FDA demonstrates regulatory power, e-cigarettes are now under its control | vaping says Ars Technica

2021-12-01 08:18:13 By : Mr. Mao Matthew

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Beth Mole-May 5, 2016 10:00 PM UTC

The US Food and Drug Administration announced on Thursday that it has expanded its authority and will now regulate e-cigarettes, waterpipe tobacco, cigars and other tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009.

The regulatory measures were first proposed in 2014 and are mainly aimed at protecting children from tobacco and nicotine products. As a result, e-cigarettes and other products will now be subject to the same federal regulations as regular cigarettes. These regulations include some relatively uncontroversial rules, such as prohibiting the sale of e-cigarettes to minors (some states have done so), buying e-cigarettes requires a photo ID, not selling e-cigarettes outside vending machines, and prohibiting Sell ​​electronic cigarettes to minors, etc. Free e-cigarette samples.

But the regulations also require e-cigarette manufacturers to register with the agency and pass any new devices through the pre-market regulatory approval process. The term "new" by the FDA refers to any new device that is put on the market after February 15, 2007. Devices released before this will be included in the regulations. However, in the relatively young e-cigarette market, most of the current products were launched after 2007 and require approval.

The FDA will allow companies to sell their products for up to two years when they submit an application for approval, and another year when the FDA reviews their application.

Since the regulatory pipeline requires the manufacturer's time and money — by submitting data and paperwork to the agency and paying user fees to the FDA — some critics believe that this will harm small e-cigarette companies and give large tobacco companies an advantage.

Critics also worry that financial pressures and approval schedules may affect the acquisition of e-cigarettes that some smokers may have used to reduce or quit using traditional cigarettes. Researchers estimate that traditional cigarettes are far more harmful than e-cigarettes.

To address this potential problem, members of Congress have recently worked hard to cancel the 2007 deadline. The amendment passed the House Subcommittee, but it may not be voted in the House of Representatives and the Senate until the end of the year.

Otherwise, the new FDA regulations will also require manufacturers and distributors to report ingredients, especially potentially harmful ingredients; include health warnings on the packaging; without FDA authorization, no use of "light", "low" or "mild" And other terms.

"This final rule is a fundamental step that enables the FDA to regulate products used by young people at an alarming rate, such as e-cigarettes, cigars, and waterpipe tobacco, which are basically unregulated," FDA Center Director Mitch Zeller (Mitch Zeller) said. The tobacco product company said in a statement.

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