WASHINGTON -- Sen. Ron Johnson (R-Wis.) is the latest person to officially voice concerns about the U.S. Food and Drug Administration’s (FDA) "deeming" regulations. Last week, the chairman of the Senate Homeland Security and Governmental Affairs Committee sent a letter to FDA commissioner Robert Califf, voicing concerns that electronic-cigarette regulations will create undue burdens on small businesses, and potentially something else.
“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,” Johnson wrote in the letter (which is posted in full on the U.S. Senate Committee on Homeland Security and Governmental Affairs website). “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.”
Johnson requested that Califf and the FDA provide additional information on three specific areas to better help the committee understand the agency’s thinking on electronic-cigarette regulations. Those areas included:
1. The Scientific Data: In the final rule, the FDA said it did “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.” Johnson questioned if the deeming rule was not “premature … given the FDA’s admission that it does not have ‘sufficient data’ about e-cigarettes to determine the effects on the public’s health.” Also, Johnson asked the FDA to explain if it would revise the deeming rule once “sufficient data” was available.
2. The Economic Impact: “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,” the letter reads. Johnson asked if the FDA had determined how many electronic-cigarette businesses would be affected by deeming and, of those businesses, how many the FDA predicts will go out of business due to the regulations.
3. Unintended Health Consequences: Finally, Johnson asked if the FDA had “considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products”—and to explain the agency’s thinking on this issue.
The FDA was asked to provide this information “as soon as possible,” no later than 5 p.m. E.S.T. May 31, 2016.
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