Pharmacy Study: 49 Illegal Nonswallowed Kratom Products Identified With Child-Unsafe Packaging

Why it matters

First systematic cataloging of sublingual, buccal, and vaping kratom products that violate dietary supplement regulations; urgent regulatory concern for child safety and bioavailability changes.

The big picture

The 1994 Dietary Supplement Health and Education Act (DSHEA) explicitly restricts dietary supplements to swallowed forms to prevent bypassing first-pass liver metabolism. This study reveals kratom manufacturers are circumventing regulations by selling 49 concentrated 7-hydroxymitragynine products in high-bioavailability forms, many with child-appealing packaging.

Key findings

• 49 kratom-derived products identified in nonswallowed formulations: 24% sublingual strips, 8% buccal pouches, 67% vaping products
• 64% of vaping products contained 7-OH as the primary alkaloid; 24% also contained intoxicating hemp cannabinoids
• Only 7 of 16 sublingual/buccal products had child-resistant packaging; most vaping products were inherently not child-safe
• 86% of vaping products used fruit or mint flavors and brightly colored packaging appealing to children
• No clinical trials, safety data, or pharmacokinetic studies exist for any nonswallowed kratom formulations
• Bypassing first-pass metabolism could substantially increase bioavailability beyond the 21% of oral mitragynine

What they say

Lead researcher C. Michael White stated: "With no clinical, safety, or pharmacokinetic data for nonswallowed kratom-derived products, people should be advised to avoid them, and regulatory action is needed to prevent their sale to consumers."

Bottom line

**Nonswallowed kratom products represent illegal dietary supplement formulations with unknown safety profiles, child-safety hazards, and significantly altered pharmacokinetics requiring immediate FDA enforcement.**