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Protect Your Health

Food, Medical Product & Cosmetic Safety

Published as part of a U.S. Food and Drug Administration and WebMD partnership to protect and promote your health. The following article is under sole editorial control of FDA.

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FDA Law Enforcers Crack Down on Botox Scammers

(continued)

How Patients Were Scammed

According to OCI agents, most of the health care professionals misrepresented the fake product to patients, leading them to believe they were receiving the real Botox Cosmetic. Some of the tactics they used were

advertising in brochures, magazines, and on Web sites that they specialized in treating facial wrinkles with Botox Cosmetic
displaying a certificate indicating they received training by the Botox Cosmetic manufacturer, when they did not
informing patients they would be receiving Botox Cosmetic
failing to tell patients they were getting a drug not approved for human use
asking patients to sign a consent form indicating they would be receiving injections of FDA-approved Botox Cosmetic

Sample Botox Cases Investigated by FDA's Office of Criminal Investigations
Defendant	Illegal Action	Result
Gayle Rothenberg, M.D., operator of Center for Image Enhancement, Houston	Injected more than 170 patients with unapproved drug, representing it as approved Botox Cosmetic	Indicted for mail fraud, misbranding a drug, making false statements to a federal agent; June 13, 2008, sentenced to 27 months in prison, restitution of $98,426, fine of $1,000
Mark E. Van Wormer, M.D., operator of GreatSkin clinic, Albuquerque, N.M.	Injected patients with unapproved drug, representing it as approved Botox Cosmetic	Indicted for fraud, misbranding a drug, tampering with documents; Dec. 14, 2007, sentenced to 1 year and 1 day in prison, restitution of $65,265, fine of $3,000
Albert Poet, M.D., operator of offices in Stafford Township and Montclair, N.J.	Injected patients with unapproved drug without telling patients	Indicted for mail fraud, misbranding a drug; Sept. 28, 2007, sentenced to 14 months in prison
Ivyl Wells, former M.D. and operator of Skinovative Laser Center, Boise, Idaho; surrendered medical license after charges were filed	Injected about 200 patients with unapproved drug, representing it as approved Botox Cosmetic	Indicted for mail fraud, misbranding a drug; Dec. 11, 2006, sentenced to 6 months in prison, 6 months home detention, restitution of $88,000, fine of $40,000, 300 hours community service
Jerome Lentini, M.D., operator of A Younger You clinics, Salem and Tigard, Ore., and his assistant, Cathryn Garcia, R.N.	Injected about 800 patients with unapproved drug, representing it as approved Botox Cosmetic	Indicted for misbranding a drug; Aug. 14, 2006, Garcia sentenced to 1 year in prison; Dec. 11, 2006, Lentini sentenced to 18 months in prison, restitution of $330,000
Chad Livdahl and Zarah Karim, owners of Toxin Research International, Tucson, Ariz.	Sold unapproved botulinum toxin, labeled "Not for Human Use," to more than 200 physicians throughout the U.S. to use on their patients	Indicted for mail and wire fraud, misbranding a drug; Jan. 26, 2006, Livdahl sentenced to 9 years in prison, restitution of $345,567, forfeiture of $882,565; Karim sentenced to 5.8 years in prison, restitution of $345,567