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FDA to Hold Public Hearing on Cannabis

The Food and Drug Administration (FDA) announced that it will hold a public hearing to collect information related to the safety, production, and sale of cannabis products. The hearing is scheduled for May 31, 2019.

The goal of the hearing conducted by the FDA is to provide information to the regulatory oversight committee about the safety of cannabis in FDA regulated products. The FDA has additionally announced its plan to form a committee to assess the process for lawfully marketing dietary supplements and food products containing cannabidiol (CBD).

Safety concerns regarding cannabis have increased as the use of cannabis products has exploded. The FDA’s need to review these matters has been bolstered by studies that raise questions about cannabis safety in medical and food products. A report by the National Academies of Sciences, Engineering, and Medicine in 2017 concluded that additional research is required to determine the safety of cannabis after identifying and reviewing the current research on cannabis.

The legal status of cannabis has undergone significant changes in various states in the past few years. Cannabis is currently permitted for medical use in 33 states and Washington, D.C.  Fourteen other states maintain medical programs under state law that permit CBD products. Cannabis may also be used recreationally in 10 states and Washington, D.C. for adults over 21 years of age.

Under federal law, the Agriculture Improvement Act of 2018, otherwise known as the 2018 Farm Bill, authorizes the FDA to regulate cannabis products or cannabis-derived compounds under the Federal Food, Drug and Cosmetic Act and Section 351 of the Public Health Service Act. The FDA recently issued warning letters to companies that sell CBD products as curative or medicinal but failed to obtain the proper approvals. The FDA also issued warning letters for foods that contain CBD and CBD products that are sold as dietary supplements. According to the FDA, the sale and marketing of medicine or food products containing CBD without FDA approval violates the law and presents public safety and health concerns.

Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your chemical regulatory compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].

Ms. Grimaldi maintains a diverse environmental law practice focusing on chemical and product regulation and litigation defense. Her practice areas include Proposition 65, California's Safer Consumer Products Regulations, California's Rigid Plastic Packaging Container Act and the federal Toxic Substances Control Act. Ms. Grimaldi graduated from the University of California Hastings College of the Law magna cum laude and holds a Bachelor of Science Degree in Bacteriology from University of California, Davis. Prior to attending law school, she worked as a research assistant in laboratories at the University of California, San Francisco Cancer Research Institute and at the University of California, San Francisco School of Medicine.