• 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
    Bioactive Resources

    Aiya America, Inc. (Aiya Matcha)

    Botanic Healthcare LLC

    KLK OLEO

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

    Aiya America, Inc. (Aiya Matcha)

    Botanic Healthcare LLC

    KLK OLEO

    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
    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
    • Health
    • labeling
    • fda
    • Dietary Supplements
    Related Knowledge Center
    • Regulations
    • Quality & Safety
    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 Breaking News

    • 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

    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

    Giedre Serritslev Appointed Managing Director Teknos
    Sheboygan Paint Company Adds Rosey Malchow as Customer Experience Manager
    PPG to Announce Second Quarter 2022 Results July 21
    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