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Sen. Ron Johnson issues third letter over FDA deeming regulations

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The letter writing campaign continues as Sen. Ron Johnson sends a third, aggressively-worded letter to the FDA over its recently announced e-cig deeming regulations. The first letter was largely ignored, and the second letter finally received an 8-page response by the FDA on July 15, 2016, some two weeks after Johnson’s requested deadline. And as many in the vaping community expected, the FDA’s response was deemed “insufficient” by Wisconsin Senator.

FDA makes false claims and offers no documentation

As Rasta Vapors reported in a previous blog, Sen Johnson has several concerns and questions regarding the May 5 announcement of the FDA deeming regulations. Johnson is the Chairman for the Senate Committee on Homeland Security and Government Affairs, and this is a guy who normally carries a great deal of political influence. However, Johnson is currently up for re-election, and his chances of winning look fairly uncertain, to say the least.

Many political insiders predict that the Republican senator may be a down-ticket victim of a possible Anti-Trump movement occurring across the country. If the FDA believes the same, then this may be a reason why the agency is being less than forthcoming in its responses to Johnson’s inquires. In fact, the lengthy response letter by the FDA contained no new information and no specific answers to the long list of questions from Johnson’s first letter, including:

  • “Will the FDA issue a revised rule if there is sufficient data that finds that e-cigarettes are a safer alternative to traditional cigarettes? Please explain.”
  • “Did the FDA determine how many e-cigarette businesses will be affected by the rule? If not, why?”
  • “If so, please provide that data.”
  • “Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products? Please explain.”

Furthermore, some of the statistics cited in the FDA response letter are completely lacking in any supporting scientific data. The agency also refused to provide the precise location of the research studies used to formulate the deeming regulations, as requested by Sen. Johnson from the very beginning.

“Tobacco is a significant public health threat that is particularly affecting youth. While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb. A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has increased from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, three million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes.”

Even if Johnson is in the middle of the re-election campaign from hell, he doesn’t appear to be taking the “insufficient response” of the FDA lying down. Even though it appears as if the FDA wants to keep regurgitating the same nonsense that they consistently post online and without any evidence, Johnson immediately sent a third letter that is even more forceful than the previous two. In one comment towards the end, Johnson even states, “The American public deserves complete answers from the FDA about its rulemaking.”

The FDA has until July 29, 2016 to respond, but will the vaping industry finally get the answers that it so richly deserves? Or will Sen. Ron Johnson lose re-election in November, forcing us to start all over again with a new vape-friendly politician? Only time will tell. 

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