Comment from Leigh Messinides

AnonymousOpposeIndividual
Summary: The commenter opposes the guidance's categorization of hallucinations as adverse events linked to abuse potential. They argue that this classification may be based on historical bias and suggest a broader definition of hallucinations that accounts for spiritual, artistic, and medical contexts.
p. 8 Commenting on the categorization of hallucinations as adverse events. This is noted in the document as based upon the association between hallucinations and abuse potential. I would question this as it may rest on historically biased viewpoints. In many cultures, plants and botanicals have been used traditionally for many years, and have been valued for healing properties, when utilized in a socially acknowledged spiritual tradition, supported by culturally informed rituals, guided by a healer who has the communities trust and expertise with these practices. These aspects of the use of the plant (socially agreed upon practices, for the purposes of healing, guided by a trusted expert) likely result in little abuse of these plants. When in the US and Europe in the 50's and 60's the effects of these plants were rediscovered, there were multiple settings, some very unsupervised, in which use was practiced. There was also a backlash that was not scientifically based but was based on the social norms of the time. The hallucination, as an aspect of an altered state of consciousness, was associated with some fear and perhaps prejudice. I am concerned that some of those fears and misunderstandings may be leading to labelling a hallucination as extricably linked to abuse potential. I would encourage additional exploration of the definitions of abuse potential. It would be useful to consider the broad definition of a hallucination as something that humans are capable of feeling in a range of settings not only as a sign of mental illness, and not necessarily as a risk factor for abuse (for ex., hallucinations occur in delirium that is medically caused, in dreams, during spiritual or artistic practices). For references see the work of Dr. Ronald Siegel ("Hallucinations: Behavior, Experience, and Measurement" (1984) Psychopharmacology Bulletin. 1984;20(3):22-29. Siegel, R.K.) and also Dr. Andrew Weil (The Natural Mind) which is based on field work on the use of psychedelic plants in multiple cultures. Thank you for your attention to my concerns.

View on Regulations.gov