After a year-long process, California-based cannabidiol (CBD) product company Elixicure has announced that its over-the-counter (OTC) drug registration for CBD-Infused Pain Relief products has been certified by the United States Food and Drug Administration (FDA).
According to Elixicure, it is the first, and currently the only company in the U.S. to register for and receive OTC certification for a topical CBD product listing.
The certification is a verification by the company of the product’s listing in the National Drug Code Directory and not an indication of FDA approval.
Elixicure is an all-natural CBD-infused pain-relief cream that is non-addictive and designed to reduce swelling, inflammation, aches, and pains.
Luxury cosmetic, health, and beauty product company Honest Globe is the manufacturer of Elixicure products, which are made with naturally-derived ingredients and industry-standard manufacturing processes.
According to Elixicure Chief of Business Development Yaniv Kotler, Elixicure and Honest Globe prioritized compliance with the strictest Good Manufacturing Practice (GMP) standards laid out by the FDA.
Under GMP guidelines, minimum operating and testing requirements must be met to ensure that manufacturers are producing products that are safe to use, and consistency is maintained from batch to batch.
“We are ecstatic to announce that Elixicure’s Registration has been Certified by the FDA,” says 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 certified by the Banned Substance Control Group (BSCG), which offers testing and GMP compliance services for dietary supplement and natural product industries in addition to a complete set of certifications.
Certification from BSCG means that Elixicure products meet quality specifications, are free of contamination, and are safe for athletes of all levels of competition to use.
Kotler says that customer trust is important to the people at Elixicure, and unlike many other companies that sell CBD products, quality and compliance have always been at the core of its business model.
Kotler says that the Elixicure’s certification requires vetting of the company’s processes, equipment, systems, vendors, as well as batch-to-batch testing to ensure that quality is maintained.
Elixicure products are certified to be free of THC, as well as microbial contamination, heavy metals, and other impurities.
Through repeated inspection and ongoing testing, Elixicure’s product and manufacturing facility have consistently met the requirements for GMP certification.
NOTE: This article was edited to further clarify that the certification is not an endorsement or approval of any product.