The Department of Health and Human Services recommended Schedule I classification if 7-hydroxymitragynine or mitragynine pseudoindoxyl makes up more than 1 percent of a product's mitragynine content.

Overview Debates Related claims Topics Sources

The Food and Drug Administration previously placed BPC-157 and more than a dozen injectable peptides on a restricted list due to potential health risks, including contamination, allergic reactions, and tumor growth.

Health and Human Services Secretary Robert F. Kennedy Jr. directed the Food and Drug Administration in 2026 to reconsider restrictions on unapproved peptides widely promoted by wellness influencers.

Food and Drug Administration staff scientists opposed easing peptide restrictions, concluding that existing data lacks sufficient evidence to establish safety or efficacy for compounds like BPC-157.

The Department of Health and Human Services and the Food and Drug Administration submitted an interim access policy for peptide compounding to the White House Office of Management and Budget on October 14, 2026.

Telehealth providers including Hims & Hers and Noom announced intentions to offer peptides if federal rules ease, addressing a market estimated by analysts at $2 billion to $3 billion.

An external Food and Drug Administration advisory panel recommended in July 2026 that the agency drop compounding restrictions on six out of seven evaluated peptides, including BPC-157.

Health Secretary Robert F. Kennedy Jr. warned that unregulated gray market peptides manufactured in China and other foreign countries remain widely available for online purchase on platforms like TikTok.

The submitted policy aims to grant compounding pharmacies temporary authorization to produce and sell previously restricted peptides while permanent federal regulations undergo formal rulemaking.

Health Secretary Robert F. Kennedy Jr. stated that domestic compounding pharmacies must be permitted to sell peptides to counteract American consumers purchasing unvetted products from foreign sources.

Under the proposed enforcement discretion policy, the Food and Drug Administration would choose not to take enforcement actions against specialty compounding pharmacies that produce specified peptides.

The U.S. Department of Justice on October 9, 2026 issued an emergency order placing 7-hydroxymitragynine (7-OH) and related synthetic kratom compounds on the Schedule I list of controlled substances.

Massachusetts issued a temporary statewide ban on all kratom products in late August 2026, while addiction clinicians expressed concern that blanket bans risk causing severe withdrawal in dependent users.

Health Secretary Robert F. Kennedy Jr. stated the recommended threshold targets concentrated synthetic extracts while avoiding sweeping natural botanical kratom into Schedule I.

The U.S. Drug Enforcement Administration previously placed three less common synthetic kratom-related compounds, including mitragynine pseudoindoxyl and MGM-15, into Schedule I without a threshold caveat.

The U.S. Drug Enforcement Administration in July 2026 proposed temporarily designating 7-hydroxymitragynine (7-OH) above a certain potency threshold as a Schedule I controlled substance.

HHS Assistant Secretary Brian Christine recommended classifying 7-hydroxymitragynine and mitragynine pseudoindoxyl as Schedule I if either compound exceeds 1 milligram per gram in solids or 1 milligram per milliliter in liquids.

Ross allies formed a group called Stop Gas Station Heroin and paid lobbying firm Checkmate Government Relations at least $750,000 to promote natural kratom as a safer option over synthetic alternatives.

Utah regulation requires kratom sales to occur only at licensed specialty tobacco stores selling registered and third-party laboratory tested products, funded through state product taxes.

An extended public comment period for the Drug Enforcement Administration's proposed 7-hydroxymitragynine scheduling rule closed on September 10, 2026 with nearly 36,000 submissions.

New York State Assemblyman Phil Steck sponsored legislation passed in June 2026 to ban synthetic kratom statewide, while acknowledging industry lobbying influenced state leaders to avoid banning natural kratom products.