Fluoride

Whether a product is regulated as a cosmetic or a drug (or both) under federal law is determined by a product's intended use. Products having both cosmetic and drug intended uses (typically defined by claims made on product labeling) include, for example, anti-dandruff shampoo, a fluoride-containing whitening toothpaste, and a skin moisturizer containing sunscreen active ingredients. These products are always required to display an OTC Drug Facts label.

In 1986, California voters overwhelmingly approved the State Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition (Prop) 65. Prop 65 was designed to safeguard the state’s drinking water against chemicals known to the state to harm humans by requiring industry to inform Californians about exposures to such chemicals within the products or services they provide for sale to the public.