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Johnson Urges FDA Commissioner to Permanently Rein In E-Cigarette Rule

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WASHINGTON — Sen. Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, sent a letter to FDA Commissioner Dr. Scott Gottlieb Wednesday urging him to consider permanently reining in the e-cigarette rule.

“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,” Johnson wrote to Commissioner Gottlieb.

Johnson has raised concerns for a year about the FDA’s e-cigarette regulation issued under the Obama administration, saying it could create undue burdens on small businesses and possibly lead to negative unintended health consequences.

The full letter can be found here and below:

 

May 17, 2017
The Honorable Scott Gottlieb, M.D.
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

 

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

November 21, 2016

Chairman Johnson and Representative Hunter’s letter to Vice President-elect Pence on December 12, 2016.

Chairman Johnson’s letter to Secretary Price on February 21, 2017.

 

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