Court orders Illinois-based company to stop distributing falsified, misbranded supplements
Waukegan, Illinois—A federal court has ordered Illinois-based Salud Natural Entrepreneur, Inc. to stop distributing adulterated and mislabeled nutritional supplements, according to a press release from the Department of Justice and the U.S. District Attorney’s Office. northern Illinois.
The United States alleged in a complaint that Salud Natural Entrepreneur, its owner Hector Pablo Oliva, production manager Michel Monfort and quality control manager Carolina L. Giral violated the FDCA by distributing adulterated and improperly supplemented supplements. labeled and unapproved new drugs that the company claims will cure, mitigate, treat, or prevent diseases such as cancer, diabetes, high blood pressure, and heart disease. The complaint further alleged that Salud failed to comply with GMP regulations designed to help ensure the safety of nutritional supplements and that on one occasion the company used ingredients that tested positive for salmonella.
“Good current manufacturing regulations are in place to protect consumers, and it is imperative that dietary supplement manufacturers comply with them to ensure that protection,” said Associate Commissioner Judy McMeekin, Pharm.D. for FDA regulatory affairs. “We also hold manufacturers accountable when their product is improperly labeled with claims for curing or preventing disease to protect consumers who are unknowingly ripped off by false or misleading claims.”
Related: FTC orders 21 companies to stop making COVID claims
Senate confirms Califf as FDA commissioner
Use caution with claims
The defendants have agreed to settle the lawsuit and to be bound by a permanent injunctive consent decree filed with the complaint. Defendants are required to stop manufacturing, processing, labeling, possessing, or distributing any product that they claim can treat or cure disease, until they comply with federal law. . They must also bring their operations into compliance with the GMPs in force.
“Nutritional supplements must be manufactured, labeled and distributed in accordance with federal law,” said U.S. Attorney John R. Lausch Jr. for the Northern District of Illinois. “The U.S. Attorney’s Office is committed to working with our colleagues in the Justice Department’s Consumer Protection Branch to ensure that the public is not misled by unsubstantiated claims.”