Extension of Comment Period Buys 7-OH Advocates More Time
/By Pat Anson
Pain patients and advocacy groups who support the continued sale of a concentrated kratom alkaloid have apparently been successful in getting the Trump administration to postpone plans to classify 7-OH (7-hydroxymitragynine) as an illegal Schedule One controlled substance.
In a notice soon to be published in the Federal Register, the Office of the Assistant Secretary for Health (OASH) at Health and Human Services (HHS) said it was extending for 15 days the public comment period on the threshold of 7-OH that can be allowed in commercial products.
7-OH occurs naturally in whole leaf kratom, but manufacturers have developed ways to concentrate 7-OH into tablets, gummies, and shots that have “opioid-like” effects and are potent pain relievers.
The earlier 30-day public comment period by HHS ended on July 31 with over 32,000 comments received. Once published, the new HHS notice will reopen and extend the comment period through September 10.
“Public comments submitted to this docket will be provided by the Secretary for Health and Human Services for consideration by the Attorney General. We are taking this action in response to a request for an extension to allow interested persons additional time to provide comments and input,” wrote Brian Christine, Assistant Secretary for Health at HHS.
“Note that OASH is not soliciting comments on any permanent scheduling decision, the general safety or utility of kratom-derived products, or other policy questions outside the scope of the threshold determination for temporary scheduling.”
In July, the Drug Enforcement Administration published plans to limit the legal threshold of 7-OH to no more than 0.05% of a product by weight or volume, the equivalent of about 1 mg 7-OH per tablet. Virtually all 7-OH products on the market have much higher dosages.
Although the extension of the HHS public comment period is not binding on the DEA, it seems likely the agency will also postpone any action on its plan to classify concentrated 7-OH products as Schedule One controlled substances, the same category as heroin and LSD.
The DEA reports to Attorney General Todd Blanche, who has the ultimate authority to decide how drugs are scheduled under the Controlled Substances Act (CSA).
“They (DEA) could have a 7-OH ban right now. I think it more likely, given that the Assistant Secretary for Health has requested the 15-day extension, that they’ll give it time to be evaluated. So you may see at the earliest, in my opinion, a month before we’ll see the 7-OH schedule come out,” said Mac Haddow, a lobbyist and spokesman for the American Kratom Association (AKA), which supports the scheduling of rival 7-OH products.
The extension of the public comment period was sought by 7-HOPE Alliance and other 7-OH advocacy groups, who said they needed more time to respond to the “highly technical and largely unprecedented scientific and regulatory questions” being asked by HHS about an appropriate threshold for 7-OH.
“Preparing a meaningful response requires consultation with scientific advisors, review of the available literature, coordination with affected stakeholders, and careful analysis of complex pharmacological and analytical issues. These are precisely the types of substantive, evidence-based comments the Agency seeks, yet they cannot reasonably be assembled within the current timeframe.” wrote Jackie Subeck, Executive Director of 7-HOPE Alliance, in a letter to OASH.
“A modest 60-day extension would significantly improve both the quality and breadth of the administrative record before the Agency. It would allow consumers to have their voices heard while providing organizations, researchers, and technical experts sufficient time to develop thoughtful, science-based submissions.”
Doctors for Drug Policy Reform made a similar request for an extension, and asked that OASH “coordinate with the Drug Enforcement Administration (DEA) to defer implementation of any temporary scheduling action.”
While 7-OH advocates didn’t get the lengthy extension they asked for, they appear to have accomplished their primary goal, which was to postpone the nationwide banning of 7-OH products.
Anticipating that DEA action was imminent, many vendors have already stopped selling 7-OH products, in many cases slashing their prices to dispose of 7-OH inventory before a ban took effect. Several states and dozens of cities and counties have already banned the sale of 7-OH products in their jurisdictions.
