Class Action Lawsuit Claims Estroven Supplements Are Ineffective, Lack FDA Approval

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I-Health, Inc. and DSM Nutritional Products, Inc. have been hit with a proposed class action lawsuit that alleges Estroven-brand Mood Boost and Stress Relief & Energy Boost supplements are misleadingly advertised as safe and effective treatments for menopause symptoms.

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The 24-page lawsuit claims that Estroven Mood Boost and Estroven Stress Relief & Energy Boost, which claim to offer relief from hot flashes, night sweats, low energy, mood swings and other menopause symptoms, are falsely advertised, as none of the so-called active ingredients—including soy isoflavones, black cohosh root extract, ginkgo biloba leaf extract and magnolia bark extract—safely and effectively improve symptoms of menopause.

Moreover, the lawsuit contends that Estroven’s efficacy claims rival those of prescription hormone replacement drugs and effectively render the products unapproved new “drugs” under the Federal Food, Drug, and Cosmetic Act (FDCA). Per the case, a drug is defined as an article intended to diagnose, cure, mitigate, treat or prevent disease or affect the “structure and function” of the human body, and a new drug is any drug that is not “generally recognized as safe and effective for the intended uses.”

The case argues that the defendants have not received approval from the FDA to sell Estroven as a new drug and that the products’ deceptive label representations, including that the supplements are “clinically proven” to provide relief for hot flashes and night sweats, lead consumers to believe that they are purchasing a safe, lawful and effective drug.

The filing conveys that unapproved new drugs are particularly dangerous because consumers risk purchasing a product that may worsen their health and may forego medically proven treatments in favor of an unapproved drug that might not treat their condition.

The lawsuit says that the Estroven supplements’ labels further violate federal law as they bear front-label claims about their purported efficacy that include an asterisk linking them to a back-label disclosure in small print that states that the products “have not been evaluated by the Food and Drug Administration” and are not intended to “diagnose, treat, cure, or prevent any disease.”

The case claims that these required disclaimers are improperly placed, as the FDCA mandates that they must be positioned “on each panel or page” of the product label where the efficacy claim appears to avoid misleading consumers.

Consumers would not have bought the Estroven supplements at issue, or would have paid less for them, had they known the products were unlawful, unsafe and ineffective for their intended purpose, the filing says.

The Estroven class action lawsuit looks to cover all California residents and citizens who purchased Estroven in California for their own personal or household use, and not for resale, from January 1, 2019 to the present.

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