CRN's FTC Enforcement Action Compilation

The purpose of this compilation is to provide information about and access to dietary supplement—and functional food-related enforcement actions issued by the Federal Trade Commission (FTC). CRN publishes this web page as a service to its members and for informational purposes only. It is not intended as a substitute for legal advice, and CRN cannot guarantee the accuracy or completeness of the information provided. Please visit the FTC’s website at www.ftc.gov for additional information about FTC and its enforcement efforts. Please consult professional legal counsel with any specific questions or for legal advice regarding the information published on this website.

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Date of Decision:
Company:
Kellogg Company
Product: Rice Krispies
Product Category:
  • Children's Immunity
Last Action:
Expanded settlement order from 2009 prohibits Kellogg from making claims about any health benefit of any food without scientific evidence
Additional Information:
Date of Decision:
Company:
Kellogg Company
Product: Frosted Mini-Wheats
Product Category:
  • Children's Cognitive Health
Last Action:
Prohibited from making cognitive health claims unless substantiated / Prohibited from misrepresenting tests or studies / Recordkeeping required to monitor compliance
Additional Information:
Date of Decision:
Company:
Kevin Wright / HCG Platinum, LLC / Right Way Nutrition, LLC
Product: HCG Platinum diet products
Product Category:
  • Weight-Loss
Last Action:
Banned from making certain weight-loss claims about any product / Other weight-loss claims require at least two randomized, double-blind, placebo-controlled human clinical trials / Prohibited from making other health benefit, safety, performance, or efficacy claims for any supplement or drug without competent and reliable scientific evidence / Prohibited from misrepresenting tests, studies, or ingredients
Additional Information:
Preservation of records required / $10 million judgment suspended upon payment of $1 million, unless financial status misrepresented / Compliance reporting and recordkeeping required
Date of Decision:
Company:
Lane Labs-USA, Inc.
Product: BeneFin / SkinAnswer / Fertil Male / AdvaCAL
Product Category:
  • Male Fertility
  • Cancer
  • Osteoporosis
Last Action:
Barred from making claims unless substantiated with scientific evidence / Barred from misrepresenting research
Additional Information:
Company appealed FTC order / Court ruled company violated final order
Date of Decision:
Company:
LeanSpa, LLC, et al.
Product: LeanSpa / LeanSpa with Acai / LeanSpa with HCA / LeanSpa Cleanse
Product Category:
  • Weight-Loss
Last Action:
$7.3 million judgment / Permanently enjoined from marketing any product, program, or service with a Negative Option Feature, or misrepresenting risk-free trials, news reports, endorsements, or any other fact material to consumers concerning any product, service, or program / Prohibited from making claims about rapid and substantial weight loss without dieting or exercise / Prohibited from making weight-loss claims without at least two randomized, double-blind, placebo-controlled trials / Prohibited from making other health-related claims without competent and reliable scientific evidence / Prohibited from misrepresenting any test or study / Affiliate marketing network and its parent company must turn over $11.9 million
Additional Information:
FTC authorized to monitor compliance
Date of Decision:
Company:
LifeSilver
Product: ASAP Solution / Patis 30 Fortified Silver Solution / ASAP Ultimate Skin & Body Care Gel
Product Category:
  • Ebola Virus
Last Action:
Joint FDA-FTC Warning Letter / Unapproved and unsubstantiated claims
Additional Information:
Date of Decision:
Company:
Lunada Biomedical, Inc.
Product: Amberen
Product Category:
  • Weight-Loss
  • Menopause
Last Action:
$40 million judgment (partially suspended)/ Prohibited from making any weight loss or menopause-related unless substantiated by competent and reliable scientific evidence that consists of human clinical testing that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant disease, condition, or function to which the representation relates, when considered in light of the entire body of relevant and reliable evidence / Such testing shall be randomized, double-blind, and placebo-controlled and conducted by qualified persons / Other health-related claims must be supported by competent and reliable scientific evidence that has been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates, and must be randomized, double-blind, and placebo-controlled when such experts would generally require such testing / All underlying data must be preserved and available for inspection and production to the FTC / Prohibited from misrepresenting any test, study, or material facts or connections regarding endorsements
Additional Information:
Date of Decision:
Company:
Medlab, Inc.; Pinnacle Holdings, Inc.; Metabolic Research Associates, Inc.; U.S.A. Health, Inc.
Product: Zyladex Plus / Questral AC / Questral AC Fat Killer Plus / Rapid Loss 245 / Rapid Loss Rx
Product Category:
  • Weight-Loss
Last Action:
$2.7 million judgment / Final order for permanent injunction to be restrained from making claims without scientific evidence / Prohibited from making efficacy claims without scientific evidence / Prohibited from misrepresenting scientific evidence
Additional Information:
FTC authorized to monitor compliance
Date of Decision:
Company:
Michael Levey and Gary Ballen / Bentley Myers International Co. / Publisher's Data Services, Inc. / Nutritional Life, Inc.
Product: Zymax / MillinesES / Serotril / CartazyneDS / EuroTrym Diet Patch / Foliplexx / Y-Bron
Product Category:
  • Weight-Loss
Last Action:
$2.2 million judgment / Prohibits claims about weight-loss or the health benefits, performance, safety or efficacy of a product without competent and reliable scientific evidence / Prohibited from misrepresenting study results, endorsements, or demonstrations / Requires prominent warning in advertising and labeling about ephedra use
Additional Information:
Date of Decision:
Company:
National Urological Group / Hi-Tech Pharmaceuticals
Product: Thermalean / Lipodrene / Spontane-ES
Product Category:
  • Weight-Loss
  • Erectile Dysfunction
Last Action:
$6 million judgment for consumer redress
Additional Information: