Kratom Vapes, Sublingual Strips, and Buccal Pouches Are Being Sold Illegally, Researchers Warn

Why it matters

Most regulatory and safety discussions around kratom assume it is swallowed. These new product forms bypass first-pass liver metabolism, potentially delivering far higher amounts of active alkaloids to the bloodstream — a risk that no clinical or pharmacokinetic data currently covers.

The big picture

The Dietary Supplement Health and Education Act of 1994 (DSHEA) explicitly requires that dietary supplements be swallowed. The FDA has not approved kratom as a dietary supplement at all, but companies have been selling it in a regulatory gray zone. The emergence of non-oral formulations — particularly vaping products, buccal pouches, and sublingual strips — represents a new frontier that existing regulations weren't designed to address. The FDA moved to schedule 7-hydroxymitragynine in 2025, but many of these products contain that same compound.

Key findings

• Researchers identified 49 kratom-derived products being sold in non-swallowed formulations: 67% vaping products, 24% sublingual strips, and 8% buccal pouches
• Most products contained 7-hydroxymitragynine (7-OH), the compound the FDA is seeking to schedule as a controlled substance
• Several products also contained mitragynine pseudoindoxyl, a novel synthetic opioid analog
• Many products had flavored, colorful, or mascot-based packaging that could appeal to children
• Most were not sold in child-resistant packaging
• No clinical, safety, or pharmacokinetic data exists for kratom products that bypass first-pass hepatic metabolism

What they say

"With no clinical, safety, or pharmacokinetic data for kratom-derived products that bypass first-pass metabolism...people should be advised to avoid these products, and regulatory action is needed to prevent their sale to consumers," the authors wrote in Public Health Reports.

Bottom line

Kratom is now being sold as vapes, sublingual strips, and buccal pouches — products that bypass liver metabolism and carry unknown risks — in direct violation of dietary supplement law, researchers warn.