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 purport to 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 recordkeeping requirements to assist the FTC in monitoring Ernest's compliance with the order.
The Commission vote to authorize staff to file the FTC complaint and stipulated order was 5-0. The FTC complaint and stipulated final order were filed in the U.S. District Court for the Central District of California, Western Division on January 16, 2003, and the stipulated order was approved by the court on January 17, 2003.
NOTE: The stipulated final order is for settlement purposes only and does not constitute an admission by the defendants of a law violation. A stipulated final order has the force of law when signed by the judge.
Copies of the complaint and the stipulated final order are available from the FTC's Web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.
(FTC File No. 012-3249)
(Civil Action No. 03-437RSWL