The U.S. Food and Drug Administration’s (FDA or Agency) Intergovernmental Affairs (IGA) team would like to share with you the following important announcement.
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Urgent Message from the U.S. Food and Drug Administration Regarding Diamond Shruumz Brand Chocolate Bars, Cones, and Gummies Sold Nationwide
June 27, 2024
To Whom it May Concern:
The U.S. Food and Drug Administration (FDA) issued a public safety alert on June 18, 2024, after receiving multiple reports of illnesses related to Diamond Shruumz Brand Microdosing Chocolate Bars, Infused Cones, and Micro & Macro Dose Gummies. Reports indicated a variety of severe symptoms including seizures, central nervous system depression (loss of consciousness, confusion, sleepiness), agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting.
We are reaching out because a number of consumers have reported purchasing these products across the country at retail smoke/vape shops, and retail locations that sell hemp-derived products such as cannabidiol (CBD) or delta-8 tetrahydrocannabinol (delta-8 THC). We wanted to inform you so you can help spread the word and encourage consumers to report adverse events to the FDA.
This message is being sent to numerous trade groups and organizations. Please disregard if it is not relevant to your specific group.
FDA is urging all retailers to STOP selling Diamond Shruumz Brand Chocolate Bars, Cones, and Gummies products. Note: These products may appeal to children and teenagers. Please share the below safety alert to help protect consumers:
- June 25, 2024 update: Recent lab testing indicates that the Diamond Shruumz Dark Chocolate Bar contains 4-acetoxy-N,N-dimethyltryptamine (4-acetoxy-DMT, also known as O-acetylpsilocin or psilacetin), desmethoxyyangonin, dihydrokavain and kavain and the Diamond Shruumz Birthday Cake Chocolate Bar contains 4-acetoxy-N,N-dimethyltryptamine (4-acetoxy-DMT, also known as O-acetylpsilocin or psilacetin).
FDA and CDC, in collaboration with America’s Poison Centers and state and local partners, continue to investigate.
Consumers and retailers should report adverse events or side effects to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Please reach out if you require clarification on this alert or anything related.
Sincerely,
Health Fraud Branch
Office of Regulatory Affairs
U.S. Food and Drug Administration
FDAAdvisory@fda.hhs.gov