Amanita muscaria, also known as fly agaric or fly amanita, is a distinctively colorful and iconic mushroom species that has captivated the human imagination for centuries. It is one of the most widely recognized mushrooms, with its signature red cap with white dots making an appearance throughout pop culture from Nintendo’s Mario to the mushroom emoji on everyone’s iPhone.
In traditional cultures, these mushrooms have been used for spiritual and medicinal purposes, primarily in shamanic practices. In low doses, the mushroom has calming and sedative effects. At high doses, the mushroom has psychedelic effects capable of intense hallucinations, thanks to psychedelic compounds muscimol and ibotenic acid present in the fungus. Amanita Muscaria seems to be having a cultural renaissance of sorts, with new products from vapes to chocolates popping up on the market all across the United States.
Federal Regulation
At the federal level, Amanita muscaria mushrooms are not specifically listed as controlled substances under the Controlled Substances Act (CSA). However, the CSA does classify psychoactive substances, such as psilocybin and psilocin found in “magic mushrooms,” as Schedule I drugs, meaning they are considered to have a high potential for abuse and no accepted medical use. While amanita muscaria has so far flown under the radar at the federal level, its potential health risks and psychoactive effects may lead to eventual regulation.
While it is generally possible to manufacture, distribute, sell, and even obtain a federal trademark for amanita muscaria products, the Food and Drug Administration (FDA) retains regulation over any food, drug, or cosmetic sold in interstate commerce. Currently, amanita muscaria mushrooms supplement products fall into the Dietary Supplement Health and Education Act of 1994 (DSHEA), which regulates vitamins, minerals, herbs and other botanicals which can be sold without FDA approval. Under DSHEA, manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. Manufacturers are held responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations. The FDA has not approved amanita or its chemicals to be sold as food additives or as a drug to treat medical conditions.
Per DSHEA regulations, amanita products, like all other supplements subject to these regulations, must not make claims to treat, diagnose, cure or alleviate the effects of diseases. Instead, labels may only include statements that “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans,” and must be accompanied by a boldface statement stating “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Most importantly, own label distributors and holders of amanita muscaria products subject to DSHEA must ensure compliance with Current Good Manufacturing Practice (“cGMP”) regulations. 21 CFR part 111. Many private label companies believe that cGMP compliance is the responsibility of the manufacturer; however, own label distributors are required to maintain oversight of the manufacturer and to ensure that the manufacturer is adhering to cGMP regulations. Currently, own label distributors are responsible for verifying that their products conform to the established specifications. The FDA’s Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements is a great resource for learning about cGMP regulations. Absent compliance, if the FDA inspects your facility or warehouse, you will receive a Form 483 citing inspector observations. Failure to respond to the Form 483 may result in a warning letter being issued from the FDA.
FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market. Therefore, it is important to follow all applicable regulations, including mandatory cGMP compliance for dietary supplement products containing amanita muscaria.
State Regulation
Amanita Muscaria has been largely unregulated at the state level, including in Texas, and is not specifically addressed in controlled substance laws for the vast majority of states. In Louisiana, it is illegal to grow, sell, possess amanita muscaria under Louisiana State Act 159, unless it is used strictly decorative purposes. As awareness of amanita muscaria products continues to grow, other states may decide to schedule amanita muscaria or otherwise impose regulations.However, even though not explicitly mentioned under state laws, the legal status of amanita mushrooms can be ambiguous, and possession or distribution of may be subject to interpretation under analog laws or local ordinances.
For example, the Florida Department of Agriculture and Consumer Services put a stop to the sales of amanita by one company, based on the fact that products were sold for consumption, which drew scrutiny from the agency because the FDA has not approved amanita as a consumable food. Products may also find themselves in conflict with local laws (in addition to federal regulations) if they contain dangerous levels of heavy metals or other harmful substances, under regulations that prohibit the sale of products that contain “poisonous or deleterious” substances, for example. It is advisable to consult state-specific legislation and a skilled attorney to understand the regulations in each jurisdiction you are seeking to sell amanita products in.
Conclusion
It is important for your amanita muscaria business to ensure that it is compliant with all federal and local regulations. The regulation of these mushrooms may change over time given the possible health impacts these products, so it is important to stay apprised of any change in regulations. Additionally, labeling laws at the federal and state levels impact amanita muscaria products and you must ensure that your labels are compliant prior to commencing sale. The lawyers at Ritter Spencer Cheng PLLC have worked in the amanita muscaria and alternative substance industry for years and are experienced in navigating the complex regulatory landscape governing amanita muscaria products.
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Rae Guyse is an associate attorney with Ritter Spencer Cheng PLLC who handles matters in alternative and psychedelic medicine in addition to cannabis and hemp regulatory matters. Chelsie Spencer, a founding principal with Ritter Spencer Cheng PLLC, represents amanita muscaria companies and other companies in the alternative substance industries in all areas of compliance. The lawyers at Ritter Spencer Cheng are prepared to advise your amanita muscaria business in all facets of the industry, including regulatory and compliance issues. Contact Ritter Spencer Cheng or give us a call at 214.295.5070 for more information.
