FDA’s synthetic 7-OH crackdown is an attack on deception not against kratom

Consumers in Georgia and beyond deserve clear labeling, safe products, and regulations that distinguish natural botanicals from dangerous synthetic lookalikes.

Public health must not be compromised through clever labeling

Credit: Christine Haas Media

Credit: Christine Haas Media

Let’s be clear: synthetic 7-OH is not kratom. It is an adulterated, lab-manipulated version of a compound that exists only in trace quantities – less than 1% – in the natural kratom leaf.

But in some commercial formulations, this synthetic derivative has been found at concentrations up to 500 times the natural amount. The result is a potent, fast-acting opioid-like substance sold without FDA approval, clinical oversight, or consumer understanding.

For years, the line between natural botanicals and synthetic analogues has been blurred by unscrupulous manufacturers who knowingly sell unlabeled, high-potency substances in the form of shots, capsules, and gummies. These products are often marketed as “kratom” but are, in fact, entirely foreign to the plant’s natural chemical profile.

The FDA’s action corrects this deception. It sends a message that public health cannot be compromised by clever labeling, and that synthetic opioids – no matter how they are packaged – will not be tolerated under the guise of dietary supplements or ethnobotanicals.

All states should pass Kratom consumer protection laws

In 2024, FDA-supported clinical trials showed that up to 12 grams of natural kratom administered to human subjects caused no serious adverse effects, only mild nausea and no measurable “drug liking” compared to placebo. This data contradicts the hyperbolic narratives that equate kratom to fentanyl or methamphetamine.

But those narratives gain power when synthetic 7-OH is allowed to pollute the market. Consumers cannot make informed decisions when labels hide the truth, or when gas station shelves offer 40 times the morphine potency without warning or dosage guidance. The FDA’s recommendation to schedule synthetic 7-OH doesn’t just clarify legality – it clarifies truth.

We must now take the next step.

I urge state legislatures to align with the FDA’s position by codifying the Kratom Consumer Protection and Safety Act (KCPSA). This model legislation caps 7-OH levels at equal or less than 1% of total alkaloids and requires certificate of analysis (COA) disclosures, batch traceability and age restrictions. Several states have already adopted it; many more should follow.

I also call on manufacturers to self-audit their supply chains and eliminate synthetic enrichment from their product lines. If we want to preserve access to safe, natural kratom, we must elevate our industry standards – not wait for regulators to do it for us.

Finally, I invite academic researchers to partner with companies like ours that maintain full spectrum kratom integrity. Together, we can build data sets that advance our understanding of the plant and support informed public policy.

The FDA’s crackdown on synthetic 7-OH is not a war on kratom. It is a war on deception – one that protects consumers, defends real science, and preserves the credibility of natural products. It is a line in the sand that distinguishes pharmacological truth from commercial manipulation.

As an industry leader, I am proud to support this effort—and I hope more will join us.

Ryan Niddel is CEO of Diversified Botanics, a botanical wellness company based in Salt Lake City.