7-OH Remains Widely Available 8 Months After FDA Scheduling Recommendation as DEA Review Stalls

Why it matters

Despite FDA Commissioner warnings in July 2025 that 7-OH "may be the fourth wave of the opioid epidemic," the DEA's scheduling process remains incomplete as of March 2026, leaving concentrated 7-OH products freely available at gas stations, vape shops, and convenience stores nationwide while states implement patchwork bans. A case study details a man's experience with 7-OH withdrawal being harder than quitting IV heroin.

The big picture

In July 2025, FDA Commissioner Dr. Marty Makary and HHS Deputy Secretary Jim O'Neill jointly announced that 7-OH should be classified as Schedule I, calling it a potential "fourth wave of the opioid epidemic" and "recipe for public health disaster." Researchers at Johns Hopkins found 7-OH binds to mu-opioid receptors with 14-22 times the affinity of morphine. Yet 9 months later, the DEA's rulemaking remains incomplete due to required public comment periods. Meanwhile, 7-OH is sold openly in gas stations as gummies, pills, shots, and candy at potencies up to 98% pure alkaloid—compared to <1% in natural leaf. Poison control calls related to kratom/7-OH surged to 1,800 by early August 2025 in Washington State alone. Confirmed fatal overdoses linked to concentrated 7-OH have occurred in Los Angeles County. Critically, 7-OH withdrawal can last up to 3 months, longer and more difficult than traditional opioid withdrawal.

Key findings

• 7-OH remains unscheduled at federal level despite July 2025 FDA recommendation for Schedule I; 7-OH binds to mu-opioid receptors with 14-22x affinity of morphine (Johns Hopkins); commercial 7-OH products reach up to 98% concentration vs. <1% in natural leaf; available in gas stations, vape shops, convenience stores as gummies, pills, shots, candy without age restriction or potency verification; Texas poison center received 192 kratom/7-OH calls by August 2025; Washington State poison center reported 1,800 kratom exposures by early August 2025, with ~1/3 involving 7-OH extracts (vs. 330-1,400 annually 2015-2024); 7-OH withdrawal significantly longer than traditional opioid withdrawal (potentially 3 months); three otherwise healthy adults aged 18-40 died from concentrated 7-OH in Los Angeles County; case study: man who survived two decades of prescription pill and heroin addiction found 7-OH triggered full opioid effect with withdrawal harder than IV heroin cessation.

What they say

One addiction survivor who used 7-OH briefly described the experience: "It was harder to get off of than shooting IV heroin. Much harder." FDA Commissioner Makary stated: "7-OH binds to the mu receptor, which means scientifically, by definition, it is an opioid. And yet it is sold in vape stores, smoke shops, convenience stores and gas stations that are popping up all over the United States." HHS Deputy Secretary O'Neill called the situation "a recipe for public health disaster."

Bottom line

**While federal agencies warn 7-OH poses "the next wave of the opioid epidemic," the DEA's stalled rulemaking leaves highly potent, unregulated 7-OH products freely available at gas stations nationwide, creating a growing harm while federal action stalls.**