• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Top Company
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Top Company
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    Cognitive Health Performance for Today, and Clarity Over a Lifetime

    Segmenting the Sports and Active Nutrition Market for Everyday and Elite Athletes

    Key Trends in Functional Foods for 2025

    The Importance of Being Responsible — Let Me Count the Ways ...

    Taking the Edge Off, Naturally: Stress Supplements See Mainstream Adoption
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Glossary
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Gattefossé Opens New Facilities in Mumbai, India

    TSI Group Unveils myHMB + Vitamin D Logo

    Indena to Showcase Metabolic, Brain Health Solutions at In-Vitality 2024

    Baker Dillon Group Enters Into Affiliation with Japan-Based PTG, Inc.

    AIDP Expands R&D Department with Promotions and Hires
    Exclusives
    Top Companies
    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

    TSI Group Unveils myHMB + Vitamin D Logo

    Indena to Showcase Metabolic, Brain Health Solutions at In-Vitality 2024

    Ashwagandha Extract Associated with Lower Stress, Cortisol Levels

    CV Sciences to Acquire Extract Labs

    Condition-Specific, Personalized, Performance-Driven Supplements Top the Charts
    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

    Gattefossé Opens New Facilities in Mumbai, India

    TSI Group Unveils myHMB + Vitamin D Logo

    Indena to Showcase Metabolic, Brain Health Solutions at In-Vitality 2024

    Baker Dillon Group Enters Into Affiliation with Japan-Based PTG, Inc.

    AIDP Expands R&D Department with Promotions and Hires
    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

    TSI Group Unveils myHMB + Vitamin D Logo

    Indena to Showcase Metabolic, Brain Health Solutions at In-Vitality 2024

    Ashwagandha Extract Associated with Lower Stress, Cortisol Levels

    Many Prenatal Supplements Lack Essential Nutrients, Contain Heavy Metals: Study

    Condition-Specific, Personalized, Performance-Driven Supplements Top the Charts
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    PhytoGaia Inc

    Botanic Healthcare LLC

    PLT Health Solutions

    FutureCeuticals, Inc.

    Saanroo
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    PhytoGaia Inc

    Botanic Healthcare LLC

    PLT Health Solutions

    FutureCeuticals, Inc.

    Saanroo
    • 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
    • Top Companies
    • 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
    Features

    Shedding Light on a Dark Day: What to Expect if FTC Investigates Your Product Claims

    The probability of a successful outcome may depend in large part on a company’s ability to present an effective summary of claim substantiation.

    Related CONTENT
    • Understanding FTC Standards for Claims Substantiation
    • NAD Refers Advertising for BodyArmor Sports Drinks to FTC
    • Political Disruption Presents Opportunity for Industry
    • Dietary Supplement Insurance: Trends & Tips for 2017
    • Prevagen Marketers Charged With Making False Claims
    John E. Villafranco, Partner, Kelley Drye & Warren LLP10.01.13
    Dietary supplement claims continue to be a principal focus of U.S. Federal Trade Commission (FTC) staff. While an FTC investigation is never a pleasant experience for an advertiser, it is much less scary when you have a sense of what to expect.

    At the outset, it is important to note there is no “typical” case at the FTC and the length of any of the investigatory phases and corresponding costs often vary significantly. For example, a less aggressive FTC staff would reduce both the timeline and costs; a more aggressive staff, or an expansive document request, could cause a company to put more time into its responses, which would increase estimated costs accordingly. 

    Full-Phase Investigation
    A full-phase investigation with consent negotiations can conclude quite abruptly after a company produces all of the requested documents and information, provided the FTC staff is satisfied with the evidence it has obtained and the respondent indicates no interest in negotiating a settlement. At the other extreme, full-phase investigations can carry on for years, although it is more common for an investigation to last 1 or 2 years. A full-phase investigation, unlike an initial-phase investigation, cannot be closed without the approval of the Bureau Director (who, in turn, notifies the Commissioners). Thus, no matter what the recommendation, the Bureau Director has considerable discretion on how to proceed. The objective for every respondent is to persuade the staff that this investigation should be closed because the advertising claims at issue are truthful and substantiated.

    During this initial stage of the proceeding, the company produces information and documents responsive to the FTC’s request. This stage is likely to last for a few months. Given the scope of FTC investigations these days, most companies proceed in multiple production phases. The FTC is normally not opposed to a phased production and the first order of business would be to negotiate the production schedule and the scope of electronic discovery. Respondents often accompany document productions with a “whitepaper” that sets forth its view of the evidence supporting the claims at issue, and possibly sets forth defenses to expected allegations. These written submissions become especially critical if the case advances to the Bureau and Commission level because a company should not expect the FTC staff to present the company’s evidence in the most favorable light. 

    Legal fees through this initial phase can be substantial, given the time required to prepare responses/productions, including preparation of the whitepapers and document review. These costs are largely dependent upon variables related to the retrieval, preparation and production of responsive electronic documents (the scope of which can be negotiated with the staff), as well as ongoing work with expert witnesses and the development of the respondent’s position. 

    Over the course of this initial phase, a respondent should maintain an open dialogue with staff and meet occasionally to present the substantiation for the claims at issue and respond to questions. If a respondent is unable to persuade the FTC staff to recommend the case be closed, then they will likely propose a formal settlement offer in the form of a proposed complaint and stipulated judgment order. A company could counter with its own settlement proposal (or remain firm that the matter should be closed). Sometimes, these settlement discussions can occur over a period of months, and even years. In past matters, the staff has decided quickly whether it wants to settle according to its proposed terms or recommend litigation. Settlement discussions also may require additional meetings and consultation with financial officers or economists regarding a company’s assets and revenues, and expenditures by purchasers of the products at issue.

    Estimated fees through this last part of the investigatory stage, including meetings with the FTC staff and settlement discussions, are largely dependent upon the FTC staff’s reactions to the various submissions.

    Recommendation to File Complaint
    If the FTC staff recommends the Bureau forward the matter to the Commission for formal action, both the FTC staff and the respondent will have an opportunity to present their support or opposition to the complaint recommendation and proposed order before the Bureau staff. It is quite common for a proposed respondent to have a formal meeting with the Bureau Director (currently Jessica Rich) to attempt to persuade her not to proceed with the action. An effective presentation can cause a case to linger for months in the Bureau Director’s office, or to be returned for additional investigation at the staff level. 

    Commission Deliberations
    If the Bureau Director decides to pursue the matter, then the Bureau will forward the proposed complaint and proposed order to the five Commissioners of the FTC, three of whom must approve the recommendation for a complaint to issue. The length of time a matter will be before the Commission varies considerably. 

    Relatively commonplace rule matters can pass through the Commission in 1 month. Complicated and contested lawsuits can cause the Commissioners to deliberate for many months, 1 year or even longer. Typically, each of the Commissioners will provide a company with the opportunity to meet with him or her and argue its case. As a result of this presentation, a company may persuade the Commission not to bring a case or to send the case back to the staff for further investigation. 

    Litigation
    If the company is unable to reach a mutually agreeable resolution with the Commissioners, then they first will have to decide whether to file the complaint in federal court alleging that the advertising claims and business practices violate the FTC Act, or to file an administrative action at the FTC. 

    If the complaint is filed in federal court, the FTC likely will seek injunctive and equitable relief, as well as consumer redress and attorneys’ fees and costs. As with any litigated case, these matters can last from months to years, depending on whether a settlement is reached or the case continues to trial. There will be discovery requests, depositions, interviews with employees and consumers, preparation of witnesses, utilization of experts, drafting litigation documents and other efforts necessary to defend the company. The estimated costs and fees during this stage depend on the length of the litigation, how the case proceeds and whether the company settles or litigates to the end.  

    If the FTC files an administrative action, it could only seek injunctive relief. The case would be expected to last 1-2 years. There will be discovery requests, depositions, interviews with employees and consumers, preparation of witnesses, utilization of experts, drafting litigation documents, counseling and other efforts necessary to defend the company. The estimated costs and fees through this stage also vary considerably, but are likely to be less than if the case were litigated.  

    Keep Moving Toward the Light
    Needless to say, the best result is to persuade the staff not to recommend any action to the Bureau of Consumer Protection. The next best outcome would be to persuade the Bureau against going forward. Like any potential litigation, the probability of success in these early efforts depends in large part on the ability to present an effective summary of a company’s substantiation. This can be a lengthy process that requires a company to keep moving toward the light at the end of the tunnel. Hopefully, through effective advocacy and interaction with the FTC staff, that light won’t be an oncoming train.    


    John E. Villafranco is a partner in the Washington, D.C. office of Kelley Drye & Warren LLP. He provides litigation and counseling services, with a focus in advertising law matters and consumer protection. Named 2011 D.C. Advertising “Lawyer of the Year” by Best Lawyers, Mr. Villafranco is highly respected for offering comprehensive legal advice that emphasizes risk analysis and sound business practices for corporations involved in advertising and marketing. He has particular experience representing dietary supplement, food and consumer product clients in FTC regulatory matters, in Lanham Act litigation and consumer class action defense, and in proceedings before the National Advertising Division of the Council of Better Business Bureaus. He can be reached at jvillafranco@kelleydrye.com. 
    Related Searches
    • Dietary Supplements
    • Research
    • Healthcare Trends
    • Dietary Supplement
    Related Knowledge Center
    • Dietary Supplements
    • Regulations
    • Research
    Suggested For You
    Understanding FTC Standards for Claims Substantiation Understanding FTC Standards for Claims Substantiation
    NAD Refers Advertising for BodyArmor Sports Drinks to FTC NAD Refers Advertising for BodyArmor Sports Drinks to FTC
    Political Disruption Presents  Opportunity for Industry Political Disruption Presents Opportunity for Industry
    Dietary Supplement Insurance: Trends & Tips for 2017 Dietary Supplement Insurance: Trends & Tips for 2017
    Prevagen Marketers Charged With Making False Claims Prevagen Marketers Charged With Making False Claims
    Marketer Settles FTC Charge Over Misleading Weight Loss and Menopause Relief Claims Marketer Settles FTC Charge Over Misleading Weight Loss and Menopause Relief Claims
    FTC Sues Weight Loss Supplement Marketers FTC Sues Weight Loss Supplement Marketers
    FTC Challenges Claims That Supplements Prevent or Reverse Gray Hair FTC Challenges Claims That Supplements Prevent or Reverse Gray Hair
    NourishLife Settles FTC Charges Over Autism Product Claims NourishLife Settles FTC Charges Over Autism Product Claims
    FTC Investigating Vitamin Shoppe Acquisition FTC Investigating Vitamin Shoppe Acquisition
    POM Wonderful: The Ripple Effect               POM Wonderful: The Ripple Effect
    FTC FTC's Complaint Against POM Claims Upheld
    Retailer’s Staff Education Toolkit Retailer’s Staff Education Toolkit
    FTC Releases Results of Weight Loss Advertising Survey FTC Releases Results of Weight Loss Advertising Survey
    FTC Files Complaint On CortiSlim, CortiStress Products; Marketers Agree To Work With FTC FTC Files Complaint On CortiSlim, CortiStress Products; Marketers Agree To Work With FTC

    Related Content

    • Dietary Supplements | Regulations | Research
      Understanding FTC Standards for Claims Substantiation

      Understanding FTC Standards for Claims Substantiation

      Randomized clinical trials aren’t the only source of competent and reliable scientific evidence.
      By Todd Harrison, Venable 06.02.17

    • Breaking News | Regulations | Regulatory News

      NAD Refers Advertising for BodyArmor Sports Drinks to FTC

      Ad urged consumers to ‘Ditch Artificial Sports Drinks,’ without limiting the claim to a specific competing sports drink.
      05.11.17

    • Dietary Supplements | Healthcare Trends | Quality & Safety | Regulations
      Political Disruption Presents  Opportunity for Industry

      Political Disruption Presents Opportunity for Industry

      How can the regulatory framework be improved in order to benefit business and consumers?
      Todd Harrison, Venable 04.03.17


    • Dietary Supplements | Healthcare Trends | Quality & Safety | Regulations
      Dietary Supplement Insurance: Trends & Tips for 2017

      Dietary Supplement Insurance: Trends & Tips for 2017

      Costs for product liability insurance are relatively low. Here’s some advice to reduce your costs and protect your company.
      Greg Doherty, Bolton & Company 03.01.17

    • Cognitive Function | Dietary Supplements | Proteins, Peptides, Amino Acids | Regulations
      Prevagen Marketers Charged With Making False Claims

      Prevagen Marketers Charged With Making False Claims

      Quincy Bioscience denied any wrongdoing and vowed to defend itself.
      Sean Moloughney, Editor 01.10.17

      Loading, Please Wait..
      Breaking News
      • Gattefossé Opens New Facilities in Mumbai, India
      • TSI Group Unveils myHMB + Vitamin D Logo
      • Indena to Showcase Metabolic, Brain Health Solutions at In-Vitality 2024
      • Baker Dillon Group Enters Into Affiliation with Japan-Based PTG, Inc.
      • AIDP Expands R&D Department with Promotions and Hires
      View Breaking News >
      CURRENT ISSUE

      October / November 2024

      • Segmenting the Sports and Active Nutrition Market for Everyday and Elite Athletes
      • Key Trends in Functional Foods for 2025
      • Cognitive Health Performance for Today, and Clarity Over a Lifetime
      • The Importance of Being Responsible — Let Me Count the Ways ...
      • Plant Sterols: Natural, Effective, Part of Healthy Diets, but Underutilized in Cardiovascular Health

      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

      Gattefossé Opens New Facilities in Mumbai, India
      TSI Group Unveils myHMB + Vitamin D Logo
      Indena to Showcase Metabolic, Brain Health Solutions at In-Vitality 2024
      Coatings World

      Latest Breaking News From Coatings World

      ChemQuest Appoints Three New Directors
      Chemetall Site in China Receives Recognition from Commitment to Sustainability
      RPM to Announce Fiscal 2025 Fourth-Quarter and Year-End Results on July 24, 2025
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      StimLabs's Umbilical Cord-Derived Wound Care Product Released in U.S.
      New Medical-Grade Bio-Based PVC Compounds Introduced
      Croívalve Reports 1st Tricuspid Coaptation Valve Implant in U.S. Feasibility Study
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Neurocrine Bioscience’s CRENESSITY Becomes Commercially Available in the U.S.
      Roche's Parkinson's Disease Drug Misses Primary Endpoint
      PTC Therapeutics Submits Vantiquinone NDA to FDA
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Weekly Recap: Coty Sells SKKN, Henkel Recall, Awards, & More
      Rare Beauty to Host Pop-Up Event with Sephora UK
      Cloud Haircare Expands to Walmart Stores Nationwide
      Happi

      Latest Breaking News From Happi

      Cosmetify Names Nikkie de Jager the World’s Most Powerful Beauty Influencer
      Big Lips in the Small Wonder
      L’Oréal’s Bioprinted Skin & Dove’s Deodorant Launch
      Ink World

      Latest Breaking News From Ink World

      BCF Sponsors Parliamentary Event to Engage with Policymakers
      Weekly Recap: DIC Corporation, BASF, Toyo Printing Inks Top This Week’s Stories
      INX International Launches Innova Plus NCF Nitrocellulose-Free Inks
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Mexico's Flexopolis adds second Bobst flexo press
      Paramount Labels installs Rotatek Brava 450
      Esko teams with Bobst for smartGRAVURE System
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      HZ Green Pulp Begins Commercial Production of Dry Molded Fiber Coffee Lids in Malaysia
      Ontex Reports Lower Volumes
      Kimberly-Clark Releases Quarterly Results
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      David Thordarson Takes Charge of American Orthopaedic Foot & Ankle Society
      UPM Biomedicals Launches FibGel Injectable Nanocellulose Hydrogel for Medical Devices
      ONWARD Medical Attracts €50 Million in Capital
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: DuPont, SEMI, Sun Chemical Top This Week’s Stories
      ORNL’s 3D-Printed Metal Molds Poised to Accelerate US Auto Manufacturing
      SRI, NSIC are Catalyzing Corporate Innovation in Japan

      Copyright © 2026 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