The Family Smoking and Prevention Tobacco Control Act Tobacco became law in June 2009 and gave the Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of all tobacco products.  On May 5, 2016, the FDA finalized a rule that brought all tobacco products under its authority, including Electronic Nicotine Delivery Systems (ENDS), such as e-cigarettes.  The regulation did some good things, such as banning sales of vaping products to anyone under age 18 and requiring warning labels, but unless their product was on the market prior to February 2007, it also mandated that vaping manufacturers submit a burdensome and expensive pre-market tobacco application (PMTA) to get marketing approval for all vaping items, costing as much as $10 million per product, according to regulatory consulting firm SciLucent LCC.

The rule took effect on August 8, 2016 and gave ENDS manufacturers two years to comply.  But, with August 2018 less than a year away, it's clear only Big Tobacco companies will be able to afford the expense for a PMTA, and even thereafter, there is no guarantee of getting a marketing order from the FDA.  Being too expensive and risky to submit a PMTA, small manufacturers of e-cigarettes will be unable to jump the costly FDA’s hurdles and simply go out of business. 

Fortunately, the FDA, thanks to the leadership of Commissioner Scott Gottlieb, M.D., is beginning to recognize that ENDS cause far less harm than smoking.  On July 28, 2017, the agency announced a new regulatory framework to strike “an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.”  As a result, the agency delayed the submission of PMTAs for non-combustible products such as ENDS until Aug. 8, 2022.

But, delaying compliance is not a permanent solution.  It could be easily reversed under a new administration.  What is needed is a change in law.

Tucked away in the Fiscal Year 2018 House of Representatives Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill is Section 753, also called the Cole-Bishop provision, which would change the predicate date for newly deemed tobacco products, such as e-cigarettes, to August 8, 2016, the date the final rule took effect.  By changing the “grandfathered” date, an e-cigarette manufacturer would still be regulated by the FDA but would have to provide the less onerous substantial equivalence application that shows their product is substantially equivalent to a product that was on the market prior to August 8, 2016.

The legislation also contains other important provisions, such as mandating that ENDS labels contain the phrase, “Keep Out of Reach of Children” and “Underage Sale Prohibited,” requiring an accurate statement of nicotine content, and telling the FDA to develop product standards for flavors and batteries.

The House has passed its appropriations bills and the Cole-Bishop provision will help keep e-cigarettes on the market, saving lives and valuable tax dollars in government-funded health programs such as Medicare, Medicaid, and the VA.  Now it is up to the Senate to do its job by passing its appropriations bills, including the Cole-Bishop provision.