• 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
    Flower Pollen Extract Benefits Women’s Urinary Incontinence, Study Finds

    3i Solutions Announces New Leadership Positions

    INS Nutra Opens Gummy Manufacturing Facility

    Vital Nutrients Launches First Vegan Omega Supplement with SPMs

    Earth Mama Organics Achieves 'Plastic Neutral' Certification
    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

    Flower Pollen Extract Benefits Women’s Urinary Incontinence, Study Finds

    Vital Nutrients Launches First Vegan Omega Supplement with SPMs

    Bill Chioffi Joins Nammex as Chief Strategy and Innovation Officer

    FDA Issues ‘No Questions’ Letter for Chiber Mushroom Fiber Preservative

    VITAL Ancillary Study Finds No Link Between Vitamin D and Bone Fracture Risk
    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

    Flower Pollen Extract Benefits Women’s Urinary Incontinence, Study Finds

    3i Solutions Announces New Leadership Positions

    INS Nutra Opens Gummy Manufacturing Facility

    Vital Nutrients Launches First Vegan Omega Supplement with SPMs

    Earth Mama Organics Achieves 'Plastic Neutral' Certification
    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

    Flower Pollen Extract Benefits Women’s Urinary Incontinence, Study Finds

    Vital Nutrients Launches First Vegan Omega Supplement with SPMs

    VITAL Ancillary Study Finds No Link Between Vitamin D and Bone Fracture Risk

    Krill Oil Study Provides Evidence of Osteoarthritis Benefits

    Immunobiotic Heat-Killed Bacteria Linked to Skin Benefits
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    ESHA Research

    Verdure Sciences

    Bioenergy Life Science, Inc. (BLS)

    Sabinsa Corporation

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

    Verdure Sciences

    Bioenergy Life Science, Inc. (BLS)

    Sabinsa Corporation

    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

    Scientific Requirements in Support of Medical Foods Claims

    The strongest evidence comes from systematic reviews, meta-analyses and prospective, randomized, controlled clinical trials.

    Scientific Requirements in Support of Medical Foods Claims
    Global sales for medical foods have been estimated to exceed $9 billion.
    Related CONTENT
    • Medical Food Addresses Fatty Acid Deficiencies, May Help Manage ADHD Symptoms
    • Guardion Inks Testing Agreement with OmegaQuant
    • ‘You Are What You Eat’ (Chapter 2): Nutrigenetics & Nutrigenomics
    • Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal
    • The Nuts and Bolts of FDA’s 2023 Budget Request
    Greg Stephens, RD, & Sheila Campbell, PhD, RD, Windrose Partners09.08.15
    Medical foods are products specifically formulated and intended for the dietary management of a disorder, disease or condition having distinctive nutritional needs not met by modification of a regular diet alone. A key marketing benefit of medical foods is their ability to refer to the “nutritional or dietary management of a specific disease or its metabolic processes” on the product label. Though medical foods do not require FDA pre-market approval or registration, there are specific criteria to qualify. FDA oversight and enforcement has escalated over the past two years.

    Global sales for medical foods have been estimated to exceed $9 billion. This includes similar regulatory categories outside the U.S. (e.g., foods for special medical purposes). The U.S. market for medical foods easily exceeds $2 billion. The category is experiencing significant growth and the number of new product launches is escalating. During the past 5 years there has been an unprecedented number of medical food launches, primarily from companies entering the category.

    Recently, the medical food market has seen surprising growth in the health practitioner channel. Most medical foods entering this channel are not “legacy” products (e.g., Pulmocare, Abbott Nutrition; Vivonex, Nestlé Health Science) but rather are new formulations launched by start-up companies and companies established in the practitioner channel. Category growth is driven by an increasing number of practitioners, including allopathic physicians, recommending nutritional interventions.

    Disease management claims are appealing to dietary supplement companies and a compelling reason many choose to venture into the category. Substantiating these claims, however, differs significantly from substantiating structure-function claims.

    For example, an intriguing and compelling story can certainly create interest in new products. These benefits are often voiced by celebrity spokespersons. We all appreciate the talents of celebrities like Gwyneth Paltrow, Neil Young and Jim Carrey. However, when they publically state their opinions about food, nutrition and health as scientific fact, their statements are not relevant in supporting medical food claims. This is because often times such claims do not provide the scientific substantiation FDA requires; therefore, they are often viewed by the agency as pseudoscience, as they are lacking fact and scientific evidence. Of course, it is not just celebrities making claims. Social and public media abounds with pseudoscience.  Though psuedoscience may be effective in marketing, FDA will not accept it as support for medical food claims.

    FDA Guidance About Medical Food Product Claims
    According to Sandy Bigelow, PhD, principal, Vanguard Global Associates LLC, in the U.S., FDA regulates product claims made on product labeling. Product labeling includes product labels as well as other materials accompanying and supporting the sale of products. These include brochures, shelf talkers and other materials where claims are made. The Federal Trade Commission (FTC) regulates claims made in advertising materials.

    FDA requires that claims, statements and representations about products must be truthful, not misleading and substantiated for dietary supplements and for foods generally (21 U.S.C. 343). Claims must reveal facts material to the representations made in context with the claims (21 U.S.C. 321(n)). Claims for medical foods cover those about the product’s capability to affect structure and function of the human body, and as such, are excluded from claims made for drugs (21 U.S.C. 321(g)). Therefore, these structure-function claims must not include claims to cure or treat disease. Only drugs are allowed to make such statements.

    Medical food claims must be substantiated. The quality and quantity of evidence supporting product claims must match the nature and specificity of the claim.  

    FDA Guidance on Evidence Required to Substantiate Claims
    It may surprise you to learn that FDA leaves it to the manufacturer to determine how to generate evidence to support product claims. However, bear in mind, the agency expects that generally accepted scientific and statistical principles are used to determine the quality of the evidentiary studies used to substantiate a claim.

    Further, claims should be supported by results of medical evaluation (i.e., clinical research). This evidence must be based on recognized scientific principles (e.g., appropriate study design using appropriate clinical measures and statistical analysis, credible and accurate data interpretation and the reliability and reproducibility of findings). 

    The “gold standard” for claims support is the prospective, randomized, controlled clinical trial (PRCT). However, trials of this type may not always be possible, practical or ethical. Other evidence, including in vitro and animal studies, as well as expert consensus opinion, may be helpful to augment the clinical studies used to support claims. 

    Guidance About Evidence Required to Substantiate Claims
    The strongest evidence comes from systematic reviews, meta-analyses and PRCT (see Figure 1). Descriptive, observational reports such as case studies and anecdotal reports provide weaker evidence because their design is not controlled and data are not generalizable to broader populations. Expert opinion provides the weakest support.

    Systematic reviews are reviews of the scientific literature focused on a particular question (e.g., “Do omega-3 fatty acids  effectively treat heart disease?”). The goal of such a review is to identify, appraise, select and interpret all high quality research evidence relevant to that question. The operative phrase is “high quality research evidence.” If you are using systematic reviews to support claims, you must be sure the studies used in the review are the result of high quality scientific research.

    A meta-analysis uses statistics to combine and analyze data from two or more independent PRCTs. Usually the PRCTs used in a meta-analysis come from the results of a systematic review. As with a systematic review, the validity of the meta-analysis depends on the quality of the studies included in the systematic review on which it is based.


    PRCTs are considered the gold-standard of study design. PRCT study design controls bias by randomly assigning subjects to receive the intervention or control treatment, and observed outcomes are due to the intervention under study rather than being due to chance. 

    In comparison, descriptive (versus analytical) reports and expert opinion provide the weakest evidence to support claims. The results of these reports cannot be analyzed statistically and are not designed to eliminate bias. However, if you have numerous case reports and expert opinion, their combined weight may be useful.

    When creating your dossier of evidence, you need to evaluate the studies you plan to use by answering the following questions for each study and report:
    1. Is the research question clearly and succinctly stated so it applies to your product and desired claims?
    2. Are appropriate endpoints and their measures clearly and appropriately defined?
    3. Is the study correctly designed to address the research question and to control for bias?
    4. Can the study findings be generalized to your population of interest?
    5. Are the statistical tests appropriate to the study design?
    6. Are the statistical results adequately analyzed and interpreted, and any potential threats to validity and reliability identified and explained?
    7. Are the conclusions drawn supported by the data?
    In summary, FDA considers the statutory definition of “medical food” to narrowly constrain the types of products that fit within this category: “They are for a patient who is seriously ill or who requires use of the product as a major component of a disease or condition’s specific dietary management.”

    Medical foods do not require pre-market approval from FDA. However, it is critical to bear in mind, the agency has developed clear guidelines regarding substantiation of claims. Following these guidelines, with consultation from qualified experts if necessary, can eliminate bumps down the road, and support a successful product launch.


    Gregory Stephens, RD
    Windrose Partners

    Greg Stephens, RD, is president of Windrose Partners, a company serving clients in the the dietary supplement, functional food and natural product industries. Formerly vice president of strategic consulting with The Natural Marketing Institute (NMI) and Vice President of Sales and Marketing for Nurture, Inc (OatVantage), he has 25 years of specialized expertise in the nutritional and pharmaceutical industries. His prior experience includes a progressive series of senior management positions with Abbott Nutrition (Ross Products Division of Abbott Laboratories), including development of global nutrition strategies for disease-specific growth platforms and business development for Abbott’s medical foods portfolio. He can be reached at 215-860-5186; E-mail: gregstephens@windrosepartners.com.


    Sheila Campbell, PhD, RD
    Sheila Campbell, PhD, RD, has practiced in the field of clinical nutrition for more than 30 years, including 17 years with Ross Products Division of Abbott Laboratories. She has authored more than 70 publications on scientific, clinical and medical topics and has presented 60 domestic and international lectures on health-related topics. She can be reached at smcampbellphdrd@gmail.com.
    Related Searches
    • Nutritional
    • Omega-3
    • Functional Food
    • Medical Foods
    Related Knowledge Center
    • Medical Nutrition
    • Research
    • Healthcare Trends
    Suggested For You
    Medical Food Addresses Fatty Acid Deficiencies, May Help Manage ADHD Symptoms Medical Food Addresses Fatty Acid Deficiencies, May Help Manage ADHD Symptoms
    Guardion Inks Testing Agreement with OmegaQuant Guardion Inks Testing Agreement with OmegaQuant
    ‘You Are What You Eat’ (Chapter 2): Nutrigenetics & Nutrigenomics ‘You Are What You Eat’ (Chapter 2): Nutrigenetics & Nutrigenomics
    Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal
    The Nuts and Bolts of FDA’s 2023 Budget Request The Nuts and Bolts of FDA’s 2023 Budget Request
    Lanfam LLC Launches Medical Food for Pain Relief Lanfam LLC Launches Medical Food for Pain Relief
    The Value of Clinical Evidence Supporting Nutraceuticals The Value of Clinical Evidence Supporting Nutraceuticals
    NEM Eggshell Membrane Receives Novel Food Approval from India’s FSSAI NEM Eggshell Membrane Receives Novel Food Approval from India’s FSSAI
    Astaxanthin: The Rising Star for Developing New Immune Products Astaxanthin: The Rising Star for Developing New Immune Products
    Understanding Exclusion (Preclusion) and a Proposed Solution Understanding Exclusion (Preclusion) and a Proposed Solution
    Claims Spell Success in Today’s Nutritional Products Market Claims Spell Success in Today’s Nutritional Products Market
    Disrupting the Immune Health Category in 2021 & Beyond Disrupting the Immune Health Category in 2021 & Beyond
    Are Dietary Supplements ‘Essential’ During Coronavirus Pandemic? Are Dietary Supplements ‘Essential’ During Coronavirus Pandemic?
    Transforming Health with Nature’s Sunshine Transforming Health with Nature’s Sunshine
    Understanding FTC Standards for Claims Substantiation Understanding FTC Standards for Claims Substantiation

    Related Breaking News

    • Breaking News | Fatty Acids | Infant & Children's Health | Medical Nutrition | Products
      Medical Food Addresses Fatty Acid Deficiencies, May Help Manage ADHD Symptoms

      Medical Food Addresses Fatty Acid Deficiencies, May Help Manage ADHD Symptoms

      Equazen Pro is now available in the U.S. through SFI Health.
      07.18.22

    • Breaking News | Fatty Acids | Industry & Market News | Medical Nutrition | Testing
      Guardion Inks Testing Agreement with OmegaQuant

      Guardion Inks Testing Agreement with OmegaQuant

      The company will apply nutritional status tests for research on current and future products.
      06.02.22

    • Dietary Supplements | Healthcare Trends | Medical Nutrition
      ‘You Are What You Eat’ (Chapter 2): Nutrigenetics & Nutrigenomics

      ‘You Are What You Eat’ (Chapter 2): Nutrigenetics & Nutrigenomics

      Personalized approaches to nutrition intervention can benefit public health by pre-empting chronic and metabolic disease.
      By Greg Stephens, Windrose Partners, and Sheila Campbell, PhD, RD 06.02.22


    • Dietary Supplements | Healthy Aging | Herbs & Botanicals | Medical Nutrition
      Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal

      Autophagy (the Body’s Garbage Disposal) Key to Cellular Renewal

      Researchers have been studying autophagy and its role in the development of chronic disease and the physical changes associated with aging.
      By Gregory Stephens, Windrose Partners, and Sheila Campbell, PhD, RD 04.14.22

    • Dietary Supplements | Quality & Safety | Regulations
      The Nuts and Bolts of FDA’s 2023 Budget Request

      The Nuts and Bolts of FDA’s 2023 Budget Request

      The U.S. Food and Drug Administration is prioritizing multiple ways to regulate the dietary supplements industry in its request for an $8.4 billion budget.
      By Mike Montemarano, Associate Editor 04.12.22

    Loading, Please Wait..
    Trending
    • First Day Life Shuts Down Children's Behavioral, Cognitive Health Claims Following Challenge
    • Study Examines Vitamin K2 Content In Cheese
    • Pycnogenol Evidenced To Have Skin Benefits In Dermatology Study
    Breaking News
    • Flower Pollen Extract Benefits Women’s Urinary Incontinence, Study Finds
    • 3i Solutions Announces New Leadership Positions
    • INS Nutra Opens Gummy Manufacturing Facility
    • Vital Nutrients Launches First Vegan Omega Supplement with SPMs
    • Earth Mama Organics Achieves 'Plastic Neutral' Certification
    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

    Flower Pollen Extract Benefits Women’s Urinary Incontinence, Study Finds
    3i Solutions Announces New Leadership Positions
    INS Nutra Opens Gummy Manufacturing Facility
    Coatings World

    Latest Breaking News From Coatings World

    Lanxess' Entire Value Chain to Become Climate-Neutral
    Custom Cars Featuring PPG DELTRON Refinish System Take Awards at Goodguys 24th Summit
    HGTV Home by Sherwin-Williams Announces 2023 Color Collection of the Year
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Endologix's AFX2 Endovascular AAA System Earns EU Nod
    Elizabeth Coleon Joins Withings as Chief Marketing Officer
    U.K. Strengthens Medical Device Regulations
    Contract Pharma

    Latest Breaking News From Contract Pharma

    BioIVT Acquires Scottish Drug-metabolizing Enzyme Manufacturer Cypex
    Schott Creates Stand-Alone Company for its Pharma Business
    Marken to Acquire Medical Courier Business of Cedra Express
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Body Shop Expands Partnership with Uber
    COSRX Launches Vitamin E Vitalizing Sunscreen
    Weekly Recap: Kylie Makeup Lab Controversy, Glossier Pivots to Retail and Wholesale & More
    Happi

    Latest Breaking News From Happi

    Hallstar To Purchase Lanxess’ Polymer Additives Production Site in Greensboro, NC
    Uber and The Body Shop Expand On-Demand Delivery Partnership Nationwide
    Australia-Based Teeth Whitening Technology Leader White Glo Enters US Market
    Ink World

    Latest Breaking News From Ink World

    Xerox Board of Directors Names Steven Bandrowczak as CEO
    ALTANA AG to Sell Its Stake in dp polar to 3D Systems
    Weekly Recap: Zeller+Gmelin, Epple Druckfarben Lead This Week’s News Stories
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eukalin acquires Adhesives Specialists
    EyeC unveils new inspection products
    Errol Moebius named VP of IST America
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: A New Day for Hygiene, Glatfelter Reports Q2 Results & More
    Dyper Achieves B Corp Certification
    Edgewell’s Sales Grow
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OSSIO Rolls Out OSSIOfiber Suture Anchors in U.S.
    MicroPort Navibot’s SkyWalker System Cleared by FDA
    NuVasive Inc. Reports Q2 2022 Financial Results
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Infineon Technologies AG Offers Secured NFC Tags
    Universal Display Announces 2Q 2022 Financial Results
    Xerox Board of Directors Appoints Steven Bandrowczak as CEO

    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