CLAIMS MADE ABOUT NON-PRESCRIPTION SUPPLEMENTS FOR FEMALE LIBIDO OFTEN LACK PROVEN BENEFIT

The International Society for the Study of Women’s Sexual Health (ISSWSH) consists of leading academics, researchers, clinicians and educators in female sexuality.  We are concerned over frequent, unsubstantiated claims made about many over-the-counter (OTC) products marketed to women for sexual enhancement. ISSWSH is committed to the highest standards of scientific research and medical care of women’s sexual health, and as such, we are not only concerned about the lack of proven benefit from such supplements, but also the potential harm to individuals who choose to take these products.

OTC supplements are not regulated by the United States Food and Drug Administration (FDA). This lack of oversight allows companies to make misleading claims about safety (implied by words such as “natural” and “herbal”) and efficacy that suit the marketing needs of the company rather than those that uphold the rigorous standards of FDA-approved pharmaceutical products. Actress Gwyneth Paltrow, founder of the wellness and lifestyle brand goop^®, recently launched a new “sexual health supplement” marketed under the name DTF.^1,2 According to advertisements, this product is intended to “support women’s sexual desire, arousal, and mood.” We believe this claim to be an example of a misleading campaign marketed to consumers that is unsupported by scientific evidence.

While we applaud the attempt to investigate herbal ingredients which are in use by consumers, the statement by goop^® that the ingredients in DTF are “clinically studied to support female sexual health and function” is egregiously misleading. According to their own website, DTF “hasn’t been evaluated by the FDA” and “is not intended to diagnose, treat, cure, or prevent.” According to the goop^® website, DTF contains three main ingredients: Libifem®, a fenugreek seed extract, shatavari root extract, and saffron stigma extract. While one small study published in Phytotherapy Research in 2017 appears to support some potential benefit of one ingredient in DTF specifically to women with the vasomotor symptoms of “hot flushes, night sweats and other associated symptoms,” which are typically associated with the menopause,^3,4 we were unable to find any data to demonstrate safety, efficacy or tolerability of the combination of active ingredients in DTF for women of any age to whom goop^® makes these claims on female desire, arousal and mood.

Forty-three percent of U.S. women report some type of sexual problem for a multitude of biopsychosocial reasons.^5,6  Lumping all sexual problems together is unlikely to lead to an appropriate treatment and improvement, which is why qualified health care providers diagnose a sexual problem before recommending a relevant treatment. Hypoactive sexual desire disorder (HSDD) is a diagnosable and treatable medical condition experienced by upwards of 10% of U.S. women.⁷  In 2018, ISSWSH published an HSDD process-of-care to assist the healthcare provider (HCP) in the diagnosis and management of pre- and postmenopausal women with HSDD. This open access article is freely available online.⁸  There are two FDA-approved treatment options (flibanserin and bremelanotide) available in the U.S. for premenopausal women with acquired, generalized HSDD with extensive safety and efficacy data. Flibanserin is also approved in Canada for premenopausal women and naturally postmenopausal women ≤60 years of age. In order to properly address low libido and HSDD, women should avoid self-treating with OTC products without the guidance of a licensed HCP.

As an organization focused on the advancement of women’s sexual health, it is our mission to promote the dissemination of evidence-based information. Women should know that the medical community has treatments approved by regulatory agencies and processes of care to guide their HCPs in the delivery of evidence-based medicine.

References

1. O’Malley, K. Gwyneth Gwyneth Paltrow's Goop just launched a supplement to boost female libido.
2. Reilly, K. Do Gwyneth Paltrow’s new ‘DTF’ libido supplements really work? Doctors weigh in.
3. Sydora BC, Fast H, Campbell S, Yuksel N, Lewis JE, Ross S. Use of the Menopause-Specific Quality of Life (MENQOL) questionnaire in research and clinical practice: a comprehensive scoping review. Menopause 2016;23:1038-1051.
4. Steels E, Steele ML, Harold M, Coulson S. Efficacy of a proprietary Trigonella foenum‐graecum L. de‐husked seed extract in reducing menopausal symptoms in otherwise healthy women: a double‐blind, randomized, placebo‐controlled study. Phytotherapy Research 2017;31:1316-1322.
5. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA 1999;281:537-544.
6. Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstetrics & Gynecology. 2008;112:970-978.
7. Brotto LA. The DSM diagnostic criteria for hypoactive sexual desire disorder in women. Archives of Sexual Behavior 2010;39:221-239.
8. Clayton AH, Goldstein I, Kim NN, Althof SE, Faubion SS, Faught BM, Parish SJ, Simon JA, Vignozzi L, Christiansen K, Davis SR. The International Society for the Study of Women's Sexual Health process of care for management of hypoactive sexual desire disorder in women. Mayo Clinic Proceedings 2018;93:467-487.