Johnson writes FDA on e-cig regulation
By Zach Hagenbucher
May 19, 2016
A Wisconsin U.S. senator is getting involved in the battle over e-cigarette regulation.
Ron Johnson sent a letter to the director of the Food and Drug Administration Wednesday on behalf of the Committee of Homeland Security and Governmental Affairs looking for details behind the decision of the FDA to implement a screening process on the manufacturing of e-juice.
This comes after a statement from the CEO of Wisconsin-based e-cigarette manufacturer Johnson Creek saying that the new regulations on the manufacturing of e-cigs could cripple small businesses based around vaping because of the potential costs.
In this excerpt from the letter, Johnson asks questions around the potential early regulation of the industry without solid knowledge to justify it.
“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.”
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?
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. 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.
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?”
A deadline for answers from the FDA has been set for May 31st.