The action targets Puff Bar and several other vaping companies that recently switched their formulas to laboratory-made nicotine to skirt FDA oversight.
The change “allows FDA to protect the public health from the harms of tobacco products, regardless of the source of nicotine,” the agency said in a statement Wednesday. Companies must register with the FDA and submit their products for review within 30 days.The FDA’s action does not automatically ban Puff Bar and similar products. Instead it brings them under the same regulatory scheme as older e-cigarettes that derived their nicotine from tobacco.
“The synthetic nicotine products do not necessarily just disappear on their own,” Robin Koval, chief executive of the Truth Initiative, an advocacy group that runs anti-tobacco ads. “The FDA will have to decide how they want to enforce the law and hopefully they will.”, usually because of their potential appeal to youngsters. Anti-tobacco advocates hope the agency will quickly do the same for any applications submitted by Puff Bar and other manufacturers.
Last month, Congress passed language clarifying that the FDA can regulate any form of nicotine, regardless of the source.