The US Food and Drug Administration announced Thursday that it has extended its authority and will now regulate electronic cigarettes, hookah tobacco, cigars, and other tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act.
The regulatory move, first proposed in 2014, is largely aimed at protecting kids from tobacco and nicotine products. The result is that e-cigs and the other products will now be subject to the same federal regulations as regular cigarettes. These regulations include some relatively uncontroversial rules such as a ban on selling e-cigs to minors (which some states have already done), requiring a photo ID to buy e-cigs, not selling e-cigs out of vending machines, and a ban on free e-cig samples.
But the regulations also require that e-cigarette manufactures register with the agency and put any new devices through a pre-market regulatory approval process. By “new,” the FDA means any novel devices put on the market after February 15, 2007. Devices released before then will be grandfathered into the regulations. However, in the relatively young e-cig market, the vast majority of current products were introduced after 2007 and will be subject to the approval process.
The FDA will allow companies to sell their products for up to two years while they submit their application for approval and an additional year as the FDA reviews their application.
Because the regulatory pipeline will require time and money from manufacturers—by way of submitting data and paperwork to the agency as well as paying FDA user fees—some critics argue that it will hurt small e-cig businesses and give big tobacco companies an advantage.
Critics also worry that the financial stress and timeline for approval could disrupt access to e-cigs that some smokers may already be using to cut down or quit using traditional cigarettes, which researchers estimate are far more harmful than e-cigs.
To address this potential problem, members of congress recently made an effort to eliminate the 2007 cut-off. The amendment passed through a House subcommittee, but it may not be up for a vote in the House and Senate until the end of the year.
Otherwise, the new FDA regulations will also require manufacturers and distributors to report ingredients, particularly potentially harmful ones; include health warnings on packaging; and refrain from using terms like “light,” “low,” or “mild” without FDA authorization.
“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars, and hookah tobacco, that had gone largely unregulated,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement.
Read More: http://arstechnica.com/science/2016/05/fda-flexes-regulatory-muscles-says-vaping-e-cigs-now-under-its-control/