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The First Over-the-counter Topics CBD Drug Has Been Given FDA Approval

Published: Jan 30, 2020   
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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, announced Elixicure chief of business development Yaniv Kotler.

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 cannabidiol (CBD) extract, one of the main active chemical compounds naturally found in the hemp plant and contributing to the beneficial medicinal qualities of hemp.

“We are ecstatic to announce that Elixicure's Registration has been Certified by the FDA,” said Kotler. “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.”

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.

Kotler said Elixicure and Honest Globe set out to comply with the most rigid standards set by the FDA, which established good manufacturing practices (GMPs) for the food, beverage, drug, cosmetic, medical device and supplement industries. GMP guidelines outline and identify minimum operating and testing requirements and standards that manufacturers must meet to ensure products are consistent in quality from batch to batch and safe for human use or consumption.

GMPs are ensured through effective quality management systems. As part of this process, Elixicure consulted and adopted quality standards and procedures set by NSF International, which sets international public health standards and certification programs that help protect the world's food, water, consumer products, and the environment. Through repeated inspection and ongoing testing, Elixicure's product and manufacturing facility have consistently proven to meet all necessary requirements for maintaining product and facility GMP certifications.

“Customer trust is important to us,” Kotler said. “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 3rd 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. With a foundation in anti-doping and sport drug testing, BSCG offers the Olympic standard in analytical testing to finished product brands, ingredient suppliers, and manufacturing facilities.

This article has been republished from material provided by Honest Globe. Note: material may have been edited for length and content. For further information, please contact the cited source.


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