(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.
Source Note: The provisions of this §229.442 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective January 1, 2005, 29 TexReg 11983