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 misbranded supplements and unapproved new drugs that the company claimed would cure, mitigate, treat, or prevent diseases such as cancer, diabetes, high blood pressure, and heart disease. The complaint further alleged that Salud did not comply with GMP regulations designed to help ensure the safety of nutritional supplements, and that on one occasion, the company used ingredients that had tested positive for salmonella.
“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.”
Related: FTC Orders 21 Companies to Stop Making COVID Claims Senate Confirms Califf as FDA Commissioner Using Caution with ClaimsThe defendants agreed to settle the suit and be bound by a consent decree of permanent injunction filed along with the complaint. The defendants are required to stop manufacturing, processing, labeling, holding, 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 current GMPs.
“Nutritional supplements must be manufactured, labeled, and distributed in compliance 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 at the Department of Justice’s Consumer Protection Branch to ensure that the public is not misled by unsubstantiated claims.”