BBB National Programs National Advertising Division Recommends Discontinuation of Health-Related Superiority Claims for FemiClear Vaginal Yeast Infection Treatment, Following Challenge by Monistat

For Immediate Release

Contact: Laura Brett, Director, National Advertising Division, 212.705.0109 / lbrett@bbbnp.org

 

New York, NY – March 2, 2020 – The National Advertising Division (NAD) recommended that OrganiCare discontinue challenged claims for its FemiClear Vaginal Yeast Infection Treatment.  Establishment and health-related superior treatment efficacy claims in FemiClear advertising were challenged by Prestige Consumer Healthcare, Inc. (“Prestige”), maker of the competing Monistat line of products.

NAD is an investigative unit of the advertising industry’s system of self-regulation and is a division of the BBB National Programs’ self-regulatory and dispute resolution programs.

The claims challenged by Prestige, appeared in online and television advertising and on product packaging, and included:

  • “Proven more powerful at killing yeast than Monistat 1, Monistat 3, Monistat 7 . . .”
  • “Tests show FemiClear kills more yeast than other over-the-counter products . . .”
  • “Nelson Laboratories, a nationally certified lab, tested FemiClear against Monistat and leading vaginal Rx to prove which would prevail at killing the most yeast. The results were undeniable: FemiClear kills more yeast than every treatment it was tested against.”
  • “Shortest yeast infection treatment on the market.”
  • “Shortest Effective Remedy.”
  • “Treated [her] yeast infection in two days with FemiClear.”
  • “Kills more yeast than Monistat.”
  • “Proven Best at Killing Yeast.”
  • “Shortest Effective Remedy 2 Day Dose.”
  • Bar Charts showing that FemiClear kills more yeast than Monistat 1, Monistat 3, and Monistat 7.

The advertiser’s FemiClear yeast infection treatment is a homeopathic product sold as an ointment with an applicator, advertised as a two-day treatment, and made from oxygenated olive oil and olive extract (comprising 95% of the formula), calendula, melaleuca, and pure lavender essential oil. FemiClear has not been approved by the FDA. All the challenger’s Monistat products have been approved by the FDA to treat yeast infections, and the three relevant formulations for the purpose of this challenge are Monistat 1, Monistat 3, and Monistat 7 (with the number referring to the respective number of applications and days for administration of the product). Miconazole nitrate is the active ingredient in all but one of the Monistat products. 

During the course of the proceeding, OrganiCare informed NAD that it permanently discontinued the claim that FemiClear is “Proven more powerful at killing yeast than Monistat 1, Monistat 3, Monistat 7 . . .” NAD, relying on the advertiser’s representation that the claim has been permanently discontinued, did not review the claim on its merits. However, the voluntarily discontinued claim will be treated, for compliance purposes, as though NAD recommended its discontinuance and the advertiser agreed to comply.

Viewing the advertiser’s claims in the contexts presented (both with and without the bar chart representing the advertiser’s underlying study results), NAD concluded that consumers will reasonably interpret the advertiser’s claims to mean that (1) FemiClear works better (is more efficacious) at treating the symptoms of, and curing, a vaginal yeast infection than the challenger’s Monistat products; (2) FemiClear works faster to cure vaginal yeast infections than competitive treatment products on the market, including the challenger’s Monistat products; and (3) the challenger’s FDA-approved Monistat products are less effective than FemiClear.

The evidence offered by the advertiser in support of its claims consisted of an in-vitro time-to-kill test measuring the reduction of the yeast strain Candida albicans after four hours of exposure to samples of 5 yeast infection treatment products: FemiClear, Monistat 1, Monistat 3, Monistat 7, and Vagistat 3. OrganiCare also submitted declarations from its representatives and consultants familiar with the testing performed.  After evaluating the evidence, NAD determined it failed to rise to the level of competent and reliable scientific evidence sufficient to provide a reasonable basis for OrganiCare’s establishment and comparative superior yeast-killing claims and the reasonably conveyed messages stemming therefrom. 

NAD recommended that OrganiCare discontinue its claims that “Tests show FemiClear kills more yeast than over-the-counter products . . .”, FemiClear “Kills more yeast than Monistat [1, 3, and 7]” and that FemiClear is “Proven Best at Killing Yeast.” NAD further recommended that the advertiser discontinue its claim that “Nelson Laboratories, a nationally certified lab, tested FemiClear against Monistat and leading vaginal Rx to prove which would prevail at killing the most yeast. The results were undeniable: FemiClear kills more yeast than every treatment it was tested against.”

With regard to OrganiCare’s bar chart showing that FemiClear kills more yeast than Monistat 1, 3, and 7, NAD determined that it reasonably conveys the unsupported message that the challenger’s products are not only less effective, but ineffective at treating the symptoms of and curing, a vaginal yeast infection.  Thus, NAD recommended that the advertiser discontinue its use of the challenged bar charts.

Finally, NAD recommended that the advertiser discontinue its use of the claims that FemiClear is the “Shortest yeast infection treatment on the market,” “Shortest Effective Remedy,” that “FemiClear “Treated [her] yeast infection in two days,” and “Shortest Effective Remedy 2 Day Dose.” NAD noted that there is no competent and reliable scientific evidence demonstrating that when used as directed under real-world conditions, FemiClear treats the symptoms of, or cures, a yeast infection faster (or better) than any of the tested Monistat products.

In its advertiser’s statement, OrganiCare took issue with NAD’s findings, however it stated that it “agrees to comply with the NAD’s recommendations.”

###

About the National Advertising Division: National Advertising Division (NAD), a division of BBB National Programs, provides independent self-regulation overseeing the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for truth and accuracy.

About BBB National Programs: BBB National Programs fosters trust, innovation, and competition in the marketplace through the development and delivery of cost-effective, third-party self-regulation, dispute resolution and other programs. BBB National Programs is the home of industry self-regulatory and dispute resolution programs that include the National Advertising Division (NAD), National Advertising Review Board (NARB), BBB EU Privacy Shield, BBB AUTO LINE, Children’s Advertising Review Unit (CARU), Children’s Food and Beverage Advertising Initiative (CFBAI), Children’s Confection Advertising Initiative (CCAI), Direct Selling Self-Regulatory Council (DSSRC), Digital Advertising Accountability Program (Accountability Program), and the Coalition for Better Advertising Dispute Resolution Program (CBA DRM). The programs are designed to resolve business issues and advance shared objectives by responding to marketplace concerns to create a better customer experience. To learn more about industry self-regulation, please visit: BBBNP.org.

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