PMTA is a pre-market tobacco product application. Before a new tobacco product can be legally sold in the United States, it must be reviewed and approved by the Food and Drug Administration.
ENDS, short for Electronic Nicotine Delivery System, falls under the definition of new tobacco products therefore all ENDS manufacturers must file for market approval to continue to stay in business. FDA categorizes ENDS to include E-Liquids, E-Cigarettes, and ENDS products that package e-liquids and e-cigarettes together.
In other words, e-cigarette products that are not approved by the FDA cannot be sold in the United States. So can synthetic nicotine abolish PMTA’s policy on plant nicotine? The answer is not necessarily, but as far as the current situation is concerned, the FDA has not taken any regulatory measures. So it is safe for the time being.
Why do say that? I will break it down from the following aspects:
How to submit a PMTA application
For peers who want to list e-cigarette products in the United States, PMTA needs to submit three ways.
- Submit PMTA through the FDA’s eSubmitter software
- If your company does not have IAM, please apply for an industry account manager (IAM) account to create a CTP portal account.
- CTP portal online submission
There are many things you need to do to apply for a PMTA, including reviewing the full instructions of the FDA guidance document. However, if you want to have a general understanding, then the following information can satisfy you:
- Applicant’s information: The information published or known by the applicant should be a complete report of all the information known to the applicant.
- Product formulations, samples, and labels: FDA needs to understand the ingredients, ingredients, additives, and characteristics of the product, as well as the principles of operation, to determine whether they are appropriate.
- Manufacturing process: The company needs to send a complete description of the manufacturing process used for the product, including information about the equipment and facilities used.
- Operating instructions and health risk survey: Mainly describe how consumers use the product, including its frequency and their tendency to harm the human body after long-term use with other tobacco products. Other products can be used and how customers can modify the product to adjust performance or composition.
- Certification Statement: All information about e-liquid, product material, battery specifications, battery test certificate examples, and potential safety functions.
How long does it take for FDA to conduct PMTA substantive review and approval?
It takes 2 years from submission to the approval of the project, and the cost is relatively expensive, depending on the situation of the product.
This process is extensive, but can be broken down as follows:
What is Synthetic nicotine?
Synthetic nicotine products state that their nicotine is developed in a lab and is not derived from tobacco leaf. It is purer than tobacco-derived or derived nicotine, and “has no residual impurities of tobacco-derived nicotine.”
What is the difference between synthetic nicotine and plant nicotine?
They are essentially the same, so why do you say that? Because the chemical formula of nicotine is C10 H14 N2. This means that it is composed of ten carbon atoms, 14 hydrogen atoms, and two nitrogen atoms, roughly arranged in two connected rings. No matter how the structure of these factors is composed and formed, the result is nicotine.
Vegetables like tomatoes and potatoes also contain nicotine, but their nicotine content is much lower than tobacco plants.
Synthetic nicotine e-liquid VS plant nicotine e-liquid price
At present, the synthetic nicotine e-liquid is more than double the nicotine e-liquid of the tobacco plant. The price of plant-derived nicotine e-liquid varies according to the grade. With the upgrading of market supply and demand and manufacturing technology, the cost of synthetic nicotine has gradually approached the price of tobacco plant nicotine.
|Plant nicotine e-liquid
|Synthetic nicotine e-liquid
|Plant nicotine e-liquid
|Synthetic nicotine e-liquid
FDA’s attitude towards synthetic nicotine
At present, the application and popularization of synthetic nicotine have not yet reached the influence of nicotine extracted from tobacco plants. Therefore, the FDA does not have a clear regulatory policy for it. But once it comes to the issue of millions of pounds of interest, it isn’t easy to guarantee. For example, suppose the FDA’s authority is based on the “made or derived from tobacco” element in defining “tobacco products”, but tobacco has never been involved. In that case, synthetic nicotine should not be covered.
In a world where regulators mechanically comply with legal provisions without further action or clarification, this theory may work as expected.
However, things will never be as simple as we thought. Just like Tully himself mentioned in an interview with Wired:
This is very similar to the FDA’s response when asked about the status of nicotine-free e-liquid.
What to pay attention to when using synthetic nicotine
If you want to be completely free of tobacco-derived impurities and have a cleaner taste of nicotine, and don’t mind spending more time, please rest assured to use synthetic nicotine. It would be a good choice, although it cannot prevent e-cigarettes from unnecessary and cumbersome supervision in the end.
Whether synthetic nicotine can become a life-saving pill to save e-cigarettes is hard to say. It seems unlikely that the FDA will accept synthetic nicotine e-juice as a non-tobacco product, but it can easily constitute a legal obstacle to slow down the process. Even if the price of synthetic nicotine can be the same as plant nicotine with future development, it can be used as a commercially viable substitute for tobacco-derived nicotine. Still, the FDA does not need to make too many adjustments to control it.
The good news is that we still have time and opportunity. According to the current FDA policy on e-cigarettes, synthetic nicotine has not been included in the scope of supervision. This has bought us time and options. During this time, we can use synthetic nicotine to replace plant nicotine—conduct marketing e-cigarettes. In contrast, we were optimizing our market response strategy based on market and policy adjustments. Of course, all prerequisites are to comply with national rules and operate the e-cigarette business within the scope of legal compliance.