The FDA Is Coming After Microdosing Chocolate Bars
Diamond Shruumz chocolate bars come in various popular flavors, including dark chocolate, cookies and cream, fruity cereal, and birthday cake. Each bar costs about $25—and contains trace amounts of magic mushrooms.
Marketed as “the leading form of microdosing,” Diamon Shruumz’s website describes its bars as a “subtle, sumptuous experience,” which leads to “a more creative state of mind.” The “creative state of mind” is mostly obtained from a microdose (a dose too small to have whole-body effects) of psilocybin- a psychedelic substance with strong hallucinogenic effects.
Psilocybin is a controversial substance. Legally, the Drug Enforcement Agency considers it a Schedule 1 substance. Medically, it occupies a grey area. Peer-reviewed research in leading journals finds evidence that it can provide unique medical benefits. However, because microdosing involves such tiny amounts of treatment, assessing how it impacts patients during clinical trials is very challenging.
These and other factors should leave us all cautiously optimistic about the potential benefits of microdosing. Psilocybin certainly has side effects, but any substance with the potential to help also has the potential to harm. Balancing both, while risky, should be a decision left to the person who risks harm to get the benefit.
That’s not how the Food and Drug Administration feels.
After receiving reports of 12 illnesses– including several hospitalizations, the FDA launched an investigation and advised everyone, “Do not eat, sell, or serve any flavor of Diamond Shruumz- Brand Chocolate Bars.” The agency is also “considering the appropriate next steps” if more people become ill.
What are these “appropriate next steps?”
Diamon Shruumz’s products will most likely be recalled. The FDA also warns consumers not to use their gummies (which are not part of their illness reports). The agency also advises adults to “take extra care to avoid this product being consumed by younger people” because the products are marketed like candy. All of these suggest more heavy-handed actions will soon follow.
Should these chocolate bars be recalled? Is there a further need for concern? Are younger people at risk? Maybe. Either way, I’m skeptical the FDA will make the right call.
Last December, the agency received 65 reported accounts of illnesses linked to products that unknowingly used lead-contaminated cinnamon. As of May, the FDA had only begun figuring out how the contamination occurred. Consequently, the agency’s warnings and recalls were ineffective, as hundreds of additional illnesses were reported.
Flummoxed and overwhelmed, the FDA asked Congress to write new laws requiring private companies to test their products for lead. Taken aback, Congress retorted, “What keeps you [the FDA] from inspecting every private manufacturing facility?”
It’s a good question, and we can ask about the FDA handling microdosing chocolate bars.
Even if more oversight, regulation, and other actions are needed to help customers avoid the side effects of microdosing, history is again not on the FDA’s side to get it right.
In 2019, the FDA received authority to regulate tobacco and vaping products in hopes it would begin a “historic crackdown” to curb the so-called epidemic of teen vaping.
It certainly cracked down, but as I wrote in The Beacon,
The [vaping] market was regulated well before recent FDA efforts. In 2014, forty states had banned e-cigarette sales to minors. The FDA first passed a regulation banning e-cigarette sales to minors in 2016. But the rate of underage e-cigarette use has increased since 2016, meaning previous regulations did not affect teen vaping and might have made the issue worse. Further, teen vaping rates were comparatively lower when states determined vaping laws.
Oregon is the only state that has legalized psilocybin access, which began in 2023. While it may be too soon to tell, early signs suggest considerable with moderate risks of side effects. However, Oregon’s legalization covered standard (not micro) doses of magic mushrooms under medical supervision. Oregon’s Psilocybin Advisory Board wrote in 2021 that the effects of repeated microdosing remain unknown and “might require further study.”
Psilocybin’s benefits, side effects, and taboo history leave us with a mixed bag of answers regarding its role in public life. The FDA’s potential to address these concerns is obvious—it overreacts and underdelivers. It hardly takes a “creative state of mind” to recognize that.
