FDA Announces Plans to Schedule 7-OH as a Controlled Substance a Week After Kratom Industry Allegedly Staged 7-OH Protests

On Tuesday, July 29, officials including Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and Food and Drug Administration (FDA) Commissioner Marty Makary announced via a press conference the FDA’s intent to recommend to the Drug Enforcement Administration (DEA) that 7-hydroxymitragynine (7-OH) be scheduled as a controlled substance.

Several times during the press conference, Makary ensured kratom leaf will not be part of that recommendation. “We’re not targeting the kratom leaf or ground-up kratom,” he said, adding that 7-OH-dominant products will be delineated from the trace amounts that occur in natural leaf kratom. Only 7-OH that occurs “above a concentration threshold” will be recommended for scheduling, he said. Makary also stated that 7-OH and plain leaf kratom are “night and day in terms of the public health risk.”

With any scheduling category, 7-OH products will be stricken from their current marketplace. 7-OH consumers will likely be subject to criminalization for possession of substances containing 7-OH above the yet-to-be-determined threshold. Certain classifications will make it more difficult for researchers to study 7-OH, as red tape for studying illicit substances has been notoriously difficult to navigate.

“The announcement lacks science, disregards how 7-OH is used in the real world, and threatens thousands of American consumers who rely on 7-OH to improve their daily lives,” said the Holistic Alternative Recovery Trust (HART) in a release. HART’s national policy director, Jeff Smith, said, “No evidence was presented at today’s press conference. Not a single study. Not one data point specific to 7-OH. The entire event focused on addiction in general, not this compound. If 7-OH posed the kind of urgent danger that would justify emergency action, evidence would have been presented. It was not. When a reporter asked if the government could attribute even a single death to 7-OH, no official was able to do so.”

Along with the press conference, the FDA released a report on 7-OH. It concludes that 7-OH is a “public health threat”. “Based on demonstrated pharmacology,” write FDA researchers, “repeated or prolonged use of 7-OH would lead to tolerance, physical dependence, and potentially to opioid addiction— typical of mu opioid agonist drugs of abuse.”

Organizations that have been against kratom prohibition have come out in favor of the prohibition of this alkaloid. The American Kratom Association (AKA) applauded the decision to prohibit 7-OH. The AKA’s Mac Haddow posted on X:

Secretary Robert F. Kennedy and FDA Commissioner Dr. Marty Makary took the bold and needed step today to protect consumers from chemically manipulated 7-OH products that pose an eminent threat to consumers. Specifically, HHS and FDA will schedule 7-OH as an “illicit substance.” Commissioner Makary said 7-OH is an opioid. Consumers have been duped by 7-OH marketing. It is time for that to stop.

Reactions from the kratom community have been mixed. Dr. Michelle Ross, a neuroscientist who advocates for drug policy reform, posted on LinkedIn that the move is “a disaster for chronic pain patients — and a direct assault on science.” “7-OH interacts with opioid receptors without the same overdose risk — it has a ‘ceiling effect’ that limits respiratory depression,” she wrote. “A ban would criminalize patients, block vital research, and hand the market to dangerous synthetic lookalikes,” she added.

Dr. Chris McCurdy, who said he wants to see only leaf kratom on the market, attended the press conference and said in a LinkedIn post that it was a “Big day to have a front row seat where our collaborative team’s research set some of the foundation to protect our nations public health!”

As of this writing, the top two posts on the most popular kratom Reddit page. r/kratom, are titled “It’s time to stop supporting the AKA” and “Support the AKA“. User incisivator alleges that the AKA has “decided to work against adults freely choosing what is best for their own healthcare, chronic pain, addiction, or mental health treatment…They want people to go prison because they have decided this kratom-derived product is better for them than the AKA members’ products.” The accusation that AKA is protecting its member companies has been echoed throughout social media. But others are loyal to the AKA as the organization that’s done the most work to protect kratom’s legality. User anteater_x, author of “Support the AKA”, says that while they believe “synthetics should not be schedule 1”, that “It is not the time for infighting, but for compromise and a united front, we all know it would be much worse to lose everything than just the newest, strongest variant.”

HART Alleges Kratom Industry Hired Protestors to Demonstrate Against 7-OH

In a bizarre aside, according to a HART press release, “Big Kratom” employed paid protestors by way of a Craigslist ad to demonstrate in against 7-OH in Las Vegas on the first day of the CHAMPS Trade Show, where a debate about 7OH took place.

A now-deleted Craigslist ad (see attached image) offered $100–$150 per day to “peaceful protesters” for a one-day gig on July 23, calling for 75–100 “reliable individuals” to stage a “high-visibility protest action.” The actors had matching t-shirts, but, according to people who engaged them they did not have the slightest idea of what they were protesting.

The paid actors had signs featuring a QR code (see also attached image) leading to a petition organized by John Ramsay, who works for MIT45: which is a founding member of the American Kratom Association (AKA) and a part of the Global Kratom Coalition (GKC). Both AKA and GKC are Big Kratom lobbying groups that have been attacking 7-OH in the media and with legislators across the country.

Mac Haddow of the AKA denied being involved in staging protests.

Along with recklessly selling untested metabolites and strong alkaloid extracts, goofy tactics like this seem to suggest a horribly thought-out long-term strategy for a sustainable industry. Despite short-term gains with the passage of Kratom Consumer Protection Acts and kratom legalization in Rhode Island, state bans passed this year in Louisiana and Connecticut are suggesting that the kratom movement is taking one step forward and two steps back, and possibly sewing the seeds of its own destruction while pretending its most popular products are not habit-forming. Occasionally, some kratom advocates have expressed exasperation in private that they have no choice but to follow questionable leaders with nefarious records that belie a destructive level of greed.

While scheduling 7-OH may work out as intended – showing that the kratom industry is responsibly eliminating bad products and the bad actors who sell them – already the New York Times ran a headline referring to 7-OH as “kratom products”, suggesting that journalists, politicians, and the general public are woefully uneducated about this issue. While Commissioner Makary clearly stated the FDA is not coming after leaf kratom, many advocates fear banning 7-OH will be a slippery slope, that, without careful, intelligent advocacy and responsible industry leaders, the kratom community will zoom down with a running start.

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