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Tag: Regulatory

  • Supreme Court Favors FDA in Flavor Battle

    Supreme Court Favors FDA in Flavor Battle

    Today (April 2), the Supreme Court unanimously overturned a lower court’s decision that the U.S. Food and Drug Administration incorrectly blocked flavored nicotine e-liquids, rejecting e-cigarette makers that were challenging regulatory hurdles on tobacco products.

    E-liquid companies Triton Distribution and Vapetasia LLC claimed the FDA unlawfully denied the marketing authorization for flavored vape products and disputed that the products appealed to children, arguing that the government was harming nicotine-addicted adults by keeping a cigarette alternative off the market.

    The vape companies argued the FDA failed to review the company’s own scientific evidence, which demonstrates its flavored products were crucial to getting smokers to switch from combustible cigarettes to e-cigarettes. The Fifth Circuit Court agreed with the e-cigarette maker, ruling that “the agency’s rejection was arbitrary and capricious because the FDA relied on conflicting evidence requirements.” The court also faulted the FDA for dismissing “out-of-hand companies’ strategies to keep their products away from minors.” The agency said such efforts haven’t proven to be effective.

    Public health groups had already sued the FDA for not moving fast enough to review the products after the agency, in 2016, finalized rules for regulating them under the 2009 Family Smoking Prevention and Tobacco Control Act. Under the Act, vape companies were forced to submit applications to the FDA in order to bring new vape flavors to market, and the FDA was to assess the public health effects of those products. A rift, however, emerged over the agency’s criteria for approving or denying those applications, which culminated in the Fifth Circuit.

    The fight was brought to the Supreme Court in November with the FDA contending it correctly applied the Tobacco Control Act, saying it considered both the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”

    Oral arguments in front of the Supreme Court centered on whether the FDA standards are a policy position or a substantive rule imposed without notice and comment. The Biden administration argued the standards fell into the policy bucket, pushing the court to give the agency deference to interpret its role under the Tobacco Control Act. 

    Under the Biden administration, the FDA rejected more than a million flavored products, saying companies failed to show that flavored vapes will do more to benefit public health by helping smokers quit tobacco products than the harm they cause by appealing to young people.

    Vaping companies hope they’ll find a friendlier regulatory environment under the Trump administration, as the President previously promised to “save” flavored vaping.

  • Regulatory Freeze Pending Review

    Regulatory Freeze Pending Review

    As the Trump Administration digs in, it has called for a regulatory freeze pending review across all agencies, citing five points:

    (1)  Do not propose or issue any rule in any manner, including by sending a rule to the Office of the Federal Register (the “OFR”), until a department or agency head appointed or designated by the President after noon on January 20, 2025, reviews and approves the rule.  

    (2)  Immediately withdraw any rules that have been sent to the OFR but not published in the Federal Register, so that they can be reviewed and approved as described in paragraph 1, subject to the exceptions described in paragraph 1. 

    (3)  Consider postponing for 60 days from the date of this memorandum the effective date for any rules that have been published in the Federal Register, or any rules that have been issued in any manner but have not taken effect, for the purpose of reviewing any questions of fact, law, and policy that the rules may raise.  

    (4)  Following the postponement described in paragraph 3, no further action needs to be taken for those rules that raise no substantial questions of fact, law, or policy.  For those rules that raise substantial questions of fact, law, or policy, agencies should notify and take further appropriate action in consultation with the OMB Director.

    (5)  Comply in all circumstances with any applicable Executive Orders concerning regulatory management.

    Should actions be identified that were undertaken before noon on January 20, 2025, that frustrate the purpose underlying this memorandum, the administration modify or extend this memorandum, to require that department and agency heads consider taking steps to address those actions.