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fda approved cbd topical analgesic

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Our powerful CBD pain cream has helped people with relief from things like:

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Having lived with the spinal cord injury and a weak low back, I have tried just about everything that has come around the bend that promises to alleviate back and neck pain. This product exceeded my expectations. Will buy again.

76 years old and sure has been a relief for my sore knees

Having lived with the spinal cord injury and a weak low back, I have tried just about everything that has come around the bend that promises to alleviate back and neck pain. This product exceeded my expectations. Will buy again.

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Although the product is not FDA-approved, inclusion in the NCD Directory and the listing's certification mark a milestone, according to Yaniv Kotler, Chief of Business Development for the Elixicure brand. "This certification requires us to vet our processes, our equipment and systems, our vendors and suppliers, and conduct batch-by-batch testing to ensure quality," Kotler said, in a press release. 1

Honest Globe’s over-the-counter (OTC) drug registration for cannabidiol (CBD)-infused pain relief products (Elixicure) has been certified by the FDA, according to the company. The action marks the first and only OTC topical drug with cannabidiol to receive certification for its listing. 1

In a prepared statement, Kotler said the product listing certification provides customers with an alternative to opioids for pain relief. 1 However, drug products containing CBD cannot legally be marketed without an FDA-approved application, according to the agency spokesperson.

Product isting certification is not an indication of the FDA's approval, but rather that the product is included in the agency's National Drug Code Directory. In an email to Pharmacy Times, an FDA spokesperson said certification is an annual requirement for drug manufacturers, and it requires that a directory listing is up-to-date and accurate. "The company certifies the records, the FDA does not," the spokesperson said. 2

The all-natural, pain relief cream is indicated to help reduce inflammation, swelling, aches, and pains. It contains CBD extract from the hemp plant that has medicinal qualities, according to a Honest Globe. 1

Currently, the only drug product containing CBD that has been approved by the FDA is Epidiolex (GW Research), an oral solution indicated to treat seizures associated with Lennox-Gastaut syndrome (LGS), and Dravet syndrome in patients aged 2 years and older. Approved by the FDA in 2018, Epidiolex is a prescription formulation of highly-purified, plant-derived CBD. 2

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.

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.

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.”

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 © 2021 Natural Medicines Inc. Commercial distribution or reproduction prohibited. Natural Medicines 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.