Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey. These products, including injectable drug products, were marketed, sold and distributed to individuals, retail outlets, health spas and clinics. The seized products, marketed on websites including, but not limited to, www.flawlessbeautyandskin.com and www.relumins.com include:
- Relumins Advanced Glutathione "kits" and
- Tatiomax Glutathione Collagen Whitening "kits"
- Many of the injectable products also include claims to treat scurvy, degenerative brain and liver diseases, and "alcoholic liver diseases."
None of these products have been proven safe or effective for their intended uses. In addition, unapproved injectable products are of concern because their quality, safety and efficacy have not been reviewed. Further, improper injection practices may result in serious injury, including the transmission of disease.
"Companies have a responsibility to ensure their products are safe for distribution," said Melinda K. Plaisier, the FDA's associate commissioner for regulatory affairs. "We have taken action to protect consumers and demonstrate our commitment to their safety by preventing these products from being distributed."
On May 16, 2014, the New Jersey Department of Health and Senior Services detained the unapproved injectable drug products located at Flawless Beauty.
"To ensure new drugs are safe, effective, and made using quality manufacturing practices, they undergo a rigorous FDA review and approval process," said Ilisa Bernstein, acting director, Office of Compliance in the FDA's Center for Drug Evaluation and Research's. "The FDA is committed to taking action to protect American consumers against companies that circumvent the drug approval process."
To date the agency has not received direct reports of illnesses or serious side effects related to the seized products. Illnesses or side effects related to the use of these products should be reported to the FDA via MedWatch's online form or by calling 1-800-FDA-1088. Consumers who experience any unexpected adverse events should also consult a health care professional as soon as possible.