• 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
    Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains

    Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality

    Nutrition and Flavor: Formulating for Modern Product Preferences

    What Do Consumers Know About the Gut Microbiome?

    How Will the European Green Deal Impact Dietary Supplements?
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market

    Tazo Transitions to Regenerative Organic Agriculture

    Protein Ingredient Formulated for Chronic Kidney Disease Patients

    IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations

    Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits
    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

    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market

    Tazo Transitions to Regenerative Organic Agriculture

    Protein Ingredient Formulated for Chronic Kidney Disease Patients

    IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations

    Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits
    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

    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market

    Tazo Transitions to Regenerative Organic Agriculture

    Protein Ingredient Formulated for Chronic Kidney Disease Patients

    IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations

    Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits
    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

    Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits

    Monk Fruit Sweetener May Have Prebiotic Activity, Study Finds

    People with Low-Fiber Diets Benefit the Most from Fiber Supplements, Study Finds

    Gut Microbiome May Be Part of Link Between Red Meat and Heart Disease Risk

    Nutritional Growth Solutions’ Healthy Heights Enters South Korea Market
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    JRS Pharma

    Aiya America, Inc. (Aiya Matcha)

    ESHA Research

    PhytoGaia Inc

    Nutrition21, LLC
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    JRS Pharma

    Aiya America, Inc. (Aiya Matcha)

    ESHA Research

    PhytoGaia Inc

    Nutrition21, LLC
    • 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
    Columns

    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.

    Safe & Accessible: Dietary Supplements Are Far From ‘Unregulated’
    Related CONTENT
    • BAPP Publishes Lab Guidance Document on Indian Frankincense (Boswellia serrata)
    • Registration Opens for Vitafoods Asia 2022
    • Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    • A Growing Herbal Products Market Still Faces Formidable Threats, Challenges
    • Medical Sales Representative Chiropractic – Irvine
    By Michael McGuffin, President, American Herbal Products Association (AHPA)06.02.22
    Critics of dietary supplements have argued that this class of goods is insufficiently regulated—calling dietary supplements everything from underregulated to flat out unregulated. They have used these false and misleading arguments to call for unnecessary new legislation. However, the U.S. Food and Drug Administration (FDA) already has sufficient authority to fully regulate dietary supplements. In fact, under federal law, dietary supplements are regulated at least as or more strictly than other food categories.

    Under applicable federal regulations, manufacturers and marketers of dietary supplements are required to, for example:

    • Register their facilities with FDA;
    • Adhere to current Good Manufacturing Practice (cGMP) regulations;
    • Include nutrition information, an ingredient list, the manufacturer, packer, or distributor’s name and address, and contact information for receipt of adverse event information on their product labels;
    • Include information on major food allergens on their labels;
    • Comply with requirements to disclose bioengineered ingredients on their labels;
    • Obtain premarket FDA authorization for certain product claims;
    • Notify FDA of certain other product claims; and
    • Include disclaimers on their labels for certain product claims.

    Dietary supplement regulations differ from those that govern drugs and conventional foods when it comes to recalls and adverse event reporting, respectively.

    Manufacturers and marketers of drugs and dietary supplements are required to submit serious adverse event reports (SAERs) to FDA, but there is no such requirement for conventional foods. FDA has mandatory recall authority for foods (including dietary supplements) but not for drugs. Adverse event reports and information reported by firms conducting voluntary recalls aid FDA in monitoring the safety of the various products it regulates. The data on both support the safety and sufficient regulation of dietary supplements.

    Adverse Event Reports

    Irrespective of the regulated category, the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines an “adverse event” for over-the-counter drugs, prescription drugs, and dietary supplements as “any health-related event associated with the use of a [over-the-counter drug/prescription drug/dietary supplement] that is adverse.” Further, a “serious adverse event” is an adverse event that results in death or serious injury.

    Unlike with marketers of conventional foods, who have no enforceable obligation to report SAERS to FDA, marketers of dietary supplements must report SAERs to the agency because industry groups lobbied for the establishment of such requirements.

    Beginning in 2002, the American Herbal Products Association (AHPA) began advocating for the establishment of an SAER law for dietary supplements. Over four years, AHPA coordinated and led industry support to establish a mandatory system for SAERs for dietary supplements through efforts such as: communicating directly with the U.S. Department of Health and Human Services and FDA; filing a citizen petition with FDA; and providing testimony to the U.S. Senate. These efforts culminated in the enactment of the Dietary Supplement and Nonprescription Consumer Protection Act of 2006, under which dietary supplement manufacturers must submit SAERs to FDA.

    Data on SAERs submitted to FDA are available to the public through the Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS). From 2018-2020, 53% of the adverse event reports listed in CAERS are for cosmetics, 32% are for dietary supplements, and 15% are for conventional foods (Figure 1). As with conventional foods, cosmetics are not subject to mandatory adverse event reporting requirements, yet cosmetics make up more than half of adverse events reports captured in this recent dataset from CAERs.

    Figure 1. 

    CAERS is one of the tools FDA uses to monitor the market for safety concerns. When FDA identifies a public health concern through adverse event reporting, the agency can take administrative or enforcement action to protect the public health. This can include requesting a recall or, in the case of foods (including dietary supplements), actually ordering one.

    Recalls

    FDA defines a recall as “a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action.” Recalls to correct or remove unsafe products from the market are not unique to the conventional food, dietary supplement, or drug industries. In fact, most consumer product categories in the U.S.—including everything from cars to toys—are subject to recall if they pose a danger to public health.

    FDA has the authority to mandate a recall of foods (including dietary supplements) when the agency determines there is a reasonable probability that the food is adulterated (or misbranded due to a violation of major food allergen labeling requirements) and that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.

    However, the agency can only request a recall of drugs, even if a drug has been identified as defective or potentially harmful. Recalls for conventional foods—such as produce (due to contamination) or processed food (due to undeclared allergens)—are most common.

    Of the nearly 2,000 recalls from 2019-2022 listed on the FDA website, only 3% of recalls were for dietary supplements, compared to 63% for conventional food and beverages, and 21% for drugs in that same time period (Figure 2). FDA gathers this data from information provided by recalling firms as well as press releases and other public notices about certain recalls of FDA-regulated products.

    Figure 2. 

    With fewer recalls than conventional foods and beverages, drugs, animal and veterinary products, and medical devices, dietary supplements could arguably be considered the safest class of goods regulated by FDA.

    This argument could find further support in the mandatory reporting of SAERs to FDA for dietary supplements, which provides the agency with data to monitor the market for safety concerns, and FDA’s mandatory recall authority for dietary supplements, with which the agency can mandate removal of unsafe products.

    Robustly Regulated & Balanced

    In addition to FDA regulations, dietary supplements are also subject to:

    • Federal Trade Commission regulations for advertising (i.e., claims must be truthful and not misleading);
    • U.S. Fish & Wildlife regulations for botanicals protected by the Convention on International Trade in Endangered Species of Wild Fauna and Flora; and
    • State and local municipality regulations.

    Altogether, dietary supplement regulations are not only robust, but, in most cases, are as strict or stricter than those that govern conventional foods. From requirements for submission of SAERs to FDA and the agency’s mandatory recall authority, dietary supplement regulations have ensured access to, and the safety of, these products for our families, friends, and neighbors who choose dietary supplements to support their personal health.


    About the Author: Michael McGuffin has served as president of the American Herbal Products Association since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia and United Plant Savers, and on the advisory boards of the USC School of Pharmacy regulatory science master’s degree program and the Appalachian Beginning Forest Farmers Coalition. An industry veteran, McGuffin has been active in the herbal community since 1974, and has taken the lead on legislative matters and regulatory advocacy that have shaped the herbal and natural products industry over the last several decades. For more information: www.ahpa.org.
    Related Searches
    • Dietary Supplements
    • Regulations
    • Quality & Safety
    Related Knowledge Center
    • Regulations
    • Dietary Supplements
    • Quality & Safety
    Suggested For You
    BAPP Publishes Lab Guidance Document on Indian Frankincense (Boswellia serrata) BAPP Publishes Lab Guidance Document on Indian Frankincense (Boswellia serrata)
    Registration Opens for Vitafoods Asia 2022 Registration Opens for Vitafoods Asia 2022
    Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    A Growing Herbal Products Market Still Faces Formidable Threats, Challenges A Growing Herbal Products Market Still Faces Formidable Threats, Challenges
    Medical Sales Representative Chiropractic – Irvine Medical Sales Representative Chiropractic – Irvine
    Medical Sales Representative – South Florida Medical Sales Representative – South Florida
    Medical Sales Representative – Riverside Medical Sales Representative – Riverside
    Medical Sales Representative – Denver Medical Sales Representative – Denver
    Medical Sales Representative – Tucson Medical Sales Representative – Tucson
    Medical Regional Sales Manager - Washington, DC Medical Regional Sales Manager - Washington, DC
    Medical Sales Representative – Sherman Oaks Medical Sales Representative – Sherman Oaks
    Medical Sales Representative - San Jose Medical Sales Representative - San Jose
    Medical Sales Representative – Atlanta Medical Sales Representative – Atlanta
    NOW Identifies Misleading Certificate of Analysis for Supplements Sold on Amazon NOW Identifies Misleading Certificate of Analysis for Supplements Sold on Amazon
    EIRICH Machines EIRICH Machines

    Related Breaking News

    • Breaking News | Herbs & Botanicals | Industry & Market News | Quality & Safety | Testing | World Markets
      BAPP Publishes Lab Guidance Document on Indian Frankincense (Boswellia serrata)

      BAPP Publishes Lab Guidance Document on Indian Frankincense (Boswellia serrata)

      U.S. retail sales of boswellia dietary supplements in 2021 totaled about $8.9 million in mass market and natural channels combined.
      08.09.22

    • Breaking News | Industry & Market News | World Markets
      Registration Opens for Vitafoods Asia 2022

      Registration Opens for Vitafoods Asia 2022

      The event, co-located with Fi Asia, will take place in Bangkok Oct. 5-7.
      08.03.22

    • Dietary Supplements | Herbs & Botanicals | Quality & Safety | Regulations | Testing
      Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality

      Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality

      Complex formulas, sophisticated adulteration, and cost expectations are key pressure points in the dietary supplement market.
      By Mike Montemarano, Associate Editor 07.18.22


    • Dietary Supplements | Healthcare Trends | Herbs & Botanicals | Mood Health & Sleep | Quality & Safety
      A Growing Herbal Products Market Still Faces Formidable Threats, Challenges

      A Growing Herbal Products Market Still Faces Formidable Threats, Challenges

      Environmental and social stewardship can help sustain long-term interests and build trust among consumers. It’s good for business too.
      By Sean Moloughney, Editor 07.18.22

    • Medical Sales Representative Chiropractic – Irvine

      Medical Sales Representative Chiropractic – Irvine

      What are you looking for in a sales career?

    Loading, Please Wait..
    Trending
    • First Day Life Shuts Down Children's Behavioral, Cognitive Health Claims Following Challenge
    • Study Examines Vitamin K2 Content In Cheese
    • Chenland Nutritionals Self-Affirms GRAS For Cumin UP60 Ingredient
    • Pycnogenol Evidenced To Have Skin Benefits In Dermatology Study
    Breaking News
    • ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    • Tazo Transitions to Regenerative Organic Agriculture
    • Protein Ingredient Formulated for Chronic Kidney Disease Patients
    • IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations
    • Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • A Growing Herbal Products Market Still Faces Formidable Threats, Challenges
    • Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    • Nutrition and Flavor: Formulating for Modern Product Preferences
    • Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains
    • How Will the European Green Deal Impact Dietary Supplements?
    • What Do Consumers Know About the Gut Microbiome?
    • 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

    Tazo Transitions to Regenerative Organic Agriculture
    Protein Ingredient Formulated for Chronic Kidney Disease Patients
    IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations
    Coatings World

    Latest Breaking News From Coatings World

    USGBC Urges the House to Pass the Inflation Reduction Act
    The ChemQuest Technology Institute Enters Agreement with Universal Matter
    Sherwin-Williams’ TERRA: Embracing Community & Connection in 2023
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Seno Medical's Imagio System Wins Supplemental FDA Approval
    Brad Fluegel Joins NeuroMetrix Board of Directors
    Actuating Implant Design Prevents Scar Tissue Buildup
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Captor Therapeutics Selects CDMO for Clinical Trial Materials
    Catalent to Acquire Metrics Contract Services for $475M
    Sartorius Stedim Biotech Agrees to Acquire Albumedix
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Anomatic & Novelis Introduce Eco-Friendly Alloy
    NJPEC Announces 2022 Package of the Year Awards
    Tree Hut Introduces New Sugar Scrubs
    Happi

    Latest Breaking News From Happi

    PASS Coalition Applauds National Academy of Sciences Study on Its Support of Sunscreen as a Skin Cancer Prevention Tool
    Sally Beauty Names Winners of 2022 Cultivate Accelerator Program
    Personal Care Products Council Applauds Sunscreen Report by National Academy of Sciences
    Ink World

    Latest Breaking News From Ink World

    INX to Highlight New Products at Labelexpo Americas
    Sonoco Names Aditya Gandhito Company’s First Chief Accounting Officer
    Quinacridone Pigments Market Size Projected to Reach $539 Million by 2030: Straits
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Heidelberg USA-Gallus opens new Screeny Demo Room in Pennsylvania
    Heidelberg enjoys successful start to financial year
    INX International Ink Co. brings wide product range to Labelexpo Americas
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Vapor Fresh Upgrades Plant-Based Gym Wipe Canisters
    Suominen Releases Half-Year Financial Report
    Essity Switches to Recyclable Packs for Feminine Pads
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Cortland Biomedical Adds Suite of Post-Processing Services & Technologies
    First Patient Enrolls in Sonex Health’s U.S. Clinical Study to Treat Carpal Tunnel Syndrome
    Robust Growth Forecast for Joint Reconstruction Market
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    SEMI Applauds President Biden’s Signing of CHIPS and Science Act of 2022
    Brewer Science Lauds US Investment in Semiconductor Manufacturing
    Emerson Reports Third Quarter 2022 Results

    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