Johnson urges FDA commissioner to review new rules for e-cigarettes
Sen. Ron Johnson (R-Wis.) is urging Scott Gottlieb, the newly minted commissioner of the Food and Drug Administration, to consider repealing first-ever rules for electronic cigarettes finalized under former President Barack Obama.
“The rules threaten an emerging industry as well as former smokers who have switched to vaping,” the chairman of the Homeland Security and Governmental Affairs Committee wrote in a letter to Gottlieb this week.
“The regulations require e-cigarette manufacturers to complete costly and time-consuming applications to get federal approval to sell e-cigarette products.”
Last week the agency delayed enforcement of the rules by three months to give the new administration time to review the rules, which are being challenged in court.
Johnson said the delay is a “positive first step” but “more must be done to permanently rein in this burdensome rule.”
When the rule was finalized in May 2016, manufactures were given 12 months after the rules took effect that August to request an exemption from product approval requirements, 18 months to submit an application proving the product has a substantial equivalent already on the market and 24 months to submit an application for pre-market approval.
“Based on some estimates, these applications could cost manufacturers, many of which are small businesses, more than $1 million to complete,” Johnson said. “That is a cost that these businesses cannot afford.”
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