A new court ruling is giving two makers of flavored vape liquids a second chance at getting their products approved by the Food and Drug Administration (FDA). The decision also highlights uncertainty around the vaping regulatory landscape.
Appeals Court Calls Out “Arbitrary and Capricious” FDA Reviews
On January 11th, 2023, the 5th U.S. Circuit Court of Appeals overturned a previous ruling that upheld the FDA’s denial of market applications from vape manufacturers Triton Distribution and Vapetasia.
In the new 9-5 decision, the court accused the FDA review process of being “arbitrary and capricious.” It stated that the agency asked companies for detailed marketing plans to support their applications but then failed to actually consider those plans when making determinations.
FDA Guidance Created “False Promise” of Potential Approval
Judge Andrew S. Oldham wrote in the ruling that the FDA had promised flavored vape companies a potential path to approval if they followed specific guidance:
“FDA circulated hundreds of pages of guidance documents, hosted public meetings, and posted formal presentations to its website—all with the (false) promise that a flavored-product manufacturer could, at least in theory, satisfy the instructions.”
However, after manufacturers invested significant time and money tailoring applications to FDA instructions, the agency still denied them without proper assessment.
Two Companies Get Another Shot While Broader Uncertainty Remains
The court order directly impacts Triton and Vapetasia, giving them a renewed chance for FDA authorization. But it also casts doubt around the integrity of the overall regulatory process.
The ruling suggests that politics and predetermined stances - not science or an open review of marketing plans - is deciding approval outcomes. This fuels uncertainty for other manufacturers awaiting application decisions or looking to enter the market.
While the court found the FDA’s denial of Triton and Vapetasia products to be unlawful, it did not make any determination on whether flavored vapes should ultimately be permitted or not. That decision remains in FDA hands.
Without clear approval standards consistently applied, however, confusion persists on what is expected and which products can legally go to market. More definitive guidance from the FDA is still needed industry-wide.
What’s Next for the Vaping Regulatory Landscape?
It remains unclear how the FDA will respond moving forward. Some potential next steps include:
- Reassessing the specific applications from Triton Distribution and Vapetasia under greater court scrutiny
- Clarifying approval standards and properly evaluating marketing plans for other submitted products
- Providing more transparent definitive guidance to the broader vaping industry on regulatory compliance
More communication and collaboration - not arbitrary denials - is necessary from the FDA. Only through an open cooperative process can manufacturers responsibly bring products to market that align with public health priorities.
This latest court ruling highlights deficiencies in current regulatory practices while reigniting debate on the role of flavored vaping products. One thing is for certain - more evolution lies ah