A consent decree has been issued against Salud Natural Entrepreneur, Inc. (Salud) for allegedly distributing adulterated and misbranded dietary supplements and unapproved new drugs. The company allegedly claimed that theoe products would cure, mitigate, treat, or prevent diseases such as cancer, diabetes, heart disease, and high blood pressure. The decree was filed by the Department of Justice in the Northern District of Illinois on March 3, 2022 on behalf of the FDA.
The decree also alleges that Salud did not comply with current Good Manufacturing practices regulations that are designed to help ensure the safety of nutritional supplements. And also, the decree alleges that on one occasion Salud used ingredients that had tend positive for Salmonella bacteria in manufacturing a product.
Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division said in a statement, “Nutritional supplement makers must comply with laws and regulations meant to protect public health. 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.”
And Associate Commissioner Judy McMeekin, Pharm.D. for FDA Regulatory Affairs, said in a statement, “Current good manufacturing regulations are in place to protect consumers, and it is imperative that dietary supplement manufacturers comply to ensure this protection. 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 that was filed along with the compliant. The order permanently enjoins Salud Natural Entrepreneur Inc. and its owners from violating the Federal Food, Drug, and Cosmetic Act (FDCA). It 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 also must bring their operations into compliance with current good manufacturing regulations.
