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

In July 2025, the FDA issued warning letters to seven companies selling concentrated 7-hydroxymitragynine products like gummies, tablets, and beverages. These products were promoted for pain relief, anxiety, and mood support. The enforcement wasn’t subtle. The message was clear: high-potency kratom alkaloids are under the microscope.

Shaman Botanicals, LLC

My Smoke Wholesale

Relax Relief Rejuvenate Trading, LLC dba RRR Trading or EDP Kratom

Thang Botanicals, Inc. d/b/a 7ΩHMZ, 7‑OHMZ, or 7OHMZ

Royal Diamond Imports, Inc. 

Hydroxie, LLC

7Tabz Retail, LLC

what triggered the warning letters?

Simply put, 7-OH isn’t approved for use in dietary supplements, foods, or drugs.

The companies are being called out for:

• Selling unapproved drugs
• Making therapeutic claims
• Introducing concentrated ingredients with unknown safety profiles

What Does it Mean for Other Supplement Brands?

Legal risk

Using 7-OH puts your product in the drug category. That comes with drug-level requirements and a very different regulatory pathway.

Safety concerns

7-OH is a potent opioid compound. In high concentrations, it may carry serious risks like dependency, overdose, or drug interactions.

Brand credibility

Getting flagged by the FDA means recalls, public scrutiny, and lasting reputation damage. It’s not just a slap on the wrist.

How to Reformulate Without 7-OH

If you’re formulating for stress, mood, or joint support, there are some compliant swaps that make sense. For pain support, turmeric with piperine or boswellia is your cleanest bet. For anxiety or stress, look to ashwagandha, L-theanine, or phosphatidylserine with documented claims. Always link claim to ingredient and make sure structure-function language fits the science.

Turmeric and Curcumin

• Good for joint comfort and inflammation support
• GRAS status, solid safety data
• Needs piperine or a phytosome format to work well

Ashwagandha

• Good for stress support and cortisol balance
• Human trials to back it
• Strong flavor and aroma unless masked

Full-Spectrum Kratom Leaf (with controlled mitragynine)

• Good for balanced mood and energy
• Traditional use, simpler NDI notification
• Regulatory gray area, plus batch variability

5-HTP

• Good for sleep, relaxation, and mood
• Precursor to serotonin, well studied
• Must include interaction warnings with SSRIs

L-Theanine

• Good for calm focus
• Fast acting, works well with caffeine
• Gentle effects may need higher dosing

Phosphatidylserine

• Good for cognitive support, cortisol regulation
• Strong data for memory and stress
• Must disclose source (soy or sunflower), higher cost

How to stay Compliant

1. Don’t let these warning letters scare you, rather, use them to create a strategic regulatory plan that includes simple steps to stay out of trouble.
2. Check your ingredients. Know what’s approved and what needs an NDI notification.
3. Control your claims. No disease claims. Stay in the structure-function lane. And include the FDA disclaimer when necessary.
4. Label clearly. That means common or usual ingredient names with clear amounts listed, no trademark names or raw material ratios.
5. Monitor changes. The rules shift often. Our newsletter flags issues early so you’re not caught off guard.
6. Get support. If you’re not sure where your label stands, we’ll review them with you. No panic or shame, just a list of possible compliance issues and how to fix them.

Now What?

The 7-OH crackdown is a reminder. Compliance protects your product, your customers, and your peace of mind. If you need help removing risky ingredients, finding safer alternatives, or cleaning up label claims, text or call 262-235-3733.

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Happy Labeling,

Lauren