The US FDA has warned two companies for illegally marketing unapproved products with cannabidiol. Other than Epidiolex®, there are no FDA-approved CBD goods because those items do not satisfy the criteria for being legally marketed with no approved drug application.
These CBD FDA warning letters state that cannabidiol cannot be marketed in the form of an inactive component of the OTC drugs that the federal agency has not yet approved. It is not possible because cannabidiol has pharmacological impacts on human users, to go with risks. The FDA documents also cite substandard production practices, which include failure to adhere to present GMPs.
The federal agency has earlier warned other companies that illegally sold CBD goods with claims that those items could prevent, treat, mitigate, or cure many different health conditions. For your information, making those claims is a move that breaches the FD&C Act, so the agency had to warn those companies.
As per the act, a drug is any item meant to diagnose, mitigate, cure, prevent or treat a disease, or any non-food item intended to impact the human body function or structure. The agency must have approved OTC drugs, or those must satisfy the criteria for marketing with no approved drug application as per the US federal government law. That applies to drug items with cannabidiol, whether their labels mention cannabidiol as either an inactive or active component.
The Food and Drug Administration reminded sellers that it has approved just one CBD prescription drug, Epidiolex®, for Lennox-Gastaut syndrome’s and Dravet syndrome’s seizures in humans. For the uninitiated, those are two different forms of epilepsy.
The regulator has told the companies in question to respond to the warnings in writing in 15 business days. The responses should either state how the companies would address the breaches, or offer their justification and supporting details about why they feel those goods do not violate the aforementioned law. The event of not adequately addressing the violations might lead to legal action against the companies, which possibly include the products’ seizure, injunction or both.
The FDA takes these measures to protect people’s safety through the regulation of pharmacological/medicinal products made for use in human beings or animals. Despite these occasional interventions from the FDA, there is a general industry perception that the agency does not regulate the CBD market properly.