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December 16, 2017

Wisconsin Senator Johnson Requests FDA to Answer for E-Cig Regulations

Wisconsin United States Senator Ron Johnson is now involved in the battle over e-cigarette regulation. Wednesday, Senator Johnson sent a letter to Robert M. Califf, M.D., Commissioner of the Food and Drug Administration, on behalf of the Committee of Homeland Security and Governmental Affairs looking for details behind their decision to implement a screening process on the manufacturing of e-juice. New regulations on the manufacturing of e-cigs could cripple small businesses based around vaping because of the potential costs.

The following 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?”

Johnson set a May 31st deadline for the FDA to answer..



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