499.0054 Advertising and labeling of drugs, devices, and cosmetics; exemptions.—
(1) It is a violation of the Florida Drug and Cosmetic Act to perform or cause the performance of any of the following acts:
(a) The dissemination of any false advertisement of any drug, device, or cosmetic. An advertisement is false if it is false or misleading in any way.
(b) The distribution in commerce of any drug, device, or cosmetic, if its labeling or advertising is in violation of this part.
(c) The manufacturing, repackaging, packaging, selling, delivery, holding, or offering for sale of any drug, device, or cosmetic for which the advertising or labeling is false or misleading.
(d) The advertising of any drug, device, or cosmetic that is adulterated or misbranded.
(e) The receiving in commerce of any drug, device, or cosmetic that is falsely advertised or labeled or the delivering or proffering for delivery of any such drug, device, or cosmetic.
(f) The advertising or labeling of any product containing ephedrine, a salt of ephedrine, an isomer of ephedrine, or a salt of an isomer of ephedrine, for the indication of stimulation, mental alertness, weight loss, appetite control, energy, or other indications not approved by the pertinent United States Food and Drug Administration Over-the-Counter Final or Tentative Final Monograph or approved new drug application under the federal act. In determining compliance with this requirement, the department may consider the following factors:
1. The packaging of the product.
2. The name and labeling of the product.
3. The manner of distribution, advertising, and promotion of the product, including verbal representations at the point of sale.
4. The duration, scope, and significance of abuse of the particular product.
(g) The advertising of any drug or device represented to have any effect in any of the following conditions, disorders, diseases, or processes:
1. Blood disorders.
2. Bone or joint diseases.
3. Kidney diseases or disorders.
4. Cancer.
5. Diabetes.
6. Gall bladder diseases or disorders.
7. Heart and vascular diseases.
8. High blood pressure.
9. Diseases or disorders of the ear or auditory apparatus, including hearing loss or deafness.
10. Mental disease or intellectual disability.
11. Paralysis.
12. Prostate gland disorders.
13. Conditions of the scalp affecting hair loss.
14. Baldness.
15. Endocrine disorders.
16. Sexual impotence.
17. Tumors.
18. Venereal diseases.
19. Varicose ulcers.
20. Breast enlargement.
21. Purifying blood.
22. Metabolic disorders.
23. Immune system disorders or conditions affecting the immune system.
24. Extension of life expectancy.
25. Stress and tension.
26. Brain stimulation or performance.
27. The body’s natural defense mechanisms.
28. Blood flow.
29. Depression.
30. Human immunodeficiency virus or acquired immune deficiency syndrome or related disorders or conditions.
(h) The representation or suggestion in labeling or advertising that an article is approved under this part, when such is not the case.
(2) In determining whether an advertisement is false or misleading, the department shall review the representations made or suggested by statement, word, design, device, sound, or any combination thereof within the advertisement and the extent to which the advertisement fails to reveal material facts with respect to consequences that can result from the use of the drug, device, or cosmetic to which the advertisement relates under the conditions of use prescribed in the labeling or advertisement.
(3)(a) An advertisement that is not prohibited under paragraph (1)(a) is not prohibited under paragraph (1)(g) if it is disseminated:
1. To the public solely to advertise the product for those indications that are safe and effective indications and the product is safe and effective for self-medication, as established by the United States Food and Drug Administration; or
2. Only to members of the medical, dental, pharmaceutical, or veterinary professions or appears only in the scientific periodicals of these professions.
(b) Compliance with this part and the rules adopted under this part creates no legal presumption that a drug or device is safe or effective.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 1, 2, 4, ch. 86-271; s. 5, ch. 88-172; s. 25, ch. 88-380; ss. 7, 8, 9, 52, ch. 92-69; ss. 2, 3, ch. 95-415; s. 36, ch. 2000-242; s. 5, ch. 2008-207; s. 17, ch. 2013-162.
Note.—Subsection (2) former s. 499.0055; subsection (3) former s. 499.0057.
