On January 5, it was reported that in the United States, the regulatory momentum for synthetic nicotine seems to be increasing.
On December 15, Congress Representative Mikie Sherrill introduced a bill to give the US Food and Drug Administration the power to regulate synthetic nicotine products, just as it regulates nicotine products made or derived from tobacco.
“This bill will ensure that all tobacco products, including those made with synthetic nicotine, are regulated by the FDA to protect children in our community and those who may seek to use these products.” Cheryl said in a statement Say.
The Federal Food, Drug, and Cosmetic Act (FDCA) currently defines a tobacco product as any product made or derived from tobacco for human consumption, including any ingredient, part or accessory of a tobacco product.
In November last year, Mitch Zeller, director of the FDA’s Tobacco Products Center, suggested that synthetic nicotine could be considered an ingredient in e-cigarettes, which would allow the agency to regulate it.
The FDA may also seek to regulate synthetic nicotine as a drug. The FDCA defines a drug as an item (except food) that is designed to affect the structure or any function of the body.
In the 1990s, the FDA tried to use nicotine as a drug and regulated cigarettes and smokeless tobacco as drug delivery devices. In FDA v. Brown & Williamson Tobacco Corp., the US Supreme Court found that the FDA lacked such power.
The 2009 Family Smoking Prevention and Tobacco Control Act granted the FDA the power to regulate tobacco products. If today the FDA regulates synthetic nicotine as a drug, it may point to the recent legislation of Congress, giving the FDA a broader role in this field. However, so far, the FDA has not taken this approach.
After a series of marketing denial orders, the FDA forced many products containing tobacco-derived nicotine to withdraw from the market, and some manufacturers have turned to synthetic nicotine to avoid the agency’s strict and costly pre-market review procedures.
In response to such actions, legislators have initiated investigations and called for supervision of the category. On November 16, nine senators wrote to the FDA, urging the agency to supervise synthetic nicotine products.
The author expressed concern that e-cigarette manufacturers like Puff Bar are turning to synthetic nicotine to avoid FDA supervision and pre-market review requirements in order to continue to sell their products-including flavored products-they claim to be very useful to young people. Attractive.
On the same day, the North Carolina Attorney General launched an investigation into Puff Bar.
On November 8, he wrote to e-cigarette manufacturers Puff Bar and Next Generation Labs requesting extensive records related to the production and marketing of synthetic nicotine products from these companies.
