• 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
    A Clearer Path to Weight Management: The Ozempic Factor

    Under Pressure: Stress and Mental Health Have Taken Center Stage

    Sustainable Business Development: Principles and Strategies for Progress

    Beauty IO MarketWatch: L’Oréal to Define the Next Era of Beauty Tech in CES 2024 Keynote

    Introducing the Happi & Nutraceuticals World Wellness Conference & Tabletop Exhibition
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    GOED Releases Sustainability Report for Omega-3s Industry

    ABC’s Journal HerbalGram Celebrates 40th Anniversary

    Curcumin May Be As Effective as PPI for Indigestion

    Adding Human Milk Component to Formula Linked to Long-term Cognitive Benefits for Babies

    Women in Nutraceuticals Launches Pilot Mentorship Program
    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

    GOED Releases Sustainability Report for Omega-3s Industry

    ABC’s Journal HerbalGram Celebrates 40th Anniversary

    Curcumin May Be As Effective as PPI for Indigestion

    Weight Loss Products Sold as Supplements Adulterated with Toxic Yellow Oleander

    Nature’s Way Canada Launches NutraSea Omega-3 Kids Chews
    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

    GOED Releases Sustainability Report for Omega-3s Industry

    ABC’s Journal HerbalGram Celebrates 40th Anniversary

    Curcumin May Be As Effective as PPI for Indigestion

    Adding Human Milk Component to Formula Linked to Long-term Cognitive Benefits for Babies

    Women in Nutraceuticals Launches Pilot Mentorship Program
    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

    Curcumin May Be As Effective as PPI for Indigestion

    Adding Human Milk Component to Formula Linked to Long-term Cognitive Benefits for Babies

    Weight Loss Products Sold as Supplements Adulterated with Toxic Yellow Oleander

    Nature’s Way Canada Launches NutraSea Omega-3 Kids Chews

    Kyowa Hakko's Immuse Postbiotic Introduced to Mexican Market
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    BGG World

    JRS Pharma

    PhytoGaia Inc

    Applied Food Sciences, Inc.

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

    JRS Pharma

    PhytoGaia Inc

    Applied Food Sciences, Inc.

    Botanic Healthcare 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
    Online Exclusives

    JAMA: FDA Warning Letters Fail to Result In Removal of Illegal Supplement Ingredients

    According to product recall reports, just a portion of products containing illegal ingredients were recalled following the issuance of warning letters.

    JAMA: FDA Warning Letters Fail to Result In Removal of Illegal Supplement Ingredients
    By Mike Montemarano, Associate Editor08.02.22
    The U.S. Food and Drug Administration (FDA) sends warning letters to companies marketing supplements or ingredients that the agency deems to be illegal and/or fail to meet the definition of a dietary supplement.

    In order to develop an estimate of how many companies follow through with removing illegal and potentially dangerous substances from the dietary supplements market, a team of researchers led by Pieter Cohen, MD, of Cambridge Health Alliance, writing in JAMA, tracked FDA warning letters for unapproved stimulants present in products on the market.

    They assessed the frequency at which these products were removed following the receipt of an FDA warning letter, specifically with warning letters which addressed amphetamine, ephedrine, and some other drugs, which are known to carry serious health risks including hemorrhagic stroke and sudden death.

    “Whether FDA warning letters lead manufacturers to recall or reformulate products is unknown. We assessed the frequency of product recalls and the presence of FDA-prohibited drugs in supplements after FDA warning letters,” the authors wrote.

    FDA issued warning letters for the unapproved stimulants BMPEA, the ephedrine analogue methylsynephrine, and DMHA in 2015, 2016, and 2019, respectively. Using Google, manufacturer’s websites, and the FDA’s websites, the team searched for evidence of recalls of the implicated products.

    Products that remained for sale online were purchased, and powder from these products was reconstituted and analyzed for the presence and quantity of FDA-prohibited ingredients using liquid chromatography-mass spectrometry.

    Of the 31 products targeted in warning letters for the presence of BMPEA, methylsynephrine, or DMHA, only one product was recalled by the manufacturer. Meanwhile, 29% of the products remained online for an average of six years after FDA issued warning letters. Four of the nine products that were still for sale online listed the presence of at least one prohibited ingredient on the label—one product listed the same prohibited ingredient mentioned in a warning letter, while three product labels declared other FDA-prohibited ingredients.

    Five of the nine products still available on the market were found to contain at least one FDA-prohibited ingredient.

    In total, 29% of the products targeted by FDA warning letters remained available for purchase, and most of them were adulterated with unapproved ingredients.

    “This study raises questions regarding the FDA’s actions to ensure that manufacturers are compliant with the agency’s warning letters. The FDA should consider ways to ensure that prohibited drugs are removed from supplements, perhaps by testing products sold after warning letters and mandating recalls whenever products remain adulterated,” the authors concluded.

    Time to Act on Authority 

    Megan Olsen, senior vice president and general counsel at the Council for Responsible Nutrition (CRN), said that warning letters alone aren’t consequential enough to be perceived as sufficient threats to bad actors.

    “It is unfortunately the case that the agency is not doing its job when one can find the same rogue ingredients in the same bad products six years after warning letters have been issued,” Olsen said. “This study demonstrates that warning letters alone are not viewed as sufficient threats by bad actors and outliers. FDA should stop assuming that everyone in the market wants to do the right thing.

    “FDA has recently been asking for new so-called ‘prohibited acts’ authority to clean up the industry,” she added. “In other words, FDA wants clear-cut ability to address illicit substances that have never been marketed as drugs, nor even studied for their potential effects, but are nevertheless marketed as supplements.”

    CRN supports this legislative priority, insofar as expanding the agency’s authority over substances that aren’t implicated by the “drug preclusion” clause of the Dietary Supplements Health and Education Act (DSHEA). While the agency can mandate recalls of dietary supplement products, it is only done in rare instances. The agency often instead requests that companies conduct voluntary recalls.

    “These illicit substances may be currently caught in a legal no-man’s land—not supplements, not drugs, and without this new authority, not clearly within FDA’s enforcement,” Olsen said. “This simple change to the law, currently part of the Senate HELP committee’s user fee legislation, would give FDA capacity that much of the industry believes it already has but FDA has been requesting explicit statutory language to clarify.”

    Like Olsen, Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA) said that he also supports comprehensive reforms to offer FDA clear authority to go after products that contain dangerous prohibited ingredients.

    “There can be no tolerance for illegal products masquerading as dietary supplements, especially after a manufacturer has already received an FDA warning letter. Yet, that is precisely what was found […] The troubling situation highlights the need for increased enforcement of current law by the FDA and the Department of Justice, and the need for more comprehensive reform of dietary supplement regulation.”

    According to Melville, the mandatory product listing (MPL) provision of the current user fee registration bill being considered by Congress won’t go far enough. Beyond MPL, he said FDA should also be able to increase facility inspections and remote regulatory assessments, the latter of which is an informal assessment of a facility that was introduced during the height of the COVID-19 pandemic.

    “As the House and Senate confer on FDA user fee reauthorizations, the need to balance consumer access to safe and beneficial dietary supplements with FDA’s ability to swiftly remove dangerous and illegal products from the marketplace should be recognized to ensure that any agree-to reforms are meaningful and not reform in name only,” Melville said.

    NPA: FDA Should Do More with the Tools it Has

    According to Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), FDA appears unwilling to take steps such as product seizures and injunctions, which it already has the authority to do. In contrast to CRN, NPA does not support granting the agency more authority when it doesn’t utilize existing tools. 

    Another point of contention is the fact that FDA’s facility inspections have been declining in frequency some time, irrespective of funding, Fabricant said. He noted that a report from the Office of the Inspector General concluded that even in response to significant inspection violations, follow-up from the agency to ensure corrections were made by the facility was rare.

    “This study reaffirms FDA’s performance failure gaps going back to a report published by the Office of the Inspector General in 2017. Companies who receive a warning letter are required to notify FDA within 15 days of receipt of their warning letter and the specific steps they have taken to address any violations. Failure to do so is supposed to result in legal action including seizure and injunction. This should be considered low-hanging fruit for the agency but it’s obvious there’s an element of willpower that’s absent.

    “These gaps in actions indicate that new authorities to the FDA clearly aren’t warranted, when current authorities, where problems have been located, aren’t followed up with,” Fabricant continued. “This study makes it clear the agency has adequate authority to pursue products masquerading as dietary supplements, the repeated absence of follow-through requires oversight and accountability.”



    Related Searches
    • Quality & Safety
    • Regulations
    • Dietary Supplements
    • Testing
    Related Knowledge Center
    • Testing
    • Quality & Safety
    • Regulations
    • Dietary Supplements
    Suggested For You
    ODSP Director Highlights Agency Priorities Amid Proposed Reorganization ODSP Director Highlights Agency Priorities Amid Proposed Reorganization
    CRN: FDA’s Guidance on Master Files Lacks Necessary Enforcement Protocols CRN: FDA’s Guidance on Master Files Lacks Necessary Enforcement Protocols
    Apex Compliance Launches Software Tool to Streamline Regulatory Risk Review Apex Compliance Launches Software Tool to Streamline Regulatory Risk Review
    The Pet Health Boom: Supplement Growth Set to Build on Rapid Expansion The Pet Health Boom: Supplement Growth Set to Build on Rapid Expansion
    Dietary Supplement Quality Assurance Programs Critical to Natural Products Industry Success Dietary Supplement Quality Assurance Programs Critical to Natural Products Industry Success
    CBD Expectations: What Happens at FDA and Congress After Agency Seeks New Regulatory Pathway? CBD Expectations: What Happens at FDA and Congress After Agency Seeks New Regulatory Pathway?
    The Top 10 Articles of 2022 on NutraceuticalsWorld.com The Top 10 Articles of 2022 on NutraceuticalsWorld.com
    What People Were Reading in November 2022 on NutraceuticalsWorld.com What People Were Reading in November 2022 on NutraceuticalsWorld.com
    FDA Warning Letters Take Aim at Foods and Beverages Containing CBD FDA Warning Letters Take Aim at Foods and Beverages Containing CBD
    FDA Warns Companies Allegedly Making Heart Disease Claims FDA Warns Companies Allegedly Making Heart Disease Claims
    Ingredients By Nature Ingredients By Nature
    Council for Responsible Nutrition (CRN) Council for Responsible Nutrition (CRN)
    Trace Minerals Trace Minerals
    Supplyside West Event Info Supplyside West Event Info
    Windrose Partners LLC Windrose Partners LLC

    Related Online Exclusives

    • Dietary Supplements | Quality & Safety | Regulations
      ODSP Director Highlights Agency Priorities Amid Proposed Reorganization

      ODSP Director Highlights Agency Priorities Amid Proposed Reorganization

      Dr. Cara Welch said the agency is eyeing many regulatory efficiencies.
      By Mike Montemarano, Associate Editor 09.18.23

    • Breaking News | Dietary Supplements | Industry & Market News | Regulations
      CRN: FDA’s Guidance on Master Files Lacks Necessary Enforcement Protocols

      CRN: FDA’s Guidance on Master Files Lacks Necessary Enforcement Protocols

      Without dedicated enforcement, the NDI program will remain as ineffectual as it is today, said Steve Mister, president and CEO of CRN.
      08.10.23

    • Breaking News | Dietary Supplements | Industry & Market News | Regulations
      Apex Compliance Launches Software Tool to Streamline Regulatory Risk Review

      Apex Compliance Launches Software Tool to Streamline Regulatory Risk Review

      The software was developed by regulatory expert Asa Waldstein.
      07.07.23


    • Consumer Trends | Delivery & Dosage Technologies | Dietary Supplements | Pet Nutraceuticals | Quality & Safety | Regulations | Research | Testing
      The Pet Health Boom: Supplement Growth Set to Build on Rapid Expansion

      The Pet Health Boom: Supplement Growth Set to Build on Rapid Expansion

      The pandemic compelled many people to add a furry friend to their family, and their spending habits demonstrate a dedication to health.
      By Sean Moloughney, Editor 05.30.23

    • Contract Manufacturing | Dietary Supplements | Quality & Safety | Regulations | Testing
      Dietary Supplement Quality Assurance Programs Critical to Natural Products Industry Success

      Dietary Supplement Quality Assurance Programs Critical to Natural Products Industry Success

      Practical steps to implementing quality measures and ensuring compliance with FDA regulations.
      By Haven McCall, DRSc, CEO, Canyon Labs 02.14.23

    Loading, Please Wait..
    Trending
    • Todd Spear Joins Protein Research As VP Of Sales And Marketing
    • Clinical Trial Shows Long-Term Joint Health Benefits Of PLT’s Boswellia Serrata Extract
    • Shiitake Mushroom Extract Appears Helpful In HPV Infections
    • HMB And Vitamin D Supplementation Linked To Reduction In Fat Stores
    • Soviets Took Probiotics To The Next Level
    Breaking News
    • GOED Releases Sustainability Report for Omega-3s Industry
    • ABC’s Journal HerbalGram Celebrates 40th Anniversary
    • Curcumin May Be As Effective as PPI for Indigestion
    • Adding Human Milk Component to Formula Linked to Long-term Cognitive Benefits for Babies
    • Women in Nutraceuticals Launches Pilot Mentorship Program
    View Breaking News >
    CURRENT ISSUE

    September 2023

    • A Clearer Path to Weight Management: The Ozempic Factor
    • Under Pressure: Stress and Mental Health Have Taken Center Stage
    • Sustainable Business Development: Principles and Strategies for Progress
    • BIOHM Health Targets ‘Digestive Plaque’ with Probiotic, Fungus, and Enzyme Formula
    • 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

    ABC’s Journal HerbalGram Celebrates 40th Anniversary
    Curcumin May Be As Effective as PPI for Indigestion
    Adding Human Milk Component to Formula Linked to Long-term Cognitive Benefits for Babies
    Coatings World

    Latest Breaking News From Coatings World

    Nouryon Manufacturing Network Transitions to 100% Electricity From Renewable Sources in Brazil
    Jay Doubman Named President and CEO of ICP Group
    “MyCarbonFootprint”: BASF Launches Dashboard for Sustainable Procurement
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA Clears MeMed BV Direct From Whole Blood
    Biostrap Debuts Tool to Measure Stress Resilience, Heart Rate Variability
    EndoTheia Announces Positive Study Results for Endoscopic Surgery Device
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Chime, Panolos Partner to Advance Multi-specific Therapeutic Proteins
    SocietalCDMO Announces Corporate Restructuring
    Altasciences Selected by Virpax to Support Flu Drug
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Hailey Bieber's Rhode Expands Into Makeup
    Avon Enters Retail Partnership with Superdrug
    IT Award Winners Announced at MakeUp in NY
    Happi

    Latest Breaking News From Happi

    Color Street Launches ‘Don’t Be Afraid’ Halloween Nail Art Collection
    Ideal Image Offers FDA-Approved Alternative to Botox
    Divi Expands in Stores at Ulta Beauty Tripling Footprint
    Ink World

    Latest Breaking News From Ink World

    INKBANK Lays Foundation for Science and Technology Park
    Successful Labelexpo Europe 2023 Concludes in Brussels
    Recyclable, Deinkable Stand-Up Pouch Wins Gold
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Flexo Wash to exhibit at FTA Fall Technical Conference
    Recyclable, deinkable stand-up pouch wins Gold in Germany
    Elkem highlights thermal protection and battery assembly products
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Lenzing Earns EU Ecolabel at Indonesian Plant
    Albis Completes Work On Extra Wide Carding, Blending Line
    Ahlstrom Launches Nonwoven Laundry Care Product
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Anika Releases RevoMotion Reverse Shoulder Arthroplasty System
    Exactech's Activit-E Polyethylene OK'ed for Vantage Total Ankle
    Tyber Nets Several Regulatory Nods for K-Wires, Steinmann Pins
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    HMI Specialist RAFI Acquires Xymox Technologies Inc.
    Infineon Heads EECONE European Research Project
    NXP Honored with Prestigious Automotive Awards

    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