Class Action: Grande Cosmetics Lash, Brow Serums Are ‘Unapproved Drugs,’ May Cause ‘Serious Adverse Effects’ [UPDATE]

A proposed class action lawsuit alleges the GrandeLASH-MD, GrandeBROW and GrandeHAIR serums sold by Grande Cosmetics contain an ingredient that can cause potentially serious side effects such as iris discoloration. 

The 26-page lawsuit alleges that although Grande Cosmetics claims its lash, eyebrow and hair enhancement serums are safe to use, contain no active drug ingredients and have no serious side effects, the products, in truth, contain isopropyl cloprostenate (ICP), a substance in the same class of compounds as the active ingredient found in prescription drugs that grow eyelashes, such as Latisse. 

According to the complaint, the Food and Drug Administration has concluded that lash and brow products that contain ICP, a prostaglandin analog that grows hair by extending the length of the hair cycle, are not safe for use except under the supervision of a licensed physician. 

The case argues that according to California Health & Safety Code, the serums are not cosmetics but drugs, meaning Grande Cosmetics was required to seek regulatory approval prior to selling the items to consumers. Rather than seek formal approval, however, Grande Cosmetics pushed the purportedly unsafe serums right to market, the complaint alleges. 

“Grande Cosmetics sought no such approval, and instead concocted a scheme to take the Enhancement Serums straight to market by selling them as cosmetics instead of prescription drugs,” the case claims. “Even though the Enhancement Serums are an unapproved drug that should never have been available for sale to consumers, Grande Cosmetics unlawfully sold hundreds of thousands of units of the Enhancement Serums to California consumers at around $65-$125 apiece.” 

The plaintiff, a Los Angeles County resident, claims to have purchased the GrandeBROW and GrandeLASH-MD serums without knowing they were “new drug[s] with potentially serious side effects” one would not reasonably expect to occur from a cosmetic, including “iris discoloration, the development of growths in the eye, and the complete loss of eyelashes.”

“Unapproved new drugs”

A key contention in the lawsuit is that the Grande Cosmetics enhancement serums qualify as “unapproved new drugs” given their intent is to “affect the structure and function of the body by growing hair.” According to the complaint, any “new drug” product, that is, one “intended to affect the structure of any function of the body of man or other animals,” sold without an approved new drug application (NDA) is considered misbranded and therefore unlawful to sell under California law. 

The suit goes on to allege that the Grande Cosmetics serums are also “misbranded” given their product labeling “fails to disclose all significant safety concerns,” “fails to disclose that it is a drug, and is a new drug sold without an approved new drug application” and “does not bear the established name and quantity of each active ingredient.” Moreover, the lawsuit says, the labeling of the serums does not include adequate warnings regarding unsafe dosages, how to apply the serums and the duration of application. Grande Cosmetics also fails to summarize in its advertising materials all side effects and contraindications of the products, the lawsuit claims.

“All of the Enhancement Serums are drugs because they contain ICP and are marketed with ‘appearance claims,’” the complaint says, referencing that the premium-priced products are touted as able to, respectively, provide “naturally longer, thicker lashes”; “bolder looking brows in just 6-8 weeks”; and “fuller & healthier looking hair,” among other apparent benefits.                 

A comparable product, Latisse, which the FDA approved in 2008 and whose active ingredient bimatoprost is similar to ICP, is classified as an ophthalmic drug and cannot be obtained without a prescription, the case mentions.

“Serious adverse effects”

According to the lawsuit, Grande Cosmetics has misled consumers by failing to disclose the potentially serious side effects linked to ICP. Specifically, the case states, the FDA has found that ICP may cause certain eye issues including ocular irritation, hyperemia, iris color changes, macular edema, eye inflammation and interference with intraocular pressure reduction therapy. The defendant also fails to mention that ICP can cause clumps of hair, brows and lashes to “completely fall out instead of grow,” the suit claims. 

“By omitting this information, Grande Cosmetics actively conceals material facts and leads reasonable consumers to believe they are purchasing Products whose sale does not violate federal and/or state law,” the complaint charges. 

Lastly, the lawsuit alleges that Grande Cosmetics is well aware of the purported damage caused by its enhancement serums, in part due to the sheer number of consumer complaints found online and submitted directly to the company. Nevertheless, the company, rather than disclose the possibility of side effects, represents only that a few users may experience “mild irritation,” the suit says. 

Who’s covered by the lawsuit?

The lawsuit looks to include all California consumers who bought the GrandeLASH-MD lash enhancing serum, GrandeBROW brow enhancing serum and/or GrandeHAIR enhancement serum for personal, family or household use “from the beginning of the applicable statute of limitations period through the present.” 

How do I add my name to the lawsuit?

For typical class action cases, there’s nothing you need to do to join or be considered included in the lawsuit. Class action lawsuits generally take time to wend their way through the legal process, and it’s only if and when a case settles that those who are covered by the lawsuit, called “class members,” will need to mobilize—that is, fill out a claim form for their piece. In some cases, compensation is given to class members automatically. 

In the meantime, consumers can stay informed by signing up for ClassAction.org’s free weekly newsletter and checking back with this page for any updates on the litigation.

The complaint can be found below.