eLaws of Florida

  SECTION 499.0054. Advertising and labeling of drugs, devices, and cosmetics; exemptions.  


Latest version.
  • 1(1) 2It is a violation of the Florida Drug and Cosmetic Act to perform or cause the performance of any of the following acts:
    25(a) 26The dissemination of any false advertisement of any drug, device, or cosmetic. An advertisement is false if it is false or misleading in any way.
    51(b) 52The distribution in commerce of any drug, device, or cosmetic, if its labeling or advertising is in violation of this part.
    73(c) 74The 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.
    101(d) 102The advertising of any drug, device, or cosmetic that is adulterated or misbranded.
    115(e) 116The 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.
    146(f) 147The 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:
    2261. 227The packaging of the product.
    2322. 233The name and labeling of the product.
    2403. 241The manner of distribution, advertising, and promotion of the product, including verbal representations at the point of sale.
    2594. 260The duration, scope, and significance of abuse of the particular product.
    271(g) 272The advertising of any drug or device represented to have any effect in any of the following conditions, disorders, diseases, or processes:
    2941. 295Blood disorders.
    2972. 298Bone or joint diseases.
    3023. 303Kidney diseases or disorders.
    3074. 308Cancer.
    3095. 310Diabetes.
    3116. 312Gall bladder diseases or disorders.
    3177. 318Heart and vascular diseases.
    3228. 323High blood pressure.
    3269. 327Diseases or disorders of the ear or auditory apparatus, including hearing loss or deafness.
    34110. 342Mental disease or intellectual disability.
    34711. 348Paralysis.
    34912. 350Prostate gland disorders.
    35313. 354Conditions of the scalp affecting hair loss.
    36114. 362Baldness.
    36315. 364Endocrine disorders.
    36616. 367Sexual impotence.
    36917. 370Tumors.
    37118. 372Venereal diseases.
    37419. 375Varicose ulcers.
    37720. 378Breast enlargement.
    38021. 381Purifying blood.
    38322. 384Metabolic disorders.
    38623. 387Immune system disorders or conditions affecting the immune system.
    39624. 397Extension of life expectancy.
    40125. 402Stress and tension.
    40526. 406Brain stimulation or performance.
    41027. 411The body’s natural defense mechanisms.
    41628. 417Blood flow.
    41929. 420Depression.
    42130. 422Human immunodeficiency virus or acquired immune deficiency syndrome or related disorders or conditions.
    435(h) 436The representation or suggestion in labeling or advertising that an article is approved under this part, when such is not the case.
    458(2) 459In 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.
    534(3)(a) 535An advertisement that is not prohibited under paragraph (1)(a) is not prohibited under paragraph (1)(g) if it is disseminated:
    5541. 555To 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
    5922. 593Only to members of the medical, dental, pharmaceutical, or veterinary professions or appears only in the scientific periodicals of these professions.
    614(b) 615Compliance 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

Note.-Subsection (2) former s. 499.0055; subsection (3) former s. 499.0057.

Bills Cite this Section:

None

Cited by Court Cases:

None