The FDA and CBD products

FDA Publishes New Consumer Update Warning of CBD's Potential Harm

SILVER SPRING, Md. — Consumer interest in CBD is growing as the more products hit the market; however, the Food and Drug Administration (FDA) is warning consumers that a lot remains unknown about CBD products.

To date, the agency has only approved one CBD product — a prescription drug to treat two rare, severe forms of epilepsy — and said there is very limited available information about CBD, including about its effects on the body.

"The FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD," the FDA said in a consumer update last week.

"The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket," it added.

Among the potential risks to consumers, according to the agency, are liver damage, drug interaction, and drowsiness when taken with alcohol.

"There are many important aspects about CBD that we just don’t know," the FDA update explained, such as:

  • What happens if you take CBD daily for sustained periods of time?
  • What is the effect of CBD on the developing brain (such as children who take CBD)?
  • What are the effects of CBD on the developing fetus or breastfed newborn?
  • How does CBD interact with herbs and botanicals?
  • Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?

In addition to the latest consumer update, the agency issued warning letters to 15 companies for illegally selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act. For the list of companies receiving letters, click here.

"As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we'll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate," said FDA Principal Deputy Commissioner Amy Abernethy.

"We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD 'can't hurt.' Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD's safety — including reports of products containing contaminants, such as pesticides and heavy metals — and there are real risks that need to be considered," she added. "We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products."

The agency plans to update its progress regarding its approach to the products in the coming weeks.