Wednesday, November 30, 2016

Senator Johnson Calls on FDA to Halt Implementation of E-Cigarette Deeming Regulations Pending the New Administration

In a letter written last week to the FDA, Senator Ron Johnson (R-WI) called on the FDA to halt implementation of the e-cigarette deeming regulations pending the change in administration coming this January.

Senator Johnson wrote: "The incoming administration and the 115th Congress will likely re-examine and unwind burdensome regulations imposed by the Obama Administration. The U.S. Food and Drug Administration's (FDA) deeming regulations of e-cigarettes is a primary example of a rule that could eliminate an entire nascent industry. Accordingly, given the substantial likelihood that this burdensome rule will be undone, I urge the FDA to cease implementation of its deeming regulation to spare the growing e-cigarette industry unnecessary and avoidable compliance costs that it currently faces."

The Rest of the Story

I do not generally agree with Republican calls for a loosening of public health regulations, but in this case, I wholeheartedly agree with Senator Johnson. The FDA e-cigarette deeming regulations are unduly burdensome and will result in the decimation of the e-cigarette industry, putting thousands of small vape shops and companies out of business and protecting cigarettes from competition from a much safer product. Moreover, the deeming regulations violate the free speech rights of e-cigarette companies, prohibit the companies from taking steps to improve the safety of their product, and force companies to lie to consumers about the primary benefits of their products. This is a public health mess, and it does need to be unraveled.

The good news is that it appears that the new administration, or at least the new Congress, are planning to conduct a serious re-examination of the regulation of electronic cigarettes. Therefore, it is possible that we may be able to come out of this with more than just the Bishop-Cole "emergency" measure that would salvage the industry. Instead, it is possible that we can achieve a more sensible regulatory framework for e-cigarettes, one that treats these products completely differently from tobacco cigarettes, allows smoking cessation and modified risk claims to be made, eliminates the burdensome pre-market applications, and instead, sets safety standards for these products to ensure uniform safety and quality control, thus maximizing the benefits of vaping products while minimizing the risks.

This presents an important opportunity for vapers to make their voices heard. While CDC director Dr. Thomas Frieden views vapers only as "anecdotes," their collective experiences truly represent data that can help inform policy. Vapers need to share their experiences with members of Congress, especially members of the Senate Homeland Security and Government Affairs Committee, so that they will be able to separate out the fact of their experiences from the fiction that so many anti-smoking groups and health agencies have been spreading.

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