Week of November 25 Regulatory Intelligence Recap

Trade Press Summary:

• Former FDA Commissioner Scott Gottlieb criticized Trump's potential HHS nominee RFK Jr.

• Elon Musk and Vivek Ramaswamy are scheduled to discuss DOGE with GOP leaders on Capitol Hill on Dec. 5

• Australia introduced a national school-based anti-vaping program called OurFutures

• Massachusetts is considering passing a generational tobacco ban

• Supreme Court will hear the Triton vaping case (Wages and White Lion Investments v. FDA) on December 2, 2024

• Wild Bill's Tobacco acquired 34 Cheap Tobacco Shops

• Korea is moving to ban vapes and restrict synthetic nicotine

• IQOS marks its 10th anniversary

• UK Parliament backed the Tobacco and Vapes Bill after second reading

• EU considering resolution to ban vaping in public places

• FDA seeking fines for 18 sellers of illegal vapes

Publications Summary:

• New studies on nicotine uptake and safety of tobacco-free products

• Research on e-cigarette exposure's impact on ventilation homogeneity in young adults

• Studies on ENDS prevalence among students globally

• Research on correlates of nicotine patch adherence

• Investigation of e-cigarette and tobacco product use among university students

• Analysis of CDC data showing declining smoking rates parallel to increased vaping

• Studies on dietary habits and alcohol consumption based on smoking types

• Research on e-cigarette exposure's effects on dental caries risk

• Studies on joint smoking-vaping prevalence rates among American youth

• Investigation of demographic factors associated with perception of passive vaping risks

Clinical Trials:

• "High Impact E-cigarette Advertisement Features" - New trial studying vaping behavior interventions using different advertisement features

• "Remote Trial - Tobacco Product Standard (VLNC)" - Study examining tobacco and non-tobacco e-cigarettes with very low nicotine content

Deep Dive - Overview of FDA v Triton Supreme Court Case being heard on December 2, 2024

The case of Food and Drug Administration (FDA) v. Triton Distribution involves several critical issues concerning the regulation of Electronic Nicotine Delivery Systems (ENDS), particularly flavored e-liquids. The central legal questions revolve around the FDA's regulatory authority and its enforcement decisions regarding premarket authorization requirements for these products.

Background:

1. Tobacco Control Act (TCA): The case is grounded in the FDA's authority under the TCA to regulate tobacco products, which has been expanded to include ENDS. The FDA requires that any new tobacco product undergo premarket review and receive authorization before being marketed.

2. FDA's Premarket Tobacco Product Applications (PMTA): The FDA mandates that manufacturers of ENDS submit PMTAs demonstrating that their products meet the public health standard. This includes showing that the benefits to adult smokers outweigh the risks, particularly concerning youth access to flavored products.

3. Regulatory Changes and Litigation: Triton Distribution and other companies challenged the FDA's denial of their PMTAs, arguing that the FDA changed its regulatory requirements arbitrarily and failed to provide adequate guidance, creating uncertainty in the application process. The Fifth Circuit Court found that Triton was likely to succeed on the merits, leading to a stay of the FDA's denial orders.

4. Circuit Splits and Supreme Court Appeal: The en banc Fifth Circuit decision, along with conflicting rulings from other circuits (such as the D.C. Circuit and Seventh Circuit), created a split in how courts view the FDA's regulatory approach. This inconsistency prompted the Supreme Court to consider the case, which could resolve these discrepancies.

Key Issues:

• Scope of FDA Authority: The extent of the FDA’s power to regulate ENDS under the TCA, particularly whether its enforcement actions and sudden regulatory shifts are justified.

• Reliance Interests: Whether the FDA appropriately considered the reliance interests of manufacturers who depended on previous FDA guidance when developing their products.

• Youth Access vs. Adult Benefits: Balancing the concerns over increased youth access to flavored ENDS with the potential public health benefits for adult smokers seeking alternatives to combustible cigarettes.

Possible Outcomes:

1. Affirmation of FDA's Actions: If the Supreme Court sides with the FDA, it could reaffirm the agency's broad regulatory authority, potentially leading to stricter controls on ENDS products, especially flavored varieties.

2. Limitation of FDA's Authority: A ruling in favor of Triton could limit the FDA’s regulatory scope, force it to provide clearer guidance, and possibly reopen the market for certain flavored ENDS products.

3. Remand for Further Consideration: The Court might remand the case for further proceedings, requesting more detailed analyses on specific aspects like scientific evidence or reliance on previous guidance.

Implications for the ENDS Industry:

• Increased Regulatory Clarity: A definitive ruling could provide clearer guidelines for compliance, helping companies align their products with regulatory expectations.

• Market Shifts: Depending on the outcome, there could be significant shifts in the availability of flavored ENDS products, impacting both manufacturers and consumers.

• Future Litigation: The decision could set a precedent affecting future litigation concerning FDA's regulation of tobacco and nicotine products, influencing broader public health policy.

The Supreme Court's decision will be pivotal in shaping the future regulatory landscape for the ENDS industry and potentially influencing how public health objectives are balanced with industry innovation.Subscribe