On November 21, Sen. Ron Johnson sent letters to three high-ranking officials in the Obama Administration urging them to stop implementing certain regulatory requirement including the FDA deeming regulations because they will likely be overturned almost immediately after President-Elect Trump takes office. The letters were sent to Gina McCarthy, Administrator for the Environmental Protection Agency (EPA), Tom Perez, Secretary for the Department of Labor, and Dr. Robert Califf, Commissioner of the U.S. Food and Drug Administration (FDA).
Sen. Johnson has been sending multiple letters to Commissioner Califf for several months now, specifically requesting a long list of answers and clarifications regarding the decision-making process behind the controversial FDA deeming regulations. On at least three separate occasions, Califf has either blatantly ignored or outright refused to provide adequate responses to Johnson’s requests.
Now that President-Elect Trump is threatening to repeal everything from Obamacare to the Department of Labor’s Overtime Rule, Sen. Johnson is re-igniting his letter writing campaign with longtime pen pal and Democratic nemesis Robert Califf. The latest Johnson letter consists of only two short paragraphs with the following two sentences delivering the political punch that is making headlines.
“The U.S. Food and Drug Administration’s (FDA) deeming regulation of e-cigarettes is a primary example of a rule that could eliminate an entire nascent industry. Accordingly, giving 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 “avoidable compliance costs” of which Sen. Ron Johnson is referring are likely those related to the Pre-Market Tobacco Applications (PMTA) process that is estimated to cost in upwards of $1 million per product and take as long as a year or more to gain approval.
Sen. Ron Johnson’s letter bolstered by Trump pick Tom Price to head DHH
The vaping industry is also taking notice that the three letters were sent by Sen. Johnson a full week before the announcement of Trump’s pick for the Department of Health and Human Services (DHH), Georgia Representative Tom Price. The DHH is the cabinet post that oversees the FDA. If Price is approved by Congress, which seems rather likely given that both houses have a Republican majority, then Price becomes Califf’s boss (and, by extension, Mitch Zeller’s).
Price has been an ardent critic of both Obamacare and Medicare in recent years, and he is no fan of the Obama Administration, in general. If FDA Commissioner Robert Califf wasn’t taking Johnson’s latest letter all that seriously, the selection of Rep. Tom Price as the Trump Pick for the DHH should definitely make Califf stand up and take notice. Either way, things appear to be looking up for the American vaping industry, at least for the time being.
Sen. Ron Johnson’s letter to FDA Commissioner Robert Califf can be found here.