FDA Sends Warning Letters to Seven Companies for Illegal Marketing of 7-OH Kratom Products

Why it matters

These FDA enforcement actions marked the opening salvo of federal regulatory pressure on the 7-OH market — directly preceding the agency's July 2025 recommendation that 7-OH be classified as Schedule I, and setting the stage for the state bans and congressional scrutiny that followed in 2026.

The big picture

Since 7-OH first appeared on the commercial kratom market, FDA had limited authority to act without a formal scheduling recommendation. By July 2025, the agency had gathered sufficient safety evidence to issue simultaneous warning letters to multiple companies, asserting that 7-OH products constitute illegal unapproved drugs, adulterated dietary supplements, and unsafe food additives — covering the full range of product forms (pills, powders, drink mixes) on the market.

Key findings

• On July 15, 2025, FDA issued warning letters to seven companies simultaneously for illegal marketing of products containing 7-hydroxymitragynine (7-OH)
• FDA characterizes 7-OH as a 'novel potent opioid' that has 'not been proven safe or effective for any use'
• The warning letters covered three distinct legal violations: marketing as unapproved new drugs, selling as adulterated dietary supplements, and distributing as food with an unsafe food additive
• Products targeted included over-the-counter medications, dietary supplements, and drink mixes
• Both kratom and 7-OH are prohibited from marketing as drug products, dietary supplements, or food additives under current FDA interpretation
• The seven simultaneous letters represented the largest coordinated federal enforcement action against the kratom/7-OH industry to date

What they say

FDA's warning letters stated that 7-OH is prohibited from being marketed in the U.S. as a drug product, dietary supplement, or food additive, as the agency views it as a novel potent opioid not proven safe or effective for any use.

Bottom line

FDA's simultaneous July 2025 warning letters to seven 7-OH companies were the federal government's first major coordinated enforcement action against the kratom industry — setting the legal and political foundation for the state bans and scheduling push that accelerated through 2026.