U.S. Food and Drug Administration main campus building. Photo: ALM

A federal judge in Trenton has enjoined two New Jersey companies from distributing unapproved injectable skin-whitening drugs and other pharmaceuticals, according to an announcement from the U.S. Department of Justice.

The two companies, Flawless Beauty of Ocean Township and Asbury Park and RDG Imports of Asbury Park, and their two principals, Jack Gindi and Susana Boleche, had entered into a consent decree with the department’s Consumer Protection Branch.

The injunction, signed by U.S. District Judge Peter Sheridan, permanently enjoins the companies from distributing unapproved and misbranded drugs in violation of the federal Food, Drug, and Cosmetic Act. In addition, the injunction requires the defendants to recall and destroy all of their unapproved injectable skin-whitening drugs, the DOJ said in the release.

The department filed a complaint in the U.S. District Court for the District of New Jersey on Sept. 14, at the request of the U.S. Food and Drug Administration, the release said. The government alleged that the defendants import, process, pack, label, hold, and distribute a variety of unapproved drugs, including unapproved prescription drugs, in violation of the FDCA.

Specifically, 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 complaint said that the vast majority of the defendants’ products are marketed with skin-whitening claims.

According to the complaint, some of the defendants’ products contain unsubstantiated therapeutic claims. For example, some of the products were promoted with claims such as “contribute to good liver function” and “clinically treat degenerative brain & liver diseases including Parkinsons,” according to the release. The complaint alleged that the defendants introduce new drugs, or cause them to be introduced, into interstate commerce in violation of the law.

The complaint alleged that defendants’ unapproved new and misbranded drugs present serious public health risks, especially defendants’ purportedly sterile injectable skin-whitening drugs.

Intravenous and intramuscular administration of drugs creates many risks, including nerve or blood vessel damage, blood-borne infection, superficial skin infection, cellulitis, and abscess formation, the release said.

The complaint alleged that, in addition to distributing unapproved drugs, some of the defendants’ drugs were misbranded because they contained labeling that is false or misleading. In particular, the complaint alleged that the labeling suggests or implies FDA approval or endorsement, when no such FDA approval for any of these products was granted.

The complaint also alleged that some of the defendants’ unapproved drugs bear inadequate directions for use, are unsafe prescription drugs, and are prescription drugs that fail to bear “Rx” on their labels.

The products referred to in the complaint include: Relumins Advanced Glutathione and New Relumins Advanced Glutathione 3500 mg; Tatiomax Glutathione Collagen Whitening; and Laennec Human Placenta Whitening; Relumins Advanced Oral Whitening & Antiaging Stack; Authentic Relumins Advanced White Stem Cell Therapy All In One Day Lotion; Authentic Relumins Advance Whitening Facial Cream With TA Stem Cell & Placenta; Relumins Medicated Professional Acne & Dark Spot Fighting Set; Natural Pearl Whitening Lotion; Authentic Kustie Beauty Slimming Activated Hot Cream; Authentic Mosbeau Placenta White Clarifying Toner; Gluta PowerPeel Soap; Relumins Advance White-Whitening Deodorant Roll-On; and Sante Barley Fusion.

The defendants agreed to settle the case and to be bound by a permanent injunction. The injunction requires defendants to stop importing, receiving, manufacturing, preparing, processing, packing, labeling, holding, and distributing any unapproved drugs, including their injectable skin-whitening drugs.

In addition, within 20 days after the district court’s order, the defendants are required to recall and destroy—under FDA supervision and to the FDA’s satisfaction—all unapproved injectable skin-whitening drugs, according to the release.

Justin Prochnow of the Denver office of Greenberg Traurig, and Amy Luria of Roseland’s Critchley, Kinum & DeNoia, represented the defendants. Neither returned calls seeking comment.

Mary Englehart of the DOJ’s Consumer Protection Branch represented the government.