FDA Cracks Down on Dangerous "7-OH" Products – Here's What You Need to Know

The U.S. Food and Drug Administration (FDA) is taking a stand against a new wave of potentially dangerous products hitting the market: those containing high levels of 7-hydroxymitragynine, or "7-OH."

What is 7-OH?

You might know of kratom, a plant that naturally contains small amounts of 7-OH. However, the FDA's recent actions are focused on products that have concentrated 7-OH, far beyond what's found naturally. We're talking about things like pills, gummies, drink mixes, and even "shots" being sold online, in smoke shops, gas stations, and corner stores.

Why is the FDA concerned?

Simply put, these concentrated 7-OH products are not legal and can be dangerous. Here's why:

Not Approved: 7-OH is not allowed in dietary supplements or regular foods. There are also no FDA-approved medications containing 7-OH.

Unproven Safety and Effectiveness: When you use these products, you're exposing yourself to something that hasn't been tested to see if it's safe or if it actually works for any claimed benefits.

Misleading Claims: Some companies are illegally marketing these products with unproven claims, like saying they can relieve pain or help with anxiety.

What did the FDA do?

The FDA recently sent out warning letters to seven companies that were illegally selling these concentrated 7-OH products. These companies include:

Shaman Botanicals, LLC

My Smoke Wholesale

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

Thang Botanicals, Inc. dba 7ΩHMZ, 7-OHMZ, or 7OHMZ

Royal Diamond Imports, Inc. dba Roxytabs.com

Hydroxie, LLC

7Tabz Retail, LLC

The FDA is demanding that these companies respond within 15 business days.

What does this mean for you?

The key takeaway is this: be cautious and informed. The FDA's action highlights their growing concern about these potent, unregulated products. If you see products containing 7-OH, especially in concentrated forms like pills or gummies, be aware that they are being marketed illegally and their safety is unproven. Your health and safety are important, so it's always best to stick to products that have been properly evaluated and approved.