Federal judge orders Flawless Beauty to stop sales of unapproved products

Judge Peter Sheridan has ruled a permanent injunction between the US, New Jersey-based Flawless Beauty, and affiliated firm RDG Imports to stop the sale of certain unapproved products.

The US Department of Justice filed a complaint on behalf of the US Food and Drug Administration (FDA) against Flawless Beauty for improperly labelling (misbranded) its injectable skin whitening drug products.

It is reported that intravenous and intramuscular administration of the unapproved products without assured sterility could lead to serious health concerns such as nerve or blood vessel damage.

Other products sold by the firm are also said to have implied approval or endorsement by the FDA.

The FDA Centre for Drug Evaluation and research office of compliance director Donald Ashley said: “Despite repeated warnings, Flawless Beauty continued to put patients at risk by selling potentially dangerous and unproven treatments to consumers.

“We urge consumers to beware of these and other unproven drug products that use deceptive marketing tactics to sell their unsafe products.”

The consent decree prohibits direct or indirect import, manufacture, and distribution of any drug products until compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The company is also required to recall all ampoules or lyophilised vials that were sold as part of whitening kits under brands Relumins, Tatiomax, TP Drug Laboratories, Laennec, Saluta, Tationil, and Laroscorbine.

In addition, Flawless Beauty, RDG Imports, and its owners are ordered to employ an expert for review of their products and obtain written permission from the FDA prior to resuming distribution.

In 2014, US Marshals seized several unapproved and improperly labelled Flawless Beauty products such as injectable skin whitening products the Relumins Advanced Glutathione and Tatiomax Glutathione Collagen Whitening kits.