FDA Warning Letters Over CBD

Three FDA warning letters issued in the past week have been concerning products containing CBD. Looks like they are starting enforcement activities in this area.

All three of the warning letters (to PotNetwork Holdings, Advanced Spine and Pain, and Nutra Pure) cited similar violations.

Drug Claims

Claims that the product would treat or mitigate various diseases, aches, and pains, including:

• slowing Alzheimers
• anti-emetic
• anti-convulsive
• neuro-psychiatric disorders
• skin conditions
• psoriasis
• inflammation
• fibromyalgia
• PTSD
• OCD
• Parkinson’s
• cancer pain
• Inflammatory Bowel Disease
• substance abuse; opioid abuse

And that’s just a sampling of the various claims made by the three companies!

Of course, CBD has not been approved as a treatment for any of these things, and so making the claims causes the product to be an unapproved new drug.

Dietary Supplements / Food

Several of these companies also stated or implied that their CBD products were food or dietary supplements, or that they could be ingested. They were cited on the basis that CBD oil is already approved as the active ingredient in the approved drug product Epidiolex. It it illegal to include an approved active drug ingredient in a food or dietary supplement.

Unsubstantiated Advertising Claims

Unlike most warning letters, these letters included a section on potential violations of the FTC laws, which say that it is unlawful to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence… substantiating that the claims are true at the time they are made.

Recipients of the warning letters were told that the FTC was concerned that some of the efficacy claims made for the products may not be adequately substantiated, and they should contact the FTC to address those concerns (within 15 days).

This joint action by the FTC and FDA is an interesting addition to the warning letters. They seem to be coming at it with both barrels, saying not only that the producers can’t CLAIM the efficacy, but also that they don’t have PROOF of the efficacy.

Cosmetic Claims

None of these letters made any reference to any cosmetic claims that may have been made about the products.