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Tuesday, January 8, 2013

ERSP Recommends Casper Labs Modify, Discontinue Certain Claims for ‘Calmestra,’ Including Claims that Reference Ovarian Cancer

The Electronic Retailing Self-Regulation Program (ERSP) has recommended that Casper Labs, LLC modify or discontinue certain claims for Calmestra, a dietary supplement marketed as providing relief for symptoms of menopause, including claims that the product has been “clinically proven” to address symptoms of menopause.

ERSP is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus. The marketer’s advertising came to the attention of ERSP pursuant to its ongoing monitoring program. 

ERSP reviewed online advertising for Calmestra and identified several claims for review, including:

  • … Calmestra relieves symptoms in as little as 2 weeks! Calmestra is Easy to Take, All-Natural and Chemical Free and has NO Aftertaste. Calmestra supports and helps: reduce heavy, painful & long period, reduce irritability, mood swings & bloating, reduce weight gain, eliminate hot flashes, increase energy & enhance sex drive, improve complexion.”
  • “… Calmestra does so WITH OUT any weight gain…in fact many of our clients actually lose weight thanks to proper hormonal balance that Calmestra reinstates.”
  • “…a breakthrough, natural solution to feminine hormonal imbalance that can help women from puberty to post-menopause.”
  • “Calmestra is clinically proven to provide relief and calm: cramps, bloating and heavy periods; mood swings and irritability; anxiety and nervousness; depression and fatigue; night sweats and insomnia; hot flashes and skin flare ups.”
  • “Yes, in clinical trials Calmesta [sic] produced dramatic improvements in pre-menopause, peri-menopause, menopause, and post-menopause as well as women who have had hysterectomies or ovarian problems including ovarian cancer.”
As support for the performance and establishment claims at issue in ERSP’s inquiry, Casper Labs submitted the results of a randomized double-blind, placebo-controlled study published in 2011.

Following its review of the evidence in the record, ERSP determined that the evidence did not support the establishment claims, exclusivity claims, claims pertaining to weight loss, and speed of action claims that were the focus of ERSP’s inquiry. ERSP recommended the marketer discontinue  such claims.

ERSP further recommended that the advertiser discontinue claims that stating the product “produced dramatic improvements in pre-menopause, peri-menopause, menopause, and post-menopause as well as women who have had hysterectomies or ovarian problems including ovarian cancer,” as well as claims referencing puberty.

ERSP did not object to general performance and safety claims and found that Casper Labs was able to support certain testimonials.

The company, in its marketer’s statement, said it would “comply with ERSP and update our advertising materials accordingly prior to re-launching the marketing campaign.”

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