US marshals seize non-FDA approved drugs claiming to treat liver diseases
US marshals have seized various unapproved injectable drug products from a New Jersey beauty company, including some that claimed to treat degenerative liver and brain diseases, alcoholic liver diseases, and scurvy, according to an FDA press release.
Flawless Beauty of Asbury Park, N.J., was marketing, selling and distributing multiple products through e-commerce that had not been FDA approved. US marshals seized the products at the request of the FDA and U.S. Attorney for New Jersey. Among the products seized were relumins advanced glutathione “kits” and tatiomax glutathione collagen whitening “kits,” according to the release.
“The FDA is committed to taking action to protect American consumers against companies that circumvent the drug-approval process,” Ilisa Bernstein, acting director at the office of compliance in the FDA’s Center for Drug Evaluation and Research, said in the release.
“Companies have a responsibility to ensure their products are safe for distribution,” Melinda K. Plaisier, FDA associate commissioner for regulatory affairs, said in the release. “We have taken action to protect consumers and demonstrate our commitment to their safety by preventing these products from being distributed.”
The release also said the agency has not received any 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’s MedWatch.