U.S. District Court orders suburban Chicago company to stop distribution of adulterated and misbranded nutritional supplements
In a consent decree entered Monday, a federal court ordered a Waukegan, Illinois, company to stop distributing nutritional supplements that violate the Federal Food, Drug and Cosmetic Act (FDCA), the Department of Justice and the U.S. Attorney’s Office for the Northern District of Illinois announced.
The United States alleged in a complaint filed in the Northern District of Illinois on March 3 that Salud Natural Entrepreneur, Inc. (Salud), its owner, Hector Pablo Oliva, production manager Michel Monfort, and quality control manager Carolina L. Giral violated the FDCA by distributing adulterated and misbranded dietary 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 United States also alleged that Salud did not comply with good manufacturing practice regulations designed to help ensure the safety of nutritional supplements, and that on one occasion Salud used ingredients that had tested positive for salmonella in manufacturing a product.
“Nutritional supplement makers must comply with laws and regulations meant to protect public health,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division.
“The department is committed to working with its agency partners to take action against manufacturers who risk the safety of consumers by failing to adhere to the FDCA.”
“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.”
“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.”
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction filed along with the complaint. The order entered by the court permanently enjoins the defendants from violating the FDCA, and requires, among other things, that the defendants stop manufacturing, processing, labeling, holding or distributing any product that they claim can treat or cure disease, until they comply with federal law. The defendants also must bring their operations into compliance with current good manufacturing regulations.
The government was represented in this matter by Special Assistant U.S. Attorney and Senior Litigation Counsel Don Lorenzen of the Justice Department’s Consumer Protection Branch, with the assistance of Leslie Cohen of the FDA’s Office of Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch.
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