Lawsuit Says Keranique Falsely Claims It Sells The Only FDA-Approved Topical For Women’s Hair Regrowth

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A proposed class action lawsuit alleges that Keranique has wrongfully advertised that its topical solutions for women’s hair regrowth are the only such products on the market that are approved by the Food and Drug Administration.

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The 28-page false advertising lawsuit contends that Keranique has deceived consumers into believing that its suite of women’s hair regrowth products are the only such topical solutions on the market with approval from the FDA. In reality, the complaint says, the FDA has given formal approval to several manufacturers to sell topical minoxidil solutions for women’s hair regrowth.

“By claiming to be ‘THE ONLY’ one, [defendants Scientific Hair Research, LLC and Profectus Beauty, LLC] attempt to erase these lawful competitors from the market, all while charging a large premium for the Keranique products,” the class action lawsuit says.

Per the suit, Keranique’s “the only” claim is listed in capital letters on the front of the company’s product packaging, and includes no modifiers, asterisks, or disclaimers to explain or qualify its inclusion.

Importantly, the case explains, the active ingredient in the Keranique products at issue is minoxidil 2%, which, per the lawsuit, was originally approved by the FDA under the brand name Rogaine. The filing says Rogaine was protected with medical-patent exclusivity upon market entry.

Upon the expiration of Rogaine’s patent exclusivity, the complaint relays, manufacturers could file Abbreviated New Drug Applications (ANDAs) with the FDA to make their own minoxidil 2% products.

“A product holding an ANDA approval is an FDA-approved product,” the case states.

Related Reading: Nutrafol Lawsuit Says ‘Misbranded’ Hair-Growth Products Not ‘Clinically Proven’ as Advertised

The suit argues that consumers are led to believe that Keranique products are the safest, most effective hair regrowth options on the market, and thus must pay more to obtain the desired results. According to the suit, Keranique sells for roughly $14.49 per ounce, whereas competing FDA-approved products “often sell for as little as $4.97 per ounce.”

Per the complaint, eight other women’s hair products with the “exact same active ingredient at the same exact concentration” are available from retailers like CVS and Amazon.com for significantly less money.

“Consumers are paying a premium for a lie,” the case summarizes.

The Keranique class action lawsuit seeks to represent all United States residents who purchased any Keranique product within the applicable statute of limitations period.

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