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At the end of July 2025, the U.S. Food and Drug Administration (FDA) announced a major move against a compound called 7-hydroxymitragynine, better known as 7-OH. The agency urged that products containing concentrated 7-OH be classified as controlled substances under federal law.
Why does this matter? Because while kratom itself remains legal in most states, 7-OH is a different story. It’s a powerful byproduct of the plant and behaves in the body much like an opioid. In fact, the FDA says it can even be stronger than morphine. That’s raised alarms about addiction, misuse, and public health.
What Exactly is 7-OH?
Kratom leaves have been used for centuries in Southeast Asia as a stimulant in small doses and as a pain reliever in larger amounts. But 7-OH, one of the plant’s natural alkaloids, is far more concentrated when extracted and sold on its own. Unlike the traditional leaf, 7-OH binds tightly to opioid receptors in the brain.
Relief is part of the picture. The rest isn’t so pretty. 7-OH can slow breathing, knock someone out, damage the liver, or spark seizures. And, like other opioids, it can hook people fast.
It’s not just the compound; it's also the packaging. 7-OH shows up as gummies, colorful candies, and even ice cream cones. Gas stations sell them. Vape shops, too. Many labels don’t say what’s inside. It’s easy to see how a teen might grab one, thinking it’s just candy.
The FDA Steps In
In its July 29 release, the FDA called 7-OH “a critical step in the fight against opioid addiction.” Already, the agency has issued warning letters to companies selling 7-OH gummies, powders, and liquid shots. That was step one. The next step? Asking that 7-OH be scheduled as a Schedule I controlled substance. That would group it with heroin, LSD, and other drugs considered to have no accepted medical use.
The decision now moves to the Drug Enforcement Administration (DEA). They’re in charge here. The DEA must open a formal rulemaking process before any scheduling takes effect, including a public comment window. The FDA is pushing hard, but the outcome isn’t locked in yet.
States Aren’t Waiting Around
Even as the federal process unfolds, some states are taking matters into their own hands. Florida moved quickly this summer, issuing an emergency rule that immediately bans concentrated forms of 7-OH. Possession, sale, or distribution in the state is now illegal.
Florida officials argue the rule was needed because 7-OH products are marketed in ways that appeal to kids; think fruit flavors and cartoonish packaging. The state also launched a public awareness effort aimed at parents and schools.
Other states are likely to follow. That means we may soon see a patchwork of regulations: legal in one jurisdiction, banned in the next. For consumers and businesses trying to stay compliant, it’s going to be confusing. BillTrack50’s regulatory tracking tool can help advocates, retailers, and journalists follow these fast-moving changes.
State legislatures have not been idle, either. This map shows 65 bills in 2025 sessions which address kratom. Click a state to see the bills in that state and click ‘Detail’ to read the bill.
A large block of bills fall under consumer protection and regulatory frameworks for kratom sales—examples include Arkansas’s SB 534, which would have established a “Kratom Consumer Protection Act” but died in committee, California’s AB 1088, which adds restrictions to ensure safe sale of kratom products, and Colorado’s SB 072 (“Daniel Bregger Act”), which the governor signed to regulate age limits, labeling, and adulteration standards. Many other states introduced nearly identical acts, aiming to treat kratom like a regulated supplement rather than an illicit substance.
A smaller but notable set of bills classify or propose to classify kratom as a controlled substance:Iowa’s SF 367 designates kratom as a Schedule I drug, Illinois’s HB 3129 places it under Schedule III, and Louisiana’s SB 154 criminalizes its possession and sale outright.
A few other kratom-related proposals take hybrid or ambiguous approaches, such as Massachusetts’s H 1631, which revises state drug law references to kratom, and Rhode Island’s H 5565, which would authorize regulated distribution.
What It Means for Kratom Users
It’s not black and white. Thousands of Americans use natural kratom leaf daily for aches, nerves, or simply energy. That’s different from 7-OH extracts. Advocates warn that treating them as the same only fuels misinformation and unfair bans.
Still, public perception doesn’t always make fine distinctions. Once headlines declare that “kratom compounds are banned,” some lawmakers and the public may view all kratom products with suspicion. That worries both consumers who depend on kratom and businesses that sell it responsibly.
Healthcare providers are also being urged to talk with patients about the difference. And for those struggling with misuse, resources for getting off of 7-OH are increasingly important.
A Broader Debate on Supplements
This crackdown also raises a bigger question: how should supplements and plant-based products be regulated? Dietary supplements in the U.S. already operate under looser rules than pharmaceuticals. That leaves space for innovation, but also for risky products to slip through.
7-OH shows how quickly that can become a public health issue. Without consistent standards for testing, dosage, or packaging, products that act like opioids are being sold next to energy drinks or candy. By contrast, hemp-derived edibles like Delta-9 gummies are typically marketed under clearer compliance frameworks, showing how regulation can vary across industries.
At the same time, advocates for natural products argue that overly broad bans could cut off access to safer alternatives. The hope among many in the kratom community is that federal and state regulators will draw a clear line between natural leaf kratom and high-risk concentrates like 7-OH.
What’s Next?
The DEA now faces the decision of whether to formally schedule 7-OH as a controlled substance. Public comments will likely shape the outcome, as stakeholders from across the spectrum (public health experts, law enforcement, industry advocates, and consumers) make their voices heard.
Until then, the FDA is pushing education campaigns and continuing enforcement actions. States may pass their own laws, creating a moving target for consumers and businesses alike.
What’s certain is that 7-OH is no longer flying under the radar. For anyone following health policy, alternative medicine, or drug regulation, this is a space you may want to watch very closely.
Jamie R
Freelancer
jaimerwrites@gmail.com