Warning letter and cup of coffee

FDA warns drug manufacturer marketing CBD products

The July 31 warning letter reflects FDA's continuing concern over the marketing of CBD products—including supplements—to treat diseases like cancer and schizophrenia without agency drug approval.

For the fourth year in a row, FDA delivered at least one warning letter related to the sale of cannabidiol (CBD), reflecting the agency’s concerns that the cannabis-based compound features claims documenting an intent to treat diseases such as cancer and schizophrenia without necessary drug approval.

FDA also reiterated its position that CBD cannot be lawfully sold as a dietary supplement because, in part, it has been subject to substantial clinical investigations held by GW Pharmaceuticals plc.

warning letter was sent to Signature Formulations LLC on July 31, 2018, a little over a month after FDA approved Epidiolex, a CBD drug manufactured by GW Pharmaceuticals used to treat seizures associated with rare forms of epilepsy typically occurring in early childhood.

In addition to raising concerns over the marketing of CBD products, FDA cited Signature Formulations for “significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.”

Based on a review of a product label for “CBD Muscle Gel” and a website where Signature Formulations markets various CBD products, FDA determined the claims established the products are unapproved new drugs.

Among the website claims quoted by FDA:

“For hundreds of years, people have used preparations made from C. Sativa, including CBD for a variety of disorders, including gout, rheumatism, malaria, pain, and fever.”
“[P]eople have reported reduced pain or positive results from taking CBD as a dietary supplement for ailments and neurological disorders such as . . . Alzheimer’s Disease . . . cancer . . . Crohn’s disease . . . diabetes . . . fibromyalgia . . . glaucoma . . . gout . . . HIV dementia . . .. . . Parkinson’s disease . . . rheumatism . . . schizophrenia . . . stress disorders like PTSD [post-traumatic stress disorder] . . .”

Signature Formulations did not immediately respond to an emailed request for comment.

In phone interviews, two lawyers who advise clients on FDA regulations said they were unaware of a warning letter sent to a company solely because it marketed CBD.

Previous letters, New York-based attorney Marc Ullman said, targeted “products making drug claims” and were consistent with a statement from FDA commissioner Scott Gottlieb, M.D., which “indicated the agency, at this point at least, is going to exercise enforcement discretion and act against the products that are making unapproved drug claims.”

Said Justin Prochnow, a partner in Denver with Greenberg Traurig LLP: “If you’re going to dip your toe into the CBD waters, at the top of the list should be, ‘Don’t make disease claims.’”

According to FDA, all CBD products sold as supplements are noncompliant, added Ullman, of counsel to Rivkin Radler LLP.

“But they [FDA officials] are using their discretion for now and acting only against the products making illegal drug claims,” the attorney said. “The thing about enforcement discretion is they could change their mind tomorrow and they are not required to give any advance notice. They can change their mind tomorrow. They can change their mind in five years.”

The warning letter, Prochnow suggested, serves as a reminder that FDA hasn’t changed its position that CBD is not a permissible ingredient in a dietary supplement. The lawyer also pointed out FDA hasn't gone beyond warning letters in its enforcement strategy related to CBD.

"While the FDA has reiterated its position on the legality of CBD in various forums, the FDA has also emphasized that its focus is on safety issues and those companies making disease claims regarding their products," Prochnow explained in a follow-up email. "To date, the FDA has not taken any further steps to enforce its position that CBD is not a permissible ingredient."

The issuance of additional warning letters, Prochnow opined, is unlikely "to change the behavior of many companies selling products with CBD in them."

That's because he said many companies have interpreted FDA's message as so "long as a company doesn’t make express disease claims, the FDA is unlikely to take action and, even if a company is making disease claims, the only repercussion is likely to be a warning letter in the file."

Editor's note: Looking for an in-depth look at the current landscape of CBD and strategies to mature it as an industry? Join us for the CBD and Hemp Extracts: How Do We Move Forward? workshop on Wednesday, Nov. 7, at SupplySide West 2018. This workshop is underwritten by CFH, CV Sciences, Elixinol, KGK Science, Neptune Wellness Solutions and RAD Extraction & Processing.

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