The seized products, marketed on websites including, but not limited to, www.flawlessbeautyandskin.com and www.relumins.com included Tatiomax Glutathione Collagen Whitening “kits”.
According to the authorities, none of these products have been proven safe or effective for their intended uses.
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.
“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.
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.