FDA Issues a Warning Letter to CBD Products Retailer

On July 22, the US Food and Drug Administration (FDA) issued a warning letter to the popular cannabidol (CBD) products retailer Curaleaf, Inc. This letter comes among a growing trend toward federal and state crackdowns on CBD products.

In its letter, the FDA outlined how various Curaleaf products violated the Food, Drug and Cosmetics (FD&C) Act in terms of unapproved and misbranded human and animal drug products.

Curaleaf marketed products that claimed to help treat cancer, Alzheimer’s, anxiety, pain, and other medical issues. Because there is not substantiated evidence for these claims, marketing their products as such is considered deceptive marketing and a violation of various state and federal consumer protection laws.

In addition, the FD&C Act defines a drug as any product which is intended for the diagnosis, cure, mitigation, treatment or prevention of a disease, or intended to affect the structure or function of the body in any way. As a result, Curaleaf’s misbranded products are considered drugs and also violate the FD&C Act’s prohibition on introducing new and unapproved drugs into the interstate marketplace.

The CBD industry is growing faster than it is possible for regulatory laws to be drafted and enforced – federal and state agencies have yet to reach a consensus. As a result, existing – often temporary – guidelines are at best hazy and at worst contradictory.

The FDA’s interest in the CBD market amplifies growing concerns in an already turbulent industry. Although the passage of the Agriculture Improvement Act of 2018 legalized hemp products, the FDA has purview over its regulation and has maintained that CBD be regulated as any other substance subject to their regulation.

The good news is that the FDA held a public hearing in May to gather information on the safety and efficacy of CBD and is actively looking into the implementation of regulations and pathways to create a lawful cannabis or cannabis-derived products market.

For more information on the FDA warning letter, go to https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curaleaf-inc-579289-07222019

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