• 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
    Xsto Solutions

    Aiya America, Inc. (Aiya Matcha)

    Atlantia Clinical Trials

    Applied Food Sciences, Inc.

    Verdure Sciences
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Xsto Solutions

    Aiya America, Inc. (Aiya Matcha)

    Atlantia Clinical Trials

    Applied Food Sciences, Inc.

    Verdure Sciences
    • 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
    Breaking News

    Federal Judge Approves Consent Decree with Company that Sold Adulterated Products

    MyNicNaxs distributed weight loss and sexual enhancement products that contained active pharmaceutical ingredients.

    Related CONTENT
    • Lonza Appoints Christian Seufert as President of Capsules, Health Ingredients
    • An Interview with Charlie Kotani, President, Charlie K Consulting
    • Daniel Wiley Joins KD Pharma Group as Vice President of Special Projects
    • FDA Warns Against Male Enhancement and Weight Loss Products Sold Online
    • Bio Health Worldwide Virtual Event Open Until Oct. 30
    03.28.18
    A federal court ordered a Florida-based company to stop selling drugs and dietary supplements until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.
     
    The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction between the U.S. and MyNicNaxs, LLC of Deltona, FL; Chevonne Torres, the company’s owner; and Michael Banner, an officer at the company. MyNicNaxs distributed weight loss and sexual enhancement products, which the company marketed as dietary supplements, directly to consumers online through the websites www.mynicnaxs.com and www.ruglamourous.com. Some of these products tested positive for undeclared active pharmaceutical ingredients.
     
    “Marketing products with undeclared active pharmaceutical ingredients poses serious safety risks to consumers. These types of products are particularly concerning because consumers do not know what the products actually contain, and the undeclared ingredients may cause serious, even life threatening, adverse reactions,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Despite previous warnings, MyNicNaxs continued violating the law. The FDA will continue to take action to protect the American public when companies knowingly violate the law and put consumers at risk.”
     
    According to the complaint filed with the consent decree, FDA tests showed some of the MyNicNaxs products contained undisclosed pharmaceutical ingredients such as:
     
    • Sildenafil, the active pharmaceutical ingredient in Viagra;
    • Sibutramine, the active pharmaceutical ingredient in Meridia, a drug that was withdrawn from the market after clinical data indicated that it poses an increased risk of heart attack and stroke; and
    • Phenolphthalein, an ingredient that the FDA deemed “not generally recognized as safe and effective” after studies indicated that it was a potential carcinogenic risk.
     
    The complaint alleged that certain MyNicNaxs products are drugs under the FD&C Act because they are intended to cure, mitigate, treat or prevent disease. Further, the drugs are misbranded because their labeling is false and misleading in that it does not declare certain active pharmaceutical ingredients, their labeling fails to bear adequate directions for use, and/or the drugs are dangerous to health when used as recommended in the labeling.
     
    The permanent injunction requires the defendants to cease directly or indirectly distributing any unapproved new drugs or misbranded drugs. MyNicNaxs is prohibited from receiving, manufacturing, holding and distributing any drugs or dietary supplements until it receives a written notification from the FDA stating that it appears to be in compliance with the decree, the FD&C Act, and its regulations, and that it may resume operations.
     
    In 2015, the FDA issued a warning letter to MyNicNaxs after it was discovered that the company continued to sell unapproved new drugs and misbranded drugs. The U.S. Department of Justice filed the complaint on behalf of the FDA.
     
    Related Searches
    • fda
    • Dietary Supplements
    • Research
    • Health
    Related Knowledge Center
    • Quality & Safety
    • Regulations
    Suggested For You
    Lonza Appoints Christian Seufert as President of Capsules, Health Ingredients Lonza Appoints Christian Seufert as President of Capsules, Health Ingredients
    An Interview with Charlie Kotani, President, Charlie K Consulting An Interview with Charlie Kotani, President, Charlie K Consulting
    Daniel Wiley Joins KD Pharma Group as Vice President of Special Projects Daniel Wiley Joins KD Pharma Group as Vice President of Special Projects
    FDA Warns Against Male Enhancement and Weight Loss Products Sold Online FDA Warns Against Male Enhancement and Weight Loss Products Sold Online
    Bio Health Worldwide Virtual Event Open Until Oct. 30 Bio Health Worldwide Virtual Event Open Until Oct. 30
    A. Holliday & Company Inc. A. Holliday & Company Inc.
    How to Assess Risk in the Current Dietary Supplement Industry How to Assess Risk in the Current Dietary Supplement Industry
    Taking the Mystery Out of Medical Foods Taking the Mystery Out of Medical Foods
    Product Liability Insurance Rates Continue Steep Decline Product Liability Insurance Rates Continue Steep Decline
    FDA Recalls and Destroys Kratom Products FDA Recalls and Destroys Kratom Products
    CRN Launches Consumer Education Initiative to Raise Awareness about Dangers of SARMs CRN Launches Consumer Education Initiative to Raise Awareness about Dangers of SARMs
    NIH Issues New Resources on Dietary Supplements for Consumers NIH Issues New Resources on Dietary Supplements for Consumers
    Data from GMP Inspections Suggests Increased Compliance Data from GMP Inspections Suggests Increased Compliance
    Nutrition Survey Finds Consumers Seeking Fermented Foods Nutrition Survey Finds Consumers Seeking Fermented Foods
    Focus on Clean Label Focus on Clean Label

    Related Content

    • Breaking News | Contract Manufacturing | Delivery & Dosage Technologies | People News | World Markets
      Lonza Appoints Christian Seufert as President of Capsules, Health Ingredients

      Lonza Appoints Christian Seufert as President of Capsules, Health Ingredients

      Seufert will officially begin his new role on July 1.
      03.23.22

    • Dietary Supplements | Regulations
      An Interview with Charlie Kotani, President, Charlie K Consulting

      An Interview with Charlie Kotani, President, Charlie K Consulting

      He was an executive officer of the Kyowa/Kirin family for 37 years helping companies solve complex challenges and decisions.
      By Sheldon Baker 11.11.21

    • Breaking News | Contract Manufacturing | Delivery & Dosage Technologies | Dietary Supplements | Herbs & Botanicals | Omega-3s | People News | World Markets
      Daniel Wiley Joins KD Pharma Group as Vice President of Special Projects

      Daniel Wiley Joins KD Pharma Group as Vice President of Special Projects

      Wiley’s expertise lies in both the nutritional and specialty chemical industries.
      10.01.21


    • Breaking News | Dietary Supplements | Quality & Safety | Regulations | Regulatory News | Sexual & Reproductive Health | Testing | Weight Management/Weight Loss | World Markets
      FDA Warns Against Male Enhancement and Weight Loss Products Sold Online

      FDA Warns Against Male Enhancement and Weight Loss Products Sold Online

      The agency reported on a list of nearly 50 products which contain potentially dangerous drug ingredients.
      12.18.20

    • Breaking News | Contract Manufacturing | Dietary Supplements | Industry & Market News | Medical Nutrition | World Markets
      Bio Health Worldwide Virtual Event Open Until Oct. 30

      Bio Health Worldwide Virtual Event Open Until Oct. 30

      The virtual event features experts, buyers, and companies seeking investment across the South Korean Health Industry, as well as 50 other countries.
      10.20.20

      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