Agent VAPE News and Notes

Breaking News: FDA Releases Regulations

ucm218078The Food and Drug Administration’s new commissioner did not waste any time: new vaping regulations will be in effect in 90 days: the agency announced Thursday.

In the regulations:

  • the sale of e-cigarettes of those 18 and under is prohibited
  • no more free samples of e-liquids
  • the FDA will govern everything in the industry: manufacturing, labelling, to distribution of products.“Manufacturers will now be required to report all ingredients and their facilities will be subject to health and safety standards. Vape shops will need to check photo ID and will no longer be able to let customers sample products before buying,” reports.

“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 press release. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

“The rules keep in place a grandfathering date for existing products that were on the market as of February 15, 2007. That means that any product that wasn’t on the market before that date now has two years to complete a lengthy, costly application process. In the new rules, the FDA estimates this process will take companies 1,500 hours to complete, for each individual product, plus an additional 200+ hours to do an environmental assessment—a time and cost constraint that the industry worries could choke out companies. Since the vaping industry really only started to emerge around 2006 and 2007, the vast majority of products currently on the market came out after that date, “Motherboard reports.

“The FDA now estimates that filing a PMTA will take over 1,700 hours per product, which brings the estimated cost for a single application up to over a million dollars [based on previous FDA cost estimations],” said Gregory Conley, the president of the American Vaping Association, a nonprofit advocacy group, told Motherboard. “This gigantic price tag is affordable to Big Tobacco companies, but small and medium-sized businesses will be crushed. This is not regulation, it is prohibition that will cost lives, kill jobs, and further entrench America’s largest cigarette companies.”

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