25 Tex. Admin. Code § 229.442 – Advertising

(a) An advertisement of a device is deemed false if it is false or misleading in any way.
(b) An advertisement of a device is false if the advertisement represents that the device affects:
1. (1) infectious and parasitic diseases;
2. (2) neoplasms;
3. (3) endocrine, nutritional, and metabolic diseases and immunity disorders;
4. (4) diseases of blood and blood-forming organs;
5. (5) mental disorders;
6. (6) diseases of the nervous system and sense organs;
7. (7) diseases of the circulatory system;
8. (8) diseases of the respiratory system;
9. (9) diseases of the digestive system;
10. (10) diseases of the genitourinary system;
11. (11) complications of pregnancy, childbirth, and the puerperium;
12. (12) diseases of the skin and subcutaneous tissue;
13. (13) diseases of the musculoskeletal system and connective tissue;
14. (14) congenital anomalies;
15. (15) certain conditions originating in the perinatal period;
16. (16) symptoms, signs, and ill-defined conditions; or
17. (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. (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. (2) only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions; or
3. (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; amended to be effective January 5, 2026, 51 TexReg 147.