Dear Dr. Gottlieb:
Congratulations on your confirmation as Commissioner of the U.S. Food and Drug Administration (FDA). I look forward to working with you as Congress and the Administration strive to repair overregulation that has expanded the size, scope, and cost of government.
Since May 2016, I have been conducting oversight of the FDA’s burdensome regulation over e-cigarettes. The rule threatens an emerging industry as well as former smokers who have switched to vaping. The regulation requires e-cigarette manufacturers to complete costly and time-consuming applications to get federal approval to sell e-cigarette products. Based on some estimates, these applications could cost manufactures, many of which are small businesses, more than $1 million to complete. That is a cost that these small businesses cannot afford.
In December 2016 and February 2017, I wrote to Vice President-elect Pence and Secretary Price, respectively, urging the administration to consider repealing or suspending the FDA’s e-cigarette rule. I am pleased that the FDA recently announced that it would delay enforcement of the regulation. Although that is a positive first step, more must be done to permanently rein in this burdensome rule. As you begin your tenure as Commissioner of the FDA, I respectfully urge you to review the FDA’s e-cigarette regulation so that the industry can continue to innovate and offer vapers an alternative to smoking.
Thank you for your attention to this important matter.
Sincerely,
Ron Johnson
Chairman
Background
Chairman Johnson’s letters to former FDA Commissioner Califf:
May 17, 2016
June 6, 2016
July 15, 2016
Nov. 21, 2016
Chairman Johnson and Representative Hunter’s letter to Vice President-elect Pence on Dec. 12, 2016.
Chairman Johnson’s letter to Secretary Price on Feb. 21, 2017.
Source: U.S. Senate Committee on Homeland Security and Governmental Affairs
