The Controversy Surrounding Microdosing Chocolate Bars

What is the future of psilocybin in medicine?

California-based company Diamond Shruumz was once one of the premier providers of microdosing products in the US. Providing “artisanal chocolates… designed for creative souls,” Diamond Shruumz offered chocolate bars, ice cream cones, gummies, and other sweets with trace amounts of psilocybin- the psychedelic found in magic mushrooms. 

Now, Diamond Shruumz is under intense scrutiny by the Food and Drug Administration. Over the past two months, the Centers for Disease Control and Prevention collected 74 reports of illnesses across 28 states associated with consuming Shrummz’s edibles. Reportedly, 38 hospitalizations and possibly one death are also linked to these products (this would arguably be the first confirmed death caused by psilocybin in US history).

Unsurprisingly, Diamond Shruumz’s products are being recalled. Until an investigation is complete, the FDA is urging patients to avoid these products and report retailers who still sell them. 

How long will this investigation take? Good question. 

Early suspicions suggest elevated amounts of muscimol (a psychedelic agent) in the products could have caused illness. However, tracing illnesses reported across dozens of states becomes complicated and time consuming. The FDA also has over 350 products on its recall list and has been bafflingly sluggish with its recent investigations. It could easily be years before Diamond Shruumz’s products return to shelves. 

Another vital question is how these recalls will affect recent efforts by the FDA to incorporate as a medication to address severe mental illness. 

Well before Diamond Shruumz recalls and microdosing became a social activity, the FDA began small-scale and heavily monitored clinical trials on the use of psychedelics to help treat severe mental illness. The results were so effective that the FDA granted breakthrough therapy status for two forms of treatment. About a year ago, the agency drafted an extensive outline to start an approval process to begin testing- and ultimately approving- other psychedelic treatments. 

Will recent recalls make the FDA shy away from the work it has done to make psilocybin-based treatments more accessible for those with severe mental illnesses? They easily could. 

The FDA approved four cannabis-based treatments last year. Yet it only recently began questioning the DEA’s Schedule 1 designation for marijuana, which states it has no known medicinal uses. In late 2020, the agency decided to establish an advisory board to review two Covid-19 vaccines after they already passed the guidelines it helped to establish.

Sadly, there are plenty of examples of the FDA standing in the way of pioneering medical science and novel treatments. Typically, all the agency needs is an excuse to act on its own overly cautious tendencies. Recalling microdosing edibles provides this avenue, and that is deeply concerning for the nearly five percent of Americans with chronic and severe mental illnesses. 

Raymond J. March is a Research Fellow and Director of FDAReview.org with the Independent Institute. He is also an Assistant Professor of Economics at Angelo State University where he is the Assistant Director of the Free Market Institute, Assistant Research Professor at Texas Tech University, Public Choice and Public Policy fellow with the American Institute for Economic Research, and an affiliated scholar with the Challey Institute for Global Innovation and Growth. His research has appeared in Health Economics, Southern Economic Journal, Public Choice, Research Policy, Food Policy, Journal of Institutional Economics, The Independent Review and other academic outlets. His popular articles have appeared in Fortune, Washington Examiner, National Interest, Washington Times, Sun Sentinel, The Hill, Real Clear Health, Medical News Daily. He earned his Ph.D. from Texas Tech University.
Beacon Posts by Raymond J. March | Full Biography and Publications
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