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The Food and Drug Administration (FDA) announced Thursday that e-cigarettes and vaporized nicotine products will be now be subject to strict federal regulation. The new measure also puts cigars and hookah products under FDA’s regulatory regime, which previously applied only to cigarettes and cigarette-related products, including smokeless tobacco. The new rules include a prohibition of selling vaping products to minors, selling them in vending machines, distributing “free samples,” and marketing any vapor product as “light,” “low,” or “mild” unless authorized by the FDA.
[See The Heartland Institute’s press release reacting to this news here.]
In 2014, the FDA began to focus on the e-cigarette and vaping industry, with a proposed rule that would require all products introduced after February 15, 2007 to “apply retroactively for approval.” This is a process, vaping companies claim, would wipe out the billion-dollar e-cigarette industry, including thousands of small businesses. The FDA apparently did not care, applying the retroactive date, which goes into effect in 90 days.
Products that were introduced on the market after the “predicate date” of February 15, 2007 “will have 12 months to submit an exemption request, 18 months to submit an application proving the product has a substantial equivalent already on the market and 24 months to submit an application for pre-market approval.” The FDA has also given itself the authority to regulate and “control the ‘parts’ and ‘components’ of tobacco.” This includes e-liquids, atomizers, batteries, flavors, and software. Manufacturers of tobacco and e-cigarette products will now have to register with the FDA and provide a list of products, ingredients, which the agency will review for approval in the market.
The complaince cost of this regulation is immense. As Michael B. Siegel points out in today’s Wall Street Journal:
The FDA itself has acknowledged that the premarket applications are a burdensome requirement that will take more than 5,000 hours to complete and will cost a minimum of $330,000 per product. Since few of the e-cigarette-product makers—most of which are small businesses—can afford to stay in business and pay for this level of resources or expertise, the majority of these companies will shut down. That will leave the market open only for e-cigarette products made by the largest of companies, some of which have already begun buying what once were small-company e-cigarette brands. For example, R.J. Reynolds now owns Vuse.
The reaction from proponents of e-cigarettes and vaporized nicotine products was immediate and strong. The Vapor Technology Association said the regulations a “will harm public health and devastate small vapor technology businesses.” The the Smoke-Free Alternatives Trade Association (SFATA) said:
Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging. Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses.
Jeff Stier, a policy advisor to Heartland and senior fellow at the National Center for Public Policy Research said:
The FDA wasn’t wrong to regulate e-cigarettes. It was wrong to effectively ban, by its own estimate, up to 98.5% of the e-cigarettes on the market today.
E-cigarettes, Public Health England says, are about 95% less harmful than smoking, are not a gateway to smoking, and could help smokers quit.Now, the FDA wants to put an end to this less harmful alternative to smoking.
It’s very simple: Cigarette smokers who switch to e-cigarettes dramatically reduce their risk, as the Royal College of Physicians put it in a landmark report last month, by using “nicotine without smoke.”
E-cigarette shouldn’t be sold to minors, and government should restrict advertising so they aren’t marketed to kids. But the FDA’s drastic overstep today will require e-cigarettes not already on the market by February 2007 to undergo a costly and onerous Premarket Tobacco Application process that holds e-cigarettes to a standard nearly impossible to prove, and one that well-established actual cigarettes don’t have to face.
No serious study has ever been produced by the FDA to conclude anything but the positive health benefits of vaporized nicotine products compared to smoking cigarettes. So the FDA’s new regulations in the name of protecting public health will actually achieve the opposite … which is sadly typical for government work these days.
Read below some of Heartland’s research, commentary, and news stories on vaping, including our event in April titled “The Vaping Wars.”
Dearborn, Michigan City Council Passes Public E-Cig Restrictions, The Heartlander (April 19, 2016)
E-Cigarettes: A Better Way to Quit Smoking, Heartland Institute Panel Says, Somewhat Reasonable (April 29, 2016)
Vaping as a Public Policy ‘War’, Somewhat Reasonable (May 2, 2016)
Research & Commentary: How Do Electronic Cigarettes Affect Adolescent Smoking, Heartland Research & Commentary (March 28, 2016)
Stroud: Move to raise legal age won’t snuff out smoking, Boston Herald (April 29, 2016)
In The Tank Podcast (ep31): R Street Institute, E-Cig Taxes, Tax Cuts, and Obamacare Turns Six, Heartland Institute (March 25, 2016)