• 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
    Citrus Support for the Blood Glucose-Immune System Connection

    A Glance At The Eye Health Market

    The Value of Vitamin D Testing

    A Growing Need for Mineral Supplementation

    More Than Just A Trend: Supplements Embedded in Consumer Health Regimens
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet

    Refined Grains Linked to Heart Attack Risk, Early Death

    Kappa Bioscience Extends Research Partnership For COVID-19 Research

    New FDA Traceability Rule Appears to Omit Dietary Supplement Manufacturers

    Clinical Trial Finds Metabolic Benefits for Polyphenols Formula
    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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet

    Refined Grains Linked to Heart Attack Risk, Early Death

    Kappa Bioscience Extends Research Partnership For COVID-19 Research

    Clinical Trial Finds Metabolic Benefits for Polyphenols Formula

    JRF Technology Debuts Elderberry Oral Film Strip
    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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet

    Refined Grains Linked to Heart Attack Risk, Early Death

    Kappa Bioscience Extends Research Partnership For COVID-19 Research

    New FDA Traceability Rule Appears to Omit Dietary Supplement Manufacturers

    GMP Laboratories of America, Inc.: Addressing Industry Challenges for 25 Years
    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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet

    Refined Grains Linked to Heart Attack Risk, Early Death

    Kappa Bioscience Extends Research Partnership For COVID-19 Research

    Clinical Trial Finds Metabolic Benefits for Polyphenols Formula

    Researchers Connect Gut Microbiome to Healthy Aging
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    Chenland Nutritionals Inc.

    Aiya America (Matcha by Aiya)

    Gencor

    Indena USA, Inc.

    AIDP
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    Indena USA, Inc.

    KLK OLEO - Davos Life Science

    Verdure Sciences

    Bioenergy Life Science, Inc. (BLS)

    AIDP
    • 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
    • eBook
    • Infographics
    • 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

    Understanding FTC Standards for Claims Substantiation

    Randomized clinical trials aren’t the only source of competent and reliable scientific evidence.

    Understanding FTC Standards for Claims Substantiation
    Related CONTENT
    • NAD Refers Advertising for BodyArmor Sports Drinks to FTC
    • Aging Ain’t Easy
    • Product Liability Insurance: Challenges in a Converging Product Market
    • Website Promotes Supplement Safety Awareness for DoD Personnel
    • Alternatives to Botanical EFSA Health Claims
    By Todd Harrison, Venable06.02.17
    Under the FTC’s guidance, “Dietary Supplements: An Advertising Guide for Industry,” (FTC Guide), the relevant standard for “truthful and not misleading” health-related claims for dietary supplements is “competent and reliable scientific evidence.”

    The FTC defines “competent and reliable scientific evidence” (referred to herein as CRSE) as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”

    A Flexible Standard
    Importantly, the FTC Guide does not require randomized clinical trials of dietary supplements and notes that “competent and reliable scientific evidence” is a “flexible” standard, and that there is “no fixed formula for the number or type of studies required.”

    There is simply no requirement for clinical studies to be published in order to be relied upon. Indeed, a finished product company may forego publishing a clinical study if a competitor can simply copy its formula and rely on that published study because it lacks strong patent protection (i.e., it is easy to design around the patent without impacting the ability to use the published study to support a product claim). 

    The CRSE standard permits full and careful consideration of a wide range of relevant scientific evidence. The FTC Guide clearly states that the “standard for evaluating substantiation is sufficiently flexible to ensure that consumers have access to information about emerging areas of science.”

    As former FTC Chairman Robert Pitofsky has pointed out, the overall goal of evaluating advertising claims is not “a broad, theoretical effort to achieve Truth, but rather a practical enterprise to ensure the existence of reliable data, which in turn will facilitate an efficient and reliable competitive market process.”

    Similarly, Acting FTC Chairman Maureen Ohlhausen noted, “adopting a one-size-fits-all approach to substantiation by imposing such rigorous and possibly costly requirements for such a broad category of health and disease-related claims may, in many instances, prevent useful information from reaching consumers in the marketplace and ultimately make consumers worse off.”

    Clinical Confusion
    However, much confusion has surfaced around exactly what the CRSE standard requires. Many are under the wrong impression that the CRSE requires two double-blind, placebo-controlled clinical studies, which arises out of two FTC consent decrees with Iovate and Nestle.

    It should be noted that the consent decrees at best represent contract negotiations between the FTC and the company that is the subject of the inquiry. During such a negotiation, the FTC can demand whatever terms it desires in order to enter into a settlement. However, it does not mean that the insertion of that term is legally tenable. Rather, it only means that particular defendant has agreed to it in order to settle the case.

    Indeed, when actually litigated, the FTC’s attempt to create such a rigid standard against its own policy guide and pronouncements has been uniformly rejected by the courts as it relates to structure/function claims for dietary supplements.

    More specifically, numerous federal courts, in rejecting the FTC’s rigid interpretation of the CRSE standard, have stated that the standard of what constitutes CRSE is a question of fact that requires careful consideration of experts in the field. For example, the Seventh Circuit explicitly held that “[n]othing in the Federal Trade Commission Act … requires placebo-controlled, double-blind studies…. [p]lacebo-controlled double-blind testing is not a legal requirement for consumer products.”

    Most recently, in issuing its decision in Brain Research Labs, LLC v. FTC, the Seventh Circuit found that the advertiser provided a reasonable basis for its claims based on clinical studies as well as the expert evaluations of those studies, in conjunction with animal and in vitro testing, explaining: “[w]hile competent and reliable scientific evidence may consist of a single study under certain circumstances, [it] does not require that every aspect of an advertising claim be contained in one study. Nor does it preclude drawing inferences and correlations between different studies.”

    In addition, in U.S. v. Bayer, the District of New Jersey recently rejected the position that “competent and reliable scientific evidence” could be met only through “human clinical trials that (1) are randomized, placebo-controlled, and double-blind; (2) use the specific product for which the claims are made; (3) are performed in the population at which the claims are directed; and (4) use validated methods and appropriate statistical methods to assess ‘outcomes.’”

    Citing the Seventh Circuit, the court noted that “placebo-controlled, double-blind testing is not a legal requirement for consumer products” and that “something less may do.” As the Bayer court instructs, the government cannot meet its burden simply by asserting that its expert disagreed with the relevant
    science. 

    In short, the substantiation standard applicable to dietary supplement health and safety claims do not necessarily require only placebo-controlled clinical study results at a 95% confidence level. Rather, the CRSE standard mandates an assessment of the relevant scientific information as a whole to evaluate whether the product achieved the claimed benefits—an assessment that is appropriately made by scientific experts. The key assessment here is not simply whether there is a double-blind placebo controlled study. With that said, when there is a double-blind study, where experts in the field would agree the claims are substantiated, there is little doubt that a court will find the claim substantiated.


    Todd Harrison
    Venable

    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
    • Adulteration
    • labeling
    • Dietary Supplements
    • Testing
    Related Knowledge Center
    • Dietary Supplements
    • Regulations
    • Research
    Suggested For You
    NAD Refers Advertising for BodyArmor Sports Drinks to FTC NAD Refers Advertising for BodyArmor Sports Drinks to FTC
    Aging Ain’t Easy Aging Ain’t Easy
    Product Liability Insurance:  Challenges in a Converging Product Market Product Liability Insurance: Challenges in a Converging Product Market
    Website Promotes Supplement Safety Awareness for DoD Personnel Website Promotes Supplement Safety Awareness for DoD Personnel
    Political Disruption Presents  Opportunity for Industry Political Disruption Presents Opportunity for Industry
    Alternatives to Botanical  EFSA Health Claims Alternatives to Botanical EFSA Health Claims
    Dietary Supplement Insurance: Trends & Tips for 2017 Dietary Supplement Insurance: Trends & Tips for 2017
    CRN Applauds Introduction of Health Savings Act CRN Applauds Introduction of Health Savings Act
    Consent Decree Targets Supplement Distributor Regeneca Worldwide Consent Decree Targets Supplement Distributor Regeneca Worldwide
    CRN Building Relationships with Congressional Newcomers CRN Building Relationships with Congressional Newcomers
    Prevagen Marketers Charged With Making False Claims Prevagen Marketers Charged With Making False Claims
    Understanding GMO Labeling Legislation Understanding GMO Labeling Legislation
    UNPA Names New VP, Regulatory & Compliance UNPA Names New VP, Regulatory & Compliance
    GNC Reaches Agreement with Department of Justice GNC Reaches Agreement with Department of Justice
    In the Post-Election Lull, Cultivate Clinical Allies In the Post-Election Lull, Cultivate Clinical Allies

    Related Columns

    • Dietary Supplements | Healthcare Trends | Medical Nutrition | Regulations
      The Off-Label On Ramp

      The Off-Label On Ramp

      With an expanding base of clinical research supporting nutritional interventions, off label use of dietary supplements and medical foods is likely to grow.
      By Gregory Stephens, Windrose Partners, and Sheila Campbell, PhD, RD 01.19.21

    • Dietary Supplements | Healthcare Trends | Immune Function | Regulations
      ‘Follow the Science’ Often Misses the Mark with Nutrition

      ‘Follow the Science’ Often Misses the Mark with Nutrition

      The mantra too often ignores common sense approaches to improving health and quality of life.
      By Todd Harrison, Venable 01.19.21

    • Dietary Supplements | Herbs & Botanicals | Regulations | World Markets
      CBD in Europe: News from the Front

      CBD in Europe: News from the Front

      A recent decision by the Court of Justice of the European Union has restored CBD’s status, and with it, the prospects of the entire industry.
      By Joerg Gruenwald, analyze & realize ag 01.19.21


    • Cardiovascular Health | Herbs & Botanicals | Immune Function | Research | Weight Management/Weight Loss
      Botanical Research: Botanicals & Immunity, Kava Challenges, Turmeric Therapeutics and More

      Botanical Research: Botanicals & Immunity, Kava Challenges, Turmeric Therapeutics and More

      AHPA compiles recent research on botanicals and plant compounds published in peer-reviewed journals.
      By Holly Johnson, PhD, American Herbal Products Association (AHPA) 01.19.21

    • Delivery & Dosage Technologies | Dietary Supplements | Herbs & Botanicals | Quality & Safety
      The Advantages of Organic, Broad Spectrum Hemp

      The Advantages of Organic, Broad Spectrum Hemp

      Mike Hennesy, Wana Brands, discusses the company’s new gummies, innovation, and continuing market evolution.
      By Sheldon Baker 12.04.20

    • Dietary Supplements | Regulations
      Insurance Rates Have Been at an All-Time Low, But a Hard Market is Coming

      Insurance Rates Have Been at an All-Time Low, But a Hard Market is Coming

      Companies can be prepared by being thorough and transparent while going through insurance policy renewals.
      By Chris Morey, Bolton & Company 12.04.20


    • Dietary Supplements | Regulations
      A Business Perspective on Protecting Confidential Information: The NDA

      A Business Perspective on Protecting Confidential Information: The NDA

      Along with taking precautions in providing access to confidential information, a non-disclosure agreement can be a great way to protect your business.
      By Gregory Stephens, Windrose Partners 11.09.20

    • Dietary Supplements | Healthcare Trends | Immune Function | Regulations | Research | Vitamins
      Using All the Tools to Improve Public Health

      Using All the Tools to Improve Public Health

      Industry needs to make a stand in compelling authorities to communicate the value of nutrition and dietary supplementation.
      By Todd Harrison, Venable 11.09.20

    • Dietary Supplements | Regulations | World Markets
      Regulation Changes Calculus for Substance-Based Medical Devices

      Regulation Changes Calculus for Substance-Based Medical Devices

      The new regulation introduces more specific requirements for the technical documentation of this class of products.
      By Joerg Gruenwald, analyze & realize ag 11.09.20


    • Cognitive Function | Herbs & Botanicals | Mood Health & Sleep | Probiotics & Prebiotics | Research | Sports Nutrition
      Botanical Research: Oral Creatine Monohydrate, Probiotics & Antimicrobial Proteins, Mushrooms & More

      Botanical Research: Oral Creatine Monohydrate, Probiotics & Antimicrobial Proteins, Mushrooms & More

      AHPA compiles recent research on botanicals and plant compounds published in peer-reviewed journals.
      By Holly Johnson, PhD, American Herbal Products Association (AHPA) 11.09.20

    • Dietary Supplements | Healthcare Trends | Immune Function | Regulations
      Federal Regulators Slam Doctors for COVID-Related Communications

      Federal Regulators Slam Doctors for COVID-Related Communications

      Some practitioners were not selling or promoting products, they were simply suggesting certain natural substances might offer benefits in improving resilience.
      By Erik Goldman, Holistic Primary Care 10.01.20

    • Delivery & Dosage Technologies | Dietary Supplements | Healthcare Trends | Herbs & Botanicals | Pet Nutraceuticals
      CBD Dog Health and Fire Flake Farm: Holistic Healing for Furry Friends

      CBD Dog Health and Fire Flake Farm: Holistic Healing for Furry Friends

      Angela Ardolino is a certified cannabis specialist and holistic pet expert who has been caring for animals for over 20 years.
      By Sheldon Baker 10.01.20


    • Dietary Supplements | Regulations
      Nuance Claims? The Red Flags Around False Advertising, Intellectual Property & Mislabeling

      Nuance Claims? The Red Flags Around False Advertising, Intellectual Property & Mislabeling

      If you are a product formulator, label designer, or manufacturing facility, an Errors and Omissions policy is worth exploring.
      By Chris Morey, Bolton & Company 10.01.20

    • Dietary Supplements | Healthcare Trends | Research
      Spotlight on Clinical Research in the COVID-19 Era

      Spotlight on Clinical Research in the COVID-19 Era

      Discerning high quality research evidence from speculation and marketing hype is more important in today’s climate.
      By Greg Stephens, Windrose Partners, & Sheila Campbell, PhD, RD 09.08.20

    • Immune Function | Regulations | Research | Vitamins
      Nutritional Status Has Critical Implications for Public Health

      Nutritional Status Has Critical Implications for Public Health

      Vitamin D, N-acetyl cysteine, and quercetin may have important roles to play in this pandemic.
      By Todd Harrison, Venable 09.08.20

    Trending
    • Nestlé To Sell North American Water Brands
    • House Resolution Calls For CDC And FDA To Back Vitamin D For COVID-19
    • Innova: Top Trends In Dairy Focus On Holistic Benefits
    • Carlson Launches New Grade Of Astaxanthin Gummies With Astaferm
    • Curcuminoid Complex Study Evidences Benefits To Gut Health And Mood
    Breaking News
    • Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    • Refined Grains Linked to Heart Attack Risk, Early Death
    • Kappa Bioscience Extends Research Partnership For COVID-19 Research
    • New FDA Traceability Rule Appears to Omit Dietary Supplement Manufacturers
    • Clinical Trial Finds Metabolic Benefits for Polyphenols Formula
    View Breaking News >
    CURRENT ISSUE

    Jan/Feb 2021

    • Modern Snacking: Where Health & Indulgence Converge
    • More Than Just A Trend: Supplements Embedded in Consumer Health Regimens
    • A Growing Need for Mineral Supplementation
    • The Value of Vitamin D Testing
    • A Glance At The Eye Health Market
    • Citrus Support for the Blood Glucose-Immune System Connection
    • 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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    PPG Appoints Tony Wu as VP, Automotive Refinish, Asia
    AkzoNobel Kicks off Paint the Future Startup Challenge in China
    Hempel Hires Global Head of Renewable Energy
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Median Technologies, UC San Diego to Partner on AI-Based Medical Imaging Technology
    Novel Heart Failure Treatment Technology Scores Positive Trial Results
    New COVID-19 Saliva Test Also Can Detect Variants and Flu Viruses
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Icon to Acquire PRA Health Sciences
    Phlow Corp. and USP Form Alliance
    BMS Expands Cell Therapy Manufacturing Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Anastasia Beverly Hills Gifts Eight $450,000 Grants
    The Top Beauty Products of 2021, According to HelloGiggles
    Weekly Recap: Becca Cosmetics is Closing, MAC Appoints SVP, Supermodel Joins SBLA Beauty & More
    Happi

    Latest Breaking News From Happi

    P2 Science Appoints Vice-Chair of Scientific Advisory Board
    Indena Becomes First Italian Company Authorized to Produce CBD
    John Paul Mitchell Systems Names New CEO
    Ink World

    Latest Breaking News From Ink World

    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Schreiner MediPharm and AARDEX partner for clinical trials
    PCMC launches fully modular digital conversion system
    Alphasonics unveils new plate loading system
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    What You’re Reading on Nonwovens-Industry.com
    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Pandemic Pain: NuVasive's 2020 Sales Fall 10 Percent
    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 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