FDA

The Agriculture Improvement Act of 2018, commonly referred to as the “Farm Bill,” effectively legalized the cultivation and sale of hemp at the federal level. The Farm Bill removed hemp, defined as cannabis (Cannabis sativa L.) and its derivatives with extremely low concentrations of the psychoactive compound THC (less than 0.3%), from the definition of marijuana under the Controlled Substances Act. It effectively made hemp containing less than 0.3% THC legal in all 50 states. However, the Farm Bill explicitly preserved the U.S. Food and Drug Administration’s (FDA) authority over hemp and other low-THC cannabis products, including CBD-containing cosmetics. Therefore, such products must comply with all applicable FDA requirements and standards.

Unlike other categories regulated under the Food, Drug, and Cosmetics Act (FD&C Act) and the Modernization of Cosmetics Regulation Act (MoCRA), cosmetics generally do not require premarket approval from FDA. Therefore, CBD-containing cosmetics may be sold without prior FDA approval, as long as the safety of CBD, like any other cosmetic ingredient, can be substantiated by the manufacturer. 

The FDA said that many unanswered questions and data gaps exist regarding CBD toxicity, and some of the available data raise serious concerns about potential harm from CBD. One area of concern is the potential cumulative exposure to CBD when people access it through a wide array of consumer products. For example, what are the implications of consuming CBD-infused food and supplements while also using CBD-infused skin cream and other CBD-based products on the same day? How much CBD, if any, is absorbed from the skin cream? Furthermore, what are the consequences of using these products daily over a week or a month? 

Alongside safety risks and unproven claims, the quality of numerous CBD products may also be questioned. The FDA is concerned that insufficient processing controls and practices may subject consumers to additional risks. FDA encourages consumers to think carefully before exposing themselves, their family or their pets to any product, especially CBD products, which may have potential risks, unknown quality and unproven benefits.

In the absence of federal action, some states have implemented additional regulatory requirements prohibiting the sale of CBD-containing products not otherwise authorized at the federal level. Approaches vary significantly across states.

CBD, regardless of its source, is not listed in the Schedules of the 1961 Single Convention on Narcotic Drugs. However, the use of CBD in cosmetics products under the general provisions of the Cosmetics Regulation of the European Union is not prohibited, if prepared as an extract, tincture or resin of Cannabis.