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Coming soon: FDA to announce e-cig regulations proposal

| April 22, 2014

It is quite literally “any day now” that the U.S. Food and Drug Administration (FDA) says it will release its proposal for the regulation of e-cigarettes, according to a spokesperson for the FDA. The rules could change the landscape of the tobacco and vapor industries.

The FDA will most likely ban sales to those under 18, set product standards, require companies to disclose e-juice ingredients and place health warnings on packaging and advertisements. The FDA will also decide whether there will be a grandfather date for products that are currently on the market and what it might be, in addition to proposing rules on advertising, sponsorships, Internet sales limitations and child-proof packaging requirements.

Last Friday, a trade-industry group was set to post a leaked copy of the impending FDA draft regulation for e-cigarettes on its website, but in a classy move, the Tobacco Vapor Electronic Cigarette Association (TVECA) changed pace on its plans to release the full report today, stating that it decided not to go ahead with formally releasing the document following informal discussions with the FDA on Friday. “[W]e all decided that [it would be] in the best interest of the regulatory process, as well as the industry and the public, not to post the document on Tuesday,” TVECA explained in a brief note on its website.

The posted title document on the TVECA homepage indicated that the FDA will classify e-cigs as “Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.”

The FDA Center for Tobacco Products—which completed a three-day meeting Friday with its scientific advisory committee on topics of nicotine addiction, population modeling and evaluating proposed modified-risk tobacco products—was quick to respond.

“The FDA has not issued its proposed rule regarding what additional tobacco products should be regulated by the agency,” it reaffirmed in a statement. “We are aware that the Tobacco Vapor Electronic Cigarette Association has indicated publicly that they have a copy of our proposal. The proposal is still in draft form and under review. As a matter of policy, the FDA does not share draft rules with outside groups while a rule is still under review.”

The agency has had e-cigarettes on its agenda for years, but finally sent its draft proposal of rules to the Office of Management and Budget (OMB) last fall; action was further delayed by the partial government shutdown. The document was still with the OMB as of last month.

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