The emergence of Puffbar, and its increasing popularity due to its disposable nature, has put synthetic nicotine in the spotlight. A recent paper reported on searches for "truth tobacco industry documents," showing that the industry has been considering the use of synthetic nicotine since the 1960s. However, previous efforts were abandoned.
The paper further explains the various types of synthetic nicotine and how many manufacturers, including leading pharmaceutical-grade nicotine suppliers, have recently developed stereoselective strategies to be able to synthesize the types of synthetic nicotine currently found in e-cigarettes.
So far, e-cigarette suppliers have been able to exploit regulatory loopholes to avoid the costly pre-market tobacco product application (PMTA) process. However, the situation may soon change.
On December 15th, New Jersey Congresswoman Mikie Sherrill introduced the 2021 Nicotine Clarification Authorization Act, a bipartisan bill that would empower the United States Food and Drug Administration (FDA) to regulate synthetic nicotine products in the same way as manufactured nicotine products, whether sourced from tobacco or not.
Representative Cheryl stated in a press release that the bill aims to protect minors. "This bill will ensure that all tobacco products, including those made with synthetic nicotine, are regulated by the FDA to protect our communities' children and those who may seek to use these products," she said.
The FDA delays the ban on synthetic nicotine.
Currently, the Federal Food, Drug, and Cosmetics Act (FDCA) defines "tobacco products" as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." However, in addition to regulating synthetic nicotine as a component of tobacco products, the FDA also has the authority to regulate it as a drug.
In the meantime, last month, the FDA began issuing warnings to unauthorized manufacturers and retailers of products containing synthetic nicotine. Despite growing pressure to ban the compound, the FDA has not taken action.
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