• 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
    Florida Food Products Acquires Javo

    Roquette Launches Nutralys Rice Protein

    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy

    CTRL Launches Meal On-The-Go Bars

    GNC and RealEats Meal Delivery Partnership Expands Nationally
    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

    Roquette Launches Nutralys Rice Protein

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

    Study Reveals Low Intake of Tocotrienols in Polish Population

    Combination of Collagen and Boswellia Serrata Shown to Reduce Joint Discomfort

    Nutralliance Adds Eggshell-Derived Ingredients for Beauty and Joint Health to Portfolio
    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

    Florida Food Products Acquires Javo

    Roquette Launches Nutralys Rice Protein

    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy

    CTRL Launches Meal On-The-Go Bars

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development
    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

    Upcycled Coffeeberry® Cascara Offers Versatility in Functional Beverage Development

    Botanical Gum for Kids Aims to Curb Sugar Cravings

    Combination of Collagen and Boswellia Serrata Shown to Reduce Joint Discomfort

    Childhood Fitness and Obesity Impact Cognition Later in Life, Study Finds

    Nutralliance Adds Eggshell-Derived Ingredients for Beauty and Joint Health to Portfolio
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Xsto Solutions

    Verdure Sciences

    JRS Pharma

    ESHA Research

    Nutrition21, LLC
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Xsto Solutions

    Verdure Sciences

    JRS Pharma

    ESHA Research

    Nutrition21, LLC
    • 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

    Capitol Comments: DSHEA: Is It Time To Move On?

    ...

    Related CONTENT
    • New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    • CHPA Hires Two Key Personnel
    • Nutralliance Adds Eggshell-Derived Ingredients for Beauty and Joint Health to Portfolio
    • Senate HELP Committee Advances Bill with Supplement Provisions That Industry Trade Groups Oppose
    • Lang Pharma Nutrition Receives MSC’s 2021 U.S. Ocean Champion Award
    Todd Harrison09.01.12
    It is the end of summer in Washington, D.C., just prior to the fall presidential campaign. No serious work will be done in this town before the election in November. We can argue about whether this is a good or bad thing for the country, but it is definitely good news for this industry because certain senators who are not friends of the industry will not be able to push their anti-natural products agenda for the remainder of 2012. 
     
    From a regulatory perspective, the revised NDI draft guidance probably won’t see the light of day until next summer (at the earliest)—and what happens might largely depend on who is President by then (no predictions here). Yes, FDA and FTC will continue to look skeptically at our industry and the class action and Prop. 65 plaintiff attorneys will continue to bring lawsuits; some legitimate, some not. But overall, it will be a quiet fall. 
     
    Creating a New DSHEA
     
    With a new Congress and potentially a new administration coming in, maybe it is time to ask ourselves whether we need a new paradigm—one that does not destroy the Dietary Supplement Health and Education Act (DSHEA), but that builds on the hard-fought foundation it provides, i.e., to guarantee American consumers access to truthful and non-misleading information regarding the true benefits of dietary supplement products. 
     
    But what are the true benefits of taking dietary supplements? Surely, some of the true benefits revolve around supporting the basic structure and function of the body, i.e., “supports overall heart health” or “supports eye health.” However, consumers typically take dietary supplements for reasons beyond supporting or maintaining healthy structure and function of the body. In fact, they are usually trying to treat an ailment, such as high cholesterol. 
     
    For example, if a consumer has elevated cholesterol or blood pressure, does that mean he needs to take an FDA-approved drug to lower cholesterol or blood pressure? The answer is not necessarily. Taking a statin or an ACE inhibitor to address these two health concerns might not be necessary when simple modifications to the diet (i.e., adding a targeted dietary supplement) might very well bring one’s cholesterol and blood pressure back in the normal range. This makes significantly more sense than using a prescription drug. 
     
    Another example relates to people with blood sugar issues. Many could address this health problem by simply adding Gymnema sylvestre to their daily routines. For men whose prostate starts to grow because they are over 40, why shouldn’t they be provided with the opportunity to reduce nighttime trips to the bathroom through the use of beta-sitosterol and saw palmetto, rather than taking the prescription drug finasteride? If the supplements don’t work, then explore more powerful means. Until then, dietary supplements should be a legitimate first line of defense when health issues arise.
     
    Of course, certain public health advocates and consumer groups would argue the reason why we do not allow dietary supplements to be promoted in this manner is to keep the consumer protected from snake oil salesman. Unfortunately, these individuals are misguided and misinformed. They ignore ancient uses of many herbal ingredients and the teachings of herbalists. They ignore the advances in science that have been able to identify the constituents that provide the potential benefits, enabling the development of standardized ingredients. More importantly, they ignore that as nutritional science has progressed over the years, we have learned that many chronic illnesses can be avoided by altering our diet. 
     
    In order to avoid the strictures, many companies have decided to market their products as medical foods or homeopathic medicines. The problem with the former is that many health issues we have today can be treated by adding a dietary supplement or a functional food to the diet. However, this is inconsistent with the medical food category because a medical food must offer benefits beyond simple modification to the diet. 
     
    The category of homeopathic drugs is an interesting one, but there are too many products being marketed as homeopathic that are not homeopathic. This is because the ingredients are not marketed in accordance with the dilution rates set forth in the Homeopathic Pharmacopoeia of the United States (HPUS) or the ingredients are simply not listed in the HPUS. So, where does this leave the industry? The answer is pretty simple: (1) Continue to market in accordance with DSHEA; or (2) Take a risk and develop a real regulatory framework that permits making meaningful claims to consumers. 
     
    Of course, making such a monumental change is not simple and requires legislation. The challenge to the industry is to come up with a viable legislative and regulatory framework. THE TIME IS NOW. Unfortunately DSHEA is restricting the growth of the industry and keeping it from making claims it should be able to make based on traditional use or scientific studies. Whether this is achieved through a monograph or application process, or combination thereof, it is time to move to the next level—without the fear of being called an unapproved drug.


    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
    • Dietary Supplement
    • Nutritional
    • DSHEA
    • Dietary Supplements
    Related Knowledge Center
    • Regulations
    • Eye Health
    • Dietary Supplements
    Suggested For You
    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    CHPA Hires Two Key Personnel CHPA Hires Two Key Personnel
    Nutralliance Adds Eggshell-Derived Ingredients for Beauty and Joint Health to Portfolio Nutralliance Adds Eggshell-Derived Ingredients for Beauty and Joint Health to Portfolio
    Senate HELP Committee Advances Bill with Supplement Provisions That Industry Trade Groups Oppose Senate HELP Committee Advances Bill with Supplement Provisions That Industry Trade Groups Oppose
    Lang Pharma Nutrition Receives MSC’s 2021 U.S. Ocean Champion Award Lang Pharma Nutrition Receives MSC’s 2021 U.S. Ocean Champion Award
    Three Grams of Omega-3s May be Optimal Dose for Reducing Blood Pressure Three Grams of Omega-3s May be Optimal Dose for Reducing Blood Pressure
    Poison Control Center Reports of Kids Ingesting Melatonin Rise by 530% Since 2012 Poison Control Center Reports of Kids Ingesting Melatonin Rise by 530% Since 2012
    FDA Debuts Dietary Supplement Education Initiative FDA Debuts Dietary Supplement Education Initiative
    NIH Study Confirms Superior Benefit of AREDS2 Formula for Eye Health NIH Study Confirms Superior Benefit of AREDS2 Formula for Eye Health
    FDCA Preemption of State-Level Misbranding Laws for Structure/Function Ingredient Claims FDCA Preemption of State-Level Misbranding Laws for Structure/Function Ingredient Claims
    ‘You Are What You Eat’ (Chapter 2): Nutrigenetics & Nutrigenomics ‘You Are What You Eat’ (Chapter 2): Nutrigenetics & Nutrigenomics
    Safe & Accessible: Dietary Supplements Are Far From ‘Unregulated’ Safe & Accessible: Dietary Supplements Are Far From ‘Unregulated’
    Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges Health Products Association - China Executive Director Reflects on Market Dynamics, Challenges
    Dietary Supplements Are Regulated, and Chronic Stress Has Been Normalized Dietary Supplements Are Regulated, and Chronic Stress Has Been Normalized
    Adaptogens: Where Ancient Remedies Meet Modern Wellness Products Adaptogens: Where Ancient Remedies Meet Modern Wellness Products

    Related Breaking News

    • 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

    • Breaking News | Dietary Supplements | People News
      CHPA Hires Two Key Personnel

      CHPA Hires Two Key Personnel

      Larisa Pavlick and Kirby Miller will each play strategic roles for the trade association on science-based policy, technical issues, and more.
      06.21.22

    • Bone & Joint Health | Breaking News | Dietary Supplements | Proteins, Peptides, Amino Acids | Skin Health | Supplier News | World Markets
      Nutralliance Adds Eggshell-Derived Ingredients for Beauty and Joint Health to Portfolio

      Nutralliance Adds Eggshell-Derived Ingredients for Beauty and Joint Health to Portfolio

      The two ingredients, Ovoderm and Ovomet, are rich in collagen.
      06.20.22


    • Dietary Supplements | Regulations
      Senate HELP Committee Advances Bill with Supplement Provisions That Industry Trade Groups Oppose

      Senate HELP Committee Advances Bill with Supplement Provisions That Industry Trade Groups Oppose

      Wide-ranging ‘must-pass’ legislation heads to the full Senate for consideration.
      By Mike Montemarano, Associate Editor 06.17.22

    • Breaking News | Dietary Supplements | Omega-3s | Supplier News | World Markets
      Lang Pharma Nutrition Receives MSC’s 2021 U.S. Ocean Champion Award

      Lang Pharma Nutrition Receives MSC’s 2021 U.S. Ocean Champion Award

      The daughter company of Aker BioMarine provides over 70 Marine Stewardship Council-certified items.
      06.16.22

    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
    • Olive/Pomegranate Extract May Improve Dyslipidemia
    Breaking News
    • Florida Food Products Acquires Javo
    • Roquette Launches Nutralys Rice Protein
    • New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    • CTRL Launches Meal On-The-Go Bars
    • GNC and RealEats Meal Delivery Partnership Expands Nationally
    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

    Florida Food Products Acquires Javo
    Roquette Launches Nutralys Rice Protein
    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    Coatings World

    Latest Breaking News From Coatings World

    Hempel Launches New Fast-drying CUI Coating
    The Southern Society for Coatings Technology's 84th Annual Technical Conference A Success
    PPG to Showcase Specialty Automotive, Aerospace Adhesives, Sealants at Adhesives & Bonding Expo
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most Read Stories This Week—June 25
    Magnetic Insight Announces $17 Million in Series B Funding
    BreatheSuite Adds Brad Fluegel to its Board
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pierre Fabre and Lonza Enter Manufacturing Agreement
    MasterControl and Elemental Machines Form Biomanufacturing Partnership
    Qosina Strengthens Aseptic Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Benefit Exec Joins Madison Reed's Board
    Peroni & Ellis Brooklyn Launch Fragrance Collection Inspired by Italian Spritz Cocktails
    Rhode Is Trending for June, Trendalytics Says
    Happi

    Latest Breaking News From Happi

    Entries Open for Dow 2022 Packaging Innovation Awards
    Dollar Shave Founder & Benefit Exec Join Madison Reed Board of Directors
    Spate’s Says The Skunk Stripe, Collagen Serum and Waterproof Eyeshadow Lead Summer Beauty Trends
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    British Coatings Federation Posts Online History
    Orion Announces Price Increases, Reduced Payment Terms
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PCMC teams with IGT, Fujifilm makes big announcement and more
    Loftware recognized as 'AIDC Company of the Year'
    Schreiner MediPharm highlights sustainability of Needle-Trap technology
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Yanpai Order Batt Forming Equipment for Needlepunch Line
    Weekly Recap: SWM and Neenah Introduce Mativ Inc., Avgol honored for Biotransformation Technology & More
    Tranzonic Names VP of Supply Chain
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 25
    3Spine Inc. Receives IDE Approval for U.S. Pivotal Clinical Trial
    Volume-Based Procurement to Reduce Chinese Orthopedic Market Value
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories
    NREL Names Jennifer Logan to Leadership Team as CFO
    National Grid Renewables Orders 2 GW of First Solar Modules

    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