Merkley Reacts to FDA Withdrawal of Flavored E-Cigarettes

Merkley Reacts to FDA Withdrawal of Flavored E-Cigarettes

“This action is outrageously overdue,” Senator says as vaping-linked lung disease sweeps across nation

WASHINGTON, D.C. – Oregon’s Senator Jeff Merkley, the top Democrat on the Appropriations Subcommittee that oversees the Food and Drug Administration (FDA), released the following statement after the FDA announced that it is temporarily pulling all flavored e-cigarette products from the market:

“This action is outrageously overdue. It’s been clear for years that an epidemic of youth e-cigarette addiction was building; that companies were surgically targeting teens in their product and marketing strategies; and that the long-term health impacts of e-cigarette use were unknown and potentially dire. Now, we have a growing crisis of serious lung disease linked to vaping, in which six have died and the average age of affected patients is just 19 years old.   

“It should never have taken multiple deaths and hundreds of cases of teenagers with lung disease for the FDA to conclude that e-cigarette flavors like ‘gummy bear,’ ‘Scooby snacks,’ and ‘strawberries and cream’ are insidious and have no place on the market. I can only hope that today’s action is made permanent soon, and that it will come in time to save the thousands of lives that may still be at risk.”

 

Background

Senator Merkley’s actions to fight back against the teenage e-cigarette addiction crisis:

 

2009

April 2009 – Sen. Merkley cosponsors legislation empowering the FDA to restrict the marketing of tobacco and ban candy-flavored cigarettes. 

April 2009 – Sen. Merkley meets with Dr. Howard Koh, Nominee for Assistant Secretary for Health at HHS and Dr. Margaret Hamburg, Nominee for FDA Commissioner and discussed FDA regulation of tobacco products.

June 2009 – Sen. Merkley speaks on Senate floor about dissolvable tobacco products that are intended to addict a new generation of children. He termed them “tobacco candy.”

 

2010

April 2010 – Sen. Merkley sends a letter to FDA urging that they use their authority to remove all tobacco candy/dissolvables from the market.

 

2011

June 2011 – Sen. Merkley sends a letter to FDA Commissioner Hamburg regarding dissolvables manufactured by Star Scientific.

July 2011 – Sen. Merkley, along with Sens. Brown and Blumenthal meet with Lawrence Deyton, Director Center for Tobacco Products, regarding dissolvables manufactured by Star Scientific.

 

2012

January 2012 – Sen. Merkley signs letter to FDAF Commissioner Margaret Hamburg urging FDA to issue regulations to restrict and prohibit the use of descriptions and marketing that mislead consumers about the safety of cigarettes.

May 2012 – Sen. Merkley meets with Lawrence Deyton, Director of the Center for Tobacco Products, regarding the status of deeming rule regulations.

June 2012 – Sen. Merkley calls Sec. Sebelius re: status of deeming regulations.

September 2012 – Sen. Merkley signs a letter to Commissioner Hamburg requesting an update on the agency’s progress and a timeline for issuing the deeming regulation.

September 2012 – Sen. Merkley signs a letter to Sec. Sebelius urging that FDA issue the draft deeming regulations as soon as possible.

 

2013

April 2013 – Sen. Merkley meets with FDA Commisioner Hamburg about the deeming regulations.

July 2013 – Sen. Merkley sends a letter to Sec. Sebelius to request update on status of deeming regulations.

September 2013 – Sen. Merkley signs a letter to CEO of e-cigarette manufacturer NJOY expressing concern about the marketing and sale of electronic cigarettes to minors, and to the Obama Administration urging FDA to issue the tobacco deeming regulations, exerting FDA oversight over these products which could include a ban on flavorings

October 2013 –  FDA sends OMB/OIRA draft regulation for review.

December 2013 – Sen. Merkley sends a letter to President Obama to request that he urge OIRA to move quickly to review the proposed deeming regulations and, following the subsequent comment period, review the final regulation expeditiously. 

 

2014

January 2014 – Sen. Merkley gives a Floor Speech on the 50th anniversary of Surgeon General's Report on dangers of tobacco, drawing parallels with the industry’s new strategies.

March 2014 – Sen. Merkley signs a letter to FDA regarding the dangers of e-liquids and dissolvables.

April 2014 – Sen. Merkley questions Commissioner Hamburg about the status of the deeming regulations at Ag/FDA Approps Subcommittee hearing and speaks about the dangers of e-cigarettes and liquid nicotine.

April 2014 – Sens. Merkley, Brown, and Blumenthal meet with Comm. Hamburg and Mitch Zeller, Director, FDA Center for Tobacco Products to discuss status of deeming regulations

April 2014 -  FDA issued proposed deeming regulations, and opened a 90-day comment period.

May 2014 – Sen. Merkley signs letter to FDA calling for the agency to acknowledge recent studies that indicate possible harmful health effects of “vapor” or “plume” on e-cigarette users and secondhand inhalers.

May 2014 – Sen. Merkley hosts a press conference at Oregon Health and Sciences University (OHSU) to discuss the status of the deeming regs and the need for FDA to regulate dissolvable tobacco and e-cigarettes.

June 2014 – Sen. Merkley releases congressional report on need for e-cigarette regulation.

July 2014 – Sen. Merkley signs letter to FDA calling for stronger protections for children in FDA’s first proposed rule regulating e-cigarettes.

July 2014 – Sen. Merkley signs a letter to the Food and Drug Administration (FDA) and the Office of Information and Regulatory Affairs (OIRA) questioning the methodology of their cost-benefit analysis related to the FDA’s proposed “deeming rule” on tobacco products.

August 2014 - Sen. Merkley sends a letter to FDA calling for stronger protections for children in the first proposed rule regulating e-cigarettes. It urges that once the deeming regulations are finalized, that newly-deemed products can only remain on the market if their manufacturers apply the restrictions imposed on traditional tobacco products to limit youth access, including a ban on flavorings, prohibition of tobacco brand-name sponsorships, and limits on advertising.

September 2014 – Sen. Merkley cosponsors S. 2047, The Protecting Children from Electronic Cigarette Advertising Act of 2014, which prohibits advertisement, promotion, or marketing in commerce of electronic cigarettes in a manner that is known, or should be known, to increase the use of electronic cigarettes by children under the age of 18.

 

2015

February 2015 – Sen. Merkley signs letter urging the FDA to finalize its plan for regulating e-cigarettes.

March 2015 – Sen. Merkley meets with FDA leaders to further urge them to regulate e-cigarettes.

April 2015 – Sen. Merkley renews calls for FDA action on e-cigarettes as new study shows e-cigarette use tripling among middle and high school students.

June 2015 – Sen. Merkley, on the six-year anniversary of the Family Smoking Prevention and Tobacco Control Act, blasts the Obama Administration’s failure to finalize anti-tobacco regulations, calling the delays “unacceptable” and noting that youth use of new tobacco products is spiking as the Administration sits on the new rules.

October 2015 – Sen. Merkley presses the White House Office of Management and Budget (OMB) to complete its review of a long-overdue rule to regulate e-cigarettes and other forms of tobacco as quickly as possible.

 

2016

April 2016 – Sen. Merkley takes to the Senate floor and decries lack of action on e-cigarette rules.

May 2016 – Sen. Merkley applauds the release of a final tobacco deeming rule which will grant the FDA authority to regulate all tobacco products. With this new authority, the FDA has the tools needed to crack down on tobacco companies that use manipulative marketing to encourage children and teens to smoke e-cigarettes, cigars, pipe tobacco, and other tobacco products.

 

2017

July 2017 – Sen. Merkley releases a statement after the FDA announced a delay in regulating e-cigarettes.

August 2017 – Sen. Merkley sends a letter to FDA Commissioner Scott Gottlieb denouncing the agency’s recent move to delay oversight of newly-regulated tobacco products, including electronic cigarettes and cigars.

 

2018

February 2018 – Sen. Merkley sends letter to FDA Commissioner Gottlieb regarding the modified-risk applications for Philip Morris’ IQOS tobacco product.

April 2018 – Sen. Merkley signs a pair of letters to FDA and JUUL Labs, Inc. regarding e-cigarette use in children and young adults.

June 2018 – Sen. Merkley signs a letter to FDA to reconsider its decision to delay regulation of e-cigs/flavorings until 2021/2022 (under the FDA’s “deeming rule” these products were set to be regulated in 2018/2019); and a series of questions about how/whether they are enforcing current tobacco regulations (per the “deeming rule,” tobacco products that were not on the market as of Aug 8, 2016 are not allowed to come to the market now without FDA review. Yet new flavorings and devices are popping up every day without FDA review.

August 2018 – Sen. Merkley cosponsors the bipartisan “Stopping Appealing Flavors in E-Cigarettes for Kids Act” (SAFE Kids Act), which would impose additional restrictions on tobacco flavors for use in e-cigarettes and ban the use of all flavors in cigars within one year.

 

2019

February 2019 – Sen. Merkley signs a HHS Secretary Azar criticizes the lack of action taken by HHS and FDA regarding the use of e-cigarettes by youth, requesting that HHS respond to the e-cigarette epidemic by: removing flavored e-cigarette products that attract kids from the market; educating the public on the dangers of e-cigarette use by youth; and researching treatments for youth already addicted to e-cigarette products.

February 2019 – Sen. Merkley sends a letter to FDA regarding a ‘nicotine arms race’ in e-cigarettes and their limited efforts to reduce nicotine levels in cigarettes and other combustible tobacco products. This letter asks FDA to make any nicotine reduction product standard applicable to other combustible tobacco products, including e-cigarettes.

March 2019 – Sen. Merkley cosponsors the Preventing Opportunities for E-Cigarette and Tobacco Addiction Act to create an initiative at CDC to prevent and research youth tobacco use and the reasons for its increasing popularity.

April 2019 – Sen. Merkley signs Senator Durbin’s letter requesting additional information from e-cigarette company JUUL about their advertising behavior and the recent investment they received from cigarette giant Altria.

April 2019 – Sen. Merkley signs a letter to FDA Acting Commissioner Ned Sharpless regarding the correlation of e-cigarette use and the occurrence of seizures, especially among youth. This letter highlights a recent report showing the correlation between the use of e-cigarettes and seizures and expresses concern over the lack of action from the FDA to regulate e-cigarettes as well as the continued delays on research into the effects of e-cigarettes on public health.

June 2019 – Sen. Merkley meets with FDA Acting Commissioner and presses him on e-cigarettes. Sen. Merkley states that with every day FDA fails to act, more children’s lives are at risk.

June 2019 – Sen. Merkley signs letter on the 10th Anniversary of the Tobacco Control Act that criticizes FDA for not acting with the speed necessary to prevent and respond to the current youth tobacco use crisis, including by delaying asserting its jurisdiction over e-cigarettes and delaying enforcement of the required public health reviews of tobacco products. This letter also urges FDA to take proactive and expedient action to protect kids from tobacco products including the new generation of products on the market.

June 2019 – Sen. Merkley cosponsors legislation that would bring the VA in line with smoke-free policies across the federal government and in the private health care system by prohibiting the smoking of cigarettes, e-cigarettes, cigars, pipes, and any other combustible tobacco products in VA facilities.

July 2019 – Sen. Merkley signs a letter to FDA Acting Commissioner Sharpless conveying that, should he be formally nominated to serve as FDA Commissioner, Merkley would not be able to support his nomination with stronger action on e-cigarettes.

September 2019 – Sen. Merkley leads 22 Senators in demanding action and answers from FDA over an outbreak of severe pulmonary illnesses and deaths linked to e-cigarette use.

 

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