E-LiquiTech says it has large quantities of Zanoprima’s SyNic in stock to help companies introduce new products to the U.S. market ahead of the mid-April deadline imposed by a new law.
On March 15, 2022, President Joe Biden signed into law a spending bill that includes a provision to regulate products containing synthetic nicotine the same as products containing tobacco-derived nicotine. This means that companies selling products containing synthetic nicotine will be required to file a premarket tobacco product application in order to keep their product(s) on the market. The deadline for filing such applications is less than 60 days away.
According to E-LiquiTech, SyNic is the same chemical composition of (S)-nicotine as natural tobacco-derived nicotine but without any of the impurities. Specifically, SyNic achieves a purity profile of 99.9 percent and is devoid of tobacco-specific nitrosamines, heavy metals and other impurities that are present in tobacco-derived nicotine.
SyNic is manufactured through a patented process in a cGMP facility approved by the U.S. Food and Drug Administration and meets or exceeds the U.S. Pharmacopeia monograph, making SyNic a 1-to-1 replacement for tobacco-derived nicotine and enabling manufacturers to use it as a CAS number substitute, according to E-LiquiTech.
The company says all of the scientific data that is applicable to tobacco-derived nicotine is equally applicable to SyNic. The manufacturing process is replicable from batch to batch, and every batch of SyNic is fully trackable 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 process for manufacturing (S)-nicotine, demonstrating its long-term commitment to the U.S. market.