Senator Demands Answers From the FDA on Vape Regulations

Senator Johnson gives the FDA commissioner a deadline to respond

Senator Ron Johnson

A member of Congress has directly challenged the FDA with hard questions about its deeming regulations, which amount to a ban on all products now available. Sen. Ron Johnson, a Republican from Wisconsin, sent a letter to FDA Commissioner Robert Califf on May 18 expressing his concerns, according to a press release from the Senate Homeland Security and Governmental Affairs Committee.

Johnson is chairman of that committee, which is reviewing the regulatory burdens that federal agencies place on small businesses. The letter may have been prompted by complaints from one of Johnson’s constituents, Christian Berkey, chairman of Johnson Creek Vapor Company, which is located in Hartland, Wisconsin. Johnson Creek is one of the oldest vapor products companies in the United States.

Berkey, according to Johnson’s letter, says the FDA regulations will “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.” This is exactly right, since the regulations mandate an exhorbitantly expensive application process that few can afford, and still doesn’t guarantee approval.

Demanding answers

United States Senate

Sen. Johnson gives the FDA commissioner a deadline of May 31 to provide answers — and supporting documentation — to a series of specific questions about the regulations:

  • “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.”
  • “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?”
  • “Did the FDA determine how many e-cigarette businesses will be affected by the rule?  If not, why? If so, please provide that data.”
  • “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?”
  • “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.”

Most encouraging is Sen. Johnson’s concern over the potential of the regulations to destroy vaping product innovation and cause vapers to go back to combustible cigarettes. That’s certainly our biggest concern too.

“Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences,” writes Sen. Johnson. “The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking.  It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.”

Thumbnail picture from Senator Ron Johnson.

Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.
  • Senator Johnson seems entirely too reasonable for an American politician.

    • Jim McDonald

      If every vapor business approached their Congressional reps to discuss their businesses, we’d be in better shape. Most House and Senate members respond well to small businesses in their states/districts. I give credit for this to Johnson Creek.

  • Michael Abrams

    Just curious, does the FDA need to be accountable to the Senator? In any case, he’s calling the FDA on the carpet, exposing their miserably faulty decision making. The FDA is imho deficient in many other ways. Just ask cancer patients who can’t get the meds they need until it’s too late. If those setting policy are not experts, they had better begin asking those who are.

    • Evan Thornton

      He’s the chairman of the Homeland Security and Government Affairs committee. This falls under his domain.

    • robert

      This is Congress’s power over the FDA. If you look at the language in the letter , senator Johnson is not asking, he is demanding the requested answers from the FDA. Senator Johnson is demanding the data the FDA used to to arrive at their Deeming Regulation. And the FDA does not have it. Yes, The FDA must Answer to this area of our government. And if the Data is not produced. The FDA will be subpoenaed to appear before congress. The FDA does not want to do that.! 😀 Senator Johnson is one out of hundreds that knows what he is doing…

    • Joe Menn

      Yes. It’s all part of the “Checks and Balances” system our government is supposed to work by. Each branch of government (Executive, Legislative and Administrative) are supposed to be able to question the validity of decisions made by another. Unfortunately, the Executive Branch (ie: The President) has in the recent past been using the Administrative Branch (ie: FDA, etc.) as if it were the Legislative Branch (Congress). Rather than legitimately passing laws through the Legislative Branch, where the Republican majority might block passage, the regulatory powers of the Administrative Branch are used. Basically, the President has been trying to do an end run around Congress and bypass the representation of the People.

      We should be thankful that we have Senators like Ron Johnson who take their responsibility seriously and will exercise their right to question, block and expose these type of abuses. Oversight of Administrative groups has been lax and very few of our representatives have been willing to stand up.

      Not to politicize the e-cig question too much, but if you look deeper into it, you’ll notice that the powers over deeming items as tobacco products was given to the FDA with the Family Smoking Prevention and Tobacco Control Act of 2009. That act was pushed through by a Democratically controlled Congress saying it was needed to “protect the children” from the evils of tobacco. Today, if you look at those representatives who are continuing to defend the frankly idiotic acts of the FDA (pronouncing that batteries, stainless steel, cotton and wire are tobacco products), you’ll see that they are all democrats, backing the Presidential belief that if you are unlikely to get a law through Congress, then use the administrative branch who can unilaterally draft a regulation to accomplish what the law was intended to accomplish.

      This is not how we are supposed to govern our citizens. The citizens have representatives who are supposed to protect them from onerous, nonsensical and oppressive laws. Using regulation to circumvent that representation is unethical, immoral and dangerously approaches fascism.

    • Jim McDonald

      If they don’t reply, he may hold hearings and ask or compel them to respond.

  • dav4life

    I voted for this man twice. Well done ron.