DEA’s 7-OH Order Amended, Ban to Take Effect Nov. 13
/By Pat Anson
The U.S. Drug Enforcement has amended its scheduling order for 7-hydroxymitragynine (7-OH), placing further restrictions on the manufacture, sale and possession of concentrated forms of the kratom alkaloid.
Under the amended order, to be published next week in the Federal Register, 7-OH products and all other concentrated kratom alkaloids will be classified as illegal Schedule One controlled substances. The order will take effect November 13, with no opportunity for public comment or further changes.
Kratom leaves have been used for centuries in Southeast Asia as a natural stimulant and pain reliever. Their active ingredients – 7-OH and other alkaloids – occur naturally in kratom in trace amounts. But in recent years manufacturers have found ways to concentrate the alkaloids in new products – essentially turning a mild pain reliever into a potent product with opioid-like effects.
7-OH and other kratom derivatives were recently involved in the deaths of two college students, and there is concern about their potential to cause addiction and overdoses. Three U.S. Senators this week called for all kratom related products to be scheduled or banned – including leaf kratom.
That created further pressure on the DEA and Justice Department to act.
“Our nation’s children and communities deserve protection from harmful substances like 7-OH and other powerful synthetic drugs. The actions taken by the Department of Justice today reflect our commitment to keeping Americans safe and holding drug traffickers accountable,” Attorney General Todd Blanche said in a DOJ press release.
Left unsaid in the press release is that the DEA’s amended order is largely in response to a lawsuit by the American Kratom Association (AKA), which represents natural leaf kratom vendors. The AKA supported the scheduling of 7-OH, but wanted a “carveout” for mitragynine pseudoindoxyl, a kratom alkaloid that the DEA banned just two months ago.
The AKA filed a lawsuit against the DEA in July, asking a federal judge to intervene and get the DEA to amend its original orders banning sales of 7-OH and mitragynine pseudoindoxyl.
“They actually did two things that were important. One is they established a carveout for mitragynine pseudoindoxyl, and they changed the standard for 7-OH to a much more restrictive standard, which we fully support because it captures more of the potential synthetic products that they could tinker with,” explained Mac Haddow, an AKA lobbyist and spokesman.
Under the new order, the ban on mitragynine pseudoindoxyl is being lifted to keep it from potentially interfering with sales of leaf kratom. Only trace amounts of 7-OH and mitragynine pseudoindoxyl will be legally allowed in tablets, gummies and liquid shots (1 mg per serving). A 100 to 1 ratio of mitragynine to the other alkaloids – what occurs in nature – must also be preserved.
AKA Lawsuit Withdrawn
The new DEA order amounts to a major legal victory for the AKA, and comes at the expense of 7-OH manufacturers and vendors, whose products were taking a substantial amount of business away from leaf kratom vendors.
“We made an agreement to dismiss our lawsuit, but it's conditioned on their publishing under the schedule that they submitted to the court,” said Haddow. “The thresholds draw the line the AKA has been asking for, targeting chemically manipulated opioid products while protecting natural kratom leaf that may contain only incidental trace amounts of these compounds.”
Not surprisingly, 7-OH manufacturers and consumers were disappointed by the DEA’s new order, but held out hope that changes could be made before November 13. Tens of thousands of Americans use 7-OH to relieve their pain, anxiety and fatigue, allowing them to work, care for family, and stay away from more dangerous substances.
“This is still a Notice of Intent, not a scheduling order,” the 7-HOPE Alliance said in a note to advocates. “It gives us more time to fight, more time to negotiate with the administration, more time that consumers can safely access products they rely on.
“The revised proposal would still threaten access to 7-OH products. We do not agree with how these new thresholds are being set. Once again, this approach favors certain product categories over others without fully considering the consumers who depend on them.”
While leaf kratom remains legal under federal law, it has been banned by dozens of states, cities and counties. The AKA hopes those local jurisdictions follow the DEA’s example, by taking leaf kratom out of their wholesale bans on 7-OH and other kratom derivatives.
