March 2020

CBD Cream Receives FDA Certification: What Patients Should Know

Elixicure is gaining attention for being the first OTC cannabidiol (CBD)-infused topical pain relief cream to receive FDA certification. Make sure patients understand what that really means.

“FDA Certification” does NOT mean the product has been evaluated or approved by the FDA for any condition. All it means is that the product is included in the agency’s National Drug Code (NDC) Directory as an OTC topical product. This listing was submitted by Honest Globe Inc, the Elixicure manufacturer – the company is responsible for the accuracy of the listing, not the FDA. And according to the FDA, giving the impression that inclusion in the NDC Directory indicates any sort of FDA approval is “misleading and constitutes misbranding.”

CBD has never been studied for chronic pain. The closest thing to pain that’s been assessed in clinical research is CBD for multiple sclerosis (MS)-related pain – the jury’s still out as to whether it can really help. And while CBD topical products in general are increasingly popular, it’s unclear to what extent, if any, CBD is absorbed when applied to the skin. It’s also important to note that Elixicure contains menthol and willow bark extract. The pain-relieving benefits it’s being marketed for could certainly be related to these ingredients.

Remind patients that the CBD market is very new. Regulations are muddy at best, and research is ongoing. Beware any promotional marketing that seems too good to be true. And keep checking our Cannabinoids and Cannabinoid-Containing Ingredient monographs – we’re updating them regularly to stay current with published research.

Related topics:

The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2023 NatMed. Commercial distribution or reproduction prohibited. NatMed is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.