| (a) An advertisement of a device shall be deemed to be false if it is false or misleading in any particular. (b) An advertisement of a device is false if the advertisement represents that the device affects: (1) infectious and parasitic diseases; (2) neoplasms; (3) endocrine, nutritional, and metabolic diseases and immunity disorders; (4) diseases of blood and blood-forming organs; (5) mental disorders; (6) diseases of the nervous system and sense organs; (7) diseases of the circulatory system; (8) diseases of the respiratory system; (9) diseases of the digestive system; (10) diseases of the genitourinary system; (11) complications of pregnancy, childbirth, and the puerperium; (12) diseases of the skin and subcutaneous tissue; (13) diseases of the musculoskeletal system and connective tissue; (14) congenital anomalies; (15) certain conditions originating in the perinatal period; (16) symptoms, signs, and ill-defined conditions; or (17) injury and poisoning. (c) Subsection (b) of this section does not apply to an advertisement of a device if the advertisement does not violate the Act, §431.182(a), and is disseminated: (1) to the public for self-medication and is consistent with the labeling claims permitted by the United States Food and Drug Administration (FDA); (2) only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions; or (3) only for the purpose of public health education by a person not commercially interested, directly or indirectly, in the sale of the device. (d) This section does not indicate that self-medication for a disease, other than a disease listed under subsection (b) of this section, is safe and effective. |
