Mile High Labs Submits Novel Food Application for CBD
BROOMFIELD, Colo., 20 April 2020 — Mile High Labs, the world’s leading producer of hemp derived cannabinoids, is pleased to announce the submission of a novel food application to the European Food Safety Authority (EFSA) and the UK Food Standards Agency (FSA) for its CBD isolate ingredient and CBD isolate-based finished products. This application is the culmination of ten months of work to generate the required data and compile adequate information to support the product’s quality, consistency and safety.
In February, the FSA stated that all CBD products on the UK market must have a novel food application through the validation phase of the review process before 31 March 2021. Under the requirements, any CBD food products failing to gain regulatory approval before the 31 March 2021 deadline will be taken off the shelves. Mile High Labs is one of the first companies to have filed a CBD novel food application with both the EFSA and FSA.
“This application was more complicated than usual because of the complexities associated with hemp-based products,” said Wendi Young, VP of Regulatory and Compliance, Mile High Labs. “It was necessary for us to address all of the concerns expressed by various regulatory agencies. We collaborated with experienced consultants from the UK to guarantee that our application met the expectations of both the EFSA as well as the FSA.”
The Company’s application includes information on the quality of the product, hemp biomass intake controls, stability data, manufacturing controls, labelling commitments, as well as testing requirements and specifications for both CBD isolate and finished products. Additionally, Mile High Labs is providing an assessment of the target population, a combined intake evaluation and toxicological data that supports the safe consumption of CBD.
“This is a monumental day for Mile High Labs and the CBD industry as a whole,” said Christian Hendriksen, VP of International Expansion, Mile High Labs. “Our novel food application is a key step in ensuring continued compliance for our customers, as well as our products, in the European market.”
Under Novel Food regulation, all food products containing cannabinoids derived from hemp will be affected. This includes CBD tinctures, gummies, soft gels, beverages and any products that are consumed orally. Hendriksen urges CBD brands to be conscious of whether their supplier is taking the proper steps to ensure compliance.
“We welcome dialogue with any European CBD company who would like to discuss how they can leverage our novel food application to not only keep their products on the shelves, but to demonstrate their commitment to safety and compliance,” said Hendriksen. “As the industry becomes increasingly regulated, it’s more important than ever to partner with a manufacturer that understands these requirements and how to meet them.”
ABOUT MILE HIGH LABS
Mile High Labs is the global leader in hemp-derived cannabinoid extraction and manufacturing. The company supplies bulk ingredients and private label CBD products to the world’s leading consumer brands. Headquartered in a 400,000-square-foot GMP and ISO 9001 certified production facility in Broomfield, Colorado, Mile High Labs produces cannabinoid-infused tinctures, capsules, tablets, topicals and gummies. In addition to finished products, the company is the largest compliant supplier of cannabinoid isolates, distillates and water soluble formulations.
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