The US Supreme Court in Washington D.C.

Latest Supreme Court Decision Unlikely to Impact FDA's Treatment of Nicotine Pouches 


 

TL;DR? Key takeaways

 

    1. New Supreme Court Decision on Chevron: The Supreme Court changed the Chevron rule that used to let government agencies have the final say in court. This change won’t really affect how the FDA handles nicotine pouches.

    2. FDA Regulation Stays the Same: Even with these changes in the Chevron rule, the FDA will most likely continue to regulate nicotine pouches as it has been.

    3. FDA’s Denial of Applications: The FDA’s decisions to reject nicotine pouch products are based on the evidence provided, not on legal interpretations. Therefore the overturning of the Chevron rule doesn’t change this. 

    4. Nicotine Pouches vs. Vapes: Nicotine pouches have fewer young users compared to vapes (1.5% vs. 7.1%). This might make it harder for the FDA to reject flavored nicotine pouch applications.

    5. Important Upcoming Court Case: Keep an eye on the upcoming Supreme Court case, FDA v. Wages and White Lion Investments, which could affect how the FDA handles applications for nicotine pouches. This case is about whether the FDA followed the rules when rejecting some products. 

 

For context: On June 28, 2024, the US Supreme Court overturned the longstanding Chevron doctrine, a precedent that once gave federal agencies a significant advantage when defending their positions in court. The ruling in Loper Bright Enterprises v. Raimondo (Loper Bright) is unlikely to affect the US Food & Drug Administration’s (FDA’s) future approach to nicotine pouch Pre-Market Tobacco Applications (PMTAs) or applicants’ challenges to marketing denial orders (MDOs) thereof.

Not sure what a PMTA is? Check out some backstory here in our US vs EU ZYN Guide.

 

Elimination of 'Chevron Deference'

The Court’s decision in Loper Bright overturned the 1984 case of Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which created the doctrine of “Chevron deference.” Under this doctrine, courts would defer to a federal agency’s interpretation of an ambiguous statute if the agency was charged with administering the statute in question and its interpretation was reasonable. 
  
For the last 40 years, Chevron emboldened agencies to take sweeping regulatory actions, secure in the expectation that their legal interpretations would receive deference in court if they were “reasonable.” And a “reasonable” interpretation under Chevron was easy to muster. As Chief Justice Roberts explained in the Loper Bright opinion, “[u]nder Chevron, executive officials can replace a ‘reasonable’ interpretation with another at any time, all without any change in the law itself. The result: Affected individuals ‘can never be sure of their legal rights and duties.’”  
  
Without Chevron, the Chief Justice explained, “federal courts will do exactly as this Court has since 2016 [the last time the Court applied Chevron], exactly as it did before the mid-1980s, and exactly as it had done since the founding: resolve cases and controversies without any systemic bias in the government’s favor.” 

Impact on Nicotine Pouch PMTAs

The overruling of Chevron could affect the overall outlook of federal courts on agency interpretations generally, possibly making courts hesitant to defer to agencies as a general practice. This being said, the Loper Bright decision is ultimately unlikely affect FDA’s future approach to regulating nicotine pouches under the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA). Unlike manufacturers of electronic nicotine delivery systems (ENDS), manufacturers of nicotine pouches are largely still awaiting FDA’s action on their PMTAs. If FDA begins issuing MDOs for nicotine pouches as it did for many ENDS, the Loper Bright case likely will not affect applicants’ options for challenging such MDOs. 
  
MDOs for nicotine pouches—like the MDOs for ENDS—would likely be based on FDA’s review of applicants’ submitted evidence. In issuing MDOs for ENDS, FDA did not rely on the now-overruled Chevron doctrine to claim interpretative leeway regarding an ambiguous statute.  
  
Instead, the MDOs generally reflect the FDA’s weighing of the evidence submitted rather than its legal interpretation. The ongoing litigation regarding FDA’s MDOs for flavored ENDS centers on the agency’s failure to consider all relevant evidence, not the agency’s statutory interpretation. Additionally, the ENDS PMTA applicants argue that FDA imposed surprise, after-the-fact requirements in a manner that violated the Administrative Procedure Act (APA). The avenues to challenge potential MDOs issued for nicotine pouches would be similar—and those challenges would not implicate Chevron.   
  
Of course, there are significant contextual differences between the ENDS PMTAs and those for nicotine pouches.  One big difference is youth use.  According to FDA’s latest data, youth use of nicotine pouches is only at 1.5%, compared to a 7.1% rate of ENDS use by youth.  This should make it harder for FDA to reject flavored nicotine pouch PMTAs for the same reasons it has rejected so many flavored ENDS applications.   

Stay Tuned on the Supreme Court

In the upcoming term, the Supreme Court will hear a case with potentially important implications for nicotine pouch PMTAs, FDA v. Wages and White Lion Investments, L.L.C. This case is an appeal of an earlier decision in which a lower court found that FDA violated the APA when it issued an MDO based on unannounced requirements, contrary to its own guidance. Although this case pertains to PMTAs for flavored ENDS, the ruling will likely speak to FDA’s treatment of PMTAs generally. Those interested in the developing regulatory landscape for nicotine pouches—particularly flavored nicotine pouches—should watch this case closely.