BioForm Medical, San Mateo, CA, Feb. 15 (Minneapolis, MN).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The manufacturer of products to treat acne and eczema was inspected Oct. 2-18, 2006, where FDA investigators determined that the products were drugs because of the company's claims in its labeling, including its web sites, and that the products are intended for use in the cure, mitigation, treatment, or prevention of disease.

Examples of some of the claims observed for these products included the following:

* Claims on the boxes for each of the Cutanix products: "Reduces Redness;" "Smoothes Scaly Skin;"

* Claims on the Cutanix Dramatic Relief for Oily and (Acne Prone Skin box: "[I]ntended for individuals with chronic skin redness and flaking ... associated with dermatologic conditions like seborrheic dermatitis or rosacea."

* Claims on the Cutanix Dramatic Relief for Normal To Dry Skin box: "[I]ntended for individuals with chronic skin redness accompanied by severely dry skin, often associated with dermatologic inflammatory conditions like eczema or rosacea."

* Claims on the Cutarix Dramatic Relief Extra Strength box: "[I]ntended for individuals with chronic, persistent facial redness associated with dermatologic inflammatory conditions like rosacea or eczema."

FDA stated that because these skin treatment products are drugs, the company must file an NDA to legally market them. NDA; F-B; Web; Lab; Doc. 14082W

Print Get the Mag Weekly Updates