Amendment Could Save the Vaping Industry From Prohibitive FDA Regulations
The reported version of an appropriations bill would change a crucial cutoff date.
This week the House Appropriations Committee approved an amendment that could save the vaping industry from a de facto ban caused by pending Food and Drug Administration regulations. The measure, which was approved by a vote of 31 to 19, changes the cutoff date for a crucial grandfather clause from February 15, 2007, when almost none of the current e-cigarette companies existed, to the effective date of the regulations.
"This is fantastic news for public health and small businesses," says Gregory Conley, president of the American Vaping Association (AVA). "The vapor industry and its consumers do not oppose sensible regulation, but the FDA's proposal is anything but sensible."
Two years ago the FDA published a rule under which manufacturers of vaping products that were not on the market as of February 15, 2007—i.e., virtually all of them—would face two daunting options. They would either have to show their products are "substantially equivalent" to the e-cigarettes available back then or get them approved as new products. Meeting either of those tests would be iffy for any company and prohibitively expensive for the smaller ones. AVA estimates that the rule, if unchanged, would eliminate 99 percent of the industry.
"Modernizing the predicate date will not interfere with the FDA's ability to regulate vapor products," Conley says. "All this change does is force the agency to regulate the vapor products rather than just ban 99%-plus of products on the market today." Such a wipeout, although justified in the name of "public health," would eliminate harm-reducing alternatives to conventional cigarettes, leading to more smoking-related disease and death than would occur if the FDA took a more restrained approach.
The amendment, which was sponsored by Reps. Tom Cole (R–Okla.) and Sanford Bishop (D–Ga.), was added to the agriculture appropriations bill for fiscal year 2017. Two Democrats, Bishop and Henry Cuellar (Texas) joined 29 Republicans in voting to change the cutoff date. If the amendment is in the final version of the bill approved by both houses of Congress, the vaping industry will get a chance to fulfill its lifesaving potential.
