Terms Used In Florida Statutes 499.035

  • 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
  • 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

(1) Dimethyl sulfoxide (DMSO) not approved for drug use must be clearly marked in at least 12-point boldfaced type: “May be unsafe. Not approved for human use.”
(2) All advertisements for the sale of dimethyl sulfoxide (DMSO) not approved for drug use must contain, within the advertisement and in bold lettering, the following statement: “Warning. May be unsafe. Not approved for human use.”