10209 ADVERTISING

10209.1 An advertisement of a device shall be deemed to be false if it is misleading in any particular.

10209.2 An advertisement of a device is false if the advertisement represents that the device affects:

1. (a) Infectious and parasitic diseases;
2. (b) Neoplasms;
3. (c) Endocrine, nutritional, and metabolic diseases and immunity disorders;
4. (d) Diseases of blood and blood-forming organs;
5. (e) Mental disorders;
6. (f) Diseases of the nervous system and sense organs;
7. (g) Diseases of the circulatory system;
8. (h) Diseases of the respiratory system;
9. (i) Diseases of the digestive system;
10. (j) Diseases of the genitourinary system;
11. (k) Complications of pregnancy, childbirth, and the puerperium;
12. (l) Diseases of the skin and subcutaneous tissue;
13. (m) Diseases of the musculoskeletal system and connective tissue;
14. (n) Congenital anomalies;
15. (o) Certain conditions originating in the perinatal period;
16. (p) Symptoms, signs, and ill-defined conditions; or
17. (q) Injury and poisoning.

10209.3 Subsection 10209.2 shall not apply to an advertisement of a device if the advertisement does not violate the Act and is disseminated:

(a) To the public for self-medication and is consistent with the FDA's labeling claims;

(b) Only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions; or

(c) Only for the purpose of public health education by a person not commercially interested, directly or indirectly, in the sale of the device.

10209.4 Nothing in this section shall be construed as establishing any official policy of the Department concerning self-medication for a disease, other than a disease listed under § 10209.2, including any official policy that such self-medication is safe and effective.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).