On Monday, the Food and Drug Administration (FDA) settled charges with the owner and two employees of Salud Natural Entrepreneur Inc. The FDA’s complaint, filed just four days before entry of the consent decree, accused the dietary supplement manufacturer’s president and owner, production manager, and quality control manager of Federal Food, Drug, and Cosmetic Act (FDCA) violations for selling tainted supplements and failing to comply with branding rules.
The FDA said that Waukegan, Illinois-based Salud is a dietary supplement manufacturer and own-label distributor. It reportedly sends products around the country to states including California, Colorado, Georgia, Pennsylvania, and Texas.
As for FDCA violations, the complaint describes numerous instances of both adulteration and labeling rule transgressions, with examples evincing lapses in potency testing and safety controls, among other regulated areas.
The complaint points to FDA investigations that revealed that the defendants “had failed to reject a lot of Senna Leaves Powder that tested positive for Salmonella.” In another instance, the FDA cited the defendants’ failure to “reject a lot of Grapefruit Powder with failing mold levels and released for distribution Psyllium Husk Powder when total aerobic plate count and yeast exceeded specifications.”
The FDA also cited multiple labeling issues. For example, some of Salud Natural’s product labels contain information in two languages but do not repeat all required information in both languages, they also fail to declare the common or usual name of each ingredient, and state incorrect serving sizes, all in violation of branding regulations.
The defendants agreed to settle the suit and to a permanent injunction filed simultaneously with the complaint. The judicial order bars the defendants from violating the FDCA, and requires, among other things, that they stop manufacturing and distributing products that they claim can treat or cure disease, until they comply with federal law. The defendants further agreed to bring their operations into compliance with current manufacturing regulations.
