• 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
    Kensing Acquires Vitae Naturals

    CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise

    Shiitake Mushroom Extract Appears Helpful in HPV Infections

    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected

    United Plant Savers Launches First Film Festival
    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

    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

    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    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

    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

    Botanical Gum for Kids Aims to Curb Sugar Cravings
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Gencor

    Atlantia Clinical Trials

    Sabinsa Corporation

    Bioenergy Life Science, Inc. (BLS)

    Ecuadorian Rainforest
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Gencor

    Atlantia Clinical Trials

    Sabinsa Corporation

    Bioenergy Life Science, Inc. (BLS)

    Ecuadorian Rainforest
    • 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 Yet to Give Definitive Response on NAC Supplements

    After issuing warning letters to companies claiming that NAC is excluded as a dietary ingredient, the agency's response to citizen petitions is still tentative.

    FDA Yet to Give Definitive Response on NAC Supplements
    Related CONTENT
    • Kensing Acquires Vitae Naturals
    • Shiitake Mushroom Extract Appears Helpful in HPV Infections
    • Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    • Florida Food Products Acquires Javo
    • New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    By Mike Montemarano, Associate Editor12.06.21
    This story was updated on December 7, 2021.
     
    In the latest response to citizen petitions it received from dietary supplement trade associations, the U.S. Food and Drug Administration (FDA) has not provided a conclusive determination on the status of N-Acetyl-Cysteine, and whether it considers it lawful to market it as a dietary ingredient.
     
    Since last year, FDA has made it apparent that it holds a newfound position that NAC, an amino acid metabolite and precursor to glutathione which has been widely incorporated into dietary supplements for several decades, is excluded from meeting the definition of a dietary ingredient.
     
    This revelation came in December 2020 when FDA issued multiple warning letters to companies selling supplements containing NAC. The agency cited that NAC was approved as a new drug in 1963. Since the warning letters were first issued, several major retailers have discontinued the sales of supplements containing NAC on their platforms, including Amazon.
     
    Since the agency issued these warning letters at the end of last year, both the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have each submitted unique citizen petitions to the agency, objecting to this policy reversal on the grounds that it was widely available as a dietary ingredient before the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
     
    Additionally, NPA filed a lawsuit against FDA due to the fact that it hasn’t provided a decisive response in the form of scheduling a hearing on its citizen petition.
     
    “We have not reached a decision on your petition because of the complex nature of your request and research that we are still working to complete,” Douglas Stearn, deputy director for regulatory affairs at the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, said in the agency’s response. Stearn invited the trade associations to submit information on the earliest date that NAC was marketed as a dietary supplement or food, as well as studies covering the safety of NAC which could bear the determination of an acceptable daily intake.
     
    ‘Going Against Precedent’
    A key provision of DSHEA is that ingredients in use in dietary supplements prior to its enactment are grandfathered into the supplement marketplace. According to NPA, the legislation also includes a “race to market” paradigm which indicates that any article marketed as both a drug and dietary ingredient prior to its passage should be allowed to continue to be marketed as both, as is the case with such ingredients as L-carnitine and caffeine, but many others as well.
     
    NAC was approved in 1963 as an inhalant branded as Mucomyst which was intended to be used as treatment for acetaminophen poisoning. However, it was also widely sold as a supplement ingredient prior to DSHEA’s passage. Today, there are hundreds of supplements containing NAC on the market which FDA has taken no action against, and the agency has approved at least one qualified health claim for NAC without objecting to the use of it in dietary supplements.
     
    Furthermore, the trade associations note that FDA, in its warning letters and correspondence, has not provided any indication that its objection stems from safety concerns.
     
    “The legal issues here are clear,” Steve Mister, president and CEO of CRN, said. “The provisions of [DSHEA] may not be interpreted retroactively to remove ingredients that were lawfully marketed in 1994 and have enjoyed a long history of safe use since then. The delay in clearing up the status of NAC by asking for more data and refusing to admit its error disregards the law and disserves consumers who use NAC […] Pharmaceutical manufacturers could not have had any expectation of exclusivity in the years prior to the creation of the provision of the law. Given the long history of safe use of NAC, FDA cannot now try to establish a safety concern in order to award this ingredient exclusively to drug makers.”
     
    What Does This Mean for the Future? 
    Unique to NPA’s citizen petition to FDA on the issue of this ingredient is its request for a Part 15 hearing, which is an evidentiary public hearing taking place before the commissioner of the agency. The trade association sued FDA due to the fact that the agency did not schedule this hearing, which requests that the agency issue a declaratory judgment that DSHEA’s drug exclusion rule doesn’t retroactively apply to NAC.
     
    In essence, the lawsuit claims that FDA does not have the authority to take final action in applying the drug preclusion component of DSHEA retroactively, as this is contradictory to the legislation. “There was no provision in DSHEA or its legislative history to overcome the presumption against statutory retroactivity. Congress expressed no clear intent in the text of DSHEA or its legislative history to support FDA’s erroneous legal determination. The legislative history shows that the drug provision was not intended to apply retroactively,” the suit reads.
     
    “We are concerned that a safe, legal natural product that has been sold for over 30 years is under what appears to be a regulatory sneak attack by the FDA, and even more concerned if this illegal approach may be used for other ingredients,” Dr. Daniel Fabricant, president and CEO of NPA, said. “The FDA has gotten this wrong at every step of the way, and we’ve been left with no choice but to seek relief from the courts. The FDA’s actions against NAC represent a reckless misuse of government resources and will to nothing to protect public health. We are hopeful that the agency will get back to its job of appropriately regulating the U.S. food and drug supply.”
     
    Prior to NPA filing suit Fabricant spoke with Nutraceuticals World about what FDA’s treatment of NAC in this case could mean for any ingredient whose use was first documented archivally as a pharmaceutical drug.
     
    “FDA sat on the fence in their letter back to us, which they really can’t do by law, they either have to initiate a rulemaking process or deny it,” Daniel Fabricant, president and CEO of NPA, said. “Like any other federal agency, FDA is governed by rules of procedure, and they can’t leave it hanging forever; that’s not how that works.”
     
    No other dietary supplement has received the kind of targeting that NAC experienced starting at the end of 2020, Fabricant said, and it sets a very concerning premise for a plethora of ingredients which have been investigated in the past for usage in drug applications, including letter vitamins, and even in theory, table salt and caffeine.
     
    “This could lead to a whole myriad of problems for other ingredients,” Fabricant said. “We could look at prescription niacin (vitamin B3) for example, which dates back to the late 40s. I don’t know anyone who has catalogs of niacin being sold as a dietary supplement which date that far back, so what should we do? Should niacin never again be available as a dietary supplement? They’ve never done this before, because it’s completely at odds with DSHEA and is a misinterpretation of the law.”
     
    “Any alphabet vitamin, minerals, and more have been cataloged as drugs before they were as supplements. The whole premise is crazy when you think about it,” Fabricant continued.
     
    The precise basis for why FDA is acting relatively quickly to remove NAC from the marketplace is unknown, Fabricant noted, and whatever safety concerns the agency might have with it are not being made clear if they do exist.
     
    “I don’t know what’s driving the agency on NAC in particular, it’s a complete black box, and when we try to get information and go through processes such as the citizen’s petition, we get the response that they’ll maybe write a regulation. The agency should either do it or not, because we don’t know if the way forward will be through the courts, or through a regulation. I’m not sure why this is the hill that FDA considers worth dying on, and we don’t know exactly what it is they’re fighting for here.”
     
    Related Searches
    • Proteins, Peptides, Amino Acids
    • Dietary Supplements
    • Regulations
    • Quality & Safety
    Related Knowledge Center
    • Proteins, Peptides, Amino Acids
    • Quality & Safety
    • Regulations
    Suggested For You
    Ingredia Ingredia
    Prinova Prinova
    Kensing Acquires Vitae Naturals Kensing Acquires Vitae Naturals
    Shiitake Mushroom Extract Appears Helpful in HPV Infections Shiitake Mushroom Extract Appears Helpful in HPV Infections
    Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    Florida Food Products Acquires Javo Florida Food Products Acquires Javo
    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development
    CHPA Hires Two Key Personnel CHPA Hires Two Key Personnel
    Study Reveals Low Intake of Tocotrienols in Polish Population Study Reveals Low Intake of Tocotrienols in Polish Population
    Botanical Gum for Kids Aims to Curb Sugar Cravings Botanical Gum for Kids Aims to Curb Sugar Cravings
    IFT Annual Meeting Event Info IFT Annual Meeting Event Info
    Childhood Fitness and Obesity Impact Cognition Later in Life, Study Finds Childhood Fitness and Obesity Impact Cognition Later in Life, Study Finds
    Danone Invests in Plant-Based Beverage Brand Minor Figures Danone Invests in Plant-Based Beverage Brand Minor Figures
    Jamieson Wellness to Acquire Nutrawise Health & Wellness Beauty Corporation Jamieson Wellness to Acquire Nutrawise Health & Wellness Beauty Corporation

    Related Breaking News

    • Antioxidants | Breaking News | Contract Manufacturing | Industry & Market News | Mergers & Acquisitions
      Kensing Acquires Vitae Naturals

      Kensing Acquires Vitae Naturals

      The acquisition will strengthen the supplier’s European footprint with a complementary portfolio.
      06.28.22

    • Breaking News | Dietary Supplements | Herbs & Botanicals | Immune Function | Medical Nutrition | Research | Research News | Sexual & Reproductive Health
      Shiitake Mushroom Extract Appears Helpful in HPV Infections

      Shiitake Mushroom Extract Appears Helpful in HPV Infections

      Nearly two thirds of study participants had cleared their HPV infections by the end of the study duration.
      06.27.22

    • Breaking News | Dietary Supplements | Functional Foods & Beverages | Industry & Market News | World Markets
      Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected

      Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected

      The in-person/online hybrid event is slated for Dec. 6-8.
      06.27.22


    • Breaking News | Functional Foods & Beverages | Mergers & Acquisitions | Supplier News
      Florida Food Products Acquires Javo

      Florida Food Products Acquires Javo

      The acquisition of the clean label coffee, tea, and botanicals specialist will diversify FFP’s portfolio of natural ingredients and products.
      06.23.22

    • Breaking News | Dietary Supplements | Industry & Market News | Regulations | World Markets
      New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy

      New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy

      Gerhard Gans, elected to IADSA on June 22, noted positive developments taking place in Europe.
      06.23.22

    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
    Breaking News
    • Kensing Acquires Vitae Naturals
    • CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise
    • Shiitake Mushroom Extract Appears Helpful in HPV Infections
    • Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
    • United Plant Savers Launches First Film Festival
    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

    Kensing Acquires Vitae Naturals
    CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise
    Shiitake Mushroom Extract Appears Helpful in HPV Infections
    Coatings World

    Latest Breaking News From Coatings World

    Sheboygan Paint Company Adds Rosey Malchow as Customer Experience Manager
    PPG to Announce Second Quarter 2022 Results July 21
    Evonik Unveils Range of Sustainable Liquid Polybutadienes
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Researchers Develop New Apparatus for the Treatment of Cardiovascular Diseases
    NovaXS Unveils New Prototype of Needle-Free Injection Therapy Smart Medical Device
    Meddux Opens New Facility in Boulder, Colorado
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Phastar Appoints Chris Schoonmaker as Chief Operations Officer
    Charles River Labs Opens Plasmid DNA CoE in Cheshire, UK
    EQT Private Equity Acquires SPT Labtech from Battery Ventures
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Highlights from Paris Packaging Week
    Walgreens Boots Alliance Decides Not to Sell Boots and No7 Beauty Company Businesses
    WWP Beauty Unveils New Packaging Collections in Collaboration with Eastman
    Happi

    Latest Breaking News From Happi

    Evonik Holds Groundbreaking Ceremony for Commercial Rhamnolipid Production Facility
    CHT USA Hosts Groundbreaking Ceremony for $20 Million US Headquarters Expansion
    Azelis Expands Global Flavors & Fragrances Platform with Acquisition in India
    Ink World

    Latest Breaking News From Ink World

    Temporary Content Title
    Amcor Lift-Off Initiative Shortlists Start-ups for Seed Funding
    Barentz Highlights Lincoln MFG’s New ISO 9001:2015 Certification
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Sibress launches FADS3D flexo plate measuring device
    Mike Brown appointed VP for Davis-Standard’s Canadian operations
    Constantia Flexibles introduces chemical resistant recycle-ready laminate
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Suominen Launches Hydraspun Reserve
    Richard Knowlson Receives Lifetime Technical Achievement Award
    Skylark Launches Thicker Label Closure Technology in North American
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Tecomet Appoints Bill Dow as President & CEO
    Medacta, InSilicoTrials Partner on Orthopedic Device Development
    Researchers Develop Microfluidic Sensors to Improve Implant Survival Rates
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Avery Dennison Launches New Dual-Frequency RFID Inlay
    Avery Dennison Highlights New Approach to Apparel with ADX Lab
    trinamiX Face Authentication Protects Users from Fraud Attacks During Mobile Payments

    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