In a move that is likely to undermine public health, the agency warns that products containing synthetic nicotine “will be subject to FDA enforcement.”
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.
Jacob Sullum – Reason – 2022-05-02.
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