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Cutanix site was taken offline for making medical claims without being backed up by research.
FDA Warning letter:
Sources:
A few people have noticed that Cutanix seems to have vanished off the face of the internet. Their web sites at cutanix.com, tvdepot.com are offline, and their corporate web site at bioformmedical.com no longer even mentions Cutanix. Also the other regular online stores for Cutanix DRL at Amazon, DermaDoctor and Skin-Etc have no stock.
So what has happened to this much loved product ? I haven't had official word from BioForm, but a recent letter from the FDA looks telling.
So what has happened to this much loved product ? I haven't had official word from BioForm, but a recent letter from the FDA looks telling.
The Food and Drug Administration (FDA). conducted an inspection of your facility at 4133 Courtney Road, Suite 10, Franksville,WI, from October 2-18, 2006. During that inspection, the investigator collected labels and product inserts for your Cutanix Dramatic Relief for Oily and Acne Prone Skin, Cutanix Dramatic Relief for Normal to.Dry Skin, Cutanix Dramatic Relief for Sensitive Skin, and Cutanix Dramatic Relief Extra Strength products. In addition, the FDA reviewed your web sites at www.bioformmedical.com, wwwtvdepot.com/getridoflhered/ and www.cutttnix.com.
The review of this labeling found the products being offered are promoted for conditio.ns that-cause..them to be drugs under sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B) and 321(g)(1)(C)]. Claims in your labeling, including your web sites, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and are intended to affect the structure or function of the body. You can find the Act and FDA's regulations through links on FDA's Internet home page, http://www.fda.gov.
Examples of some of the claims observed for these products include:
Claims on the boxes for each of your Cutanix products:
"Reduces Redness"
"Smoothes Scaly Skin"
The review of this labeling found the products being offered are promoted for conditio.ns that-cause..them to be drugs under sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B) and 321(g)(1)(C)]. Claims in your labeling, including your web sites, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and are intended to affect the structure or function of the body. You can find the Act and FDA's regulations through links on FDA's Internet home page, http://www.fda.gov.
Examples of some of the claims observed for these products include:
Claims on the boxes for each of your Cutanix products:
"Reduces Redness"
"Smoothes Scaly Skin"
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