The use of CBD poses several safety issues, especially with long-term use. Studies have demonstrated the possibility of liver damage, interactions with certain medications, and possible damage to the male reproductive system. The use of CBD poses safety concerns, especially with long-term use. Scientific studies show possible damage to the male reproductive system, including testicular atrophy, liver damage, and interactions with certain medications.
The FDA has not found adequate information showing how much CBD can be consumed and for how long before causing harm. This is particularly true for vulnerable populations, such as children and pregnant women. People should be aware of the potential risks associated with the use of CBD products. Therefore, the FDA has concluded that it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any food or animal feed) to which THC or CBD has been added.
Today's actions come at a time when the FDA continues to explore possible avenues to legally market several types of CBD products. The Food and Drug Administration (FDA) published warning letters to five companies for illegally selling products containing cannabidiol (CBD). In addition, the manufacturing process of unapproved CBD drugs has not been reviewed by the FDA as part of the approval processes for drugs for humans or animals. The FDA has approved Epidiolex, which contains a purified form of the drug CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year and older.
FDA experts commented on the agency's concerns regarding the addition of CBD to foods and the information they want consumers to know. The data on CBD points to real risks, and the FDA is especially concerned about the risks for children, people who are pregnant or breastfeeding, and people taking other medications. Based on the lack of scientific information that supports the safety of CBD in food, the FDA also indicates today that it cannot conclude that CBD is generally recognized as safe (GRAS) among experts qualified for use in human or animal foods. Questions remain about the effects of CBD on the liver, the male reproductive system and on pregnant women and children, according to the FDA statement.
The FDA also released a revised consumer update detailing safety issues related to CBD products more broadly. Douglas Stearn and Kristi Muldoon-Jacobs discuss FDA concerns with companies that sell products that contain CBD and that may cause accidental or excessive consumption of CBD. In the past, the FDA sent warning letters to companies that illegally sold CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. The FDA has received more and more adverse reports on products containing cannabidiol (CBD) that consumers may mistake for conventional foods and beverages.
The FDA remains concerned about the proliferation of products that claim to contain CBD and that are marketed for therapeutic or medical uses, although they have not been approved by the FDA. However, based on available evidence, the FDA has concluded that neither of these factors is the case with THC or CBD. There is very limited information on other marketed CBD products, which are likely to differ in composition from that of the FDA-approved product, and their possible adverse effects on the body have not been evaluated.