The US Food and Drug Administration (FDA) has cautioned a number of companies for what it believes to be the illegal sale of products containing CBD and violating the Federal Food, Drug, and Cosmetic Act
According to a press release issued by the FDA, 15 US companies have been sent warning letters for marketing their CBD products as dietary supplements, advertising products using therapeutic claims for humans and animals, and adding CBD to human or animal food, all of which are an apparent breach of the 2018 act.
The public health agency was also concerned that some of the products may have been aimed at children.
The move comes amid a flurry of calls on the FDA to speed up the regulation of the mass CBD market expanding rapidly across the US.
FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D, said:
“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.”
The official goes on to say many Americans wrongly believe that CBD products are regulated or approved by the FDA. She also reaffirmed that the only FDA-approved CBD product is Epidiolex, which was approved in June 2018:
“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.
“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 15 companies in receipt of these red flag letters have 15 days to respond to the FDA’s concerns, outlining how they intend to amend the marketing of their products. Failure to do so could result in legal action, such as product seizure and/or court injunctions.
More to follow.