Elixir Cosmetics Lawsuit Alleges Babe Brow, Babe Lash Serums Are Illegal to Sell Without FDA Approval

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A new class action lawsuit alleges the maker of Babe Lash Essential Serum and Babe Brow Amplifying Serum has misleadingly failed to warn consumers of the serious physical and/or medical risks associated with using the cosmetic products.

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The 27-page proposed class action against Elixir Cosmetics Opco says that although the manufacturer has touted the Babe Lash and Babe Brow serums as safe and legal, the cosmetics contain isopropyl cloprostenate (ICP), a chemical compound found in prescription drugs. Unlike prescription drugs, the lawsuit says, the Babe Lash and Babe Brow products at issue are sold without a prescription and/or a disclosure of their known association with certain adverse side effects. 

According to the filing, the risk of harm from using Babe Lash Essential Serum and Babe Brow Amplifying Serum, which are purportedly able to give users longer-looking lashes and fuller-looking brows, is “well known” to Elixir Cosmetics. The company, the case contends, has “no excuse” to sell the items to unsuspecting consumers under the guise that they are safe and can be used without medical consultation or a disclosure of serious potential side effects. 

The complaint mentions that the FDA has warned cosmetics makers that items containing ICP are considered drugs by definition under the Federal Food, Drug, and Cosmetic Act, and that selling them “poses a danger to the consuming public” and is illegal. 

“Because the Products are drugs, Elixir was required to seek regulatory approval for safety and efficacy before selling them to consumers,” the case summarizes. “Elixir failed to seek such approval, and instead deceptively marketed and sold the Products as cosmetics, even though they are unapproved drugs.”

Many consumers bought the Elixir Cosmetics serums without knowing that they are “illegal and unapproved drugs” with potentially serious side effects that would not be reasonably expected from a cosmetic. These potential side effects include the risk of permanent dry eyes; permanent iris discoloration, including the changing of light-colored eyes to brown; spotting of the iris; the permanent appearance or enhancement of dark circles under the eyes; and the loss of eyelashes, among others, the lawsuit says. 

“Plaintiffs would not have purchased the Products had they been transparently marketed and advertised as having the characteristics that they do—that is, of illegality and with risk of causing serious physical injury and harm, and have been harmed economically by purchasing the Products as a result of Defendant’s deception,” the case reads. 

The lawsuit alleges Elixir Cosmetics purposefully highlights the products’ “effective” ingredients as biotin, panthenol and amino acids so as to “create the image of a clean and healthy product.” The suit claims the company “purposefully obfuscat[es]” the serums’ active ingredient, ICP, which is principally responsible for the stimulation of eyelash length and boldness. 

“Despite containing a drug with known serious side-effects, Elixir omits reference to the known risks, instead providing the most basic generic, uninformative warnings – no different than those found on virtually every cosmetic applied to or near the eyes.” 

More specifically, isopropyl cloprostenate resides in a class of drugs known as prostaglandin analogs, which are typically prescribed to reduce intraocular pressure in glaucoma patients, the lawsuit explains. The dangers of prostaglandin analogs are well known to Elixir, and some of the company’s competitors, the suit says.

The lawsuit adds that Elixir markets the serums without adequate medical disclosures even though the FDA in 2011 issued a warning letter to Lifetech Resources, which makes RapidLash EyeLash Renewal Serum and NeuveauBrow Active Eyebrow Technology, because the products contain ICP as their active ingredient. 

“As detailed above, just like LifeTech and NeauveauBrow, Elixir’s marketing and advertising claims are dedicated to the physical appearance of eye lashes (i.e., specifically to increase length and thickness) and clearly intended to affect the structure or function of the body, within the meaning established under federal and state cosmetics laws.” 

The Elixir lawsuit looks to cover all persons in New York who bought the Babe Lash Essential Serum and Babe Brow Amplifying Serum products within the applicable statute of limitations period. 

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