The Food & Drug Administration (FDA) has issued a fresh warning to five companies that have been marketing CBD products with unauthorized claims. One of the companies has also been warned about selling illegal delta-8-THC products. This is not the first time that the FDA has issued warning letters for unapproved CBD sales.
Cannabidiol (CBD) is one of the numerous bioactive molecules in hemp and cannabis, and probably the most popular. It is non-intoxicating and hence does not make the user “ high”, but it is known for its calming and anti-anxiety effects. CBD is currently legal throughout the US, as long as it is derived from hemp and has very low THC counts. However, CBD is not approved by the FDA as either a food supplement or a drug. Making claims about CBD’s ability to cure, treat, or prevent disease is therefore illegal.
The companies have been accused of claiming that their CBD products can “cure, mitigate, treat or prevent various diseases.” The companies warned include 11-11-11 Brands, Naturally Infused LLC, Newhere Inc and Infusionz LLC. CBD American Shaman has been warned about packaging their products in a way that is appealing to children. The companies have been given fifteen days to provide explanations to the FDA.
In 2018, the FDA approved the first-ever CBD based drug (Epidiolex) as a treatment for severe childhood seizures. However, cannabis remains as a schedule 1 substance under federal law and hence its therapeutic potential remains unacknowledged.