Flawless Beauty LLC, a company based in Ocean Township and Asbury Park, New Jersey, and two individuals, Jack H. Gindi and Susana B. Boleche, have been permanently enjoined from distributing unapproved and misbranded drugs in violation of federal law.
The U.S. District Court for the District of New Jersey entered a consent decree of permanent injunction against Flawless Beauty LLC, RDG Imports LLC, and the two individuals. The injunction permanently enjoins the defendants from distributing unapproved and misbranded drugs in violation of the federal Food, Drug, and Cosmetic Act (FDCA). In addition, the injunction requires the defendants to recall and destroy all of their unapproved injectable skin whitening drugs.
The Department of Justice filed a complaint in the District of New Jersey on September 14, at the request of the U.S. Food and Drug Administration (FDA). The complaint alleged that the defendants import, process, pack, label, hold, and/or distribute a variety of unapproved drugs, including unapproved prescription drugs, in violation of the FDCA.
‘The Department of Justice is committed to enforcing federal consumer protection laws,’ said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. ‘We will continue to work diligently with the FDA to ensure that companies and individuals follow the laws designed to protect American consumers.’
The complaint alleged that the defendants sold a number of skin whitening drugs, including injectable drugs, despite the absence of FDA approval or a sufficient showing that these products were safe and effective. The defendants’ products present serious public health risks, especially their purportedly sterile injectable skin whitening drugs.
The complaint listed a number of products, including Relumins Advanced Glutathione and New Relumins Advanced Glutathione 3500 mg; Tatiomax Glutathione Collagen Whitening; and Laennec Human Placenta Whitening.
The injunction requires the defendants to recall and destroy all of their unapproved injectable skin whitening drugs. The outcome of this case is a permanent injunction against Flawless Beauty LLC, RDG Imports LLC, Jack H. Gindi, and Susana B. Boleche. The exact date of the injunction is not specified in the provided information.
Key Facts
- State: New Jersey
- Category: Drug Trafficking
- Source: DOJ Press Release â†â€â€
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