The Food and Drug Administration is investigating a death that may be associated with mushroom-infused chocolates or sweets from the brand Diamond Shruumz.
As of Monday, 48 illnesses and 27 hospitalizations had been linked to the candies, according to the agency.
Prophet Premium Blends of Santa Ana, California, which manufactures the products, initiated a nationwide recall for Diamond Shruumz-brand chocolate bars, cones and gummies on Thursday. The recall was announced Friday in a statement published on the FDA website.
The FDA, along with the Centers for Disease Control and Prevention, poison control centers and local agencies, has launched an investigation into the illnesses.
People who became ill after having eaten the mushroom-infused sweets have reported a variety of severe symptoms, including seizures, loss of consciousness, confusion, sleepiness, agitation, abnormal heart rates, high or low blood pressure, nausea and vomiting, the FDA said.
Prophet Premium Blends did not immediately offer comment in response to an inquiry.
In a statement on the Diamond Shruumz website, the company said that “it is crucial that all of our consumers refrain from ingesting this product while we, alongside the FDA, continue our investigation as to what is the cause of the serious adverse effects.”
Twenty-four states have reported cases of illness linked to the products, though the scale of the outbreak may be even larger. Poison control centers nationwide have received 82 reports of exposure to the candies so far.
According to Prophet Premium Blends, the recalled products contain muscimol, a chemical found in some mushrooms, that “could be a potential cause of symptoms consistent with those observed in persons who became ill.”
The company said it received two complaints on May 27 about consumers who became ill after having consumed an entire chocolate bar. After a review, the company said, it found “higher than normal amounts of muscicol” in the products.
According to research published last month in the American Journal of Preventive Medicine, muscimol can significantly alter mood, perception, cognition and behavior, and it can be fatal at high enough doses. The chemical slows down the central nervous system, similar to alcohol or benzodiazepines, and its effects may include dizziness, nausea, tiredness, a feeling of weightlessness, visual and auditory hypersensitivity, space distortion, unawareness of time and hallucinations.
The review noted that products containing muscimol, such as gummies and vapes, have become more available in the past few years. It calls for “a new regulatory approach” for such products.
Customers who bought Diamond Shruumz chocolates or candies should immediately discard them, officials warned, as the items “may appeal to children and teenagers.”
Retailers were told to stop selling or distributing the products and to “hold the product in a secure location until additional instructions can be provided on how to return or safely dispose of the product.”
Diamond Shruumz bills its products as meant for microdosing, though the company’s website says they do not contain psychedelic substances. (The candies do not appear to contain psilocybin.)
Several toxicology experts have told NBC News that mushrooms listed as ingredients, such as lion’s mane or ashwagandha, do not produce the effects the company touts, like relaxation or euphoria.
The FDA has not approved muscimol as a food additive, and the chemical is largely unregulated. It is not a federally controlled substance.
The CDC warned health care providers last month that products containing psychoactive ingredients are becoming more available in the U.S. overall and are often sold as gummy candies or chocolate. Such products may contain undisclosed or potentially harmful ingredients that are not approved for use in food, the agency said.
CORRECTION (July 2, 2024, 9:55 a.m. ET): A previous version of this article misstated the origin of the recall. The manufacturer voluntarily recalled the products in an announcement published by the FDA; the FDA did not issue the recall.