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TKO Distribution, LLC

Received an FDA warning letter over 1,500 mg delta-8 THC gummies sold online

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According to U.S. Food and Drug Administration, Apr 17, 2025 · Read the source · +1 more

Where
Florida, United States
First reported
Last checked

Summary

TKO Distribution, LLC of Hallandale Beach, Florida, received an FDA warning letter dated April 17, 2025. The FDA says it reviewed the company's website in March 2025 and found it taking orders for delta-8 THC gummies sold under the 'Trippy Smak'd' name in watermelon, pineapple and grape flavors, each listed at 1,500 mg. The agency said delta-8 THC is not approved for use in any conventional food and is not generally recognized as safe, so it considered the gummies adulterated. The letter repeats the FDA's broader concerns about delta-8 THC: no safety evaluation by the agency, adverse event reports, intoxicating effects, questions about how the compound is manufactured, and packaging that may appeal to children. The company was asked to respond within 15 working days, and the FDA said failing to correct the violations could lead to seizure or an injunction. Current status was not verified.

What the source found

  • The FDA reviewed the tkodistro[.]com website in March 2025.
  • Three 1,500 mg delta-8 THC gummy products (watermelon, pineapple and grape 'Trippy Smak'd' blends) are named.
  • The FDA considered the gummies adulterated because delta-8 THC is an unapproved food additive.
  • The letter lists concerns including adverse event reports and packaging or labeling that may appeal to children.

Products named

  • delta-8 THC gummies

Timeline

  1. FDA warning letter issued

Sources

  1. Regulator

    U.S. Food and Drug Administration · Apr 17, 2025

    TKO Distribution, LLC - 696557 - 04/17/2025
  2. Regulator

    U.S. Food and Drug Administration · Aug 25, 2025

    Warning Letters for Cannabis-Derived Products

Wording on this page follows the sources. Found an error? See the corrections process in our editorial policy.

Status notes

Current status not verified. No close-out letter was noted on the FDA letter page when checked in September 2026.

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