Chicago-area company sold unapproved drugs that claimed to treat diseases, including cancer: prosecutors
WAUKEGAN, Ill. - A Waukegan-based company has been ordered to stop distributing nutritional supplements that they claimed would cure, treat or prevent various diseases including cancer.
Salud Natural Entrepreneur Inc. violated the Federal Food, Drug, and Cosmetic Act (FDCA) after it distributed "adulterated and misbranded dietary supplements and unapproved new drugs," a complaint filed by the U.S. Attorney's Office for the Northern District of Illinois said.
Prosecutors said the company, including its owner, Hector Pablo Oliva, production manager Michel Monfort, and quality control manager Carolina L. Giral, claimed their products could cure, treat or prevent a variety of diseases including cancer, diabetes, high blood pressure and heart disease.
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"Current good manufacturing regulations are in place to protect consumers, and it is imperative that dietary supplement manufacturers comply to ensure this protection," said Associate Commissioner Judy McMeekin, Pharm.D. for FDA Regulatory Affairs. "We also hold manufacturers responsible when their product is inappropriately labeled with claims to cure or prevent disease to protect consumers who are unknowingly scammed by false or misleading claims."
Prosecutors also said Salud failed to comply with proper manufacturing regulations to ensure their supplements were safe for consumers to use. On one occasion, the company used ingredients in one of their products that had tested positive for salmonella, according to the complaint.
Salud agreed to settle the lawsuit and be bound by the court order that requires the company to no longer distribute products claiming to treat or cure disease until they comply with federal law.
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The company was also required to bring their operations up to date to comply with good manufacturing standards.