FDA sends another round of warnings to CBD producers

Federal drug authorities have sent another round of warning letters to CBD producers about making health claims.

The recipients include CW Hemp, the Colorado Springs, Colorado, company that supplies the popular Charlotte’s Web medicine for intractable epilepsy.

The Food and Drug Administration sent four warning letters Wednesday to two Colorado companies – CW Hemp and Pueblo-based That’s Natural! Marketing & Consulting – as well as to Greenroads Health of Pembroke Pines, Florida, and Natural Alchemist of El Dorado Hills, California.

The warnings were first reported by The Denver Post.

The FDA accused the four companies of making unsubstantiated health claims about their products for treating cancer, Alzheimer’s and “other serious diseases.”

Dr. Scott Gottlieb, the FDA’s commissioner, said the CBD marketing “may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

The FDA has repeatedly reviewed cannabis as a medical treatment and rejected it.

The agency has stepped up warnings about medical marijuana and CBD in recent years. Last year the agency sent eight warning letters to CBD makers about health claims.

FDA warning letters generally result in a manufacturer changing its marketing.

Unheeded FDA warning letters can result in product seizures. It doesn’t appear that the FDA has pursued product seizures or an injunction after warning a CBD manufacturer not to make health claims.

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

3 comments on “FDA sends another round of warnings to CBD producers
  1. Rick Fague on

    This is ridiculous, there’s already substantial evidence, both clinical and anecdotal, that CBD is an effective treatment for various forms of epilepsy that traditional medications don’t work anywhere near as well on as treatments.

    While I agree that companies shouldn’t be making unsubstantiated claims about cancer cures, etc., every medical condition listed by the states that allow medical marijuana are illnesses or conditions that MMJ and/or CBD clearly helps patients with, so the FDA needs to at least recognize this fact before Congress forces them to.

  2. HCV on

    Did they not try to do the same thing with Kratom, to the point where the DEA was making it an emergency health threat and place in Schedule 1 along with Heroin, LSD, Marijuana, Hemp and assorted what not’s..
    Oh wait, I forgot that Congresswomen Nancy Polesi’s son, Paulie Jr. is a head honcho in that industry.
    Amazing how quickly everyone, FDA, DEA, NIH and the rest of the alphabet, backed off and disappeared.

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