Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Noramco Presents Comments And Answers Questions At FDA Hearing On Cannabidiol


News provided by

Noramco

05 Jun, 2019, 12:00 GMT

Share this article

Share toX

Share this article

Share toX

Support for emerging market includes positions on rigorous science, consumer safety and monitoring of intermediates and end-products

WILMINGTON, Delaware, June 5, 2019 /PRNewswire/ -- 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.

  1. 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)
  2. CBD producers (extraction or synthesis) should control THC to ≤ 0.1% (Noramco committed to 0.10% in DMF 33223)
  3. FDA adopt ICH guidelines for control of related substances, setting specifications and for monitoring product stability for CBD producers (extraction or synthesis)
  4. 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 not suggesting 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.

About Noramco

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

Media Contact
Resource Advantage
Barbara A. Mecchi-Knoll
bmecchi@resourceadvantage.com

Related Links

http://www.noramco.com

Modal title

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.