To avoid FDA oversight, companies created synthetic nicotine in the lab—rather than derived from tobacco, which is the agency’s purview. But the national spending law passed on March 15 “makes it clear that the FDA can regulate tobacco products that contain nicotine from any source,” the agency said Wednesday, a day before the law finally went into effect.
Now anyone who makes or sells “non-tobacco nicotine” must comply with FDA regulations, which include selling to anyone under the age of 21, giving away free samples, and not claiming that their products are less harmful than cigarettes. prohibited without FDA approval.
Companies that manufacture these products must also register them with the agency and submit a “premarket application” by May 14 to legally remain on the market. This review includes, for example, looking at their marketing and reception by youth.
By the end of January, over 6.6 million products had been successfully submitted to the agency, almost all of them e-cigarette products. Only a small handful have been allowed to remain in the market and over 1.2 million have been turned down while others remain in regulatory limbo.
Last week, FDA executives penned a statement in The Hill describing how vaping companies would switch their nicotine source after being warned by the FDA. Now these companies will be “bound by the same public health standards that we have worked so hard to implement for other tobacco products,” they wrote.
Among the products new to FDA oversight is a single-use brand called Puff Bar, which comes in a variety of flavors and was the most popular among high school students in 2021. More than a quarter of students currently vaping said Puff Bar was their usual brand. CNN reached out to Puff Bar for comment.