Texas Administrative Code|§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;   (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

Please wait a moment while we load this page.

New Envelope