Little-known Facts about Non Therapeutic Uses of Drugs and Devices | Patti Zettler

In today’s episode of DarshanTalks Podcast, host Darshan Kulkarni welcomes guest Patti Zettler to talk about the non-therapeutic uses of drugs and devices. We talk about the ongoing discussions of regulating cannabis. We also talk about how the tobacco industry is being regulated. Further, we discuss what role should the Food and Drug Administration (FDA) play when it comes to regulating non-therapeutic uses of drugs and devices. What is FDA’s definition of ‘drug?’ • As per the FDA, a drug is defined as any substance (other than food) that is used to  prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition,  affect the structure or any function of the body. • The FDA’s definition of drug is quite broad and captures substances which are not necessarily used to treat only diseases. It covers a lot of other products like antiperspirant a person uses etc. What is FDA’s role when it approves a drug? • We should note that FDA does not approve drugs. It approves the drug for specific uses only. • FDA’s definition of drug is broad. Therefore, FDA gets authority to regulate certain products that have non-therapeutic uses. This includes products for aesthetic uses like botox or dermal fillers etc. Will cannabis be removed from Schedule I of the Controlled Substances Act? Who should regulate cannabis? • Cannabis might be removed from Schedule I of the Controlled Substances Act. The government released a draft bill to discuss the proposal to legalize and regulate cannabis in July 2021. Congress might give FDA the authority to regulate cannabis if cannabis is legalized. However, there is no clarity on which agency will regulate cannabis if it is legalized. Should there be a separate a FDA Center for Cannabis Products to regulate cannabis? • It is still not clear whether cannabis needs a separate FDA Center for Cannabis Products or whether it should be regulated as any other drug by the FDA. • According to the draft bill, if cannabis is being used for a medical purpose, it can be regulated by FDA. However, if cannabis is intended for a recreational use, the Center for Cannabis Products should have authority to regulate cannabis. • The idea is that drugs used for recreational purposes should be regulated differently than the drugs used for medical purposes. It will be interesting to see how cannabis is regulated if it is legalized as it might serve as a template for other botanical recreational products including psychedelics. However, we must note that the safety profile of cannabis and psychedelics is different. #fda #fdalaw #healthcare #drugs&devices #nontherapeuticuses #darshantalks #kulkarnilawfirm