(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.

Terms Used In Florida Statutes 499.0054

  • Advertisement: means any representation disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of drugs, devices, or cosmetics. See Florida Statutes 499.003
  • blood: means whole blood collected from a single donor and processed for transfusion or further manufacturing, and the term "blood components" means that part of the blood separated by physical or mechanical means. See Florida Statutes 499.003
  • Cosmetic: means an article, with the exception of soap, that is:
    (a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or
    (b) Intended for use as a component of any such article. See Florida Statutes 499.003
  • Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.003
  • Device: means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including its components, parts, or accessories, which is:
    (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, or any supplement thereof,
    (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or
    (c) Intended to affect the structure or any function of the body of humans or other animals,

    and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. See Florida Statutes 499.003

  • distribution: means to sell, purchase, trade, deliver, handle, store, or receive. See Florida Statutes 499.003
  • Drug: means an article that is:
    (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications;
    (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals;
    (c) Intended to affect the structure or any function of the body of humans or other animals; or
    (d) Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories. See Florida Statutes 499.003
  • Federal act: means the Federal Food, Drug, and Cosmetic Act, 21 U. See Florida Statutes 499.003
  • Labeling: means all labels and other written, printed, or graphic matters:
    (a) Upon a drug, device, or cosmetic, or any of its containers or wrappers; or
    (b) Accompanying or related to such drug, device, or cosmetic. See Florida Statutes 499.003
  • New drug: means :
    (a) Any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of that drug; or
    (b) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under certain conditions, has been recognized for use under such conditions, but which drug has not, other than in those investigations, been used to a material extent or for a material time under such conditions. See Florida Statutes 499.003
(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.
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