Florida HB 525: Foods Containing Vaccines or Vaccine Materials

Bill Text

HB 525 2025

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A bill to be entitled 1
An act relating to foods containing vaccines or 2
vaccine materials; amending s. 499.003, F.S.; revising 3
the definition of the term "drug"; defining the term 4
"vaccine or vaccine material"; amending s. 499.007, 5
F.S.; deeming a drug misbranded if it is a food 6
containing a vaccine or vaccine material, but its 7
label does not include specified information; amending 8
s. 500.11, F.S.; deeming a food misbranded if it 9
contains a vaccine or vaccine material, but its label 10
does not include specified information; amending ss. 11
499.01 and 499.05, F.S.; conforming cross-references; 12
providing an effective date. 13
14
Be It Enacted by the Legislature of the State of Florida: 15
16
Section 1. Present subsections (47), (48), and (49) of 17
section 499.003, Florida Statutes, are redesignated as 18
subsections (48), (49), and (50), respectively, a new subsection 19
(47) is added to that section, and subsections (17) and (40) of 20
that section are amended, to read: 21
499.003 Definitions of terms used in this part.—As used in 22
this part, the term: 23
(17) "Drug" means an article that is: 24
(a) Recognized in the current edition of the United States 25

HB 525 2025

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Pharmacopoeia and National Formulary, official Homeopathic 26
Pharmacopoeia of the United States, or any supplement to any of 27
those publications; 28
(b) Intended for use in the diagnosis, cure, mitigation, 29
treatment, therapy, or prevention of disease in humans or other 30
animals; 31
(c) Intended to affect the structure or any function of 32
the body of humans or other animals; or 33
(d) Intended for use as a component of any article 34
specified in paragraph (a), paragraph (b), or paragraph (c), and 35
includes active pharmaceutical ingredients, but does not include 36
devices or their nondrug components, parts, or accessories; or 37
(e) Food as defined in s. 500.03 which contains a vaccine 38
or vaccine material. 39
(40) "Prescription drug" means a prescription, medicinal, 40
or legend drug, including, but not limited to, finished dosage 41
forms or active pharmaceutical ingredients subject to, defined 42
by, or described by s. 503(b) of the federal act or s. 465.003, 43
s. 499.007(13), subsection (31), or subsection (48) (47), except 44
that an active pharmaceutical ingredient is a prescription drug 45
only if substantially all finished dosage forms in which it may 46
be lawfully dispensed or administered in this state are also 47
prescription drugs. 48
(47) "Vaccine or vaccine material" means a substance 49
authorized or approved by the United States Food and Drug 50

HB 525 2025

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Administration which is intended for use in humans to stimulate 51
the production of antibodies and provide immunity against 52
disease and which is prepared from the causative agent of a 53
disease, its products, or a synthetic substitute and is treated 54
to act as an antigen without inducing the disease. 55
Section 2. Present subsection (17) of section 499.007, 56
Florida Statutes, is redesignated as subsection (18), and a new 57
subsection (17) is added to that section, to read: 58
499.007 Misbranded drug or device.—A drug or device is 59
misbranded: 60
(17) If it is a food as defined in s. 500.03 and contains 61
a vaccine or vaccine material, but its label does not bear, in 62
type of uniform size and prominence, the words "contains vaccine 63
or vaccine material" and does not specify that the food is 64
classified as a drug under the Florida Drug and Cosmetic Act. 65
Section 3. Paragraph (q) is added to subsection (1) of 66
section 500.11, Florida Statutes, to read: 67
500.11 Food deemed misbranded.— 68
(1) A food is deemed to be misbranded: 69
(q) If it contains a vaccine or vaccine material as 70
defined in s. 499.003, unless its label bears, in type of 71
uniform size and prominence, the words "contains vaccine or 72
vaccine material" and specifies that the food is classified as a 73
drug under the Florida Drug and Cosmetic Act. 74
Section 4. Paragraphs (a), (b), and (h) of subsection (2) 75

HB 525 2025

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of section 499.01, Florida Statutes, are amended to read: 76
499.01 Permits.— 77
(2) The following permits are established: 78
(a) Prescription drug manufacturer permit.—A prescription 79
drug manufacturer permit is required for any person that is a 80
manufacturer of a prescription drug and that manufactures or 81
distrib