HEADLINE

According to VitalLaw on August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit vacated an FDA marketing denial order (MDO) against NicQuid LLC, ruling that the agency’s comparative-efficacy standard for electronic nicotine delivery system (ENDS) applications had become a substantive rule requiring notice-and-comment rulemaking under the Administrative Procedure Act (APA). The court did not reject FDA’s authority to compare the public health benefits and risks of flavored vapes, but held that the agency could not establish a broadly binding standard through informal adjudications. The case was remanded to FDA for further proceedings.

South Korea’s new vape regulations are reshaping the e-liquid market, raising compliance requirements for manufacturers, retailers and overseas suppliers. In an interview with 2Firsts, Korean nicotine products specialist Sam Kim discusses licensing barriers, inventory impacts, China-linked supply chains, and emerging regulatory challenges around nicotine analogues, nicotine-free products and DIY mixing. The Korean case may offer broader insights as governments worldwide adapt to rapidly evolving nicotine products.

FDA’s proposed foreign tobacco establishment registration and product listing rule remains unfinished, but Accorto told 2Firsts it reflects a shift toward structured oversight similar to medical device and pharmaceutical compliance frameworks. For Chinese and global e-cigarette suppliers, U.S. market access is moving beyond product authorization toward full-chain compliance covering manufacturing, documentation, import control, distribution, retail and marketing discipline.

As e-cigarettes, heated tobacco products and nicotine pouches expand across global markets, a central question is gaining urgency: can tobacco control rely on a universal policy model? In an interview with 2Firsts, Asian public health and addiction medicine specialist Dr. Rashidi Mohamed bin Pakri Mohamed says Western experience remains relevant, but policies must be adapted to local culture, healthcare systems, enforcement capacity, illicit markets and clinical evidence.

U.S. premium cigar culture is shifting toward education, broader choice and deeper links to craftsmanship and origin, cigar educator Mechelle Merkerson told 2Firsts. She sees boutique brands, women consumers and production-region experiences making knowledge central to cigar participation. For global brands, retailers and emerging markets such as China, education may help turn curiosity into sustained engagement.