Merkley blasts FDA over flavored e-cigarette policy

Claims administration 'going spineless in face of corporate lobbying'

WASHINGTON (KTVZ) -- Sen. Jeff Merkley, D-Ore., the top Democrat on the Appropriations Subcommittee that oversees the Food and Drug Administration, released the following statement Thursday after the FDA announced an e-cigarette policy on flavors that he said fell far short of a previously planned ban on the flavors that have been shown to attract children:

“Yet again, President Trump and the FDA are going spineless in the face of corporate lobbying. The health of millions of American children will continue to suffer because of today’s announcement.

“It’s no secret that an epidemic of youth e-cigarette addiction has been building over the course of many years. For years, e-cigarette companies have been given free rein by the FDA to pursue a massively successful strategy of addicting a new generation on nicotine, targeting middle and high school students with social media influencers and sweet flavors blatantly designed to appeal to children.

"We knew that the long-term health impacts of e-cigarette use would be devastating to the next generation. Now, we know in addition to the health impacts of nicotine addiction, we are facing vaping illnesses related to the additives that have contributed to multiple deaths across the country—including two in Oregon.    

“I’m deeply disturbed that industry lobbyists were able to get President Trump to gut the ban on flavors that the FDA was belatedly planning.  Instead, this announcement is simply saying that FDA will target its enforcement on flavors, and even then it is carving out loopholes for tobacco and menthol flavors, and vape shops.

"FDA’s own announcement of preliminary data from the 2019 National Youth Tobacco Survey shows that youth use of menthol e-cigarettes soared in 2019 after Juul stopped selling fruit flavors. Industry profits and politics should never take precedence over children’s lives and health but that’s the choice the Trump Administration is making today.”

Background – Sen. Merkley actions to combat the youth e-cigarette epidemic:

2009

April 2009 – Sen. Merkley cosponsors legislation empowering the Food and Drug Administration (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 Health and Human Services (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 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 they use their authority to remove all tobacco candy/dissolvables from the market.

October 2010 – Sen. Merkley Urges Oregonians to Share Concerns over Tobacco Candy with FDA (press release)

2011

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

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

2012

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

March 2012 - The Tobacco Products Scientific Advisory Committee (TPSAC) report on dissolvables/tobacco candy was released.  It determined that to date there was little use of DTPs by youth, and availability was limited to test market areas.  The Indiana experience during test marketing of Camel Orbs suggested that some youth would try dissolvables, particularly those already smoking cigarettes.  Data from a survey in Virginia suggested that youth not perceiving dissolvables as a tobacco product would be more likely to try them.  The report also stated that packaging design could make products more appealing to youth.

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

June 2012 – Sen. Merkley speaks with Secretary of Health and Human Services Kathleen Sebelius about deeming regulations and sends her tobacco candy packages (orbs, sticks, strips) with which she was not familiar.

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

2013

April 2013 – Sen. Merkley meets with FDA Commissioner Hamburg and she promises an update on the status of deeming regulations in 2 months.

July 2013 – Sen. Merkley sends a letter to Secretary Sebelius to request update on the 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 the Office of Management and Budget and Office of Information and Regulatory Affairs draft regulation for review.

December 2013 – Sen. Merkley sends a letter to President Obama to request that he urge the Office of Information and Regulatory Affairs 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 Tobacco Candy Floor Speech on the 50th anniversary of Surgeon General's Report on dangers of tobacco.

March 2014 – Sen. Merkley signs a letter to FDA regarding the dangers of e-liquids and dissolvables, which was the focus of a New York Times article.

April 2014 – Sen. Merkley questioned Commissioner Hamburg about the status of the deeming regulations at an Agriculture Appropriations Subcommittee hearing and spoke about the dangers of e-cigarettes and liquid nicotine.

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

April 2014 – FDA issues 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 hosted a press conference at OHSU to discuss the status of the deeming regulations 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 FDA and the Office of Information and Regulatory Affairs 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, blasted 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 pressed 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.

April 2016 – Sen. Merkley and Sen. Blumenthal write an opinion piece in The Hill urging the Administration to take swift and immediate action to finalize critical tobacco and nicotine regulations.

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 released 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 and 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.

September 2018 – Sen. Merkley called Commissioner Gottlieb regarding a big tobacco enforcement announcement from the FDA. A federal court ordered the FDA to expeditiously issue a final rule requiring graphic health warnings on cigarette packs and advertising, as mandated by a 2009 federal law – the court set FDAs deadline as September 26, 2018.

October 2018 – Sen. Merkley signs a letter to the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) regarding Big Tobacco’s use of deceptive social media in promoting tobacco products to minors – in violation of federal law.

October 2018 – Sen. Merkley signs a letter with Sen. Wyden to the FDA to ban kid-friendly e-cigarette flavors and requests the FDA to make public the responses it receives from manufacturers in response to FDA’s letters outlining their recently announced enforcement actions to reduce youth use of e-cigarettes.

December 2018 – Sen. Merkley cosponsors the Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act, which would eliminate the current tax incentive for tobacco companies to manipulate pipe tobacco and cigar loopholes in order to avoid taxation. The bill would also ensures that all FDA-deemed tobacco product (including e-cigarettes) are taxed at the same level as other tobacco products and increases this federal tax to $2.02 per pack of cigarettes. 

December 2018 – Sen. Merkley signs a letter to the FDA encourages the agency to implement a ban on menthol in combustible tobacco products as soon as possible and urges FDA to remove all flavored e-cigarette products, including menthol and mint, from the market until the FDA thoroughly reviews whether they present a public health benefit.

2019

February 2019 – Sen. Merkley signs a letter to HHS Secretary Azar that 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 Teen 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.

July 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 without 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.

September 2019 – Sen. Merkley sponsors the E-Cigarette Tax Parity Act to tax e-cigarettes the same as other tobacco products.

September 2019 – Sen. Merkley secures language in the 2020 Agriculture/FDA appropriations bill requiring the FDA to address the outbreak of vaping-related lung disease and directing the FDA to work with the Centers for Disease Control (CDC) and Drug Enforcement Administration (DEA) to conduct a full investigation.

September 2019 – Sen. Merkley and Sen. Mitt Romney (R-UT) introduce the bipartisan Ending New Nicotine Dependencies (ENND) Act, which would ban non-tobacco flavors, impose the same tobacco excise tax on vaping products, and ensure that nicotine delivery devices are tamper-proof.

September 2019 – Sen. Merkley and Sen. Lisa Murkowski (R-AK) introduce the bipartisan E-Cigarette Device Standards Act, which would require safety standards for the design of e-cigarette and vaping devices.

October 2019 – Sen. Merkley joins eight of his colleagues pressing JUUL and Altria for answers about the companies’ marketing tactics and the potential to tamper with their e-cigarette devices to vape illicit substances.

October 2019 – Sen. Merkley joins twenty-five of his colleagues in pressing the FDA to keep its promise to ban flavored e-cigarettes and to include mint and menthol flavors in the ban.

November 2019 – Sen. Merkley signs a pair of letters to Juul and the FDA regarding news reports alleging that Juul shipped one million contaminated pods to consumers despite warnings from employees.

November 2019 – Sen. Merkley sends a letter to President Donald Trump expressing outrage at his decision to walk away from promised action on flavored e-cigarettes after industry pressure.

December 2019 – Sen. Merkley sends a letter to the Department of Health and Human Services (HHS) regarding the agency’s decision to abandon plans to lower the level of nicotine in combustible cigarettes.

December 2019 – Sen. Merkley votes against Dr. Stephen Hahn’s nomination to serve as commissioner of the FDA over his belief that Dr. Hahn will not prioritize the health of American children over industry, and Dr. Hahn’s refusal to commit to implementing strong tobacco policy.