Republican Senator Urges FDA to Cease Implementation of E-Cigarette Regulations Pending Administration Change
Republican Senator Ron Johnson, a long-time supporter of vaping, recently wrote to a letter to the Food and Drug Administration, urging it to cease the implementation of e-cigarette deeming regulations pending the change in administration coming in January.
“On November 8, the American people voiced their disapproval of the type of government that ignores the input of small business owners, consumers, and job creators. The incoming Administration and the 115th Congress will likely re-examine and unwind burdensome regulations imposed by the Obama Administration,” Senator Johnson (R-WI) wrote in his letter to FDA Commissioner Robert Califf. The U.S. Food and Drug Administration’s deeming regulation 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.”
Johnson is obviously referring to the costs associated with the Pre-Market Tobacco Applications (PMTA) that every single products will have to go through in order to remain on the market after August 8th 2018. After the deeming regulations went into effect on August 8th 2016, companies have two years to apply for a PMTA, a process that many believe is likely to cost upward of $1 million per products. That’s every e-liquid flavor, every nicotine concentration, every type of coil-head, etc. You can imagine that the costs add up pretty fast, so it’s unlikely that any independent company will be able to pay tens of millions of dollars without going out of business. But you know who can easily bare these costs? Big Tobacco, which basically means that the FDA is handing over the whole industry to the very companies it is accusing of endangering the lives of millions of Americans.
For months, Senator Johnson has been sending letters to the FDA, requesting answers and clarifications regarding the controversial regulations of electronic cigarettes. Unfortunately, the Administration has chosen to flat-out ignore his requests, or simply failed to provide an adequate answer. However, after the results of the Presidential election, that is likely to change. President elect Donald Trump has announced Georgia Representative Tom Price as his pick for the Department of Health and Human Services (DHH), the cabinet that overseas the Food and Drug Administration. Price has been an ardent critic of both Obamacare and the Obama Administration in general. And, come January, Price will become the “boss” of both FDA Commissioner Robert Califf and Mitch Zeller, director of the Center for Tobacco Products. In his latest letter, Senator Johnson seems convinced that under Tom Price, the current regulation will be repealed.
“In light of the significant economic costs on the e-cigarette industry and the substantial likelihood that the upcoming Administration and the 115th Congress will unwind this burdensome regulation, I call on the FDA to cease its implementation of the current regulation over e-cigarettes,” Johnson writes. “I hope that the FDA wil acknowledge the reality of the situation and ensure that small businesses and consumers do not continue to incur avoidable financial costs due of this regulation.”
This means that instead of the Bishop-Cole Amendment, which would at least move up the predicate date from February 15, 2007 to August 8th, 2016 (the day the new regulations went into effect), thus making it possible for all vaping products launched on the market until then to be sold without going through an expensive PMTA process, we might actually get a whole new regulation framework. Hopefully, the new Administration will separate vaping products from tobacco products, eliminates the astronomical compliance costs and focuses more on quality control measures.
At this point, we can only hope, but at the very least, things look a whole lot better than they did just a month ago.
If you want to do your part to ensure that vaping gets some sensible regulations this time, Dr. Michael Siegel of Tobacco Analysis has some advice: “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.” Better pick up that phone and call your representatives.
You can read Senator Ron Johnson’s letter to the FDA, here.