In March 2021, the FDA issued warning notices to two companies in the US that sell CBD products. Those warning letters draw attention to the federal agency’s continuous vigilance on CBD product marketing. Has your CBD product not been through rigorous testing, plus the FDA’s review of it and approval? If it has not, selling it with certain health claims about disease treatment/prevention or body structure/function would result in the FD&C Act’s violation on your part. Consequently, your brand may get one of those FDA warning documents.
In the two FDA CBD warning letters 2021, the agency underlines that any CBD product cannot be marketed with no approval of the new drug application, whether or not the cannabidiol is an active component. That means no manufacturer can work cannabidiol into a product, buyable with no prescription, albeit that producer lists it as an inert/inactive component.
The US FDA clarified that the goods in the letters portrayed cannabidiol as active despite the ingredient labels categorizing it otherwise. Do you sell any cannabidiol product with inactive components being listed in a way that causes any impression of worth that exceeds its true functional part in its formulation? If yes, then its labeling might be deemed misleading.
The federal agency has usually been less keen on wellness language like rejuvenating. That is why industry players tend to carefully create marketing content to include comparable language and concept options. Anyhow, the latest letters from the FDA illustrate that combining the following details is unacceptable.
- The claim associated with a without-prescription product
- Wellness language associated with the cannabidiol that is included in that item
The letters suggest that the US agency plans on challenging attempts to sneak cannabidiol through its regulatory openings in the form of an inactive element. As per the agency, cannabidiol in that form has neither been proven to be safe nor been regarded as suitable. Why? Because it lacks known functional roles, like, say, to make product delivery better or act as an organic preservative. Further, judging by the FDA’s language, inactive components can have no pharmacological effects. Referring to Epidiolex®, the FDA said that there are known pharmacological CBD activities with shown risks.
The latest CBD FDA warning serves as a reminder that this agency keeps monitoring the cannabidiol market. Through it, the agency has essentially told the industry that it considers widening CBD enforcement efforts.