FDA authorizes sale of e-cigarettes for the first time, shifting debate and drawing fire from critics
For the first time, the FDA on Tuesday authorized tobacco companies to market electronic cigarettes.
Regulators authorized three products in a similar fashion as they would with pharmaceuticals, although this time it was for longtime tobacco company RJ Reynolds.
The authorizations were for a vaping device and associated tobacco-flavored pods, with FDA saying the benefits in weaning longtime smokers off traditional cigarettes outweighed the risks of getting younger people addicted. The agency emphasized it is only authorizing products that taste like tobacco, rather than flavored pods more appealing to kids and teenagers, such as candy, mint and fruit.
Nonetheless, the move will likely shift public debate about e-cigarettes and is already drawing criticism from anti-smoking advocates, the New York Times and others reported.
Energy & Commerce committee chair Frank Pallone (D-NJ) said in a statement, “While I am pleased that FDA denied requests by the manufacturer to market certain flavors, I remain concerned given this product’s popularity with youth.”
“FDA has turned its back on the public health by approving a high-nicotine e-cigarette,” Rep. Raja Krishnamoorthi (D-IL) said in a statement, adding, “FDA has ignored the data and missed another opportunity to address the youth vaping epidemic.”
In explaining its reasons for the authorization, the FDA appeared to approach its decision similar to how it considers experimental drugs. The agency studied how e-cigarettes have helped smokers who fully switched to the electronic products, reducing exposure to harmful carcinogens.
FDA then weighed that benefit against the risk of youth becoming more addicted to vaping products. Regulators said they conducted studies saying tobacco-flavored products were among the least preferred by young e-cigarette users, and noted RJ Reynolds will have to complete post-marketing requirements to ensure the authorization does not get revoked.
The Vuse products will also be forbidden from being marketed as safe or “FDA approved,” the agency said. In the same announcement, FDA placed strict limitations on digital, radio and television advertising, as well as denying authorization to 10 flavored Vuse cartridges.
E-cigarettes first emerged in the early-to-mid-2000s, aimed at attracting longtime smokers to switch to a less harmful product while avoiding the withdrawal symptoms typically accompanying stopping traditional cigarette use. But flavored products soon appeared on the market, notably in brands like Juul and Vuse, and use among teenagers began to skyrocket.
Vaping has long been unregulated but the FDA has been moving to crack down in recent years. This past August, regulators ordered several e-cigarette and pod manufacturers to pull more than 55,000 flavors or planned flavors from the market or risk enforcement, saying they failed to provide enough evidence the products provided a public health benefit.