FDA issues warning to companies selling unauthorized CBD products 

CBD is sometimes used in health products, such as creams or pills, and is marketed as having an array of benefits. For example, many manufacturers of these products claim they can treat conditions including anxiety, eczema, hypertension, insomnia, and more. 

But, at the moment, in the US, any product that has CBD marked as an inactive ingredient cannot be sold over the counter without the approval of the Food and Drug Administration. 

The FDA says that, since CBD has “demonstrated risks” to consumers’ health, any companies selling products that don’t have approval would be violating the Food, Drug and Cosmetic Act and would therefore have its products removed from sale. 

In the latest case, the FDA has sent warning letters to two pharmaceutical companies – Honest Globe Inc and Biolyte Laboritories LLC – after accusations that they are illegally selling over-the-counter products labeled as containing CBD, which is also known as cannabidiol. 

The products in question are “ELIXICURE ORIGINAL PAIN RELIEF with CBD” and “ELIXCURE LAVENDER PAIN RELIEF with CBD”. The FDA says that these drugs are misbranded, as they haven’t been approved by the agency to be marketed as treatments for conditions. 

So far, the FDA has only issued approval for one prescription drug that contains CBD, which is intended to be used to treat seizures associated with several conditions. 

In a statement, the FDA said it will continue to monitor any unapproved CBD products being sold in the US and will address any potential safety or efficacy concerns. 

The statement says, “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other unapproved, CBD products may have dangerous health impacts and side effects.”

“We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety.” 

“Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”


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