J. Michael Ernest, Ph.D., developer of a so-called breast enhancement product marketed as "The Isis System," has agreed to settle Federal Trade Commission charges that he made deceptive statements in his endorsements of the product.
The Isis System consists of a dietary supplement and a topical cream that supposedly increase a woman's breast size. The FTC alleges that Ernest made unsubstantiated claims that The Isis System significantly increases breast size, works by stimulating breast cells to regenerate the growth process, and is safe. The FTC further alleges that Ernest had not conducted the kind of examination or testing of the products needed to support his conclusions.
On December 26, 2002, the FTC announced that it had filed in federal district court a complaint and stipulated order against Vital Dynamics, Inc., the vendor of The Isis System. The action announced today is a companion action to that case. Ernest developed Isis and was featured in ads for the product. The Isis product was advertised extensively through print, radio, TV, and on the Internet.
The proposed stipulated final order requires Ernest to have competent and reliable scientific evidence before making any claims about the benefits, performance, efficacy, safety, or side effects about Isis or any dietary supplement, food, drug, cosmetic, or device. In the event he makes claims as an expert endorser, he must also rely on an actual exercise of his represented expertise, in the form of an examination or testing at least as extensive as an expert in the field would normally conduct, to support such conclusions. The settlement allows Ernest to make representations specifically permitted by the U.S. Food and Drug Administration. Finally, the settlement contains various record-keeping requirements to assist the FTC in monitoring Ernest's compliance with the order.
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