Criterion 3: Claims an effect on a

Criterion 3: Claims an effect on a condition associated with a natural state or process (see section G, starting on page 1019 of the preamble to the rule).What is meant by "a natural state or process?"Some natural states or processes such as aging, menopause, and the menstrual cycle are not themselves diseases, but can be associated with abnormal conditions that are diseases.What is the determining characteristic when a claim to effect these states is a disease claim?The conditions associated with these stages or processes can vary from common, relatively mild abnormalities, for which medical attention is not required, to serious conditions that can cause significant or permanent harm if not treated effectively. Two criteria determine if such a condition will be considered a disease: (1) if the condition is uncommon; or (2) if the condition can cause significant or permanent harm. For purposes of the rule, a condition is uncommon if it occurs in fewer than one-half of those experiencing that stage or process. A condition can cause significant or permanent harm if it must be treated effectively to prevent that harm and for which effective treatments are available.Examples of acceptable structure/function claims are "mild memory loss associated with aging," "noncystic acne," or "mild mood changes, cramps, and edema associated with the menstrual cycle."Examples of disease claims are "Alzheimer's disease or senile dementias in the elderly," "cystic acne," or "severe depression associated with the menstrual cycle."