The FDA is now moving to ban non-tobacco products as “tobacco products” — specifically, banning vaping liquids that contain no tobacco extracts, only synthetically generated nicotine. This is alarming, because nicotine — unlike tobacco smoke — does not cause cancer. Indeed, nicotine helps with Alzheimer’s and Parkinson’s diseases, according to a study. “Study finds nicotine safe, helps in Alzheimer’s, Parkinson’s,” reported the Tampa Bay Times on April 17.
Yet, the FDA is now moving to ban vaping products that contain nicotine not derived from tobacco, and don’t emit smoke, citing the Family Smoking and Tobacco Control Act. Reason Magazine reports:
The Food and Drug Administration (FDA) is moving fast to close off what seems to be the last remaining legal option for vaping companies that want to provide the e-liquid flavors that former smokers overwhelmingly prefer. Exercising regulatory authority that Congress recently gave it, the FDA has set a May 14 deadline for seeking “premarket” approval of vaping products that deliver nicotine derived from sources other than tobacco. Companies that fail to submit applications by then, the agency warns, “will be subject to FDA enforcement.”
The Consolidated Appropriations Act of 2022, which President Joe Biden signed into law on March 15, included a provision that expanded the FDA’s authority over “tobacco products” to include products that do not contain tobacco or tobacco derivatives. Congress achieved that counterintuitive result by amending the Family Smoking Prevention and Tobacco Control Act, the 2009 law that first authorized the FDA to regulate tobacco.
The FDA says that amendment, which took effect on April 14, “makes clear that FDA can regulate tobacco products containing nicotine from any source.” The agency describes the change as a response to manufacturers “who saw a loophole in the current law” and used it to “skirt federal regulation” so they could sell products “packed with nicotine and sold in a myriad of kid-appealing flavors.” According to the FDA, that situation was intolerable, because the agency “has made it one of our top priorities to reduce youth use of these products.” That gloss is misleading for several reasons.
First, the Tobacco Control Act defined “tobacco product” as “any product made or derived from tobacco that is intended for human consumption,” including “any component, part, or accessory of a tobacco product.” Although the law did not mention vaping or e-cigarettes, the FDA successfully argued that products delivering nicotine derived from tobacco were covered by that definition. The amendment did not clarify the definition; it expanded the definition in a way that rendered the term tobacco product a misnomer.
As Reason reported, the FDA is poised to ban almost every vaping product currently available in the United States. By last September, it had received some 6 million applications—one for every kind of device or e-liquid that firms want to keep selling. Although the FDA was supposed to act on those applications by last year, it missed that court-ordered deadline. The FDA now says it has “completed the review of and made determinations on more than 99 percent” of those products. Out of all those products, the FDA has granted approval for only two device brands: Vuse Solo, which was approved in October, and Logic, which was approved this March. The FDA approved tobacco-flavored cartridges/capsules for those firms’ devices while rejecting applications for all other flavors than tobacco.
