Thousands of Public Comments Support Keeping 7-OH Legal
/By Pat Anson
Over 3,000 additional comments were posted in the Federal Register during the 15-day extension of the public comment period on the Trump administration’s plans to set a legal threshold for the kratom alkaloid 7-OH (7-hydroxymitragynine).
Almost all of the additional comments oppose the DEA’s plan to set a limit of 1 mg per 7-OH tablet, gummy or shot, saying there is no evidence to support it. Left unchanged, the DEA order would classify 7-OH products containing more than 1 mg (or more than 0.05% of a product by weight or volume) as illegal Schedule One controlled substances.
Pain sufferers who use 7-OH – often because they can’t get opioid pain medication – say 1 mg is too low of a dose and is far below what they are already taking.
“I currently take 15 mg twice a day every 4-6 hours as needed for my pain,” said April Sikes, a licensed practical nurse. “Please do not take another tool away from people who are simply trying to function, work, and live with dignity.”
“I am a 31-year-old adult with severe chronic pain and a complex medical history who has used 7-OH for years. My typical amount is approximately 25 to 50 milligrams at a time, generally every 6 to 8 hours as needed,” wrote Veronika Livinska.
“I currently use approximately 20 mg of 7-OH per day,” said Amy Cullen, who lives with chronic joint pain, anxiety and depression. “7-OH has personally been beneficial to me because it helps me manage my pain and makes it easier for me to function.”
“I am a responsible member of the 7oh community and found 20mg 3 times a day is an appropriate dosage in maintaining my flare ups of lupus,” wrote Terry Matilda. “Please consider a reasonable threshold for 7oh rather than completely taking the one thing that keeps many pain patients functional.”
‘Little Information’ on 7-OH Safety
Exactly what is a “reasonable threshold” is difficult to determine for 7-OH. The alkaloid occurs naturally in whole leaf kratom – in trace amounts – and many people find those natural levels effective for pain relief, as well as other conditions such as anxiety, depression and withdrawal symptoms.
But manufacturers have developed ways to concentrate 7-OH – turning a mild pain reliever into a potent analgesic that has “opioid-like” side effects, such as withdrawal and addiction.
Several states and dozens of cities and counties have already banned 7-OH, relying mainly on anecdotal stories about a growing number of calls to poison control centers and reports of overdoses and hospitalizations involving 7-OH.
Despite the growing alarm about 7-OH and its characterization as “an imminent threat to public health,” there are no clinical trials or toxicological studies showing that 7-OH is toxic or unsafe to humans. Conversely, no studies have been conducted to establish what a “safe” 7-OH threshold is.
In a 2025 scientific assessment of 7-OH, the FDA acknowledged there is “little information” available on the safety profile of 7-OH. The few studies that exist were done on animals – rodents primarily – which found that 7-OH is a potent analgesic 4 to 6 times stronger than morphine.
But, when taken orally, researchers say 7-OH did not cause the same respiration depression in animals that causes overdoses in humans.
“If researchers couldn’t kill mice with oral 7OH, how would humans be dying from ingesting the same substance?” asked Joseph Garnella in his public comment. “Millions of 7OH doses have been consumed with zero overdose deaths. The only related deaths had multiple drugs and alcohol in their system.”
“No concentration or quantity of 7-OH has been identified as an imminent hazard,” said Chris O’Donoghue, who like other 7-OH users supports some degree of regulation. “I support age limits and lab testing. Licensed retail so you can get it out of gas stations.”
“It most certainly must be regulated in some way. It absolutely must not be allowed to be sold at gas stations and head-shops," said William Baldwin. “A license (akin to a tobacco or liquor license) should be required by any business involved selling it in the US, and quality control measures amongst the suppliers should be rather stringent.”
“I know people that would be alive today if they had a drug as safe as 7-OH to use, instead of things like heroin or fentanyl. If we ban this compound we are guaranteed to see a massive rise of fentanyl deaths or other dangerous black-market opioids,” said Collin Lomelino.
“I understand that we should probably regulate 7-OH, but the outright banning of this compound is going to leave hundreds of thousands of people no option but to turn to the street, which is filled with highly deadly drugs that will kill so many people.”
In all, nearly 36-thousand public comments were made in the Federal Register since the Department of Health and Human Services (HHS) made its initial request for information on a 7-OH threshold in early July.
It’s unclear what, if any, impact all those comments will have on the DEA, which reports to U.S. Attorney General Todd Blanche – not HHS.
DEA could amend its scheduling threshold to allow for more than 1 mg. Or it could implement the scheduling order at any time as it is currently written – making the manufacture, sale and possession of 7-OH illegal – and turning law-abiding 7-OH consumers into felons overnight.
