• 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
    Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains

    Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality

    Nutrition and Flavor: Formulating for Modern Product Preferences

    What Do Consumers Know About the Gut Microbiome?

    How Will the European Green Deal Impact Dietary Supplements?
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    IFIC 2022 Food & Health Survey Highlights Eating Behavior Trends

    Icon Foods Appoints Operations and Marketing Leaders

    Annatto Tocotrienol Shown to Improve Weight Loss and Inflammation Markers in Patients with NAFLD

    GC Rieber VivoMega Continues to Find Operational Efficiencies, Minimize Environmental Impact

    Vitamin A Deficiency: 53% of Primary School Children in Rural Malaysia Found to be Malnourished
    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

    Icon Foods Appoints Operations and Marketing Leaders

    Annatto Tocotrienol Shown to Improve Weight Loss and Inflammation Markers in Patients with NAFLD

    GC Rieber VivoMega Continues to Find Operational Efficiencies, Minimize Environmental Impact

    Vitamin A Deficiency: 53% of Primary School Children in Rural Malaysia Found to be Malnourished

    PLT to Supply Traceable, Standardized Organic Elderberry Extract
    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

    IFIC 2022 Food & Health Survey Highlights Eating Behavior Trends

    Icon Foods Appoints Operations and Marketing Leaders

    Annatto Tocotrienol Shown to Improve Weight Loss and Inflammation Markers in Patients with NAFLD

    Vitamin A Deficiency: 53% of Primary School Children in Rural Malaysia Found to be Malnourished

    PLT to Supply Traceable, Standardized Organic Elderberry Extract
    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

    Annatto Tocotrienol Shown to Improve Weight Loss and Inflammation Markers in Patients with NAFLD

    Vitamin A Deficiency: 53% of Primary School Children in Rural Malaysia Found to be Malnourished

    PLT to Supply Traceable, Standardized Organic Elderberry Extract

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Verdure Sciences

    Nutrition21, LLC

    PhytoGaia Inc

    Sabinsa Corporation

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

    Nutrition21, LLC

    PhytoGaia Inc

    Sabinsa Corporation

    BGG World
    • 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

    Consent Decree Approved with Florida Supplement Distributor Viruxo

    Company sold a product claiming to treat herpes.

    Related CONTENT
    • AHPA Issues White Paper on Good Herbal Compounding & Dispensing Practices
    • NSF International Launches Raised Without Antibiotics Certification
    • Building Foundations for Healthy Living
    • AHPA Science Officer Discusses Key Initiatives at Botanical Conference
    • Trump Taps Scott Gottlieb to Lead FDA
    02.29.16
    A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which the company claimed could treat herpes.
     
    Senior U.S. District Judge James S. Moody, Jr. for the Middle District of Florida entered a consent decree of permanent injunction between the U.S. and James R. Hill of Florida, doing business as Viruxo LLC, a distributor of dietary supplements. The complaint, filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration, sought a permanent injunction against Mr. Hill for unlawfully distributing an unapproved new drug and misbranded drug. The complaint also includes a civil fraud charge for Mr. Hill’s intent to defraud consumers by promoting his product to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific evidence to substantiate his claims.
     
    As part of the decree, Mr. Hill represented to the court that he is not directly or indirectly engaged in distributing dietary supplements or drugs. However, if Mr. Hill intends to distribute dietary supplements or drugs, he must notify the FDA in writing at least 90 days before doing so and comply with additional requirements specified in the decree.
     
    “Products being sold as treatments for which they have not been studied or approved defrauds consumers and can cause harm if proper treatment is delayed,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “When a company refuses to comply with regulations, we will take enforcement action to protect the public.”
     
    In April 2011, the FDA and the U.S. Federal Trade Commission sent Mr. Hill a warning letter for making therapeutic claims on his website establishing that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The FDA has not approved Mr. Hill’s product for any use. In addition, the warning letter stated that Mr. Hill’s product is also a misbranded drug because its labeling failed to provide adequate directions for use.
     
    Despite assurances that Mr. Hill was correcting violations noted in the warning letter, he continued to market his product on the Internet to consumers as a treatment for herpes.
     
    The consent decree prohibits Mr. Hill from marketing misbranded or unapproved new drugs. Before he can resume operations, he must, among other things, hire a labeling expert, remove all representations from his website and other promotional materials that his product can cure, mitigate, treat, or prevent disease, and receive written permission from the FDA to resume operations. In addition, the decree requires Mr. Hill to notify the FDA at least 14 days before the creation of a new website, or link or reference to another website, which conveys information about his products. 
    Related Searches
    • Dietary Supplement
    • Prevention
    • labeling
    • Dietary Supplements
    Related Knowledge Center
    • Regulations
    • Dietary Supplements
    • Quality & Safety
    Suggested For You
    AHPA Issues White Paper on Good Herbal Compounding & Dispensing Practices AHPA Issues White Paper on Good Herbal Compounding & Dispensing Practices
    NSF International Launches Raised Without Antibiotics Certification NSF International Launches Raised Without Antibiotics Certification
    Building Foundations for Healthy Living Building Foundations for Healthy Living
    AHPA Science Officer Discusses Key Initiatives at Botanical Conference AHPA Science Officer Discusses Key Initiatives at Botanical Conference
    Trump Taps Scott Gottlieb to Lead FDA Trump Taps Scott Gottlieb to Lead FDA
    Consent Decree Targets Supplement Distributor Regeneca Worldwide Consent Decree Targets Supplement Distributor Regeneca Worldwide
    U.S. Marshals Seize Products Containing Kratom U.S. Marshals Seize Products Containing Kratom
    Lessons For Industry From Bayer’s Victory Lessons For Industry From Bayer’s Victory
    Judge Orders Injunction Against Florida Supplement Company Judge Orders Injunction Against Florida Supplement Company
    DSM Study Finds Similar Bioavailability Between Fish and Krill Omega-3s DSM Study Finds Similar Bioavailability Between Fish and Krill Omega-3s
    U.S. Files Complaint Against Three Wisconsin Supplement Manufacturers U.S. Files Complaint Against Three Wisconsin Supplement Manufacturers
    FDA Sends Warning Letter to KIND FDA Sends Warning Letter to KIND
    Injunction Filed Against California Supplement Manufacturer Injunction Filed Against California Supplement Manufacturer
    Regulatory Review: 20 Years Since DSHEA Regulatory Review: 20 Years Since DSHEA

    Related Breaking News

    • Breaking News | Dietary Supplements | Herbs & Botanicals | Industry & Market News | Medical Nutrition | Quality & Safety

      AHPA Issues White Paper on Good Herbal Compounding & Dispensing Practices

      Association invites feedback to help ensure it is relevant to practitioners trained in a variety of disciplines.
      05.15.17

    • Breaking News | Certifications, Approvals & Patents | Testing

      NSF International Launches Raised Without Antibiotics Certification

      New protocol helps consumers identify animal products that do not contribute to growth of antibiotic-resistant bacteria.
      05.03.17

    • Antioxidants | Bone & Joint Health | Cardiovascular Health | Cognitive Function | Diabetes & Blood Sugar Management | Fiber & Carbohydrates | Healthcare Trends | Healthy Aging | Herbs & Botanicals | Minerals | Proteins, Peptides, Amino Acids | Skin Health
      Building Foundations for Healthy Living

      Building Foundations for Healthy Living

      Preventive approaches to healthcare throughout the lifespan can significantly benefit consumers of all age groups.
      By Sean Moloughney, Editor 05.01.17


    • Breaking News | Herbs & Botanicals | Industry & Market News | Quality & Safety | Regulations

      AHPA Science Officer Discusses Key Initiatives at Botanical Conference

      Maged Sharaf, PhD, explored several quality and sustainability topics at 17th ICSB in Mississippi.
      04.17.17

    • People News | Regulations
      Trump Taps Scott Gottlieb to Lead FDA

      Trump Taps Scott Gottlieb to Lead FDA

      Physician served as FDA deputy commissioner for medical and scientific affairs during George W. Bush administration.
      03.13.17

    Loading, Please Wait..
    Trending
    • Evolution Nutraceuticals To Discontinue Challenged Claims For ‘Cardio Miracle’ Dietary Supplement
    • Vitamin K2 Status May Impact Blood Pressure And Pulse Wave Velocity
    • Zeus Hygia Launches Muscle Recovery Ingredient, Gremin
    • Study Examines Vitamin K2 Content In Cheese
    • Chenland Nutritionals Self-Affirms GRAS For Cumin UP60 Ingredient
    Breaking News
    • IFIC 2022 Food & Health Survey Highlights Eating Behavior Trends
    • Icon Foods Appoints Operations and Marketing Leaders
    • Annatto Tocotrienol Shown to Improve Weight Loss and Inflammation Markers in Patients with NAFLD
    • GC Rieber VivoMega Continues to Find Operational Efficiencies, Minimize Environmental Impact
    • Vitamin A Deficiency: 53% of Primary School Children in Rural Malaysia Found to be Malnourished
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • A Growing Herbal Products Market Still Faces Formidable Threats, Challenges
    • Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    • Nutrition and Flavor: Formulating for Modern Product Preferences
    • Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains
    • How Will the European Green Deal Impact Dietary Supplements?
    • What Do Consumers Know About the Gut Microbiome?
    • 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

    IFIC 2022 Food & Health Survey Highlights Eating Behavior Trends
    Icon Foods Appoints Operations and Marketing Leaders
    Annatto Tocotrienol Shown to Improve Weight Loss and Inflammation Markers in Patients with NAFLD
    Coatings World

    Latest Breaking News From Coatings World

    Birla Carbon, NREL Collaboration to be Presented at ACS Conference
    Coating Resins Market Worth $70.9 Billion by 2027: MarketsandMarkets
    PPG Appoints Brad Budde Vice President and Chief Digital Officer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    EchoNous Partners with Samsung
    Solid Growth Forecast for Global Ostomy Devices Market
    KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility
    Contract Pharma

    Latest Breaking News From Contract Pharma

    GRAM to Fill and Finish Smallpox/Monkeypox Vaccines
    bluebird bio Wins FDA Approval of ZYNTEGLO
    Pace Life Sciences Acquires Meridian BioGroup
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Sephora at Kohl’s to Expand Sephora Presence to All 1,100+ Kohl’s Locations
    Emma Watson to Front New Fragrance Campaign for Prada
    The Estée Lauder Companies Delivers Strong Results in Fiscal 2022
    Happi

    Latest Breaking News From Happi

    Amorepacific, MIT Develop World's First Chip-less Wireless Electronic Skin Enabled by Semiconductors
    Maesa Launches Itk Skincare with TikTok Stars Brooklyn and Bailey McKnight
    Skin Delivery Formulation
    Ink World

    Latest Breaking News From Ink World

    Xeikon to Introduce TITON Food-Safe Dry-Toner Technology at Labelexpo Americas 2022
    Smurfit Kappa Employees Charity Cycle Across Europe
    ProAmpac’s Rocky Mount, VA Facility Receives ISCC Plus Certification
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    ePac makes big announcement, Avery Dennison debuts new technology and more
    Techkon USA announces latest handheld spectrodensitometer
    Maxcess China now manufacturing solid dies in Huzhou
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    INDA Appoints Director of Membership and Industry Relations
    Nexwear Acquires Incontinence Products Brand Lily Bird
    Because Market Expands into Retail Stores
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Theragen Receives Patent for Spine Fusion Bone Growth Stimulator System
    Study: BONESUPPORT’s CERAMENT G Can Help Save Infected Limbs
    Zavation’s Cervical Intervertebral Body Fusion Device Cleared by FDA
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    NREL, Birla Carbon Collaboration to be Shown at ACS Conference
    ORNL Celebrates Launch of Frontier, the World’s Fastest Supercomputer
    DuPont Names 2022 Lavoisier and Pedersen Award Medalists

    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