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The Food and Drug Administration recently announced that a Nevada-based water bottle company Real Water Inc. will need to stop operations until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) along with other requirements.
The FD&C Act is a set of laws that oversees food safety, drugs, medical devices, and cosmetics, prohibiting the movement of commerce of adulterated (or making a product poorer quality by adding inferior substances) or misbranded contents.
A complaint made by the Department of Justice (DOJ) for the FDA states that the company has violated the FD&C Act by operating their facilities while failing to comply with the set regulations and laws, resulting in food hazards. Their product has suspicions of contamination. They are also alleged to have misbranded their products by failing to label the common or usual names of ingredients included. FDA food registration and FDA device registration, along with compliance, are a must.
Consumption of “Real Water” brand alkaline water was found to be the sole common link in five cases of acute liver failure in children that occurred in late 2020. Eleven additional cases of acute non-viral hepatitis, including a death, have been reported with links to the water.
The FDA issued an outbreak advisory in March and has continued to investigate this case along with the Centers for Disease Control and Prevention (CDC) and the Southern Nevada Health District. The company has since issued a recall of all its Real Water brand water and concentrate. The company has consented to halt production until they complete correction actions.