Department of Justice
U.S. Attorney’s Office
District of Puerto Rico
FOR IMMEDIATE RELEASE
Tuesday, November 2, 2021
SAN JUAN, Puerto Rico – Michelle Andujar-González, the president of BAJA PESO YA INC., Sahen L. Maldonado-López, the secretary, and María de Lourdes Irizarry-Rodríguez, an associate of the company, were charged and pled guilty on November 2, 2021, to participating in a mail fraud conspiracy to illegally sell weight loss products. The defendants marketed, sold, and delivered through the mail what they described as dietary supplements for weight loss but were in fact misbranded drugs containing ingredients that were not declared on the products’ labeling. W. Stephen Muldrow, United States Attorney for the District of Puerto Rico, and Justin C. Fielder, Special Agent in Charge of the FDA, Office of Criminal Investigations Miami Field Office, announced the convictions of the defendants for their role in the scheme. Homeland Security Investigations (HSI) and the United States Postal Inspection Service (USPIS) collaborated during the investigation.
Specifically, as part of the scheme, from 2018 through May 2021, the defendants sold products which contained undeclared drugs—sibutramine, phenolphthalein, and tadalafil. The defendants purchased the products from suppliers in China and used Facebook and the BAJA PESO YA INC. website to advertise and promote the illegal products. The defendants delivered the products to their customers via mail across the United States.
The products the defendants sold included:
- “Slimmer Extreme”, which was labeled as containing a “Thermogenic Formula” that will “Help contain appetite and hunger cravings” and “Support losing excess body fat”;
- “Adipotrim Hardcore”, which was labeled as containing an “Original Formula” to “Reduce waist and hip size,” “Lose weight starting in one week,” “Most weight loss advanced formula,” and “Boost energy and metabolism”;
- “Adipessum”, which was labeled as “Miracle Slimming Capsules” containing an “Advanced Formula” that “Burns Fat and Calories” and will “Boost Energy,” “Control Appetite,” “Speed Metabolism,” and “Eliminate Excess Water”; and
- “Li Da Daidaihua,” which was labeled as “Weight Loss Capsules” “Made of Natural Herbs” and “Safe and Free of Side Effects.”
From April 2015 through July 2019, the FDA published notifications via www.fda.gov for products sold by the defendants:
|FDA Notification Date||Product||FDA Lab Results|
|04/30/15||Li Da Daidaihua||Contained undeclared sibutramine|
|11/20/17||Adipessum||Contained undeclared sibutramine and phenolphthalein|
|01/28/19||Slimmer Extreme||Contained undeclared sibutramine and phenolphthalein|
|07/01/19||Lipro||Contained undeclared tadalafil|
|07/16/19||Reduktis Max||Contained undeclared sibutramine|
Sibutramine is a Schedule IV controlled substance banned by the FDA in October 2010 because of a risk of heart problems and strokes. Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity, and subsequently withdrawn from the United States market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.
Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Phenolphthalein was used in some laxative products until 1999. The FDA no longer recognizes the drug as “safe and effective.” Studies have indicated that it presents a cancer-causing risk.
Tadalafil is the active pharmaceutical ingredient in Cialis, an FDA-approved drug used to treat erectile dysfunction (ED).
“Consumers must be able to trust that the products they buy are safe and the claims on the product’s label can be relied on,” said U.S. Attorney Muldrow. “The U.S. Attorney’s Office will continue to work with our law enforcement partners to take action against irresponsible business owners that make unsubstantiated claims about products that can lead to serious health issues.”
“Products that claim to be dietary supplements but contain unapproved drug ingredients pose a serious risk to public health,” said Special Agent in Charge Justin C. Fielder, FDA Office of Criminal Investigations Miami Field Office. “We will continue to investigate and bring to justice those who put profits above the health and safety of U.S. consumers.”
“Protecting the health and safety of consumers is one of HSI San Juan’s highest priorities,” said HSI Special Agent in Charge Ivan J. Arvelo. “This investigation demonstrates how law enforcement partners work jointly to investigate these criminals and bring them to justice.”
“At a time when the United States Postal Service is playing such a critical role in the nation’s supply chain, Postal Inspectors will be ever vigilant in our pursuit of criminals who use the U.S. Mail to ship counterfeit prescription drugs. We will continue to work with our law enforcement partners to prevent the conveyance of misbranded medications that can potentially cause severe injury or harm to unsuspecting consumers,” said Inspector in Charge Raymundo Marrero, Newark Division.
As part of their guilty pleas, the defendants agreed to forfeit $400,000, which were proceeds traceable to the mail fraud conspiracy. The defendants face a maximum sentence of twenty years in prison; a fine not to exceed $250,000; and a supervised release term of not more than three years.
The FDA-OCI-SJP led the investigation with the collaboration of Homeland Security Investigations and the US Postal Inspection Service. The case was prosecuted by Assistant United States Attorney Victor O. Acevedo-Hernández.
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USAO - Puerto Rico