• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Blogs
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Blogs
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    Healthy Snacking: Matching Lifestyle with Nutrition

    Vitamins & Minerals: Traditions in Preventive Health

    Fiber Revisited: Closing the Gap

    Green Power for Future Generations

    2019 International Buyers' Guide
    Blogs & Guest Articles
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Live From Shows
    Top News
    Tilray Buys Hemp-Foods Company Manitoba Harvest for $318 Million

    Kemin Receives GRAS Approval for Oil-Soluble Green Tea Extract

    Health Drives Surge in Alternative, Plant-Based Product Options

    PepsiCo to Acquire CytoSport from Hormel Foods

    Study Shows Collagen Peptides Aid Runners in Injury Recovery
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    Tilray Buys Hemp-Foods Company Manitoba Harvest for $318 Million

    Kemin Receives GRAS Approval for Oil-Soluble Green Tea Extract

    Health Drives Surge in Alternative, Plant-Based Product Options

    PepsiCo to Acquire CytoSport from Hormel Foods

    Study Shows Collagen Peptides Aid Runners in Injury Recovery
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    Tilray Buys Hemp-Foods Company Manitoba Harvest for $318 Million

    Kemin Receives GRAS Approval for Oil-Soluble Green Tea Extract

    Health Drives Surge in Alternative, Plant-Based Product Options

    PepsiCo to Acquire CytoSport from Hormel Foods

    Study Shows Collagen Peptides Aid Runners in Injury Recovery
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    Study Shows Collagen Peptides Aid Runners in Injury Recovery

    Podcast: Talking Hemp & CBD 101 with AHPA’s Jane Wilson

    Afrigetics Botanicals Sponsors Bulbine through ABC’s Adopt-an-Herb Program

    Research on Stratum Eggshell Membrane Explores Benefits for Cartilage Protection

    New Monograph on Centella asiatica Looks to Expand Use and Applications
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Sabinsa Corporation

    BatchMaster Software, Inc.

    Shanghai Freemen

    Herbally Yours

    Watson Inc.
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Herbally Yours

    Barrington Nutritionals

    Sabinsa Corporation

    Watson Inc.

    Shanghai Freemen
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Columns

    Quality: The Mantra for Developing Evidence-Based Nutraceuticals

    The use of dietary supplements and traditional herbal medicines must be based on quality, safety, efficacy and consistency.

    Quality: The Mantra for Developing Evidence-Based Nutraceuticals
    Quality: The Mantra for Developing Evidence-Based Nutraceuticals
    Related CONTENT
    • Finding the Perfect Genes
    • Combating Migraine Headaches From A Nutritional Vantage Point
    • Natural Medicine: From ‘Seed to Patient’
    • Blood Circulation & Heart Health Supported by Capros
    • Bridging The Health Gap For Women In Developing Nations
    Dilip Ghosh, PhD, FACN, nutriConnect07.01.15
    Because of the unique health benefits and relatively low side effects, natural products such as food/dietary supplements, nutraceuticals and herbal medicines have been gaining popularity all over the world.

    The gap between the popularity of these remedies and the frequently weak scientific basis of their use is striking. In reality, the efficacy and true frequency of side effects for most herbal medicine products is not known because the majority have not yet been tested in large clinical trials and because pharmacovigilance systems are much less extensive than those in place for pharmaceutical products. In contrast to the popularity of herbal medicinal products, physicians and consumers often have a very critical view of robust efficacy and safety profiles.

    Genesis
    “The use of traditional medicines, phytotherapeuticals, and dietary supplements should be based on quality, safety, efficacy, and consistency (QSEC)” (Cordell GA, Phytochemistry Letters, 2014). Traditional medicine was the only form of drug-based healing system in many parts of the world prior to introduction of aspirin in 1899. Over time, more than 50,000 biologically active plants have been described around the world (IUCN, 2007). The World Health Organization has recognized this need for an evidence base for all aspects of traditional medicine, making it clear in documents for many years (2002-2005, 2012) that the introduction of traditional medicine (TM) into healthcare systems must be based on evidence of QSEC.

    The food/dietary supplements and herbal medicine products that are ingested are becoming a subject of increasing scrutiny and surveillance. Nowadays, the official regulatory agencies such as Food and Drug Administration (FDA), European Medicines Agency (EMA), European Food Safety Authority (EFSA), Therapeutic Goods Administration (TGA), Health Canada and so on ask industry for development of the food quality assurance program. In the past, there was not a widespread focus on the quality and safety of ingested health supplements. However, that does not mean that adulteration did not exist.

    Seed-to-Patient Control
    Due to the inherent variability of the constituents of herbal products, it is difficult to establish quality control parameters, and batch-to-batch variation. In the absence of reference standards for identification, variability can start from the collection of raw material, and increase during storage and further processing.

    Generally, it is believed that the risk associated with herbal drugs is very low, but several reports on serious reactions are indicating the need for the development of safety profiles and stringent quality control systems for authentication, isolation, and standardization of herbal medicine (see Figure 1). Reliable and consistent quality is the basis for efficacy and safety of herbal medicinal products. Proper validation of herbs used in TM needs to be done for their promotion and development.


    In conducting a clinical trial or during the preparation of food supplements, it is essential to clearly identify the plant component. The botanical identification is the first step of correct work. As a guidance tool, some experienced and tested approaches have been proposed to assist researchers in determining the quality and the safety of plant material (Zangara and Ghosh, 2014, “Clinical aspects of functional foods and nutraceuticals,” CRC Press).

    Quality Issues
    Excipients used in both pharmaceutical and nutraceuticals are no longer inert materials but they are effective and able to improve the characteristics of the products’ quality, stability, functionality, safety, solubility and acceptance among patients. They can change the medicament characteristics when they interact with the active ingredients (Abdellah A et al., 2015, Saudi Pharmaceutical Journal).

    Since the introduction of the good manufacturing practice (GMP) regulations in the U.S. in 2007, the dietary supplements industry has continued to experience solid growth and now it’s part of the product approval system in many countries. Now the onus is on dietary supplement manufacturers/marketers to ensure that dietary supplements are safe and meet the quality standards that consumers and regulators are expecting. This can only be achieved through the rigorous application of in-house hazard analysis and critical control points (HACCP) and GMP systems from incoming raw material qualification and compliance to finished products (LeDoux et al., European Journal of Nutrition, 2015: 54).

    The Way Forward
    Several recent cases of adulteration and contamination of herbal medicinal products, which may have led to severe illness and possibly death in some cases, have revealed the necessity and urgency of identifying the plant material in botanicals and phytomedicines.

    The older system of organoleptic (or identification through microscopic observation of plant parts) is not convincing, and plants are often misidentified. Recently, DNA-based methods have been applied to these products because “DNA is not changed by growth conditions unlike the chemical constituents of many active pharmaceutical agents,” (Moraes et al., 2015, Planta Medica).

    The New York State attorney general recently called for the removal of certain herbal supplements from retail stores because DNA barcoding allegedly showed that most of the tested products did not contain the herbs listed on their labels. Although there is  a strong counter-argument, DNA-based authentication of the ingredients incorporated into natural products is “perhaps the most efficient and economical method by which adverse effects of adulterants and plant or microbial contaminants may be minimized,” (Moraes et al 2015).


    Dilip Ghosh, PhD, FACN
    nutriConnect

    Dilip Ghosh, PhD, FACN, is director of nutriConnect, based in Sydney, Australia. He is also professionally involved with Soho Flordis International, the University of Western Sydney, Australia, and is an Honorary Ambassador with the Global Harmonization Initiative (GHI). Dr. Ghosh received his PhD in biomedical science from University of Calcutta, India. He has been involved in drug-development (both synthetic and natural) and functional food research and development both in academic and industry domains. Dr. Ghosh has published more than 60 papers in peer-reviewed journals, and he has authored two recent books, “Biotechnology in Functional Foods and Nutraceuticals,” and “Innovation in Healthy and Functional Foods,” under CRC Press. His next book, “Clinical Perspective of Functional Foods and Nutraceuticals” is in press. He can be reached at dilipghosh@nutriconnect.com.au; www.nutriconnect.com.au
    Related Searches
    • Food Safety
    • Regulatory
    • Natural
    • Functional Food
    Related Knowledge Center
    • Quality & Safety
    • Testing
    • Dietary Supplements
    Suggested For You
    New Medical Device Regulation Update New Medical Device Regulation Update
    Lipofoods Introduces Palm-free, Water-Dispersible Phytosterols Lipofoods Introduces Palm-free, Water-Dispersible Phytosterols
    Food to Feed the Brain Food to Feed the Brain
    Alternatives to Botanical  EFSA Health Claims Alternatives to Botanical EFSA Health Claims
    Influencing the Microbiota-Gut-Brain Axis Through Diet Influencing the Microbiota-Gut-Brain Axis Through Diet
    Botanical Research Highlights Botanical Research Highlights
    Herbal Hopes for Brain Health Herbal Hopes for Brain Health
    Nexira Gains EFSA Health Claim for Fibregum Nexira Gains EFSA Health Claim for Fibregum
    Phytopharmaceutical:  An Emerging Platform Phytopharmaceutical: An Emerging Platform
    Fenugreek: An Herb To Watch Fenugreek: An Herb To Watch
    Bridging The Health Gap For Women In Developing Nations Bridging The Health Gap For Women In Developing Nations
    Blood Circulation & Heart Health Supported by Capros Blood Circulation & Heart Health Supported by Capros
    Natural Medicine: From ‘Seed to Patient’ Natural Medicine: From ‘Seed to Patient’
    Combating Migraine Headaches From A Nutritional Vantage Point Combating Migraine Headaches From A Nutritional Vantage Point
    Finding the Perfect Genes Finding the Perfect Genes

    Related Columns

    • Dietary Supplements | Healthcare Trends | Medical Nutrition | Regulations | Research
      Nuances of the Healthcare Institutional Nutrition Market

      Nuances of the Healthcare Institutional Nutrition Market

      The opportunity for distribution of nutritional products in hospitals, rehabilitation facilities, nursing homes, and home care is growing dramatically.
      By Gregory Stephens, RD, Trish Cadwallader & Sheila Campbell, PhD, RD 01.03.19

    • Dietary Supplements | Herbs & Botanicals | Quality & Safety | Regulations
      The Magical Mystery Tour Also Known as Cannabis Sativa

      The Magical Mystery Tour Also Known as Cannabis Sativa

      What’s in the new Farm Bill and what does it mean for hemp and CBD?
      By Todd Harrison & Meryl Nolan, Venable 01.03.19

    • Dietary Supplements | Healthcare Trends | Regulations | World Markets
      Personalized Nutrition: New Opportunities for Product Development

      Personalized Nutrition: New Opportunities for Product Development

      The introduction of effectively targeted solutions has strong potential to improve consumer health and well-being.
      By Joerg Gruenwald, analyze & realize GmbH 01.03.19


    • Cancer Risk | Herbs & Botanicals | Mood Health & Sleep | Quality & Safety | Research | Testing
      Botanical Science: Ginseng for Stress Response & Data Transparency

      Botanical Science: Ginseng for Stress Response & Data Transparency

      AHPA compiles recent research on botanicals and plant compounds published in peer-reviewed journals.
      By Holly E. Johnson, PhD, American Herbal Products Association 01.03.19

    • Dietary Supplements | Healthcare Trends | Medical Nutrition | Quality & Safety
      How Do Practitioners Define Dietary Supplement Quality?

      How Do Practitioners Define Dietary Supplement Quality?

      Beyond what’s in a product, quality encompasses everything from science behind a formulation to diligence of staff.
      By Erik Goldman, Holistic Primary Care 12.06.18

    • Dietary Supplements | Herbs & Botanicals | Quality & Safety | Regulations
      Availability of CBD Liability Insurance (and Actual Coverage) is Often Scarce

      Availability of CBD Liability Insurance (and Actual Coverage) is Often Scarce

      The wild west of CBD is fraught with perils, not the least of which is buying liability insurance you can rely on.
      By Greg Doherty, Bolton & Company 12.06.18


    • Digestive Health | Mood Health & Sleep | Research
      Potential Role of Microbe-Gut-Brain Axis on Mood

      Potential Role of Microbe-Gut-Brain Axis on Mood

      Research is at an early stage in understanding the role of gut microbes.
      By Dilip Ghosh, PhD, FACN, nutriConnect 10.01.18

    • Dietary Supplements | Healthcare Trends | Regulations
      Is Google’s AdSense System Biased Against Dietary Supplements?

      Is Google’s AdSense System Biased Against Dietary Supplements?

      The company lumps drugs and supplements into a single ad category, creating an unwitting bias in favor of pharma.
      By Erik Goldman, Holistic Primary Care 10.01.18

    • Dietary Supplements | Regulations | World Markets
      New Novel Food Regulation: An Overview

      New Novel Food Regulation: An Overview

      Industry reaction has been generally positive, some questions remain.
      By Joerg Gruenwald, analyze & realize ag 09.10.18


    • Bone & Joint Health | Diabetes & Blood Sugar Management | Herbs & Botanicals | Men's Health | Mood Health & Sleep | Quality & Safety | Research | Sports Nutrition
      Botanical Research: Herbal Efficacy & Testing

      Botanical Research: Herbal Efficacy & Testing

      AHPA compiles recent research on botanicals and plant compounds published in peer-reviewed journals.
      By Holly E. Johnson, PhD, American Herbal Products Association (AHPA) 09.10.18

    • Dietary Supplements | Herbs & Botanicals | Medical Nutrition | Regulations
      Confusion Over Cannabis & The Fate of CBD

      Confusion Over Cannabis & The Fate of CBD

      Fair and reasonable or not, FDA could very well be a major buzzkill in the CBD supplement sector.
      By Erik Goldman, Holistic Primary Care 07.02.18

    • Quality & Safety | Regulations
      Tips & Tricks for Walking the Insurance Application Minefield

      Tips & Tricks for Walking the Insurance Application Minefield

      Product liability insurance applications can be challenging to complete, so companies need to be diligent.
      By Greg Doherty, Bolton & Company 07.02.18

    • Cardiovascular Health | Cognitive Function | Herbs & Botanicals | Mood Health & Sleep | Quality & Safety | Research | Testing
      Botanical Research: Benefits for Cognitive Function, Insomnia & Other Conditions

      Botanical Research: Benefits for Cognitive Function, Insomnia & Other Conditions

      AHPA compiles recent research on botanicals and plant compounds published in peer-reviewed journals.
      By Holly Johnson, PhD, American Herbal Products Association (AHPA) 06.04.18

    • Regulations | World Markets
      Safeguarding Your Intellectual Property for Nutraceuticals

      Safeguarding Your Intellectual Property for Nutraceuticals

      Securing patents and trademarks will help protect your brand and lead to commercial success.
      By Gregory Stephens, Windrose Partners 06.01.18

    • Infant & Children's Health | Regulations | Vitamins | Women's Health
      Petition Seeks Health Claim for Vitamin D, Lower Risk of Preterm Birth

      Petition Seeks Health Claim for Vitamin D, Lower Risk of Preterm Birth

      Supplements are affordable, safe, and effective for modifying maternal serum vitamin D levels to improve pregnancy outcomes.
      By Todd Harrison & Michelle Jackson, Venable 06.01.18

    Breaking News
    • Solabia Earns Halal Certification for Peptones and Hydrolysates
    • Tilray Buys Hemp-Foods Company Manitoba Harvest for $318 Million
    • Kemin Receives GRAS Approval for Oil-Soluble Green Tea Extract
    • Health Drives Surge in Alternative, Plant-Based Product Options
    • PepsiCo to Acquire CytoSport from Hormel Foods
    View Breaking News >
    CURRENT ISSUE

    Jan/Feb 2019

    • Healthy Snacking: Matching Lifestyle with Nutrition
    • Vitamins & Minerals: Traditions in Preventive Health
    • Fiber Revisited: Closing the Gap
    • Green Power for Future Generations
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • privacy policy
    • term and condition
    • about us
    • contact us

    follow us

    Subscribe

    magazines

    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image

    Copyright © 2019 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login