cannabis
Cannabis sativa L is generally categorized, grown, manufactured, and used based on its content of tetrahydrocannabinol (THC). THC is the major chemical constituent in cannabis that produces the psychoactive effect or sense of being “high”. There are over 100 other cannabinoids present in the plant, with the most abundant of these being cannabidiol (CBD). CBD does not have psychoactive effects and is instead reported to have potential therapeutic benefits.
The regulation of cannabis is also determined by the content of THC.
- By mid-2018, 45 individual States and the District of Columbia had laws that broadly legalized cannabis in some form based on the THC content, including recreational use for adults, medical use, and other limited use;
- Federal regulation under the Agriculture Improvement Act of 2018, referred to as the Farm Bill, in December of 2018: defined “hemp” as a category of cannabis with a (delta-9) THC content of not more than 0.3% on a dry weight basis. The Farm Bill also removed hemp from the Controlled Substances Act and created a new regulatory system for the category under the United States Department of Agriculture (USDA).
The Farm Bill, did not however, change the fact that the U.S. Food and Drug Administration (FDA) has authority over food and dietary supplement products that hemp may be added to; and that doing so is currently illegal. Then FDA Commissioner, Scott Gottlieb, M.D., stated this immediately following the signing, and this position has been repeatedly reiterated by the FDA. Documentation of the FDA’s formal position about cannabis, and particularly CBD is available on the FDA.gov website.
In accordance to the Food, Drug, and Cosmetic (FD&C) Act, a drug is any product that is intended to diagnose, cure, mitigate, prevent, or treat a disease, or any product (other than food) intended to affect the structure or any function of the body. This means any product containing cannabis or cannabis-derived compound marketed with a claim of therapeutic benefit, or with any other disease claim, is considered a drug. All new drugs must be approved by the FDA through a New Drug Application (NDA). This is a long and arduous process that requires significant investments in research, time and money. A large number of Warning Letters have been issued to companies marketing cannabis products as drugs without approval.
Notwithstanding the FDA’s position, cannabis products are cultivated, processed, and marketed in the U.S. under a patchwork of State regulatory requirements that vary widely. The intent of these requirements is to ensure that products are consistently manufactured to meet pre-assigned high quality standards. The best way to ensure that this is the case is to establish a Current Good Manufacturing Practice (cGMP) quality management system (QMS).
TLC Regulatory and Laboratory Consulting can provide assistance to clients with the development, improvement, and implementation of a cGMP QMS, to ensure that cannabis products are consistently manufactured to meet quality specifications.