E-liquitech said it has a large stockpile of Zanoprima's synthetic nicotine (SyNic) to help it launch the new product in the U.S. market ahead of a mid-April deadline mandated by the new law.
On March 15, 2022, President Joe Biden signed a spending bill that includes a provision to regulate products containing synthetic nicotine as well as those containing tobacco-derived nicotine. This means that companies selling products containing synthetic nicotine will be required to file premarket tobacco product applications in order to keep their products on the market. The deadline for submitting such applications is less than 60 days.
According to E-Liquitech, SyNic's (S) -nicotine is chemically identical to nicotine derived from natural tobacco, but does not contain any impurities. Specifically, SyNic is 99.9 percent pure and free of nitrosamines, heavy metals and other impurities found in tobacco-derived nicotine that are characteristic of tobacco.
SyNic is manufactured in a U.S. Food and Drug Administration-approved cGMP facility through a patented process that meets or exceeds U.S. Pharmacopeia specificity, making SyNic a one-to-one alternative to tobacco-derived nicotine and enabling manufacturers to use it as a Cas-numbered alternative, according to E-Liquitech.
The company says all the scientific data that applies to tobacco-derived nicotine also applies to SyNic. The manufacturing process can be replicated batch by batch, and each batch of SyNic is fully traceable and traceable.
Earlier this month, Zanoprima filed a patent lawsuit against Hangsen International in the U.S. District Court for the Western District of Texas to enforce Zanoprima's patented Manufacturing (S) -nicotine process, demonstrating its long-term commitment to the U.S. market.