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 United States Attorney’s Office for the Northern District of Illinois announced.
The United States alleged in a lawsuit 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 head of quality control Carolina L. Giral had violated the FDCA by distributing adulterated and mislabeled 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 failed to 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 the manufacture of a product.
“Nutritional supplement manufacturers must comply with laws and regulations intended to protect public health,” said Senior Assistant Deputy Attorney General Brian M. Boynton, Chief of the Justice Department’s Civil Division. “The department is committed to working with its partner agencies to take action against manufacturers who risk consumer safety by failing to comply with the FDCA.”
“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.”
“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.”
The defendants have agreed to settle the lawsuit and to be bound by a permanent injunctive consent decree filed with the complaint. The court’s order permanently bars defendants from violating the FDCA and requires, among other things, that defendants cease manufacturing, processing, labeling, possessing or distributing any product that they claim may treat or cure the disease, until they comply with federal law. Defendants must also bring their operations into compliance with applicable good manufacturing regulations.
The government was represented in this case by Special Assistant U.S. Attorney and Senior Litigation Counsel Don Lorenzen of the Justice Department’s Consumer Protection Branch, with assistance from Leslie Cohen of the Office of the FDA legal counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts can be found at http://www.justice.gov/civil/consumer-protection-branch.