Criterion 4: It is an implied disea

Criterion 4: It is an implied disease claim because of the product name, formulation, use of pictures, or other factors (see sections H through M, starting on page 1021 of the preamble to the rule).1. Claims that are the name of the product.Two principles form the basis for the distinction between product names that are structure/function claims and those that are disease claims. To be a structure/ function claim: (1) the name should not contain the name, or a recognizable portion of the name, of a disease; and (2) the name should not use terms such as "cure," "treat," "correct," "prevent," or other terms that suggest treatment or prevention of a disease. Additionally, context is very important here.Names such as "CarpalHealth" or "CircuCure" are disease claims because they are implied disease claims for carpal tunnel syndrome and circulatory disorders, respectively. In some cases, whether a product name is a disease claim will depend on context. For example, "Soothing Sleep" could be considered a claim to treat insomnia, a disease, unless other context in the labeling makes clear that the claim relates to a non-disease condition, such as occasional sleeplessness.