FDA Flavored ENDS Premarket Guidance & HPHC Expansions
Key Questions
What is the FDA's draft guidance on flavored ENDS PMAs?
The FDA issued draft guidance on March 11, 2026, for flavored ENDS Premarket Tobacco Product Applications, with comments due by May 11, 2026. This stalls MRTPAs for products like ZYN, Velo, and on!.
What are the new HPHC additions by the FDA?
The FDA proposed 18 new harmful and potentially harmful constituents (HPHCs) for tobacco products, with comments due in May 2026. These additions burden Altria's cigarettes, ENDS, NJOY, and on! products.
How are companies working around menthol bans?
Companies use synthetic coolants in products relabeled as non-menthol to circumvent menthol bans. These products often feature similar packaging colors like blue and green.
What criticisms exist of the FDA's regulatory approach?
Critics including Makary, the White House, and RFK Jr. challenge the FDA's blockade on e-cigarettes. Youth e-cig use reached 1.63 million in 2024, with 85% illicit, and nicotine pouch PMTAs are potential for January 2025.
Is vaping defended as harm reduction?
E-cig harm reduction is defended against misleading claims, such as exaggerated health risks like ulcers or heart attacks primarily linked to nicotine. Reviews on vaping safety have been slammed as misleading.
FDA draft 3/11/26 flavored ENDS PMAs comments 5/11/26 stalls ZYN/Velo/on! MRTPAs; new HPHC 18 additions comments May26 burdens Altria cigs/ENDS/NJOY/on!; menthol ban workarounds via synthetic coolants relabeled non-menthol. Makary/White House/RFK Jr. critiques FDA blockade; youth e-cigs 1.63M '24 85% illicit, nicotine pouch PMTAs Jan2025 potential; e-cig harm reduction defended vs misleading claims.