During its upcoming term, the Supreme Court will hear FDA’s appeal of a Fifth Circuit decision that struck down the agency’s denials of applications from an e-cigarette manufacturer
WASHINGTON – 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 curiae breve to the Supreme Court today urging the Court to support the Food and Drug Administration’s (FDA) authority and actions to regulate e-cigarettes. During its upcoming term, the Supreme Court will hear FDA’s appeal of a Fifth Circuit decision that the agency acted “arbitrarily and capriciously” in denying premarket tobacco product applications (PMTAs) from an e-cigarette manufacturer selling addictive, kid-friendly vaping devices with flavors including, “Peachy Strawberry” and “Mother’s Milk and Cookies.”
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’s decision setting aside the FDA’s marketing denial orders threatens to undermine both the past public health successes of the 2009 Ley de control del tabaco y prevención del tabaquismo en la familia (“The Act”) and its future efficacy.
Under the law, e-cigarette manufacturers must prove to FDA, with high-quality scientific evidence, that a tobacco product is “appropriate for the protection of public health” 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’s decision jeopardizes FDA’s ability to regulate this market, and risks a new wave of children falling prey to tobacco products.
The amicus brief states, “In 2009, Congress recognized that ‘[t]he use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults.” 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) ‘to address issues of particular concern . . . especially the use of tobacco by young people’ has remained ‘flexible,’ allowing FDA to respond to evolving challenges in the marketplace.”
The amicus brief continues, “FDA 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… Judicial oversight of FDA’s decisions on these applications has been generally consistent and has allowed FDA to exercise its statutory authority efficiently and correctly… But now the Fifth Circuit has set aside FDA’s carefully reasoned conclusion that certain sweet and fruity flavored tobacco products—with names like ‘Milk and Cookies,’ ‘Rainbow Road,’ and ‘Strawberry Astronaut’—are 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’s conclusion was incorrect. Nor could it—FDA’s decision on Respondents’ PMTAs was substantively correct. Instead, the Fifth Circuit has set aside FDA’s marketing orders and would require FDA to unnecessarily re-evaluate Respondents’ PMTAs in a less efficient, more resource-intensive manner before reaching the same result and once again denying the applications.”
“The key to reducing tobacco related deaths is preventing youth tobacco use, and FDA’s authority to oversee e-cigarette products, including by denying authorization to sell specific products, is a foundational intervention in doing so. The Fifth Circuit’s decision flies directly in the face of that authority, and threatens to undermine both the Act’s 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,” escribieron los legisladores.
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.
In June, the Senate Judiciary Committee held a audiencia entitled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use—including the role of the tobacco industry in flooding the market with kid-friendly, flavored vaping devices —and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.
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).
The lawmakers’ amicus brief to the Supreme Court can be read in full aquí.
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