FDA Says Fusion’s Claims For Facial “Lift” Products Make Them Drugs

FDA expects Fusion Brands' written response to an April 24 warning letter within the next two weeks, the agency told "The Rose Sheet" May 30.

According to FDA, Fusion Brands is in violation of the Federal Food, Drug and Cosmetic Act for labeling associated with three products under its LiftFusion skin-care brand.

FDA says it reviewed the Canadian company's Web site and product labeling to determine that the Micro-injected M-Tox Transdermal Face Lift, Mini Micro-injected M-Tox Transdermal Face Lift and Micro-injected M-Tox Transdermal Eye Lift all claim to alter the structure or function of the body and would therefore be considered drugs, not cosmetics.

As the items are not generally recognized as safe and effective by qualified experts, they cannot be marketed in the U.S. as indicated without approval via a New Drug Application, the agency says.

FDA lists a number of claims that it says overstep cosmetic boundaries, including "the first topical-injectable alternative to doctor-administered anti-wrinkle injections: proven more effective than Botox in a clinical study"; "features patented nanosphere technology that delivers a powerful blend of anti-aging elements to actively counteract fine lines and deep wrinkles"; and "blocks muscle contractions within 10 minutes of application to the skin which helps prevent new lines and wrinkles from forming."

Even if Fusion Brands retracts the claims in question, its products are still misbranded due to the firm's failure to "accurately" identify the manufacturer, packer or distributor on the labeling and include a reachable business address.

FDA requested in April that Fusion Brands notify it in writing within 15 days of the warning letter's receipt as to the specific steps it had taken to correct the violations. The company has since been granted an extension.

Other Fusion Brands products include offerings under its LipFusion , LashFusion and GlowFusion lines.

- Molly Lass ([email protected])