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ATLRx, Inc.

Received an FDA warning letter over delta-8 THC and CBD products promoted with disease-treatment claims

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According to U.S. Food and Drug Administration, May 4, 2022 · Read the source · +1 more

Where
Georgia, United States
First reported
Last checked

Summary

ATLRx, Inc. of Alpharetta, Georgia, received an FDA warning letter dated May 4, 2022, in the agency's first round of letters on delta-8 THC. The FDA says it reviewed the company's website and social media accounts and found delta-8 THC gummies, chocolates, caramels, tinctures and softgels alongside CBD products for people and pets. According to the letter, the marketing claimed or implied benefits for conditions such as cancer, seizures, epilepsy, multiple sclerosis, PTSD, anxiety, depression and chemotherapy-related nausea. The FDA said this made the products unapproved and misbranded drugs, that foods containing delta-8 THC or CBD were adulterated, and that the pet products were unapproved animal drugs and adulterated animal food. A written response was requested within 15 working days. Whether the company changed the marketing cited in the letter was not verified.

What the source found

  • The FDA reviewed atlrx[.]com and the company's Twitter, Facebook and Instagram accounts.
  • Products cited include delta-8 THC gummies, chocolates, caramels, tinctures and soft gels, CBD gummies, capsules and topicals, and CBD pet products.
  • According to the letter, the marketing referred to cancer, seizures, epilepsy, multiple sclerosis, PTSD, anxiety, depression, insomnia and chemotherapy-induced nausea, among other conditions.
  • The FDA cited unapproved new human and animal drugs, misbranding, and adulterated human and animal food.

Products named

  • delta-8 THC gummies, chocolates and caramels
  • delta-8 THC tinctures and soft gels
  • CBD products
  • CBD pet products

Timeline

  1. FDA warning letter issued and publicly announced

Sources

  1. Regulator

    U.S. Food and Drug Administration · May 4, 2022

    ATLRx, Inc. - 618341 - 05/04/2022
  2. Regulator

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

Status notes

Current status not verified. A search result seen in September 2026 showed the company's website still publishing delta-8 content; no close-out letter was noted on the FDA letter page.

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