FDA Cracks Down on 7-Hydroxymitragynine: What Supplement Brands Must Know

In July 2025, the FDA issued seven warning letters to companies marketing products containing 7-hydroxymitragynine (7-OH), a powerful alkaloid found in trace amounts in the kratom plant. These products, including gummies, tablets, drink mixes, and shots, were sold online and in retail outlets such as gas stations, smoke shops, and convenience stores. The FDA’s message was unequivocal: 7-OH is not a lawful dietary ingredient, and its inclusion in supplements or foods violates federal law.

For supplement manufacturers, this enforcement action is a wake-up call. It underscores the importance of ingredient vetting, safety substantiation, and compliance with the Dietary Supplement Health and Education Act (DSHEA). This blog breaks down the FDA’s position on 7-OH, the legal implications, and what companies must do to avoid enforcement.

What Is 7-Hydroxymitragynine?

7-OH is a minor alkaloid found in Mitragyna speciosa, commonly known as kratom. While kratom has been used traditionally in Southeast Asia for its stimulant and analgesic properties, 7-OH is significantly more potent, with opioid-like effects that raise serious safety concerns.

In natural kratom leaf, 7-OH occurs in concentrations below 0.01%. However, many products on the U.S. market contain concentrated or synthetic forms of 7-OH, with doses ranging from 5 mg to 30 mg per serving, levels that far exceed what is found in nature.

Why Is 7-OH Unlawful in Supplements?

Under DSHEA, a dietary supplement must contain ingredients that are either:

• Present in the food supply in a non-chemically altered form

• Marketed in the U.S. before October 15, 1994 (grandfathered)

• Submitted to FDA via a New Dietary Ingredient (NDI) notification with safety data

7-OH fails all three tests:

• It is not present in the food supply in a conventional form.

• There is no evidence it was marketed before 1994.

• No NDI notification has been submitted or accepted for 7-OH.

As a result, the FDA considers 7-OH a new dietary ingredient for which there is inadequate safety data, rendering any supplement containing it adulterated under Section 402(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act.

FDA’s Enforcement Actions

The FDA’s July 2025 warning letters targeted seven companies, including:

• Shaman Botanicals LLC

• My Smoke Wholesale

• Relax Relief Rejuvenate Trading LLC (EDP Kratom)

• Thang Botanicals Inc. (7OHMZ)

• Royal Diamond Imports Inc.

• Hydroxie LLC

• 7Tabz Retail LLC

These companies were cited for:

• Marketing adulterated dietary supplements

• Selling unapproved new drugs with therapeutic claims (e.g., pain relief, anxiety management)

• Introducing unsafe food additives into conventional foods

• Failing to submit NDI notifications or demonstrate safety

The FDA warned that consumers using these products “are exposing themselves to products that have not been proven safe or effective for any use”.

Safety Concerns and Public Health Risks

The FDA’s concerns about 7-OH are grounded in both scientific literature and adverse event reports. Documented risks include:

• Liver and cardiovascular toxicity

• Seizures and respiratory depression

• Addiction and withdrawal symptoms

• Death in extreme cases

Because 7-OH is more potent than mitragynine (the primary alkaloid in kratom), concentrated products pose a significantly higher risk — especially when consumed in formats appealing to children, such as flavored gummies.

Legal Implications for Supplement Brands

If your product contains 7-OH — either as a declared ingredient or as part of a kratom extract — you may be in violation of multiple federal statutes:

• Adulterated dietary supplement (Section 402(f))

• Unsafe food additive (Section 409)

• Unapproved new drug (Section 505)

• Misbranding due to unsubstantiated claims (Section 403)

These violations can result in:

• Warning letters

• Product seizures

• Injunctions

• Criminal liability in severe cases

What You Should Do

As a regulatory attorney, I advise supplement companies to take the following steps immediately:

1. Audit your product portfolio: Identify any products containing kratom, kratom extracts, or 7-OH.

2. Review ingredient sourcing: Ensure suppliers are not providing concentrated or synthetic 7-OH.

3. Evaluate marketing claims: Remove any references to pain relief, anxiety reduction, or opioid alternatives unless supported by FDA-approved drug status.

4. Submit NDI notifications for novel ingredients, but only if safety data is robust and defensible.

5. Prepare for FDA scrutiny: If you’ve received a warning letter, respond within 15 business days with corrective actions and documentation.

Final Thoughts

The FDA’s crackdown on 7-hydroxymitragynine is part of a broader effort to protect consumers from unregulated, high-risk substances masquerading as dietary supplements. For responsible brands, this is an opportunity to reinforce trust, transparency, and safety.

At Bustos Law Group, we help supplement companies navigate complex regulatory terrain, from ingredient vetting and NDI submissions to enforcement response and risk mitigation. If you’re unsure whether your product is compliant, we’re here to help you assess, adapt, and move forward with confidence.