First US over-the-counter CBD drug given FDA certification

First US over-the-counter CBD drug given FDA certification
iStock-Tinnakorn Jorruang

A CBD-infused pain relief drug has been given the first ever over-the-counter (OTC) approval in the US.

Elixicure‘s Over-The-Counter Drug Registration has been Certified by the US Food and Drug Administration (FDA) for its Elixicure CBD-infused pain relief products following a successful year-long process.

This marks the very first, and currently only, Over-The-Counter (OTC) Topical drug with cannabidiol (CBD) to be registered and certified to date.

Elixicure is an all-natural, non-addictive pain relief cream developed to help reduce inflammation, swelling, aches and pains. The product contains CBD extract, one of the main active chemical compounds naturally found in the hemp plant and contributing to the beneficial medicinal qualities of hemp. Unlike THC, hemp CBD extract does not make you feel “high”.

FDA registration

Elixicure is manufactured by Honest Globe, developers of luxury cosmetic, health and beauty products. The company’s products are made with naturally-derived ingredients, using certified industry-standard manufacturing processes.

Elixicure Chief of Business Development, Yaniv Kotler, said: “We are ecstatic to announce that Elixicure’s Registration has been Certified by the FDA.

“This is a major milestone in our commitment to quality, and offering customers healthier options for pain relief using effective natural products, as an alternative to opioids and other dangerous pharmaceuticals.

“Customer trust is important to us. Unlike so many companies that market CBD and CBD products, our business model has always been driven by quality and compliance, which is verified by third party certifiers.

“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.”

Elixicure is also certified by Banned Substance Control Group (BSCG), and thus safe for use by athletes at all competitive levels.

BSCG offers a complete suite of certification, testing and GMP compliance services to the dietary supplement and natural product communities. Through their ongoing compliance process, which includes random testing of product on the shelf, BSCG certifies the product contains no heavy metals, microbials, no THC, while certifying presence of the active ingredients and amounts CBD present.

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