Noramco, a leading manufacturer of cannabidiol (CBD) and related compounds presented testimony and answered questions at the Food and Drug Administration’s (FDA) Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, Part 15 Public Hearing, that took place on Friday, May 31, 2019 in Silver Spring, Maryland. Speaking on behalf of Noramco, Bill Grubb, Chief Innovation Officer and Executive Vice President of Business Development, outlined the company’s positions on a wide range of topics based on its 40 years of experience including over a decade of science and market leadership in cannabinoids production. These included the need to produce CBD in food supplements and drugs in compliance with cGMP requirements, a limit of THC content of <0.1% regardless of source, that the FDA adopt ICH guidelines for control of related substances and that the FDA work with the United States Pharmacopeia (USP) to formulate manufacturing standards for pharmaceutical grade and dietary supplement grade CBD ingredients.
According to Jim Mish, President and CEO of Noramco, the FDA hearing was an important and appropriate step toward addressing safety, scientific and efficacy concerns surrounding the fast-emerging CBD market. “On behalf of Noramco, I would like to thank acting Commissioner Ned Sharpless and the entire FDA for holding this hearing and for giving people the opportunity to weigh in on what we feel are the needs for this growing market and its potential to improve human health. Last Friday’s hearing brought together a diverse group of intelligent and passionate people to create a dialogue that can contribute to the health of potentially billions of people as we move forward into a world where CBD and related compounds become a part of our lives. For our part, we at Noramco were honored to have had the opportunity to be included in this dialogue,” he said. “One of the most noticeable things we saw during the day of hearings is that – regardless of whether people were talking about farm-based, biosynthetic or pharmaceutical approaches to creating CBD compounds – there is general agreement on the need for rigorous science, purity, safety and effective regulatory oversight if we are going to realize the potential of CBD,” he added. Mish went on to point out that Noramco currently has the capability to produce high purity CBD compounds that can form the starting point for clinical and commercial activities in every market sector – from pharmaceutical to food and beverage, nutraceuticals and personal care.
Patients and consumers deserve CBD produced in accordance with cGMP
Noramco’s Bill Grubb focused on four main points in his statements before the FDA panel – all of which suggested a CBD market driven by transparency, quality science, product integrity and consumer trust.
- Production of CBD for Food, Supplements or Drugs be required to be produced in compliance with cGMP requirements (21 CFR Part 117, 111, 210 or 211 as appropriate) for human or animal applications, regardless of CBD origin (extraction or synthesis), intended use (food, supplement, or drug), and irrespective of delivery mechanism (oral, topical or inhalation)
- CBD producers (extraction or synthesis) should control THC to ≤ 0.1% (Noramco committed to 0.10% in DMF 33223)
- FDA adopt ICH guidelines for control of related substances, setting specifications and for monitoring product stability for CBD producers (extraction or synthesis)
- FDA work with United States Pharmacopeia (USP) to formulate manufacturing standards for pharmaceutical grade and dietary supplement grade CBD ingredients
As part of his statement, Grubb pointed to the existence of impure or mislabeled CBD in the marketplace. “A 2017 JAMA study of 84 CBD extract products showed that almost 70% were mislabeled, which triggered FDA warning letters to 14 businesses. An average THC content of 0.4% was observed – which is enough to produce intoxication or impairment, especially among children. These examples highlight the need for federal oversight of manufacturing, testing and distribution of CBD products,” he said. Grubb went on to point out that despite the need for oversight, Noramco was notsuggesting that all CBD produced or consumed should be subject to full drug regulations.
Both Jim Mish and Bill Grubb invited scientists and companies working in the CBD field to contact the company and to engage in a dialogue. “For many people, CBD is a hot new thing. At Noramco, we’ve been thinking about and working with CBD compounds for decades. We have some of the brightest and most experienced people in the field working with us. And we’re committed to seeing this market grow. If people are interested, we’d love to talk,” said Mish.
Noramco is the world’s largest producer of high-quality synthetic cannabinoid active pharmaceutical ingredients for the pharmaceutical and healthcare industry. Headquartered in Wilmington, Delaware, the company offers cannabinoids and other controlled substance APIs for use in abuse deterrence, attention deficit disorder, pain management, and addiction management. Established in 1979, Noramco maintains production and R&D facilities in Wilmington, Delaware, Athens, Georgia and Neuhausen, Switzerland. Additional information about Noramco can be obtained by visiting Noramco’s web site at www.Noramco.com
Barbara A. Mecchi-Knoll