PurelyWhite Lawsuit Says Teeth-Whitening Kits Are Misbranded as FDA-Approved

New to ClassAction.org? Read our Newswire Disclaimer

A proposed class action lawsuit alleges PurelyWhite Deluxe Tooth Whitening Kits are mislabeled and misrepresented as approved by the United States Food and Drug Administration (FDA), which does not issue clearance or approval for cosmetic, over-the-counter teeth-whitening products. 

Want to stay in the loop on class actions that matter to you? Sign up for ClassAction.org’s free weekly newsletter here. 

The 25-page complaint says that although the packaging of the purportedly “dental grade” teeth whitening kits includes the FDA name and logo, these representations are false and likely to deceive a reasonable consumer into believing the agency “favor[s], endorse[s] or approve[s]” the products. The false advertising lawsuit highlights that the products, which utilize a whitening gel and LED light that supposedly accelerates the teeth-whitening process, are categorized as low-risk Class I medical devices that receive no FDA clearance or approval before being made available to consumers nationwide.

Importantly, over-the-counter teeth whitening product are considered cosmetics and thus regulated by the FDA pursuant to the federal Food, Drug and Cosmetics Act, under which it is illegal to distribute any type of cosmetic that is misbranded due to false or misleading labeling, the suit relays. Further still, the FDA prohibits private companies, such as defendant HBL Beauty & Co., from using its name and logo on their product materials, the complaint shares. 

“Any cosmetic product that is misbranded is illegal to sell,” the filing emphasizes. “Misbranded products thus have no economic value and are legally worthless.” 

The lawsuit goes on to accuse the PurelyWhite Deluxe whitening kit manufacturer of falsely touting limited-time discounts online, namely by showing consumers “fake limited-time sales, fake regular prices, and fake discounts based on the fake regular prices.” 

In reality, the PurelyWhite Deluxe teeth-whitening kits are “always on sale, and these sales persist,” the suit says, alleging the company misleads consumers “into believing they are getting a good deal.” 

“For example, Defendant has prominently displayed, since at least August 2020, the Products on sale for $49.99 on its website. This sale is designed to induce consumers to purchase its Products under the mistaken belief that they are getting a significant bargain because they are buying while the sale is going on.” 

The case contends that proposed class members would not have bought the PurelyWhite Deluxe teeth-whitening kits had they known the products were not endorsed or approved by the FDA or that their supposed “sale” prices were false. 

The lawsuit looks to cover all persons in the United States who, within the applicable statute of limitations period, bought PurelyWhite Deluxe Tooth Whitening Kits for personal, family or household use and not for resale. 

Get class action lawsuit news sent to your inbox – sign up for ClassAction.org’s free weekly newsletter here.