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As a result of combined investigations by FDA, the IRS Criminal Division, and the U.S. Department of Justice, Elisane Garcia was sentenced on July 25 for disguising controlled substances as "Brazilian diet pills" and smuggling them into the United States with intent to distribute. She was also convicted of 1 count of money-laundering.
In 2008, the FDA took action against 300 products marketed sold as dietary supplements that FDA demonstrated were not safe. “The burden of proof is on FDA to prove that the product is not safe,” said Siobhan DeLancey, FDA spokesperson. FDA has been able to show that many of these products are adulterated. FDA screens the market, looks for products in stores and in advertisements on late-night television, and analyzes them, according to DeLancey.
The sentencing of Elisane Garcia for smuggling “Brazilian diet pills” was the result of combined investigations by FDA, the IRS Criminal Division, and the U.S. Department of Justice. Interpol, the international police organization, issued a criminal tracker alert for Garcia, saying that she was wanted for “money-laundering and drug-related crimes.”
After her capture, Garcia pled guilty to a 4-count indictment for disguising controlled substances as “Brazilian diet pills” and smuggling them into the United States with intent to distribute. The indictment also included 1 count of “money laundering” that involved the transfer of money from the United States to Brazil as payment for the supposed diet pills. On Monday, July 25, Garcia was sentenced to time served (approximately 10 months) and 2 more years of probation. At the completion of her sentence, she will be deported to Brazil.
The thousands of pills smuggled by Garcia and sold as supplements contained a mixture of 2 Schedule IV substances (fluoxetine and chlordiazepoxide) and an illegal drug (fenproporex). Fluoxetine is an antidepressant sold under the brand name Prozac and chlordiazepoxide is an anti-anxiety drug sold under the brand name Librium. Fenproporex is a stimulant that has not been approved for sale in the United States. Together these drugs suppress appetite and increase metabolism.
Brazilian diet pills have been popular in South Florida and New England. According to DeLancey, consumers often assume that because these products are supplements, they are safe, and they don’t tell their physicians they are using them.
In this case, medication health fraud was involved. Purchase of the products takes place without the involvement of a pharmacist or physician.