{"id":20351,"date":"2024-09-03T16:20:58","date_gmt":"2024-09-03T20:20:58","guid":{"rendered":"https:\/\/www.merkley.senate.gov\/?p=20351"},"modified":"2024-09-10T12:18:19","modified_gmt":"2024-09-10T16:18:19","slug":"durbin-pallone-merkley-lead-amicus-brief-urging-supreme-court-to-support-fdas-public-health-authority-and-actions-to-regulate-e-cigarettes","status":"publish","type":"post","link":"https:\/\/www.merkley.senate.gov\/es\/durbin-pallone-merkley-lead-amicus-brief-urging-supreme-court-to-support-fdas-public-health-authority-and-actions-to-regulate-e-cigarettes\/","title":{"rendered":"DURBIN, PALLONE, MERKLEY LEAD AMICUS BRIEF URGING SUPREME COURT TO SUPPORT FDA\u2019S PUBLIC HEALTH AUTHORITY AND ACTIONS TO REGULATE E-CIGARETTES"},"content":{"rendered":"\n

During its upcoming term, the Supreme Court will hear FDA\u2019s appeal of a Fifth Circuit decision that struck down the agency\u2019s denials of applications from an e-cigarette manufacturer<\/em><\/p>\n\n\n\n

WASHINGTON \u2013 U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee; U.S. Representative Frank Pallone, Jr. (D-NJ-06), Ranking Member of the House Energy and Commerce Committee; and U.S. Senator Jeff Merkley (D-OR) led a group of sixteen lawmakers in filing an amicus brief<\/a> to the Supreme Court today urging the Court to support the Food and Drug Administration\u2019s (FDA) authority and actions to regulate e-cigarettes.  During its upcoming term, the Supreme Court will hear FDA\u2019s appeal of a Fifth Circuit decision that the agency acted \u201carbitrarily and capriciously\u201d in denying premarket tobacco product applications (PMTAs) from an e-cigarette manufacturer selling addictive, kid-friendly vaping devices with flavors including, \u201cPeachy Strawberry\u201d and \u201cMother\u2019s Milk and Cookies.\u201d<\/p>\n\n\n\n

In the bicameral brief, the lawmakers urge the Court to reverse the Fifth Circuit decision and reinstate the marketing denial orders.  They argue that the Fifth Circuit\u2019s decision setting aside the FDA\u2019s marketing denial orders threatens to undermine both the past public health successes of the 2009 Family Smoking Prevention and Tobacco Control Act<\/em> (\u201cThe Act\u201d) and its future efficacy. <\/p>\n\n\n\n

Under the law, e-cigarette manufacturers must prove to FDA, with high-quality scientific evidence, that a tobacco product is \u201cappropriate for the protection of public health\u201d before the product is sold in the United States.  FDA has rejected PMTAs from hundreds of manufacturers representing millions of e-cigarette products for failing to demonstrate this public health benefit.  For approximately two dozen denials, the manufacturers have appealed the denials to federal courts.  FDA has prevailed in the majority of the cases, winning on the merits in seven of the nine courts of appeals that have ruled.  But the Fifth Circuit\u2019s decision jeopardizes FDA\u2019s ability to regulate this market, and risks a new wave of children falling prey to tobacco products.<\/p>\n\n\n\n

\n

The amicus brief states,<\/strong> \u201cIn 2009, Congress recognized that \u2018[t]he use of tobacco products by the Nation\u2019s children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults.\u201d Recognizing the danger, Congress took overwhelmingly bipartisan action, passing the Act and bringing about sweeping changes in the federal oversight of the tobacco market.  In the fifteen years since the passage of the Act, the authority of the Food and Drug Administration (FDA) \u2018to address issues of particular concern . . . especially the use of tobacco by young people\u2019<\/sup> has remained \u2018flexible,\u2019 allowing FDA to respond to evolving challenges in the marketplace.\u201d<\/p>\n<\/blockquote>\n\n\n\n

\n

The amicus brief continues,<\/strong> \u201cFDA has utilized its regulatory and enforcement authorities to address the health threat posed by e-cigarettes, and has done so in a manner consistent with Congressional intent as expressed in the Act\u2026 Judicial oversight of FDA\u2019s decisions on these applications has been generally consistent and has allowed FDA to exercise its statutory authority efficiently and correctly\u2026 But now the Fifth Circuit has set aside FDA\u2019s carefully reasoned conclusion that certain sweet and fruity flavored tobacco products\u2014with names like \u2018Milk and Cookies,\u2019 \u2018Rainbow Road,\u2019 and \u2018Strawberry Astronaut\u2019\u2014are not appropriate to protect the public health because they are more likely to appeal to youth consumers than they are to help current adult tobacco users quit.  The Fifth Circuit does not suggest that FDA\u2019s conclusion was incorrect.  Nor could it\u2014FDA\u2019s decision on Respondents\u2019 PMTAs was substantively correct.  Instead, the Fifth Circuit has set aside FDA\u2019s marketing orders and would require FDA to unnecessarily re-evaluate Respondents\u2019 PMTAs in a less efficient, more resource-intensive manner before reaching the same result and once again denying the applications.\u201d<\/p>\n<\/blockquote>\n\n\n\n

\n

\u201cThe key to reducing tobacco related deaths is preventing youth tobacco use, and FDA\u2019s authority to oversee e-cigarette products, including by denying authorization to sell specific products, is a foundational intervention in doing so.  The Fifth Circuit\u2019s decision flies directly in the face of that authority, and threatens to undermine both the Act\u2019s success to date and future federal oversight of tobacco, dragging federal regulation of e-cigarettes backwards and imperiling countless American youth.  This Court should reverse the Fifth Circuit; if it were instead to affirm the Fifth Circuit on any basis, the result would be diametrically opposed to the intent of Congress in passing the Act and would have devastating consequences for the American health system and individual Americans,\u201d wrote the lawmakers.<\/strong><\/p>\n<\/blockquote>\n\n\n\n

Durbin has been a vocal leader in the fight against Big Tobacco, particularly since he lost his father to lung cancer when Durbin was 14. He went after Big Tobacco when he served in the House of Representatives and led the charge to ban smoking on airplanes, which eventually led to restaurants, office buildings, trains, and much more. Durbin has also led efforts to grant FDA jurisdiction over tobacco, raise tobacco taxes to prevent youth initiation, and enhance support for tobacco cessation tools.<\/p>\n\n\n\n

In June, the Senate Judiciary Committee held a hearing<\/a> entitled \u201cCombatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.\u201d The hearing underscored the alarming level of youth e-cigarette use\u2014including the role of the tobacco industry in flooding the market with kid-friendly, flavored vaping devices \u2014and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.<\/p>\n\n\n\n

In addition to Durbin, Pallone, and Merkley, the amicus brief was signed by U.S. Senators Ron Wyden (D-OR), Richard Blumenthal (D-CT), Tammy Baldwin (D-WI), Jack Reed (D-RI), Elizabeth Warren (D-MA), Jeanne Shaheen (D-NH), Ed Markey (D-MA), and U.S. Representatives Raja Krishnamoorthi (D-IL-08), Diana DeGette (D-CO-01), Rosa DeLauro (D-CT-03), Kim Schrier, M.D. (D-WA-08), Debbie Wasserman Schultz (D-FL-25), and Barbara Lee (D-CA-13).<\/p>\n\n\n\n

The lawmakers\u2019 amicus brief to the Supreme Court can be read in full here<\/a><\/u><\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"

During its upcoming term, the Supreme Court will hear FDA\u2019s appeal of a Fifth Circuit decision that struck down the agency\u2019s denials of applications from an e-cigarette manufacturer WASHINGTON \u2013 U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee; U.S. Representative Frank Pallone, Jr. (D-NJ-06), Ranking Member of the House Energy and […]<\/p>\n","protected":false},"author":15,"featured_media":18847,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[24],"tags":[37,47],"class_list":["post-20351","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-releases","tag-health-care","tag-protecting-consumers-taxpayers-and-the-economy"],"acf":[],"yoast_head":"\nDURBIN, PALLONE, MERKLEY LEAD AMICUS BRIEF URGING SUPREME COURT TO SUPPORT FDA\u2019S PUBLIC HEALTH AUTHORITY AND ACTIONS TO REGULATE E-CIGARETTES - 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