• 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
    Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges

    Blood Sugar Management: Personalized Testing Drives Home The Need for Early Intervention

    New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance

    Tapping Functional Beverages to Meet Modern Wellness Needs

    Adaptogens: Where Ancient Remedies Meet Modern Wellness Products
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Pharmavite Expands in Ohio with $200 Million Investment

    Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company

    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products

    NOW Identifies Misleading Certificate of Analysis for Supplements Sold on Amazon

    Kensing Acquires Vitae Naturals
    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

    Kensing Acquires Vitae Naturals

    Lynside® Forte B offers full range of B-vitamin benefits with nutritional yeast

    CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise

    Shiitake Mushroom Extract Appears Helpful in HPV Infections

    United Plant Savers Launches First Film Festival
    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

    Pharmavite Expands in Ohio with $200 Million Investment

    Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company

    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products

    NOW Identifies Misleading Certificate of Analysis for Supplements Sold on Amazon

    Kensing Acquires Vitae Naturals
    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

    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products

    Lynside® Forte B offers full range of B-vitamin benefits with nutritional yeast

    CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise

    Shiitake Mushroom Extract Appears Helpful in HPV Infections

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Botanic Healthcare LLC

    Atlantia Clinical Trials

    Aiya America, Inc. (Aiya Matcha)

    Bioenergy Life Science, Inc. (BLS)

    ESHA Research
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Botanic Healthcare LLC

    Atlantia Clinical Trials

    Aiya America, Inc. (Aiya Matcha)

    Bioenergy Life Science, Inc. (BLS)

    ESHA Research
    • 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
    Online Exclusives

    FDA to Make Adverse Event Report Data Public

    CRN applauded the move, but warned against potential misinterpretation by consumers and media.

    FDA to Make Adverse Event Report Data Public
    Related CONTENT
    • Safe & Accessible: Dietary Supplements Are Far From ‘Unregulated’
    • FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Products
    • FDA Issues Warning Letters to Companies Selling CBD, Delta-8 THC Products
    • NPA Letter Spells Out Perceived Failings of Proposed Dietary Supplement Listing Act
    • Rhode Island Bill Would Restrict Sales of Weight Loss Supplements to Minors
    12.13.16
    In an effort to increase transparency and improve access to government data for consumers, healthcare providers, researchers and academics, the U.S. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) will now post on a quarterly basis data extracted from adverse event reports, including conventional foods and dietary supplements, and cosmetics. The agency is also making available raw data files that can be downloaded in .csv format or through OpenFDA.gov as an application program interface (API).
     
    The CFSAN Adverse Event Reporting System (CAERS) is one of the post-market surveillance tools the FDA uses to monitor the safety of foods and cosmetic products. Adverse event reports related to conventional foods, dietary supplements, and cosmetics come primarily from consumers and healthcare providers; of these products, only dietary supplement manufacturers have a legal obligation to report adverse events to the agency.
     
    The FDA uses adverse event reports as part of its overall strategy to help monitor the safety of foods and cosmetics. The FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, healthcare providers and other members of the public. The agency said complete and detailed reports are immensely helpful when identifying safety signals and choosing particular products for further scrutiny.
     
    CAERS captures any adverse events or complaints related to foods or cosmetics. These can include minor to major medical events, but also complaints about off-taste or color of a product, defective packaging, and other non-medical issues. However, it’s also important to understand the information in the database is exactly as reported to the FDA, and the agency has not necessarily determined if the products(s) in question were the actual cause of the events reported.
     
    From Jan. 1, 2004 through Sep. 30, 2016, the FDA received 56,574 adverse event reports. Of these, 26,840 adverse events were reported for conventional food; 25,412 were reported for dietary supplements; and 4,322 were reported for cosmetic products. FDA staff reviewed f these reports and, collectively, initiated follow-up on hundreds of complaints to investigate potential safety signals.
     
    The FDA is currently modernizing CAERS, improving the process for consumers, healthcare providers, and other members of the public to provide information to the agency, and expects to have a more user-friendly platform in one to two years. The move to post these data now is an important first step in increasing public access to such information, and the public can expect improved access to even better data in the future, the agency said.
     
    The Council for Responsible Nutrition (CRN), Washington, D.C., embraced FDA's decision to make data public, calling it a demonstration of the agency’s commitment to transparency. CRN noted, however, that publishing these reports online increases the potential for public misinterpretation of adverse event reports, and stressed the importance of FDA providing context for its data.
     
    “We’re encouraged by FDA’s move to make this information public as consumers expect and deserve transparency,” said Duffy MacKay, ND, senior vice president, scientific & regulatory affairs, CRN. “When the Dietary Supplement and Nonprescription Drug Consumer Act was introduced, our industry was a strong proponent of its passing and emphasized the benefits it would provide consumers. Since the law’s passage in 2006, the industry’s track record demonstrates a strong safety profile for our industry both in comparison to other FDA-regulated industries and considering that more than 170 million Americans take dietary supplements each year. This law gave the FDA a valuable tool to identify potential safety concerns through patterns and signals. It’s essential to understand, however, that an AER does not demonstrate a causal relationship.”
     
    In its announcement, FDA noted that “adverse events about a particular product and the total number of adverse event reports for a product in the CAERS database only reflect the information reported and do not represent any conclusion by FDA about whether the product actually caused the adverse event(s).”
     
    “We advise the public to be cautious when reviewing these reports and to consider the fuller picture,” Dr. MacKay continued. “If consumers are looking to make decisions about safe or unsafe products, they would do best to pay attention to FDA’s consumer advisories rather than looking at individual adverse event reports which, at the end of the day, may not be related to the supplement product.”
     
    CRN reminded the dietary supplement industry that under the law, supplement companies are required to report serious adverse events to FDA no later than 15 business days after the company receives the report. CRN urged the industry to follow the law.
    Related Searches
    • Regulations
    • Quality & Safety
    • Healthcare Trends
    • Dietary Supplements
    Related Knowledge Center
    • Quality & Safety
    • Dietary Supplements
    • Regulations
    Suggested For You
    Safe & Accessible: Dietary Supplements Are Far From ‘Unregulated’ Safe & Accessible: Dietary Supplements Are Far From ‘Unregulated’
    FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Products  FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Products
    FDA Issues Warning Letters to Companies Selling CBD, Delta-8 THC Products FDA Issues Warning Letters to Companies Selling CBD, Delta-8 THC Products
    NPA Letter Spells Out Perceived Failings of Proposed Dietary Supplement Listing Act NPA Letter Spells Out Perceived Failings of Proposed Dietary Supplement Listing Act
    Rhode Island Bill Would Restrict Sales of Weight Loss Supplements to Minors Rhode Island Bill Would Restrict Sales of Weight Loss Supplements to Minors
    SIDI Work Group Seeks Comments on Updated Protocol Draft SIDI Work Group Seeks Comments on Updated Protocol Draft
    Supplement OWL Goes Live Supplement OWL Goes Live
    Olly Supports Challenged Claims for Kids Immunity Supplement Olly Supports Challenged Claims for Kids Immunity Supplement
    ABC Endorses Supplement OWL Product Registry ABC Endorses Supplement OWL Product Registry
    Vitamin D Shows Promise in Reducing Cancer in Older Women Vitamin D Shows Promise in Reducing Cancer in Older Women
    CRN Addresses Audience of Attorneys General CRN Addresses Audience of Attorneys General
    CRN & ACI Partner for Dietary Supplements Conference CRN & ACI Partner for Dietary Supplements Conference
    CRN Applauds Introduction of Health Savings Act CRN Applauds Introduction of Health Savings Act
    CRN Building Relationships with Congressional Newcomers CRN Building Relationships with Congressional Newcomers
    Supplement Industry Encouraged to Participate in Product Registry Supplement Industry Encouraged to Participate in Product Registry

    Related Columns

    • Dietary Supplements | Quality & Safety | Regulations
      Safe & Accessible: Dietary Supplements Are Far From ‘Unregulated’

      Safe & Accessible: Dietary Supplements Are Far From ‘Unregulated’

      With fewer recalls than conventional foods, drugs, animal products and medical devices, supplements could be considered the safest class of goods FDA regulates.
      By Michael McGuffin, President, American Herbal Products Association (AHPA) 06.02.22

    • Breaking News | Dietary Supplements | Industry & Market News | Quality & Safety | Sports Nutrition
      FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Products

      FDA Warns About Steroids or Steroid-Like Substances in Bodybuilding Products

      According to the agency, these products are promoted as hormone products or alternatives to anabolic steroids.
      05.18.22

    • Breaking News | Herbs & Botanicals | Industry & Market News | Quality & Safety | Regulations
      FDA Issues Warning Letters to Companies Selling CBD, Delta-8 THC Products

      FDA Issues Warning Letters to Companies Selling CBD, Delta-8 THC Products

      This marked the first time the agency took enforcement action against a delta-8 THC-containing product.
      05.04.22


    • Dietary Supplements | Regulations
      NPA Letter Spells Out Perceived Failings of Proposed Dietary Supplement Listing Act

      NPA Letter Spells Out Perceived Failings of Proposed Dietary Supplement Listing Act

      Daniel Fabricant, NPA president and CEO, lays out ‘grave concerns’ with mandatory product listing bill in message to Sens. Durbin and Braun.
      By Mike Montemarano, Associate Editor 04.29.22

    • Breaking News | Dietary Supplements | Regulations | Regulatory News | Weight Management/Weight Loss
      Rhode Island Bill Would Restrict Sales of Weight Loss Supplements to Minors

      Rhode Island Bill Would Restrict Sales of Weight Loss Supplements to Minors

      The bill, similar to legislation being introduced in other states, calls for all retailers to keep supplements behind the counter.
      By Mike Montemarano, Associate Editor 04.05.22

    Loading, Please Wait..
    Trending
    • Three Grams Of Omega-3s May Be Optimal Dose For Reducing Blood Pressure
    • 3 grams of Omega-3s May be Optimal Dose for Reducing Blood Pressu
    • High Blood DHA Levels Linked To 49% Reduced Risk Of Alzheimer’s
    • CoQ10 And Royal Jelly Supplementation May Improve High Intensity Exercise
    • First Day Life Shuts Down Children's Behavioral, Cognitive Health Claims Following Challenge
    Breaking News
    • Pharmavite Expands in Ohio with $200 Million Investment
    • Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company
    • Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products
    • NOW Identifies Misleading Certificate of Analysis for Supplements Sold on Amazon
    • Kensing Acquires Vitae Naturals
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • Tapping Functional Beverages to Meet Modern Wellness Needs
    • Adaptogens: Where Ancient Remedies Meet Modern Wellness Products
    • New and Evolving Formulation Options Must Be Mindful of Blood Sugar Maintenance
    • Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges
    • Blood Sugar Management: Personalized Testing Drives Home The Need for Early Intervention
    • 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

    Pharmavite Expands in Ohio with $200 Million Investment
    Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company
    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products
    Coatings World

    Latest Breaking News From Coatings World

    Azelis Acquires Chemical Partners, Strengthens Leadership in Africa and Middle East
    Emmanuelle Bromet Named Arkema Sustainable Development VP
    ROSS Planetary Dual Dispersers Have Unique Processing Flexibility
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—July 2
    OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser
    Pancryos Forges License Agreement for Microencapsulation Device
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bayer Opens New Research and Innovation Center at Kendall Square
    Lonza Names Maria Soler Nunez as Head, Group Operations
    Eurofins DiscoverX Opens Shanghai Office
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Dexlevo Introduces Beauty Treatment technique, ‘GOURI’
    Revision Skincare Exec Wins Ernst & Young Entrepreneur of the Year
    Latest Updates About Cosmoprof North America
    Happi

    Latest Breaking News From Happi

    Toning Collection For Zero-Brass Blondes is New at Colorproof
    Esthetician Studio Beauty Concepts Files Trademark Infringement Lawsuit Against Kim Kardashian and Coty, Inc.
    Joy Liquid Dishwash Brand Expands Into Auto Dish Market
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Flint OPS, Xerox and MNYPIA Top This Week’s News
    Azelis Acquires Chemical Partners, Adds to Leadership in Africa and Middle East
    International Paper Publishes 2021 Sustainability Report
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    UPM Raflatac boosts operations in US, All4Labels returns to HP and more
    Fedrigoni Self-Adhesives to exhibit at Labelexpo Americas for first time
    CELAB Europe wins Paper Recycling award
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Glatfelter, Blue Ocean Closures Partner with Absolut
    What You’re Reading on Nonwovens-Industry.com
    Daio, Livedo Partner to Recycle Diapers
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—July 2
    NuVasive Inc. Opens Singapore Experience Center
    Pedicle Screw Systems Market to Top $3B in 2027
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: eMagin, Identiv, and Japan Display Top This Week’s Stories
    Epishine is Building a New Solar Cell Factory in Linköping, Sweden
    Toppan Establishes CVC Fund and Investment Management Company in the US

    Copyright © 2022 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