will view your disposable zero-nicotine product as a "tobacco product." Manufacturers need to evaluate this themselves.

On the other hand, products without nicotine cannot produce addictive properties, losing their tobacco attributes, and these products will completely become "toys," primarily targeting non-addicted youth, allowing customers to stop using or switch products at any time. This presents a market risk for zero-nicotine products. Furthermore, even if these products contain no nicotine, various flavorings and chemical solvents still exist, and the toxic and harmful substances released after soaking the atomizer core and components at high temperatures are actually not less than those found in nicotine-containing e-cigarettes; aldehydes and heavy metals still exist. Therefore, even if the CTP does not regulate them, considering the health protection of the target audience, the FDA may also view them as devices or combination products for regulation.

Thus, I sincerely do not recommend domestic e-cigarette companies trying to exploit this loophole. It’s important to understand that the FDA's operational mechanism is best at closing loopholes. If you want to successfully market zero-nicotine e-cigarettes in the long term, it’s best to develop a series of products that include both zero-nicotine and nicotine-containing products for PMTA submission. Currently, known American e-liquid manufacturers often adopt this approach when submitting PMTA, starting with a nicotine concentration of 0 and gradually increasing. Only by doing so can you ensure safety and sustainability in the long run.

If you have any further questions or opinions regarding zero-nicotine or PMTA, feel free to join our technical discussion group for in-depth discussions!