Class Action Lawsuit Claims Aphrona Moonlight Pro LED Facial Mask Falsely Advertised as FDA-Approved

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A proposed class action lawsuit claims that Daman Beauty has falsely advertised that its Aphrona Moonlight Pro LED Facial Masks are approved, favored or endorsed by the FDA by mislabeling product packaging with the agency’s name and logo.

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According to the 17-page lawsuit, the LED facial masks, which use different colors to purportedly treat acne and other skin conditions, are advertised on product packaging and the websites of Aphrona and third-party retailers as FDA-approved. However, the lawsuit claims that due to the way the FDA classifies medical and cosmetic devices, the LED face masks cannot possibly receive FDA approval or endorsement, only clearance to be sold.

“Any device that is misbranded is illegal to sell,” the complaint states. “Misbranded devices thus have no economic value and are legally worthless.”

The FDA categorizes medical devices into three regulatory classes, Class I, Class II, and Class III, the case explains. Like nearly half of all medical devices, the Aphrona Moonlight Pro LED Facial Mask is considered a Class II device, meaning that the manufacturer need only demonstrate that it is similar to a pre-existing item on the market in order to be cleared to sell it, the complaint relays.

Per the suit, FDA approval is required only for Class III medical devices before they are introduced to the market. To receive FDA approval for a Class III device, a manufacturer must establish “to a satisfactory and science-backed standard” that there exists reasonable assurance that a device is safe and effective for its intended use, the lawsuit explains

Given that it is a Class II device, the Aphrona Moonlight Pro LED Facial Mask cannot receive the FDA approval touted in the product’s marketing, the case contends. The lawsuit charges that the product’s labeling and marketing violate the Food, Drug and Cosmetic Act and FDA regulations that prohibit the unauthorized use of the agency’s name and logo so as to not mislead consumers into thinking that the Food and Drug Administration has endorsed a product.

“Defendant’s representations were material because they were likely to deceive reasonable consumers to induce them to purchase the Products without being aware that the Products were not favored, endorsed or approved by the FDA,” the suit summarizes.

The class action lawsuit against Moonlight Pro manufacturer Daman Beauty seeks to represent anyone in the United States who purchased the Aphrona Moonlight Pro LED Facial Mask for personal, family or household use and not for resale within the applicable statute of limitations period.

Learn all about the legal process: What is a class action lawsuit?