CBD water is a type of beverage infused with cannabidiol (CBD), a non-psychoactive compound found in cannabis plants. The Food and Drug Administration (FDA) is responsible for regulating the safety and efficacy of food and drugs in the United States. However, when it comes to CBD water, the FDA has not explicitly approved or regulated its use.
To understand why CBD water is not FDA approved, we need to delve into the regulatory framework surrounding CBD products. In 2018, the Farm Bill was passed, legalizing the cultivation and sale of hemp-derived CBD products containing less than 0.3% THC. This bill removed hemp from the list of controlled substances, paving the way for CBD products to enter the market.
While the Farm Bill opened up opportunities for CBD products, it did not automatically grant them FDA approval. The FDA has approved only one CBD-based drug called Epidiolex, which is used to treat certain types of seizures associated with epilepsy. This approval was based on rigorous clinical trials and safety assessments.
The FDA has taken the position that CBD cannot be marketed as a dietary supplement or added to food products because it was first investigated as a drug. Under the Federal Food, Drug, and Cosmetic Act, substances that have been approved as drugs cannot be added to food or dietary supplements, unless they were in use prior to the drug approval or are “generally recognized as safe” (GRAS).
The FDA has not recognized CBD as GRAS for use in human or animal food. The agency has raised concerns about the potential risks associated with CBD, such as liver damage, drug interactions, and misleading marketing claims. They have also emphasized the need for further research to better understand the long-term effects of CBD use.
As a result of these regulations and FDA’s stance, CBD water and other CBD-infused food and beverages remain in a regulatory gray area. Some companies have still marketed and sold CBD water, claiming its potential health benefits, but they do so at their own risk without FDA approval.
It is worth noting that state regulations may vary, and some states have implemented their own rules regarding CBD products, including CBD water. However, from a federal standpoint, CBD water is not FDA approved.
CBD water is not FDA approved. The FDA has not recognized CBD as GRAS for use in human or animal food, and the agency prohibits adding approved drugs, like CBD, to food or dietary supplements in interstate commerce. The lack of FDA approval means that the safety and efficacy of CBD water have not been evaluated by the agency.