Leading Researchers Reject FDA’s Position, Find No Evidence of Harm From 7-OH in Response From Shaman Botanicals to FDA

WASHINGTON, DC, August 21, 2025 (EZ Newswire) --

Shaman Botanicals has issued a formal response to the FDA’s recent warning letter on its 7-hydroxymitragynine (7-OH) products, backed by reports from leading researchers at Johns Hopkins, Harvard, UCLA, and other institutions. The company argues that current scientific evidence supports the safety of 7-OH, directly countering FDA’s claims. Experts consulted — including those previously cited by FDA — stress that 7-OH should not be considered a public health crisis and that available data shows no evidence of overdose deaths, respiratory depression, or widespread dependence.

The experts also emphasize that 7-OH is a naturally occurring kratom-derived compound, not synthetic, and that preclinical studies commissioned by Shaman found no serio