Background
Drip More LLC sought FDA authorization to market 64 candy- and fruit-flavored e-liquids for electronic nicotine delivery systems, including products sold under the Candy King brand. The Tobacco Control Act requires manufacturers of new tobacco products to show that marketing a product is appropriate for the protection of the public health.
FDA issued a marketing denial order in October 2021. It concluded that Drip More had not supplied robust, reliable evidence showing that its non-tobacco-flavored products offered adult smokers a benefit over tobacco-flavored ENDS sufficient to outweigh the established risks that flavored ENDS pose to youth. Drip More petitioned for review.
The Court’s Holding
The Ninth Circuit denied the petition. Applying its earlier decision in Lotus Vaping and the Supreme Court’s decision in FDA v. Wages & White Lion Investments, the court held that FDA acted neither arbitrarily nor capriciously by requiring comparative-efficacy evidence. Drip More provided no evidence or explanation distinguishing the youth risk of its own candy- and fruit-flavored products from the broader risk associated with flavored ENDS.
The court also held that FDA adequately explained why it did not evaluate Drip More’s marketing and sales-access restrictions after finding the required comparative evidence absent; in any event, any error was harmless. FDA properly included Drip More’s zero-nicotine options because Drip More’s own applications represented that they were tobacco products. Finally, the court held that neither the Tobacco Control Act nor the APA required notice-and-comment rulemaking before FDA applied the comparative-efficacy requirement in adjudicating Drip More’s applications.
Key Takeaways
- FDA may require flavored-ENDS applicants to provide comparative evidence of benefits to adult smokers relative to tobacco-flavored ENDS.
- Brand-specific online sales data and the absence of named youth survey respondents did not rebut FDA’s evidence of youth risks from flavored ENDS.
- FDA may develop and apply the comparative-efficacy requirement through individual application adjudications rather than rulemaking.
Why It Matters
The decision reinforces that flavored-vape manufacturers bear the burden of producing reliable comparative evidence that their products’ adult-smoking benefits outweigh youth-use risks. Marketing restrictions alone generally cannot cure the absence of that evidence.
It also confirms, in the Ninth Circuit, that FDA’s use of case-by-case adjudication to apply this requirement is authorized by the Tobacco Control Act and does not itself trigger APA notice-and-comment procedures.