On March 3, 2022, the United States Government, on behalf of FDA, filed a complaint against Salud Natural Entrepreneur, Inc. (“Salud”), as well as its owner, production manager, and quality control manager. The complaint alleged that the defendants violated the Federal Food, Drug and Cosmetic Act by distributing adulterated and misbranded dietary supplements and unapproved new drugs. The complaint also alleged that Salud did not comply with good manufacturing practices.
The complaint followed inspections of Salud’s facility in May 2021, during which FDA found that the company was not complying with Good Manufacturing Practice regulations for dietary supplements. During a previous inspection, FDA found that Salud had used ingredients that had tested positive for Salmonella. Further, the complaint alleged that Salud’s products did not comply with labeling requirements and made unapproved drug claims (e.g, Aloe Vera Juice as an “antiviral” and Liver Detox Tea as treating alcoholism and gallbladder pain).
On March 8, 2022 the U.S. Department of Justice announced that a consent decree had been issued by the Northern District of Illinois. As a result, the defendants are permanently enjoined from manufacturing, holding, or distributing any products that they claim may treat or cure disease, until the products comply with federal law.