U.S. Department of Justice United States Attorney July 7, 1999 FOR IMMEDIATE RELEASE United States Attorney Lynne A. Battaglia, Acting Assistant Attorney General David W. Ogden, and Food and Drug Administration Commissioner Jane E. Henney, M.D., announced today the indictment of Allen J. Hoffman, Odus M. Hennessee, Donald L. MacNay, M.D., and T-Up, Inc. on criminal charges of conspiring to commit violations of federal laws in connection with the promotion, sale, and distribution of an unapproved new drug known as "T-UP," purportedly a concentrated form of aloe vera. Allen J. Hoffman, age 52, is a Baltimore resident. Mr. Hoffman is the President of T-Up, Inc., which is a Maryland corporation and corporate defendant located in Baltimore, Maryland. Odus M. Hennessee, a 50 year old Oklahoma resident, is the President of Cosmetic Specialty Labs, Inc., a corporation located in Lawton, Oklahoma. Dr. Donald L. MacNay is a 62 year old resident of Manassas, Virginia. Dr. McNay had a practice in Manassas and in Annandale, Virginia, doing business under the name of "The Piedmont Orthopedic Clinic." The twenty-count Indictment charges that from about September 1996 through about November 1997, defendants conspired to promote, sell, and distribute "T-UP," an unapproved new drug, as a treatment, mitigation and cure for cancer, AIDS, herpes and other auto-immune disorders. The defendants are charged with one count of conspiring to introduce an unapproved new drug into interstate commerce and to commit mail and wire fraud. The Indictment also charges five counts of introducing an unapproved new drug into interstate commerce; four counts of mail fraud; and ten counts of wire fraud in connection with the scheme to defraud consumers and the Food and Drug Administration ("FDA"). According to the Indictment, the defendants sold T-UP in two forms. One form, "T-UP Whole Leaf Aloe Vera Concentrate," referred to as "T-UP Aloe Juice," was taken orally. The second form, "Filtered and Sterilized T-UP Whole Leaf Aloe Vera Concentrate," referred to as "T-UP Filtered and Sterilized," was administered intravenously. The Indictment states that defendants promoted both forms of T-UP as a treatment for cancer, AIDS, herpes, and other auto-immune disorders. The Indictment charges that the defendants promoted T-UP by mass mailings of promotional materials, including an audio-tape entitled "There is Hope: You Do Not Have To Die!," and a brochure entitled "Boost Your Immune System." The Indictment charges that these mass mailings were sent to potential customers, patients and family members of patients across the United States. The Indictment further states that the defendants promoted T-UP on interstate radio broadcasts, by videotapes, by word-of-mouth, by telephone, and on the Internet. The Indictment charges that defendant Odus Hennessee, of Cosmetic Specialty Labs, Inc., in Lawton, Oklahoma, supplied Baltimore defendants Hoffman and T-Up, Inc. with both forms of T-UP. The Indictment charges that the defendants sold or administered T-UP to cancer patients and other customers throughout the United States. Specifically, the Indictment states that defendant Hoffman and MacNay intravenously administered "T-UP Filtered and Sterilized" to several cancer patients, including a patient from Baltimore who had kidney cancer and a liver cancer patient from Franktown, Colorado. The Indictment charges that the intravenous administration of the T-UP cost the patients or their family members approximately $12,000 for a two-week course of treatment. The Indictment further states that defendants Hoffman and T-Up, Inc. sold 2 oz. bottles of "T-UP Aloe Juice" to cancer patients and other customers for approximately $75.00 a bottle. The Indictment charges that to induce cancer patients and other consumers to purchase T-UP, defendants Hoffman, Hennessee and MacNay defrauded and misled consumers and cancer patients about their educational qualifications, medical qualifications, experience, and credentials. The Indictment further charges that defendants told consumers, cancer patients and their family members that T-UP was approved by FDA, when, in truth, T-UP was not approved by FDA. The maximum penalty for the conspiracy count and each count of mail and wire fraud is a $250,000 fine and 5 years imprisonment. The maximum penalty for each count of introducing an unapproved new drug into interstate commerce is a $250,000 fine and 3 years imprisonment. Donald MacNay, M.D. is scheduled for an initial appearance before U.S. Magistrate Judge Susan Gauvey on July 8, 1999 at 11 am. Allen Hoffman and Odus Hennessee are scheduled to have their initial appearances on July 16, 1999 at 10:00 am. This case was investigated by FDA's Office of Criminal Investigations, the Internal Revenue Service and the United States Postal Inspectors, with the assistance of the Maryland State Attorney General's Office of Consumer Protection. It is being prosecuted by Assistant U.S. Attorney Virginia B. Evans and Karen M. Valentine, Trial Attorney, Office of Consumer Litigation, U.S. Department of Justice. |