WASHINGTON The nonprofit Center for Science in the Public Interest on Wednesday filed a claim to the Food and Drug Administration that the red-clover dietary supplement Promensil, distributed by Natrol, “is being deceptively marketed to women for the relief of hot flashes, night sweats, and mood swings,” the organization stated.
“Natrol’s ads for Promensil are some of the most dishonest we’ve seen for a dietary supplement in a while,” stated CSPI senior nutritionist David Schardt. CSPI conducted a detailed analysis of the scientific research on Promensil, the organization stated, and how it doesn’t support Natrol’s claims. CSPI’s letters to the FDA ask that Natrol reimburse deceived consumers, run corrective advertising to set the record straight, and pay a fine.
In response, Natrol today issued a press release outlining a published clinical treatment protocol that recommends supplementation with red clover isoflavones for women experiencing menopause symptoms.
According to the company, the protocol was developed by physicians and other healthcare professionals from the United States, United Kingdom, Canada, Australia and The Netherlands, and recommends supplementation with red clover isoflavones as a complementary therapy for treating mild-to-moderate menopause symptoms, as well as for treating severe symptoms when hormone replacement therapy is contraindicated.
“We have long had confidence in the significant body of clinical research indicating Promensil provides benefits for menopausal women by offering a unique isoflavone ratio that is a safe alternative to HRT,” stated Natrol vice president of research and development Michael Yatcilla. “Promensil can help relieve the frequency and severity of hot flashes, and promote breast and heart health, as well as emotional well-being.”