Current through Reg. 50, No. 1; January 3, 2025
Section 229.442 - Advertising(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;(3) endocrine, nutritional, and metabolic diseases and immunity disorders;(4) diseases of blood and blood-forming organs;(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.25 Tex. Admin. Code § 229.442
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