Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS
Section 229.442 - Advertising

Current through Reg. 49, No. 38; September 20, 2024

(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.

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