Federal authorities say a Waukegan company violated federal law by distributing nutritional supplements that falsely claimed to treat and cure diseases.
The U.S. Food and Drug Administration filed a lawsuit on Thursday against Salud Natural Entrepreneur Inc., a Waukegan-based company.
The FDA alleged in the complaint that Salud Natural Entrepreneur Inc., its owner, Hector Pablo Oliva, production manager Michel Monfort, and quality control manager Carolina L. Giral violated the Federal Food, Drug, and Cosmetic Act (FDCA).
The complaint alleges the company 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 FDA also alleged that Salud did not comply with good manufacturing practice regulations designed to help ensure the safety of nutritional supplements.
On one occasion, Salud used ingredients that had tested positive for salmonella in manufacturing a product, the complaint said.
On Monday, a judge ordered entered a consent decree that ordered the company to stop distributing nutritional supplements that violate the FDCA, the U.S. Department of Justice and the U.S. Attorney’s Office announced.
“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,” Boynton said.
The order entered by the court also requires 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 were also ordered to bring their operations into compliance with current manufacturing regulations.
“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,” McMeekin said.