District Court Enters Permanent Injunction Against Two New Jersey Companies and Two Individuals to Stop Distribution of Unapproved and Misbranded Drugs
Two companies in New Jersey and two individuals have been enjoined from distributing their unapproved injectable skin whitening drugs and other drugs in violation of federal law, the Department of Justice announced today.
The U.S. District Court for the District of New Jersey entered a consent decree of permanent injunction against Flawless Beauty LLC of Ocean Township and Asbury Park, New Jersey; RDG Imports LLC of Asbury Park, New Jersey; and Jack H. Gindi and Susana B. Boleche. 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 filed a complaint in the District of New Jersey on Sept. 14, at the request of the U.S. Food and Drug Administration (FDA). As detailed in the complaint, the defendants import, process, pack, label, hold, and/or 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 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.”
As noted in the complaint, the vast majority of the defendants’ products are marketed with skin whitening claims. According to the complaint, some of 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.” 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, abscess formation and toxic systemic reactions.
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 existed. The complaint further alleged that some of defendants’ unapproved drugs are misbranded because they bear inadequate directions for use, are unsafe prescription drugs, and are prescription drugs that fail to bear ‘Rx’ on their labels.
Products referenced 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.
In conjunction with the filing of the complaint, 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/or distributing any unapproved drugs, including their injectable skin whitening drugs, unless and until defendants comply with specific remedial measures set forth in the permanent injunction.
In addition, within 20 days after the district court’s order, the defendants are required to recall and destroy, under FDA supervision and to FDA’s satisfaction, all unapproved injectable skin whitening drugs.
“Distributing unapproved drugs and mislabeling them to give the impression that they have been approved by the FDA is a practice that cannot be tolerated,” said Acting U.S. Attorney William E. Fitzpatrick, District of New Jersey. “This decree ensures that these products will be removed from the marketplace and that the defendants will not be allowed to distribute them until they bring the products into compliance with the law.”
The government is represented by Trial Attorney Mary M. Englehart of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Anthony Labruna of the U.S. Attorney’s Office for the District of New Jersey, with the assistance of Associate Chief Counsel for Enforcement Sonia Nath of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of New Jersey, visit its website at https://www.justice.gov/usao-nj.