Criterion 2: Claims an effect on ch

Criterion 2: Claims an effect on characteristic signs or symptoms of disease using scientific or lay terminology (see section F, starting on page 1015 of the preamble to the rule).How can I tell if a particular claimed effect is a sign or symptom of a specific disease?The test of whether claimed effects are characteristic signs or symptoms depends on 2 questions: (1) Is the condition, to which the signs and symptoms refer, related to a disease; and (2) are the signs and symptoms referred to in the labeling characteristic of the disease and permit the inference that the product is intended to affect that disease.Does it matter if I don't use every sign or symptom of a condition or if I use layman's terms instead of technical language?No. The standard focuses on whether the labeling suggests that the product will produce a change in a set of one or more signs or symptoms that are characteristic of the disease. You can meet this standard using technical or layman's language and it isn't necessary that every possible sign or symptom is used.