The U.S. Food and Drug Administration (FDA) is investigating a food poisoning outbreak involving seizures and other severe symptoms and has warned the public not to eat the suspected products; specifically, mushroom-based chocolates and candies that are marketed as a way to “microdose” (implying a drug-like effect), but also claim not to contain psychedelic substances.

As of June 13, 2024, FDA and the U.S. Centers for Disease Control and Prevention (CDC), in collaboration with America’s Poison Centers and state and local partners, have identified a total of 12 connected cases of illness, including ten hospitalizations, across eight states (Alabama, Arizona, Indiana, Kentucky, Missouri, Nevada, Pennsylvania, and South Carolina). Patients reported experiencing seizures, central nervous system depression (i.e., loss of consciousness, confusion, and sleepiness), agitation, abnormal heart rates, hyper- and hypotension, nausea, and vomiting. In some cases, intubation was required. The most recent onset of illness was June 9, 2024.

The products, including chocolate bars, cones, and gummies, are produced by the brand Diamond Shruumz. At this time, it is unclear what the actual composition of the mushroom-based products are, with conflicting information provided on product packaging and the Diamond Shruumz website. For example, the packaging for the Double Chocolate Chip Infused Cones reads “EXTREMELY POTENT!” and claims to cause euphoria, all thanks to a “proprietary blend of nootropic and functional mushrooms.” Meanwhile, in the “Labs” section of the Diamond Shruumz website, certificate of analyses produced by ACS Laboratory, a third party, are provided for the company’s range of products, which claim undetectable total levels of psilocybin and psilocin (both are psychedelics associated with “magic mushrooms”). The mushrooms that are listed as ingredients in Diamond Shruumz products, such as lion’s mane and ashwagandha, are well-known, legal, and are not capable of causing strong psychoactive effects.

Diamond Shruumz products can be purchased online and at locations nationwide like smoke and vape shops, gas stations, and other retailers that typically carry edible products containing hemp-derived compounds (e.g., cannabidiol [CBD] or delta-8 tetrahydrocannabinol [delta-8 THC]). The murky legal and regulatory status of recreational, possibly psychoactive edibles have been called into question with increasing frequency as state laws evolve and different substances begin to emerge on the market in the form of consumables.

Update, June 19, 2024: A total of 26 illnesses and 16 hospitalizations have been reported from 16 states (Alabama, Arizona, California, Colorado, Indiana, Kentucky, Maryland, Missouri, Montana, Nevada, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, and Tennessee). FDA has been in contact with Diamond Shruumz about a possible voluntary recall, but discussions are still ongoing. As part of its investigation, FDA and state partners have collected multiple samples of Diamond Shruumz Chocolate Bars and is conducting analyses.

Update, June 26, 2024: FDA and state partners have collected multiple samples of Diamond Shruumz-brand products for testing and analysis. Additional sample analysis is ongoing, but as of June 25, 2024, test results for two individual chocolate bars collected from a retail store have identified the presence of the following undisclosed compounds:    

• In the Diamond Shruumz Dark Chocolate Bar
  • 4-acetoxy-N,N-dimethyltryptamine (4-acetoxy-DMT, also known as O-acetylpsilocin or psilacetin)
  • desmethoxyyangonin
  • dihydrokavain
  • kavain
• In the Diamond Shruumz Birthday Cake Chocolate Bar:
  • 4-acetoxy-DMT

Considered an alternative to psilocybin, 4-acetoxy-DMT is a is a semi-synthetic psychoactive drug that is ambiguously legal as a research chemical. Desmethoxyyangonin, dihydrokavain, and kavain are derived from the psychoactive kava plant, which is legal and unregulated in the U.S. (but is regulated in some other countries).

There are now a total of 39 cases of illness and 23 hospitalizations associated with consumption of Diamond Shruumz-brand products, affecting 19 states (Alabama, Arizona, California, Colorado, Indiana, Iowa, Kentucky, Maryland, Minnesota, Missouri, Montana, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, and Tennessee).

Update, July 1, 2024: All flavors of Diamond Shruumz-brand products have been recalled by the manufacturer, Prophet Premium Blends LLC, because of the presence of Muscimol, a chemical found in mushrooms of the genus Amanita. Muscimol is the potential cause of adverse symptoms experienced by consumers.  

There are now a total of 39 illnesses and 23 hospitalizations in 20 states (Alabama, Arizona, California, Colorado, Georgia, Indiana, Iowa, Kentucky, Maryland, Minnesota, Missouri, Montana, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, and Tennessee).  

Update, July 2, 2024: A total of 48 illnesses have been reported from 24 states: Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Iowa, Kentucky, Maryland, Minnesota, Missouri, Montana, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, and Tennessee. Of the case patients, 46  have reported seeking medical care and 27 have been hospitalized. There is one potentially associated death under investigation.

Update, July 16, 2024: A total of 69 illnesses have been reported from 28 states; 60 of the 69 patients have reported seeking medical care, 36 have been hospitalized, and there is one potentially associated death under investigation. FDA is aware that recalled Diamond Shruumz-brand products are still on the shelves at several smoke/vape shops, and at retailers that sell hemp-derived products. FDA is working with the National Association of Convenience Stores and the National Smoke Shop Association to increase awareness of the recall.

Update, July 24, 2024: A total of 74 illnesses, 38 hospitalizations, and two potentially associated deaths have been reported from 28 states.

Update, July 31, 2024: FDA has published a list of store names and locations known to sell Diamond Shruumz-brand products, due to reports of retailers continuing to sell the recalled products. The list can be found here.

At present, a total of 78 illnesses have been reported from 28 states; 65 of the 78 people have reported seeking medical care, 40 have been hospitalized, and there are two potentially associated deaths under investigation. 

Update, August 8, 2024: FDA has tested 19 samples of Diamond Shruumz  chocolate bars and one raw ingredient that was reportedly used in the manufacturing of some Diamond Shruumz-brand products. A total of six of the 19 Chocolate Bars and the raw ingredient were found to contain muscimol. Muscimol does not appear in all products and cannot explain all the symptoms reported by ill patients who consumed the Diamond Shruumz-brand chocolate bars.

In addition to muscimol, FDA analyses of Diamond Shruumz-brand Chocolate Bar samples identified the presence of the following compounds:

• Acetylpsilocin (also known as 4-acetoxy-N,N-dimethyltryptamine, 4-acetoxy-DMT, O-acetylpsilocin, or psilacetin) was found in nine chocolate bar samples
• Psilocin, a Schedule I-controlled substance, was found in four chocolate bar samples
• Pregabalin, a prescription drug, was found in three chocolate bar samples
• Desmethoxyyangonin, dihydrokavain, and kavain (kavalactones found in the kava plant), were all present together in 15 chocolate bar samples.

As of August 2, 2024, a total of 113 illnesses have been reported from 28 states; 42 have been hospitalized, and there are two potentially associated deaths. FDA has also updated its list of store names and locations known to sell Diamond Shruumz-brand products.

Update, August 14, 2024: A total of 130 illnesses have been reported from 29 states; 53 have been hospitalized, and there are two potentially associated deaths. Product testing is still ongoing.

Update, August 21, 2024: Test results are available for 22 Diamond Shruumz-brand Chocolate Bars and have been summarized here. FDA has also published an updated list of store names and locations known to sell Diamond Shruumz-brand products. At present, a total of 145 illnesses have been reported from 29 states; 59 have been hospitalized, and there are two potentially associated deaths.

Update, September 5, 2024: Test results are available for 10 additional Diamond Shruumz-brand Infused Cones, summarized here. A total of 158 illnesses have been reported from 32 states, 63 people have been hospitalized, and there are two potentially associated deaths.

Update, September 19, 2024: As of September 13, a total of 169 illnesses have been reported from 33 states; 66 have been hospitalized, and there are two potentially associated deaths.

Update, October 3, 2024: As of September 27, 2024, a total of 175 illnesses have been reported from 33 states; 70 have been hospitalized, and there are three potentially associated deaths.

Update, November 15, 2024: FDA has concluding its testing of Diamond Shruumz products, summarized here. As of October 31, 2024, CDC’s investigation identified a total of 180 illnesses reported from 34 states; 73 people have been hospitalized, and there are three potentially associated deaths. The agency has transitioned from its initial response activities to post-incident response, which may include additional surveillance, as well as prevention and compliance activities.