Senate Committee Asks FDA Tough Questions

I’ve spent a good part of this week talking about senators preening themselves with shallow demands to smack around the vaping industry.  Today we have yet another Senator.  This time, there’s some serious questions.

Senator Ron Johnson (R-WI) is the chairman of the Senate Homeland Security and Governmental Affairs Committee (that’s a mouthful). The senator and his committee requested the FDA respond to a few questions they have.

The questions aren’t some softballs like you’d expect, but actual questions that are bound to make someone sweat.  Specifically, they want to know if the FDA is actually aware of what their little plan is going to do to actual small businesses.

1. The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.”  Further, the final rule states that “comments were divided on the safety and toxicity of e-liquids, e-cigarettes, and the exhaled aerosol.”

  1. 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.
  2. How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health?

2. Some stakeholders claim that the FDA’s rule on e-cigarettes will stifle innovation and result in the closure of many small businesses that create and sell e-cigarette products.

  1. Did the FDA determine how many e-cigarette businesses will be affected by the rule?  If not, why?
  2. If so, please provide that data.
  3. Of the e-cigarette businesses that will be affected by the rule, how many of those businesses does the FDA predict will exit the market as a result of the new requirements?

3. 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.


Yes, not only did this guy apparently pay attention to what the regulations say, he’s managed to read between the lines and see what they are capable of doing. Not only that, but these are actual valid questions that more people should have asked two years ago.

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Oh wait, that’s exactly what the entire community has been doing.  Of course I don’t have a whole lot of faith in politicians.  Just because a committee has questions doesn’t mean they can or will actually do anything about it.

I’d have to guess these were the same questions the OMB asked the FDA before they finally let the agency shovel their regulation down our throats.  It seems that more action will probably be required to stop this train wreck from leaving the station.

Naturally, I encourage you to reach out to the Senator, or any other members of the committee if they happen to represent you.  You can find out who the members are here.

Steve K

Hello and welcome to Steve K