DEA Schedules Widely Available Opioid Compounds as Controlled Substances

The Drug Enforcement Administration (DEA) announced that it issued a temporary order to schedule three opioid compounds as controlled substances.

“The DEA bases this action on a finding that placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in Schedule I is necessary to avoid an imminent hazard to public safety,” the rule, published in the Federal Register, noted.

From February 2025 to May 2026, mitragynine pseudoindoxyl was linked to at least 56 overdose cases, of which 48 were fatal. From February to April 2026, MGM-15 was tied to 17 overdose cases, of which 16 were fatal.

“Analysis of marketed mitragynine pseudoindoxyl products revealed misleading marketing strategies with claims that the products are ‘kratom,'” the order noted, when, in fact, “the concentrated alkaloid products often contain more than one alkaloid with opioid activity.”

In a press release, the Department of Justice (DOJ) clarified that these actions apply to “deliberately manufactured and concentrated opioid products, not traditional botanical kratom.”

The targeted products are sold under names like Kama, Hydroxie, Fruity Perks, and Happie Tabs, and can be purchased online and in gas stations, corner stores, and vape shops, in “consumer-friendly forms” including flavored chewable tablets, powders, and liquid shots, often without any age restrictions, the order said. These products are aggressively and deceptively marketed, billed as “precision-formulated,” using terms like “botanical extracts” and “mood booster.”

“The branding creates a false sense of safety for unknowing consumers who may equate the term ‘botanical’ with lower risk,” the order noted. “Furthermore, there is a paucity of data on quality control or standardized dosage available for these products, making their use especially dangerous.”

In the DOJ press release, Attorney General Todd Blanche noted that “these are potent opioids being manufactured and sold in consumer products, often under labels that obscure their true risks.”

“The Justice Department is acting before these dangerous compounds become a broader threat,” he said.

Under the Controlled Substances Act, the attorney general can temporarily categorize a product or substance as a Schedule I drug for 2 years if deemed necessary for public safety.

The DOJ noted that “preclinical evidence indicates that all three are potent mu-opioid receptor agonists and may present risks associated with other mu-opioid agonists, including dependence and respiratory depression.”

Of note, the DEA order pointed out that the manufacturers’ use of fruity flavors and chewable substances may indicate an attempt to appeal to younger consumers.

A study of 51 products containing mitragynine pseudoindoxyl sold online found that 35 had an appealing flavor such as pink lemonade, candy apple, or mango; 32 were sold in brightly colored packaging; and 39 were sold as chewable tablets, 9 were sold as liquids, two were sold as “dried ice cream cones with ice cream,” and one was sold as a chocolate bar.

The order also highlighted a case study of a 34-year-old man who advanced from powdered kratom to 7-hydroxymitragynine (7-OH) tablets and then to mitragynine pseudoindoxyl tablets, ultimately taking nine 20-mg doses a day. He unsuccessfully attempted to reduce his dose and later experienced opioid withdrawal symptoms, including hypertension, tachycardia, severe body aches, gastrointestinal distress, and chills. He required supportive management for 3 to 4 days and was later administered naltrexone depot (Vivitrol) injections.

In July 2025, the FDA raised concerns about the dangers of 7-OH, and urged the DEA to classify it as a Schedule I drug.