Thursday, June 9, 2016

FDA Deeming Rule Threatens Vapers’ Options and Health

Smokers and vapers, this post is for you.  The FDA’s proposed deeming rule could severely limit your e-cigarette choices in the next few years.

FDA tobacco center director Mitch Zeller and HHS Secretary Sylvia Burwell cast the FDA rule as necessary to protect children from products that lead to cigarette use.  That argument has no scientific basis.  Government surveys provide no evidence that e-cigarettes have slowed the steep decline in youth smoking; on the contrary, evidence suggests that e-cigarettes may have accelerated that decline (here).  E-cigarettes are actually a gateway to stop smoking for adults who cannot quit with FDA-approved medicines and other aids.  As for protecting children, nearly all states currently ban e-cigarette sales to minors.

The FDA is exercising its regulatory power over all tobacco manufacturers, encompassing not only giant cigarette companies but also the strip-mall vape shops that sell nicotine liquids (juice) and vaping hardware. The FDA’s authority over products containing nicotine derived from tobacco was granted in the 2009 Tobacco Control Act, discussed here and confirmed by the courts here.

With the FDA hell-bent on tobacco prohibition, Congress deaf to consumer demands for smokeless tobacco products and both institutions blind to scientific evidence of tobacco harm reduction’s public health validity, smokers and vapors are the worse off.

The only immediate hope for relief from the deeming rule is the Cole-Bishop amendment to the 2017 Agriculture appropriations bill (here).  It would affect the rule’s grandfather date, allowing most e-cigarette products to remain in the marketplace.  The FDA wants manufacturers whose e-cigarettes were not available prior to 2007 to seek FDA approval during the next two to three years, a daunting and expensive task that the FDA estimates will cost over $330,000 per product.  The Cole-Bishop amendment would change that date to August 8, 2016, assuring that all existing products would stay on the market.  Senator Ron Johnson (R-WI), chairman of the Senate Homeland Security and Governmental Affairs Committee, has addressed the potential “negative unintended health consequences” of the FDA’s grandfather date in a public letter (here).

Manufacturers are already challenging the FDA’s action in the courts (here).

If Congress and the courts fail to alter the FDA’s course, smaller independent vape shops and a host of e-cigarette products will disappear in that two- to three-year time frame.

If you are one of the six million vapers who also smoke or one of the two million vapers who no longer smoke (here), don’t become a casualty.  Monitor news on the deeming issue and tell elected officials to rein in runaway regulation.

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