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with; HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
WASHINGTON, or: 20510. 6250

May 17, 2017

The Honorable Scott Gottlieb, M.D.
Commissioner

US. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Dr. Gottlieb:

Congratulations on your con?rmation as Commissioner of the US. 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 burdensome regulation
over e-cigarettes.1 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.2 Based on some
estimates, these applications could cost manufactures, many of which are small businesses, more
than $1 million to complete.3 That is a cost that these small businesses cannot afford.4

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
e-cigarette rule. I am pleased that the FDA recently announced that it would delay
enforcement of the regulation.5 Although that is a positive ?rst 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 e-cigarette regulation so that the industry can
continue to innovate and offer vapors an alternative to smoking.

 

See, e. g, Letter from Ron Johnson to Robert M. Califf, MD. (May 17, 2016),


2 Michael Siege], The FDA ?3 Vaporous Thinking About E?Cigs, WALL ST. J. (May 5, 2016),
1462487690.

3 Sabrina Tavernise, F. DA. Imposes Rules for E-Cigarettes in a Landmark Move, NY TIMES (May 5, 2016),


4 Michael Siege], The FDA ?s Vaporous Thinking About E-Cigs, WALL ST. J. (May 5, 2016),


5 Juliet Eilperin, FDA delays enforcement of stricter standards for e-cigarette, cigar industry, WASH. POST (May 2,
2017), 
cigar-industry/ZO 1 7/05/02/be7e557a-2ed6-l 1e7-95 3f67fe895 d.

The Honorable Scott Gottlieb, MD.
May 17, 2017
Page 2

Thank you for your attention to this important matter.

Sincerely,

 

co: The Honorable Claire McCaskill
Ranking Member