Rep. Duncan Hunter (R-CA) has just announced his intentions to release a new bill that would essentially repeal and replace FDA deeming regulations that threaten to bankrupt the American vaping industry. Entitled the Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017, the bill would remove vaping technology from the FDA’s classification as tobacco products while establishing an entirely new regulatory framework.
Hunter’s comprehensive legislation also attempts to eliminate the requirement for the million-dollar Pre-Market Tobacco Application (PMTA) process previously only reserved for Big Tobacco companies. However, a preliminary review of the Hunter bill is being met with mixed reactions within the American vaping community.
Related Article: NEW FDA E-CIG REGULATIONS AND THE MILLION-DOLLAR PMTA PROCESS
Of specific concern is a possible ban on the sales of certain mechanical mods and other unregulated devices. Some within the vaping community find this notion to be extremely severe while others consider mech mods to be somewhat dangerous when sold to an uneducated public.
Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017
The Hunter vaping bill is readily available online, and a cursory review indicates an extensive overhaul of the original FDA deeming regulations. And like every other bill that attempts to gain passage from both chambers of Congress, the legislation might very well go through several rewrites before being approved and signed into law. The key high-points of the bill include the following.
- Vaping products will be removed from the definition of “tobacco” that is currently identified in the Tobacco Control Act.
- As a result, the need for vaping manufacturers to undergo the expensive and time-consuming PMTA process will be eliminated and replaced with new, and less costly, approval protocols yet to be defined.
- An independent regulatory framework separate from Big Tobacco products will be established.
- New standards for e-liquid and vaping technology manufacturing will also be put into place with special attention to battery safety, short circuit protection capabilities, and discharge monitoring (It is this section of the bill that is perhaps causing the most pushback).
- Serial and lot number tracking for vaping technology will also be put into place.
- New vaping regulations will be enacted with a special emphasis on vaping as a tool for harm reduction for the purposes of quitting smoking.
- The name of the Center for Tobacco Products of the FDA (currently headed by anti-vaping protagonist Mitch Zeller) will be changed to the Center for Tobacco Products and Harm Reduction.
- The bill would also authorize the Secretary of Health and Human Services (Currently Tom Price) to undertake a detailed assessment of comparative risks associated with smoking vs. vaping vs. other nicotine replacement therapies.
According to Hunter, the bill could drop as early as next week, but some within the vaping community are concerned about Hunter’s timing. In recent days, Donald Trump has announced some very aggressive plans to push several legislative agendas through Congress before his first 100 days expire on Saturday, April 29. In the next five days, Trump has promised to repeal and replace Obamacare, restructure the federal tax codes, and pass his first fiscal budget that will include a financial down payment for building “the wall.”
Will the Republicans have enough political capital left over to repeal and replace the FDA deeming regulations at almost the same time? According to a recent Regulator Watch interview with Larry Flick of the American E-Liquid Manufacturer Standards Association, overturning the FDA deeming regulations is highly unlikely until Trump’s pick to become the new FDA Chief, Scott Gottlieb, is confirmed by the Senate.
“Repealing or suspending the deeming regulations, it won’t happen until the FDA Commissioner gets confirmed. And then the effort to get executive action on the deeming regulation by suspending the deadlines or postponing implementation, that will begin in earnest at that point.”
Regulator watch also posts an audio conference call and strategy session between Rep. Duncan Hunter and members of the Electronic Vaping Coalition of America (EVCA). In the audio exclusive to Regulator Watch, Hunter goes into more specifics about his planned release of the new vaping bill in the coming days.
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