CBD is “thriving” in the current regulatory environment, but is it doing so illegally?
As former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb opined last week, “the CBD craze is getting out of hand. The FDA needs to act.” Since the passage of the Farm Bill in December of 2018, there has been a marked uptick in interest in the cannabidiol (CBD) space from businesses and users alike. Congress explicitly preserved the FDA’s authority to regulate CBD-containing products to ensure that they are safe and that their claims are valid. Current federal law expressly allows for the distribution of hemp-derived CBD products that contain 0.3% tetrahydrocannabidiol (THC) or less to be sold, with certain caveats. The FDA has provided clarity that hulled hemp seed, hemp protein powder, and hemp seed oil can be legally used in foods. Other CBD products, however, are still subject to various state law regulations as well as the U.S. Food, Drug, and Cosmetic Act (FD&C Act), which requires FDA pre-market approval for drug products. Currently, the FDA treats CBD products aimed at human or animal consumption as drugs and therefore they cannot be distributed without prior approval or a rulemaking exception (more on this below). The following is a brief update on recent developments within the federal regulatory regime of CBD products.