May 31, 2016
“Accountable: a person, organization, or institution required or expected to justify actions or decisions; responsible. Government must be accountable to its citizens.”
May 17, 2016. The FDA receives a letter addressed to FDA Commissioner Robert M. Califf, MD. A letter that Dr. Califf and many others at the FDA will not turn a blind eye or a deaf ear to. The FDA will respond. The May 17th letter is signed by Ron Johnson – United States Senator, Ron Johnson (R – Wis). But in the eyes of the FDA, Sen. Johnson is not just any Senator. Sen. Johnson is Chairman of the U.S. Senate Committee on Homeland Security and Governmental Affairs.
Later this year, the Senate will consider passage of the Fiscal Year 2017 Agricultural Appropriations Bill. A $21.3 billion spending bill. Which includes $2.7 billion of “discretionary funding” for the FDA. That is more than half (56%) of the $4.78 billion total FDA funding for 2017. Funding that prior to moving to the Senate floor for debate, could be changed, by the committee, chaired by Sen. Johnson.
The Appropriations Bill also has a rider on it. One that would change the “predicate date” (aka the Grandfather date) to the date FDA regulations become effective. Every vaping product on the market prior to the effective date of FDA regulations would not be subject to Pre-Market Tobacco Application requirements.
The FDA has “skin in the game”. Sen. Johnson is in a position to influence how much skin the FDA keeps. Or loses.
Sen. Johnson is “requesting” FDA provide answers to some very pointed questions.
“I write to request your assistance in understanding the consequences that this new regulation may have on small businesses and the public’s health.”
Sen. Johnson then goes on to say:
“In order to assist the Committee in better understanding the FDA’s decision to expand its authority on e-cigarettes, I ask that you please provide the following information and materials:
- 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?”
Sufficient data. The FDA justifies their regulatory action on the basis of data they do not have. Questions they have no answers to. Perceived threats they cannot objectively substantiate. Given the sweeping and prohibitive nature of their regulation, is it not prudent and reasonable to expect FDA to provide plausible justification for their actions?
- What is FDA’s definition of “sufficient data”?
- In the last seven years, how much of the billions of dollars of “discretionary funding” has FDA allocated toward gathering “sufficient data”?
- How much of the billions of dollars of future “discretionary funding” will FDA allocate toward gathering “sufficient data”?
- What is FDA’s estimated timeline for gathering “sufficient data”?
- What is FDA’s estimate of the number of American lives that will be lost to the deadliest consumer product ever created, while FDA gathers “sufficient data”?
- Is the FDA seriously suggesting that “comments were divided on the safety and toxicity of e-liquids, e-cigarettes, and the exhaled aerosol” is justification for the most blatant example of Prohibition in more than 80 years?
“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.
- Did 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?”
By their act of imposing these regulations, FDA would have us believe that:
- They have “sufficient data” to decimate the vaping industry.
- They have “sufficient data” to justify elimination of tens of thousands of jobs.
- They have “sufficient data” to force thousands of small businesses to close their doors.
- They have “sufficient data” to justify handing the entire vaping industry over to Big Tobacco.
- The FDA does not have “sufficient data” on which to meet their mandate to regulate. But they have “sufficient data” to arbitrarily and single handedly eliminate.
“Has FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products? Please explain.”
Yes indeed FDA, please explain.
- How the regulations you are implementing will reduce the estimated 480,000 Americans who die, every year, as the result of combustible tobacco products.
- How the regulations you are implementing will reduce the estimated 6 million deaths worldwide, every year, as the result of combustible tobacco products.
- How the regulations you are implementing will reduce the estimated 1 billion who will die, in the 21st Century, as the result of combustible tobacco products.
- How the regulations you are implementing will impact reductions in smoking rates achieved over the last five years. Reductions so dramatic they have no historical precedent. Reductions achieved in five years that could not be accomplished in more than fifty years of efforts to reduce smoking. Fifty years of failed efforts. Fifty years with no viable alternative to combustible tobacco products.
- How will the regulations you are implementing contribute, in any way, to tobacco harm reduction?
- How the consequences of the regulations you are implementing could in any rational context be considered “unintended”.
Sen. Johnson closes his letter with two very succinct messages to the FDA.
- “Please provide this as soon as possible but no later than 5:00 p.m. on May 31, 2016.” And…
- “The Committee on Homeland Security and Governmental Affairs is authorized by Rule XXV of the Standing Rules of the Senate to investigate “the efficiency and economy of operations of all branches of the Government.” Additionally, S. Res. 73 (114th Congress) authorize the Committee to examine “the efficiency and economy of all branches and functions of Government with particular references to the operations and management of Federal regulatory policies and programs.”
This is the Legislative Branch of government sending a clear message to the Executive Branch of government – justify your actions. Explain the efficiency and economy of the operations and management of FDA. And do so by 5:00 p.m. today.
The FDA now has “sufficient data” to draw an important public health conclusion – the FDA is – accountable.
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Dave Coggin has a Master’s Degree in business and spent 35 years in corporate America. He is a co-founder and partner in DIYELS. He has spent the last five years actively researching and following the evolution of the e-cigarette industry. He is a strong proponent of e-cigarettes as the most promising option currently known for tobacco harm reduction. He may be contacted directly at email@example.com .