UPDATE: FDA's response to Grassley can be found HERE.

WASHINGTON – U.S. Sen. Chuck Grassley of Iowa, chairman of the Senate Judiciary Committee, sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb seeking answers regarding the agency’s oversight efforts of e-cigarette manufacturers and their marketing efforts to minors. Specifically, Grassley is seeking more information on FDA’s plan to ensure that manufacturers and retailers follow the law and pay any fines that have been imposed.

“…the FDA has stated that it is currently ‘[i]nvestigating whether manufacturers of certain e-cigarette products may be marketing new products that were not on the market as of Aug. 8, 2016, thus falling outside of the FDA’s compliance policy, and have not gone through premarket review,’” Grassley wrote. “It is important for the Committee to better understand the FDA’s plans to investigate potential violations of premarket review requirements and the history and efficacy of past enforcement efforts.”  

Grassley, chairman of the Senate Caucus on International Narcotics Control, reintroduced the bipartisan Protecting Kids from Candy-Flavored Drugs Act with Sen. Dianne Feinstein of California in 2017. Grassley and Feinstein have introduced similar legislation seeking to increase the criminal penalties for marketing candy-flavored drugs to appeal to children each Congress for more than a decade. 

You can view the letter here and below.

 

The Honorable Dr. Scott Gottlieb

Commissioner

Food and Drug Administration

 

Dear Commissioner Gottlieb:

I read with interest your September 12, 2018, statement regarding the Food and Drug Administration’s (FDA) enforcement efforts related to the sale and marketing of e-cigarette products to minors. You rightly describe e-cigarette use as an epidemic among our nation’s youth that must be stopped.  The measures that you are taking to penalize retailers that sell these products to minors and to require manufacturers that are marketing products in violation of federal laws to submit plans on how they will combat use by minors are steps in the right direction. 

Your statement and the accompanying press release also raise important questions about the FDA’s investigative and enforcement efforts.  According to the FDA’s September 12, 2018, press release, the agency “issued more than 1,300 warning letters and civil monetary complaints (fines)…” Although the names of businesses that were warned or fined have been made public on your website, information concerning the amounts of the fines imposed have not. 

In addition, the FDA has stated that it is currently “[i]nvestigating whether manufacturers of certain e-cigarette products may be marketing new products that were not on the market as of Aug. 8, 2016, thus falling outside of the FDA’s compliance policy, and have not gone through premarket review.” It is important for the Committee to better understand the FDA’s plans to investigate potential violations of premarket review requirements and the history and efficacy of past enforcement efforts. 

      Please answer the following no later than October 4, 2018:

  1. With respect to the 1,300 civil monetary penalty cases, please provide a list of all companies that received an order to pay a fine and the amount.  In addition, please note whether the company has paid the fine, and, if not, what steps you have taken, or plan to take, to ensure the fine is paid.
  2. What efforts were undertaken prior to September 12, 2018, to identify and penalize manufacturers marketing e-cigarette products in violation of the FDA’s premarket review requirements?  If efforts were not undertaken, please explain why not. 
  3. For companies that have marketed and sold e-cigarette products that were not on the market as of August 8, 2016, and have not gone through premarket review, please explain in detail what type of enforcement efforts the FDA has engaged in to bring the companies back into compliance, to include any fines. 
  4. Will you make responses to your warning letters public and produce them to the Committee?  If not, why not? 
  5. Will you make plans for combatting the youth e-cigarette use epidemic submitted by e-cigarette manufacturers public and produce them to the Committee?  If not, why not?

Thank you in advance for your prompt attention to these matters.  Should you have any questions, please contact Josh Flynn-Brown of my staff at (202) 224-5225.

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