• 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
    Nutraceuticals for Men: Muscle Health and Performance Nutrition

    Aging in Place: Healthy Lifestyles Supplement Science-Based Solutions

    Getting an Edge in Esports: Meeting the Health Needs of Competitive Gamers

    Beyond CBD: Cannabis Compounds Warrant Recognition and More Research

    Leveling Out the Energy Segment for Mainstream, and Rethinking Caffeine
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
    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

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort

    Cargill’s Stevia Sustainability Program Benchmarked by FSA

    GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe
    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

    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports

    GC Rieber Foundations Expand Philanthropic Efforts

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
    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

    Thorne Relaunches Gut Health Test with Microbiome Wipe

    Danone Celebrates 10th anniversary of Grant Program for Probiotics Research

    Beyond Raw Launches Concept X Pre-Workout Line

    Botanical Ingredient MorActive Evidenced to Relieve Back Discomfort

    Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Botanic Healthcare LLC

    KLK OLEO

    Applied Food Sciences, Inc.

    Xsto Solutions

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

    KLK OLEO

    Applied Food Sciences, Inc.

    Xsto Solutions

    Gencor
    • 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

    Warning Letters: What Authority Do They Carry?

    An FDA warning letter is informal and advisory. It communicates the agency’s position on a matter, but does not commit the agency to taking enforcement action.

    Warning Letters: What Authority Do They Carry?
    By Todd Harrison, Venable06.02.21
    The past year of the COVID-19 pandemic and associated lockdown has brought a spate of warning letters from FDA that have attacked, in some cases, legitimate blogs that are not intended to market products. Other warning letters have offered questionable legal positions on whether certain ingredients are actually permissible dietary ingredients. 
     
    While FDA has the right to issue these warning letters, they are often misused by class action plaintiff lawyers, platforms, e-tailers, and payment processors as a basis of cutting off business with companies or excluding products from the market. If this was not bad enough, plaintiff attorneys use these letters as a basis to allege that products are unlawfully marketed and, therefore, serve as a basis for deceptive trade practice class action under various state laws.
     
    Also, enter into this world companies that have sold themselves to many platforms and e-tailers as gatekeepers of all things FDA. Yet, these companies themselves often do not understand the meaning behind warning letters. Rather—without any critical thinking or research— they even attempt to determine whether FDA’s position is legally valid.
     
    Not Final Agency Action
    Indeed, to put it bluntly, FDA can issue a warning letter for a host of things—and be wrong on every single point—knowing that a company has little legal recourse because a warning letter is not considered final agency action. Effectively, this strategy precludes a company from suing FDA over a position it has set forth in a warning letter. To make matters worse, FDA often does not publish the company’s responses to warning letters on its website, thereby only providing the agency’s view on matters.
     
    The FDA’s most recent warning letters on CBD and NAC provide an excellent example of a one-sided conversation regarding the issues. As companies in the nutraceuticals world are aware, FDA has issued warning letters stating that CBD and NAC cannot be used as ingredients in dietary supplements. However, reliance on the FDA’s warning letters by third parties is misguided at best, and at worst removes validly marketed products from the marketplace.
     
    Informal & Advisory
    Importantly, FDA warning letters are not law, nor are they legally binding on any entity. Rather, warning letters constitute FDA’s request to a particular company to achieve voluntary compliance with its recommendations, and to establish prior notice as to that company. (See U.S. Food & Drug Administration, Inspections, Compliance, Enforcement, and Criminal Investigations Regulatory Procedures Manual (the “Manual”), Section 4-1-1.)
     
    In this respect, an FDA warning letter “is informal and advisory. It communicates the agency’s position on a matter, but does not commit FDA to taking enforcement action.” The Manual states that the violations for which warning letters are issued “may lead to enforcement action if not promptly and adequately corrected,” not that they inevitably will. The Manual further provides that “[a] Warning Letter is informal and advisory. It communicates the agency’s position on a matter.” For these reasons, neither FDA nor reviewing courts consider warning letters to be final agency action on an issue. (Id. See also Holistic Candlers & Consumers Ass’n v. Food & Drug Admin., 664 F.3d 940, 943 (D.C. Cir. 2012).)
     
    FDA has many enforcement tools available that have direct legal consequences. Such tools include filing an injunction in federal district court, initiating a seizure against violative products, and filing a criminal complaint. (See 21 U.S.C. § 331 et seq.) Warning letters, on the other hand, “[do] not mark the consummation of FDA’s decision making process.” (Holistic Candlers and Consumers Ass’n v. Food and Drug Admin., Brief of Food and Drug Administration, 2012 WL 3991471 (U.S.), at 9-10.) Instead, warning letters invite companies to respond with further information to aid the FDA’s considerations of the concerns raised.
     
    Of great importance, multiple courts have reiterated that warning letters are not final agency action sufficient to establish legal obligations on the industry. (Holistic Candlers & Consumers Ass’n v. FDA., 664 F.3d 940, 944 (D.C. Cir. 2012).) FDA warning letters do not represent final agency action subject to judicial review, and “[i]n short, an FDA warning letter compels action by neither the recipient nor the agency.” (See also Orton Motor, Inc. v. United States Dep’t of Health & Human Servs., 884 F.3d 1205, 1215 (D.C. Cir. 2018).) “This Court has rejected the idea that an FDA warning letter itself is a consequence subject to judicial review ... The lack of legal consequences distinguishes an FDA warning letter in this context...”); CytoSport, Inc. v. Vital Pharm., Inc., 894 F. Supp. 2d 1285, 1294 (E.D. Cal. 2012), “FDA warning letters are informal and advisory, and do not amount to an FDA action.”
     
    Opening Arguments
    Thus, FDA’s warning letters are not final agency actions, but rather an opening statement of its current reasoning and an invitation to those with legal and factual arguments to respond and present an alternative point of view. For instance, the hemp and dietary supplement industry has pushed back significantly on FDA’s position on CBD.
     
    Similarly, the dietary supplement industry is pushing back on FDA in regard to NAC. Yet, third parties appear unwilling to consider the agency is incorrect in its application of the law, nor attempt to make an independent determination about whether FDA’s position within the warning letter is correct—except relying on another third party, which quite frankly does not appear to understand the meaning behind a warning letter. Rather, they simply believe if they sell or process payment then they are running afoul of the law. But FDA’s position is not binding on the legality or regulatory status of CBD or NAC.
     
    No Redress
    Unfortunately, other than engaging in these discussions, the industry’s current options to pursue redress against FDA’s position on CBD and NAC are limited. For example, the industry cannot file a lawsuit requesting that a court establish the legality of either ingredient challenging FDA’s warning letters because these letters do not constitute “final agency action” that can form the basis of such a lawsuit.
     
    More specifically, the Administrative Procedures Act, which provides an avenue for challenging agency actions in federal district court, precludes such lawsuits unless FDA has taken “final agency action” establishing legal obligations, which it has not done with CBD and NAC (because, as noted above, its warning letters are only advisory and informal).
     
    Final agency action in this instance would be either the issuance of a final rule finding that neither CBD nor NAC are dietary ingredients after formal notice and comment period, or a binding court decision establishing the ingredient’s legality.  
     
    The greater issue, however, is that FDA simply leaves these warning letters sitting out there with no available recourse by a company that has received one, or other companies that are impacted by the warning letters. FDA often issues warning letters without taking formal enforcement action against a company—with no apparent regard for the necessity to resolve the issue by going through the administrative process to exclude a dietary ingredient.
     
    Final Ruling
    Indeed, the best way for the agency to deal with these concerns regarding whether an ingredient that has been on the market for decades (like NAC) is legal, is to issue an Advanced Notice of Proposed Rulemaking or a Proposed Final Rule and allow industry to comment on it. 
     
    In the meantime, third parties should understand that a warning letter does not establish violation of the law, but only represents the FDA’s present thinking on a particular matter. In regard to CBD and NAC, the agency should go through the rulemaking process rather than raising issues in warning letters regarding the regulatory status of the ingredient.
     
    By doing so, FDA would do itself and industry a favor because it would allow industry to engage in a public manner and allow the agency to issue a final rule (one way or the other), which can be challenged by industry if the final rule is believed to be wrong.
     
    In the meantime, third parties should not treat a warning letter as a conclusive violation of the law, especially when there is a genuine dispute whether the agency is correct, and especially when dealing with a dietary ingredient that has been marketed for decades without any enforcement action. I encourage everyone marketing CBD and NAC to raise this significant issue and distinctions with companies that are unjustifiably relying on a warning letter to establish that a product violates the law.


    About the Author: Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
    Related Searches
    • Regulations
    • Dietary Supplements
    • Quality & Safety
    Related Knowledge Center
    • Regulations
    • Dietary Supplements
    • Quality & Safety

    Related Content

      Trending
      • Leaven Essential To Launch Branded Botanical Extracts To Global Markets | Nutraceuticals World
      • Oregon Files Lawsuit Against GNC | Nutraceuticals World
      • Vitamin D3, Omega-3s, Exercise May Cumulatively Reduce Cancer Risk In Older Adults | Nutraceuticals World
      • Coca-Cola To Phase Out Honest Tea Brand By Year’s End, Citing Supply Chain Challenges | Nutraceuticals World
      Breaking News
      • Thorne Relaunches Gut Health Test with Microbiome Wipe
      • Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      • GC Rieber Foundations Expand Philanthropic Efforts
      • Danone Celebrates 10th anniversary of Grant Program for Probiotics Research
      • Stratum Nutrition’s Patent Portfolio Grows to Europe and Canada
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Aging in Place: Lifestyle Supplements Science-Based Solutions
      • Getting an Edge in Esports: Meeting Health & Nutrition Needs
      • Nutraceuticals for Men: Muscle Health and Performance Nutrition

      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

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      PPG Hosts The Future of Coatings' Technology Innovation Day in Amsterdam
      Azelis Expands Presence in India with Acquisition of Chemo India and Unipharm Laboratories
      Teknos Publishes Sustainability Report
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Pediatric Medical Device Competition Reveals Five Finalists
      Medical Device Packaging Market to Reach $34B by 2027
      Penumbra Secures CE Mark for its Advanced Mechanical Thrombectomy Tech
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Mirum Pharmaceuticals Acquires San Diego-based Satiogen
      Catalyst Biosciences Sells Complement Portfolio to Vertex Pharmaceuticals
      Insmed Appoints Drayton Wise as Chief Commercial Officer
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      La Roche-Posay Launches Matte Moisturizer for Oily Skin
      3 Amorepacific Employees Stole $2.3 Million
      L'Oreal CEO Nicolas Hieronimus On Sustainability Initiatives
      Happi

      Latest Breaking News From Happi

      Thayers Natural Remedies Celebrates 175 Years with Social Campaign
      Former Model Shirley Powell’s Indie Beauty Brand LaJeanell Comprises Gender Inclusive Skincare and Makeup
      L’Oréal's New UVMune 400 Sun Filtering Technology Protects Skin From Ultra-Long UVA Rays
      Ink World

      Latest Breaking News From Ink World

      Flint Group Flexible Packaging Europe Implements Further Price Increase
      Nazdar Launches 205 Series Inks for Roland TrueVIS SG2 and VG2 Series Printers
      Quad Adds Landa S10P Nanographic Printing Press
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      AWA to host 22nd Global Release Liner Industry Conference & Exhibition
      Domino assists Grace Label with supply chain disruptions
      Rotocon wins AI Business Excellence Award
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Study Confirms Knee Shapes are Highly Individualized
      Stryker Launches EasyFuse Dynamic Compression for Foot & Ankle
      Extremity Medical Rolls Out OMNI Stable Ankle Fracture System
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      InnovationLab Acquires Flexible Printed Battery Technology from Evonik
      Canatu Receives IATF 16949:2016 Certification
      Applied Materials Announces 2Q 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