Nutrafol Class Action Says ‘Misbranded’ Hair-Growth Products Not ‘Clinically Proven’ as Advertised

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A proposed class action lawsuit alleges the maker of Nutrafol hair-growth supplements has misleadingly advertised the products by positioning them as “dietary supplements” and falsely claiming they are “clinically proven” to aid hair growth and prevent shedding. 

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The 39-page clean Nutraceuticals lawsuit says that Nutrafol products, unbeknownst to consumers, are not “clinically proven,” as this claim from defendant Nutraceutical Wellness is backed by nothing more than “deeply flawed studies.” 

To make matters worse, the suit continues, the Nutrafol supplements at issue are labeled as “hair growth” products—making them, by law, unapproved drugs—and advertised with other “improper disease claims” that the FDA mandates must come with disclaimers. 

“As such,” the lawsuit says, the [Nutrafol] Products are considered unapproved and misbranded ‘new drugs’ under the Food, Drug, and Cosmetic Act … which are illegal to sell and worthless.”

The Nutrafol products the lawsuit alleges are misleadingly advertised and misbranded include:

• Nutrafol Women;
• Nutrafol Women’s Vegan;
• Nutrafol Women’s Balance;
• Nutrafol Postpartum; and
• Nutrafol Men. 

Per the suit, there exist only three FDA-approved drugs that are clinically proven to help treat hair loss, and an increasing number of consumers have come to use hair growth supplements and/or cosmetics to deal with hair loss or thinning. As such, the market for hair growth supplements has exploded and is expected to surpass $2.86 billion by 2031, the lawsuit relays. 

As the case tells it, the maker of Nutrafol is among the “major players” to have capitalized on this demand.

According to the lawsuit, the federal Food, Drug, and Cosmetic Act (FDCA) defines “drug” as any article intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease.” The suit contends that although Nutrafol is positioned as a “dietary supplement,” the products are in fact drugs “for the simple reason that their front labels conspicuously state that their intended use is to improve ‘hair growth.’” 

“FDA regulations expressly establish that hair growth products are ‘new drugs,’” the filing states.

The suit says that Nutraceutical Wellness has not filed with the FDA an application for the approval of Nutrafol even though the products are “new drugs.”

“Indeed, the FDA has repeatedly admonished companies who labeled and/or advertised their dietary supplements and cosmetic products for hair growth or hair loss prevention, like Defendant’s Products, as unapproved drugs that are not generally recognized as safe and effective for the uses and claims made by Defendant.” 

Even if Nutrafol products do not qualify as new drugs, their labels nevertheless include improper “disease” claims impermissible under FDA regulations for dietary supplements, the suit adds. Generally, a statement counts as a disease claim if, for instance, the statement explicitly or implicitly says that the product has an effect on a disease, a sign or symptom of a disease or an “abnormal condition”; has a role in the body’s response to a disease; or is a substitute for, is similar to or augments a product that diagnoses, treats or prevents a disease. 

“Applying these criteria to Defendant, the Products go beyond structure/function claims by making statements related to the causes, symptoms, and treatment of a group of diseases: namely, alopecia areata and telogen effluvium (among others),” the lawsuit expands. 

Citations across the defendant’s website imply that Nutrafol products have an effect on hair loss and thinning, namely in that they compare or contrast the products with other supplements or interventions that actually diagnose, treat or prevent these diseases, the case explains. 

“To make matters worse, all of Defendant’s statements about its Products fail to include a mandatory disclaimer stating that they have not been evaluated by the FDA, nor are intended to diagnose, cure, or prevent a disease,” the suit appends. 

The lawsuit looks to cover all persons in the United States who, during the maximum period of time allowed by law, bought Nutrafol products primarily for personal, family or household use, and not for resale. 

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