FDA sends warning letters to CBD companies, including Colorado’s CW Hemp

The Colorado company known for the “Charlotte’s Web” cannabidiol-rich extract and three other businesses that make CBD products were put on notice by the FDA for illegally making unsubstantiated health claims.

The U.S. Food and Drug Administration on Wednesday issued warning letters to four firms: Greenroads Health, of Pembroke Pines, Fla.; Natural Alchemist, of El Dorado Hills, Calif.; That’s Natural! Marketing & Consulting, of Pueblo, Colo.; and Stanley Brothers Social Enterprises LLC, which does business as CW Hemp, of Colorado Springs, Colo.

In a statement, FDA officials said they’ve becoming increasingly concerned about the “proliferation” of products that claim to treat or cure diseases such as cancer.

The companies subject to the correspondence could not be immediately reached Wednesday by The Cannabist for comment.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” FDA Commissioner Dr. Scott Gottlieb said in the statement.

The CBD products in question have not been subject to FDA review or approval, officials said.

In the warning letters, the FDA denied the companies’ claims that the products can be classified as dietary supplements, citing the Investigational New Drug Applications submitted for CBD-containing pharmaceutical drug candidates Sativex and Epidiolex.

The FDA issued similar warning letters to CBD product makers in 2015 and 2016.

Nearly a month ago, Gottlieb indicated that additional actions against cannabis companies could be coming. Gottlieb, speaking at an Oct. 3 hearing before Congress on a separate matter, said the agency would be looking into the rules around the marijuana plant and claims made by companies that “marijuana has antitumor effects in the setting of cancer.”

The FDA has requested that the companies correct the noted violations. Failure to correct the violations promptly could trigger legal actions such as product seizures or a court-filed injunction, FDA spokesman Michael Felberbaum told The Cannabist via email.

“When a product is in violation of the Federal Food, Drug, and Cosmetic Act, the FDA considers many factors in deciding whether or not to issue warning letters,” he said. “Those factors include, among other things, agency resources and the threat to the public health.”

This is a developing story that will be updated.


Cannabist Special Report: CBD, TBD

Part I – Forbidden medicine: Caught between a doctor’s CBD advice and federal laws

Part II – How advocates are inspiring congressional action on CBD legalization

Part III – With DEA digging in its heels on “marijuana extracts,” legality of CBD oil on trial in federal courts

Part IV – CBD research is going to the dogs in quest to legitimize pet products

Part V – CBD on the international stage: WHO committee delving into science, control status of cannabis compound

Part VI – Race for CBD medication breakthrough: Is pharma firm’s boon the hemp industry’s doom?

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