Convictions for the President, Secretary, and an Associate of theWeight Loss Company BAJA PESO YA INC. | USAO-PR

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 affiliate of the corporate, had been charged and pled responsible on November 2, 2021, to collaborating in a mail fraud conspiracy to illegally promote weight reduction merchandise. The defendants marketed, offered, and delivered via the mail what they described as dietary dietary supplements for weight reduction however had been in actual fact misbranded medicine containing elements that weren’t declared on the merchandise’ labeling. W. Stephen Muldrow, United States Legal professional for the District of Puerto Rico, and Justin C. Fielder, Particular Agent in Cost of the FDA, Workplace of Legal Investigations Miami Subject Workplace, introduced the convictions of the defendants for his or her function within the scheme. Homeland Safety Investigations (HSI) and the USA Postal Inspection Service (USPIS) collaborated in the course of the investigation.

Particularly, as a part of the scheme, from 2018 via Might 2021, the defendants offered merchandise which contained undeclared medicine—sibutramine, phenolphthalein, and tadalafil. The defendants bought the merchandise from suppliers in China and used Fb and the BAJA PESO YA INC. web site to promote and promote the unlawful merchandise. The defendants delivered the merchandise to their clients by way of mail throughout the USA.

The merchandise the defendants offered included:

1. “Slimmer Excessive”, which was labeled as containing a “Thermogenic Formulation” that can “Assist comprise urge for food and starvation cravings” and “Help dropping extra physique fats”;
2. “Adipotrim Hardcore”, which was labeled as containing an “Authentic Formulation” to “Scale back waist and hip measurement,” “Reduce weight beginning in a single week,” “Most weight reduction superior method,” and “Enhance power and metabolism”;
3. “Adipessum”, which was labeled as “Miracle Slimming Capsules” containing an “Superior Formulation” that “Burns Fats and Energy” and can “Enhance Vitality,” “Management Urge for food,” “Pace Metabolism,” and “Remove Extra Water”; and
4. “Li Da Daidaihua,” which was labeled as “Weight Loss Capsules” “Made from Pure Herbs” and “Protected and Freed from Aspect Results.”

From April 2015 via July 2019, the FDA revealed notifications by way of www.fda.gov for merchandise offered by the defendants:

Sibutramine is a Schedule IV managed substance banned by the FDA in October 2010 due to a danger of coronary heart issues and strokes. Sibutramine is the lively pharmaceutical ingredient in Meridia, a brand new drug accepted by FDA for advertising in 1997 for prescription remedy of weight problems, and subsequently withdrawn from the USA market on December 21, 2010, after scientific knowledge indicated sibutramine poses an elevated danger of coronary heart assault and stroke.

Phenolphthalein is a chemical that isn’t an lively ingredient in any accepted drug in the USA. Phenolphthalein was utilized in some laxative merchandise till 1999. The FDA now not acknowledges the drug as “secure and efficient.” Research have indicated that it presents a cancer-causing danger.

Tadalafil is the lively pharmaceutical ingredient in Cialis, an FDA-approved drug used to deal with erectile dysfunction (ED).

“Shoppers should have the ability to belief that the merchandise they purchase are secure and the claims on the product’s label may be relied on,” mentioned U.S. Legal professional Muldrow. “The U.S. Legal professional’s Workplace will proceed to work with our legislation enforcement companions to take motion towards irresponsible enterprise house owners that make unsubstantiated claims about merchandise that may result in critical well being points.”

“Merchandise that declare to be dietary dietary supplements however comprise unapproved drug elements pose a critical danger to public well being,” mentioned Particular Agent in Cost Justin C. Fielder, FDA Workplace of Legal Investigations Miami Subject Workplace. “We’ll proceed to research and produce to justice those that put earnings above the well being and security of U.S. shoppers.”

“Defending the well being and security of shoppers is certainly one of HSI San Juan’s highest priorities,” mentioned HSI Particular Agent in Cost Ivan J. Arvelo. “This investigation demonstrates how legislation enforcement companions work collectively to research these criminals and produce them to justice.”

“At a time when the USA Postal Service is taking part in such a vital function within the nation’s provide chain, Postal Inspectors might be ever vigilant in our pursuit of criminals who use the U.S. Mail to ship counterfeit prescribed drugs. We’ll proceed to work with our legislation enforcement companions to forestall the conveyance of misbranded drugs that may doubtlessly trigger extreme damage or hurt to unsuspecting shoppers,” mentioned Inspector in Cost Raymundo Marrero, Newark Division.

As a part of their responsible pleas, the defendants agreed to forfeit $400,000, which had been proceeds traceable to the mail fraud conspiracy. The defendants face a most sentence of twenty years in jail; a fantastic to not exceed $250,000; and a supervised launch time period of no more than three years.

The FDA-OCI-SJP led the investigation with the collaboration of Homeland Safety Investigations and the US Postal Inspection Service. The case was prosecuted by Assistant United States Legal professional Victor O. Acevedo-Hernández.

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