subject: FDA says Nuviderm Tattoo Removal Cream Is Hazardous to Customers and Should Be Banned [print this page] FDA says Nuviderm Tattoo Removal Cream Is Hazardous to Customers and Should Be Banned
The FDA hit Nuviderm.com with a warning letter over "serious violations" at a facility at 2951 Marina Bay Dr # 130-478, League City, TX, USA over their featured product "Nuviderm".
According to the FDA, "Nuviderm" is essentially a "highly hazardous chemical skin peel."
A chemical skin peel involves the application of a solution to the entire face or to specific areas of the body to peel away the skin's top layers. The product "Nuviderm" claims to essentially "peel away" the users tattoo by burning and peeling the skin layer-by-layer until the tattoo is no longer visible.
Nuviderm's main ingredient is trichloroacetic acid (TCA). TCA has been used in a variety of government studies, experiments and tests; however, there is no official approval by the FDA for the acid's use as a licensed topical cream.
The watchdog agency says the company Nuviderm.com inc., failed to obtain regulatory approval for a clinical study before enrolling human subjects.
Nuviderm.com inc.'s study on its TCA Tattoo Fade and Removal Cream included the implantation of the test on 750 subjects, according to the warning letter. (http://www.accessdata.fda.gov/cdrh_docs/reviews/K061069.pdf)
Since the study, health professionals have seen an increased amount of hypo-pigmentation in the subjects skin development. Hypo-pigmentation is when the top layer of the skin has spotted patches of lighter or darker pigment.
The majority of cases of hypo-pigmentation has been observed in subjects with darker skin pigment. Furthermore, the subjects of the study have formed a union with a group of unsatisfied customers and have pursued legal action.
A class-action lawsuit first filed in federal court in Illinois has been re-filed in Madison County accusing the League City, TX based Nuviderm.com inc of being a "scam", "fraud", "rip-off", "snake-oil salesmen" etc.
The class action filed in Madison County this month launches similar allegations as those made by the attorneys general. St. Louis attorney Jay Kanzler, one of several lawyers bringing the class-action suit, tells Daily Press that his team is representing more than a thousand alleged victims in the states of Illinois, Missouri, Utah and Georgia.
"What Nuviderm.com inc. has done to these innocent people is disgraceful," says Kanzler. He adds, "I will make sure that every victim is compensated in FULL one million times for these crimes!" the charismatic Chicago lawyer asserted.
In January 2011, the company failed to submit a required investigational exemption to the FDA because of the risks posed to the study's participants.
The FDA considers Nuviderm.com inc.'s TCA Tattoo Fade and Removal Cream, and other topical Tattoo Removal Creams a "significant risk" because of the high concentration of acid in the solution, and furthermore these acidic creams "present a potential for serious risk to the health, safety, or welfare" of an individual.
