Enlarge / President of Multidisciplinary Association for Psychedelic Studies (MAPS) Rick Doblin speaks onstage during the 2023 Concordia Annual Summit at Sheraton New York on September 18, 2023, in New York City. (credit: Getty | John Lamparski)

There's more bad news for the company behind an experimental MDMA therapy for post-traumatic stress disorder, which the Food and Drug Administration roundly rejected earlier this month.

According to a report from The Wall Street Journal, the FDA is now expanding an investigation into clinical trials behind the experimental psychedelic therapy—even though the agency has already rejected it. Agency investigators reportedly interviewed four additional people last week, asking questions regarding whether the trials underreported side effects.

People involved in the trial have previously alleged, among other things, that ill effects, such as suicidal thoughts, went undocumented, and trial participants were discouraged from reporting them to bolster the chances of FDA approval. Overall, the MDMA trials faced crushing criticism amid the FDA's review, with outside experts and agency advisers calling out allegations of sexual misconduct at one trial site, as well as flaws in overall trial designs, multiple sources of biases, and claims that the company behind the therapy, Lykos, fostered a cult-like belief in psychedelics.

Enlarge (credit: Diamond Shruumz)

Newly released testing data of Diamond Shruumz-brand gummies purchased in 2023 identified the presence of psilocin, a hallucinogenic drug closely related to the magic-mushroom drug psilocybin that is classified as a Schedule I drug, alongside psilocybin, heroin, and LSD.

The finding comes as Diamond Shruumz's current line of gummies, chocolates, and candy cones is being recalled and are under active investigation in connection to a nationwide rash of severe illnesses, which have involved seizures, intubation, and intensive care. As of the latest update on July 15, 69 people in 28 states have been sickened after eating a Diamond Shruumz product. Sixty of the 69 sought medical care, 36 were hospitalized, and there is one potentially associated death under investigation.

The new finding, published by researchers at the University of Virginia, of psilocin in the products adds to growing concern about psychedelic mushroom candies generally. Although the candies are marketed as being legal, they have often been found to contain various undisclosed illegal drugs or gray market synthetic versions of drugs, as well as dangerous adulterants and contaminants.

Enlarge / The Birthday Cake flavored bar.

One person may have died from eating Diamond Shruumz microdosing candies, which were recalled last week amid a rash of severe illnesses involving seizures, intubation, and intensive care stays.

According to an update this week from the Food and Drug Administration, the cluster of cases continues to increase across the country. To date, 48 people across 24 states have fallen ill after eating the candies, which include chocolate bars, gummies, and candy cones that were sold online and in retail locations, such as smoke and vape shops. Of the 48 people sickened, 46 were ill enough to seek medical care, and 27 were admitted to a hospital.

For now, the death noted in the FDA's latest update is only "potentially associated" with the candies and is still under investigation. No other information is yet available.