• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    PowerBar Maker Jennifer Maxwell Drums Up Organic Energy with JamBar Brand

    Economic Pressures Lead to Slower Growth in Dietary Supplement Industry

    Supporting Musculoskeletal Health: Tending to Muscles, Joints, and Bones

    2023 Contract Manufacturing Survey

    Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Wiley Eliminates Outer Carton From Packaging to Reduce Waste

    ACG Expands as Vantage Nutrition Acquires ComboCap and its Dual-Chamber Capsule Technology

    Melodea Launches New Plastic-Free Packaging Solution

    GOED and NASC Announce Strategic Partnership

    NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill
    Exclusives
    Blogs & Guest Articles
    Health E-Insights
    Area Code 420
    eBook
    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

    Wiley Eliminates Outer Carton From Packaging to Reduce Waste

    PowerBar Maker Jennifer Maxwell Drums Up Organic Energy with JamBar Brand

    Harmonizing the EU's Upper Limits For Micronutrients

    GOOD Meat Receives FDA Go-Ahead for Cultured Meat

    IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain
    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

    Wiley Eliminates Outer Carton From Packaging to Reduce Waste

    ACG Expands as Vantage Nutrition Acquires ComboCap and its Dual-Chamber Capsule Technology

    PowerBar Maker Jennifer Maxwell Drums Up Organic Energy with JamBar Brand

    Economic Pressures Lead to Slower Growth in Dietary Supplement Industry

    Melodea Launches New Plastic-Free Packaging Solution
    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

    Economic Pressures Lead to Slower Growth in Dietary Supplement Industry

    NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill

    Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets

    DolCas Biotech's Curcugen Featured in Beauty-From-Within Supplement

    NOW Tests Bromelain Supplements Purchased on Amazon
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    JRS Pharma

    Gencor

    PhytoGaia Inc

    Aiya America, Inc. (Aiya Matcha)

    Chenguang Biotech Group Co., Ltd.
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    JRS Pharma

    Gencor

    PhytoGaia Inc

    Aiya America, Inc. (Aiya Matcha)

    Chenguang Biotech Group Co., Ltd.
    • 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
    • eBook
    • 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
    Breaking News

    Study Finds Shortcomings in Reported Safety Data for Probiotics

    A review found harms-related data for probiotics, prebiotics, and synbiotics were not sufficiently reported.

    Study Finds Shortcomings in Reported Safety Data for Probiotics
    07.23.18
    A new review published in the Annals of Internal Medicine sought to examine how harms-related information was reported in publications of randomized controlled trials (RCTs) for probiotics, prebiotics, and synbiotics, and found correlating data to be significantly lacking. 
     
    Researched utilized RCTS assessing the safety or efficacy of at least one intervention involving probiotics, prebiotics, or synbiotics alone or in combination with another intervention compared with any control (such as a placebo or an antibiotic) for any clinical condition.
     
    In a review of 384 trials conducted in healthy volunteers, researchers found:
    • Trials most often evaluated probiotics (69%);
    • No harms-related data were reported for 28% of trials;
    • Safety results were not reported 37% of trials;
    • The number of serious adverse events (SAEs) per study group was not given for 80% of trials.
    Of 242 studies mentioning harms-related results, 37% used only generic statements to describe AEs and 16% used inadequate metrics. Overall, the researchers found 375 trials (98%) did not give a definition for AEs or SAEs, the number of participant withdrawals due to harms, or the number of AEs and SAEs per study group with denominators.
     
    While the researchers were limited in their reported by only using English-language studies, they concluded that harms reporting in published reports of RCTs assessing these ingredients provided insufficient information. Furthermore, they suggested that they could not verify the safety of such ingredient without adequate data. 
     
    Industry Responds
    Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs, for the Council for Responsible Nutrition (CRN), said that while the review raised from legitimate concerns about the importance of including safety data in published RCT results, he believes“drawing any conclusions about the safety of probiotics, prebiotics, or synbiotics, based on this review, is misguided.”
     
    Dr. MacKay said that as the authors themselves state, “the only conclusion that can be drawn from the review is that reporting of harms-related information in clinical trials of these products is lacking. An absence of harms data does not signify the presence of safety concerns; it simply means we need to be better at reporting this crucial information.”
     
    CRN encouraged researchers to publish all relevant safety data to better inform the medical community when using probiotics for clinical conditions. “While a significant number of clinical trials on probiotics have not yielded any evidence of safety issues, the current literature is not well-equipped to confidently answer specific safety questions about using these products therapeutically in different patient populations,” he stated.

    Probiotics and prebiotics have wide spread use in the food industry, Dr. MacKay noted, and suggested their safe application has been well-supported throughout their longstanding history. Products featuring probiotics and prebiotics are also subject to pre-market evaluation of safety by the U.S. Food and Drug Administration (FDA).“Under the law, dietary supplements containing these ingredients are accountable for manufacturing standards that include testing procedures, labeling and storage requirements, and other practices examined and enforced by regulatory agencies at both the federal and state levels,” explained Dr. MacKay.
     
    The Natural Products Association (NPA) also stressed that FDA considers probiotics to be safe, and that robust adverse event reporting systems are in place to monitor the use of probiotic and prebiotic supplements.      
     
    “This so-called study is an absurd outlier compared to the overwhelming number of studies supporting the safety and efficacy of probiotics in modern medicine,” said Daniel Fabricant, PhD, president and CEO of NPA. “Consumers should always consult with their doctors or medical professionals before using probiotics, but to suggest that there are potentially widespread adverse events is just plain wrong. There are robust government reporting requirements to document adverse reactions when they do occur, but for the vast majority of people side effects are minimal and almost never exceed some slight discomfort. FDA considers probiotics to be safe and millions of Americans use them every day.”
     
    NPA added that thousands of studies have supported the safe use and efficacy of probiotics for a range of treatments and patient populations, including:  
    • Treating acute bowl infections; preventing antibiotic-associated diarrhea in healthy children; and preventing necrotizing enterocolitis, a devastating disease that affects bowls in premature infants.[1]
    • Managing irritable bowel syndrome.[2]
    • Improving not only gut health but liver health as well.[3]
    • Reducing the severity of skin rashes in children and eliminate the need for topical corticosteroids to treat symptom flare-ups.[4]
    • Reducing the likelihood of infection during antibiotic treatments, with no adverse events.[5]
    Related Searches
    • Prebiotics
    • adverse event reporting
    • fda
    • microbiota
    Related Knowledge Center
    • Research
    • Probiotics & Prebiotics
    • Quality & Safety
    Suggested For You
    IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain
    Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets
    Intake of Live Microbes from the Diet, Including Fermented Foods, Associated with Better Health Intake of Live Microbes from the Diet, Including Fermented Foods, Associated with Better Health
    Vitamin D Remains Top Supplement Among Users, Popularity of Probiotics on the Rise: ConsumerLab Vitamin D Remains Top Supplement Among Users, Popularity of Probiotics on the Rise: ConsumerLab
    Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges
    Prinova Navigates Market Forces with Flexibility and Adaptation Prinova Navigates Market Forces with Flexibility and Adaptation
    Manufacturing Dietary Supplements in Economic Uncertainty Manufacturing Dietary Supplements in Economic Uncertainty
    International Probiotics Association Adds Prebiotics, Postbiotics, and Synbiotics to Strategic Focus International Probiotics Association Adds Prebiotics, Postbiotics, and Synbiotics to Strategic Focus
    ICYMI: Top Content from January 2023 on NutraceuticalsWorld.com ICYMI: Top Content from January 2023 on NutraceuticalsWorld.com
    ADM Expands Production to Meet Demand for Probiotics ADM Expands Production to Meet Demand for Probiotics
    Innovation in Nutraceuticals: Dose Forms and Application Science Help Meet Consumer Demand Innovation in Nutraceuticals: Dose Forms and Application Science Help Meet Consumer Demand
    Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients
    Probiotic Reduces S. aureus Colonization in Phase 2 Trial Probiotic Reduces S. aureus Colonization in Phase 2 Trial
    Top 2023 Food Trends Include Healthy Drinks, Probiotics, Protein, Food Labels Top 2023 Food Trends Include Healthy Drinks, Probiotics, Protein, Food Labels
    The Top 10 Articles of 2022 on NutraceuticalsWorld.com The Top 10 Articles of 2022 on NutraceuticalsWorld.com

    Related Breaking News

    • Breaking News | Dietary Supplements | Probiotics & Prebiotics | Supplier News
      IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain

      IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain

      The Akkermansia species will be produced at a food-grade manufacturing and R&D site at Dangé-Saint-Romain.
      03.22.23

    • Breaking News | Dietary Supplements | Digestive Health | Probiotics & Prebiotics | Products
      Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets

      Nordic Naturals Debuts Probiotic Line in More Than 375 Sprouts Farmer’s Markets

      The company's Nordic Flora line includes three blends: Immune Health, Maximum Care, and Women’s Balance.
      03.21.23

    • Breaking News | Cardiovascular Health | Diabetes & Blood Sugar Management | Digestive Health | Research | Research News | Weight Management/Weight Loss
      Intake of Live Microbes from the Diet, Including Fermented Foods, Associated with Better Health

      Intake of Live Microbes from the Diet, Including Fermented Foods, Associated with Better Health

      Increased consumption of live microbes tied to better blood pressure and blood glucose, lower waist circumference and body mass index.
      03.17.23


    • Breaking News | Consumer Trends | Dietary Supplements | Industry & Market News
      Vitamin D Remains Top Supplement Among Users, Popularity of Probiotics on the Rise: ConsumerLab

      Vitamin D Remains Top Supplement Among Users, Popularity of Probiotics on the Rise: ConsumerLab

      Quercetin and vitamin K among supplements posting fastest growth.
      03.06.23

    • Consumer Trends | Contract Manufacturing | Delivery & Dosage Technologies | Dietary Supplements
      Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges

      Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges

      Advancing technologies enhance solubility, bioavailability, and metabolism of challenging dietary supplement formulations.
      By Mike Montemarano, Associate Editor 03.01.23

    Loading, Please Wait..
    Trending
    • Shiitake Mushroom Extract Appears Helpful In HPV Infections
    • The Functional Chocolate Company Launches Painfree Chocolate
    Breaking News
    • Wiley Eliminates Outer Carton From Packaging to Reduce Waste
    • ACG Expands as Vantage Nutrition Acquires ComboCap and its Dual-Chamber Capsule Technology
    • Melodea Launches New Plastic-Free Packaging Solution
    • GOED and NASC Announce Strategic Partnership
    • NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill
    View Breaking News >
    CURRENT ISSUE

    March 2023

    • Supporting Musculoskeletal Health: Tending to Muscles, Joints, and Bones
    • Dosage and Delivery Innovations Help Manufacturers Meet Common Challenges
    • 2023 Contract Manufacturing Survey
    • Manufacturing Dietary Supplements in Economic Uncertainty
    • Beyond Antioxidants: The Power of Berries
    • A Paradigm Shift for Antioxidants?
    • Ayana Bio on Path to Scale Bioactives Derived from Plant Cell Cultures
    • Nuritas: Leveraging Artificial Intelligence to Speak the Language of Life
    • Dietary Supplement Quality Assurance Programs Critical to Natural Products Industry Success
    • Innovation in Nutraceuticals: Dose Forms and Application Science Help Meet Consumer Demand
    • 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”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Wiley Eliminates Outer Carton From Packaging to Reduce Waste
    ACG Expands as Vantage Nutrition Acquires ComboCap and its Dual-Chamber Capsule Technology
    Melodea Launches New Plastic-Free Packaging Solution
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Appoints Ricardo Rosso as Pontiac Site Manager
    Sherwin-Williams Publishes Sustainable Packaging White Paper
    Heubach Launches Automotive Styling Shades 2027
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Q’Apel Medical Inc. Receives CE Mark for Walrus Balloon Guide Catheter
    Medinbox and Abbott Partner to Increase Efficiency in Electrophysiology Labs
    Bronwyn Brophy Named CEO at Vitrolife AB
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Evotec, BMS Expand Strategic Neurodegeneration Pact
    Regeneron, Sonoma Biotherapeutics Partner on Treg Cell Therapies
    Astellas, MIMETAS Enter Strategic Immuno-Oncology Alliance
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Millie Bobby Brown’s Florence by Mills Launches Eye-Centric Color Cosmetics Line
    Colorsmith Introduces ‘Salon-Quality’ Stylers for Men
    Panama Jack Launches Tropical Fragrances, Essential Oils & Body Mists
    Happi

    Latest Breaking News From Happi

    Kao Launches Space Shampoo Sheet
    Procter & Gamble Brings Tide ‘Loads of Hope’ Relief to Residents Affected by Deadly Tornado Outbreak in Mississippi
    Sederma Introduces Active Ingredient to Address Pigment Disorders
    Ink World

    Latest Breaking News From Ink World

    NAPIM Honors 2023 Ault, Pioneer Award Recipients
    Kodak to Showcase Prepress and Print Technologies at Print China 2023
    CPIPC Hosts Technical Dinner
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    CORLABEL invests in HP and a second GM finishing machine
    Elkem's Sean Duffy receives AWA Leadership Award
    eProductivity Software acquires Tharstern Group
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Ahlstrom Releases Sustainability Report
    Albaad Uses Upgrades Lenzing Fibers in Flushable Wipes
    Midwest Filtration, Monadnock Announce Partnership in Filtration
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Conventus Flower Ortho Appoints Jeff Culhane as COO
    Solid Growth Forecast for OTC Braces and Supports Market
    Exactech Boosts AI Expertise with Licensing Deal, Team of Scientists
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Japan Display to Acquire JOLED IP
    Graphenest, Hubron to Partner on Graphene Project
    CSEM Nominates Andreas Rickenbacher as New Chair of the Board

    Copyright © 2023 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