Florida Senate - 2025 CS for CS for SB 196
By the Appropriations Committee on Agriculture, Environment, and
General Government; the Committee on Regulated Industries; and
Senator Gruters
601-03464-25 2025196c2
1 A bill to be entitled
2 An act relating to chemicals in consumer products;
3 amending s. 499.003, F.S.; revising the definition of
4 the term “drug”; defining the term “vaccine or vaccine
5 material”; amending s. 499.007, F.S.; deeming a drug
6 misbranded if it is a food containing a vaccine or
7 vaccine material, but its label does not include
8 specified information; creating s. 499.0095, F.S.;
9 defining terms; requiring that, beginning on a
10 specified date, cosmetics manufactured, sold, offered
11 or distributed for sale, or distributed for use in
12 this state provide notice of specified added
13 ingredients on the single-use packaging of such
14 cosmetics; providing an exception; providing
15 construction; providing penalties and remedies;
16 providing applicability; requiring the Department of
17 Business and Professional Regulation to adopt rules;
18 amending s. 500.03, F.S.; defining the term “messenger
19 ribonucleic acid vaccine” or “mRNA vaccine”; amending
20 s. 500.04, F.S.; prohibiting the use of fruits and
21 vegetables to deliver an mRNA vaccine; amending s.
22 500.11, F.S.; deeming a food misbranded if it contains
23 a vaccine or vaccine material, but its label does not
24 include specified information; amending ss. 499.01 and
25 499.05, F.S.; conforming cross-references; providing
26 an effective date.
27
28 Be It Enacted by the Legislature of the State of Florida:
29
30 Section 1. Present subsections (47), (48), and (49) of
31 section 499.003, Florida Statutes, are redesignated as
32 subsections (48), (49), and (50), respectively, a new subsection
33 (47) is added to that section, and subsections (17) and (40) of
34 that section are amended, to read:
35 499.003 Definitions of terms used in this part.—As used in
36 this part, the term:
37 (17) “Drug” means an article that is:
38 (a) Recognized in the current edition of the United States
39 Pharmacopoeia and National Formulary, official Homeopathic
40 Pharmacopoeia of the United States, or any supplement to any of
41 those publications;
42 (b) Intended for use in the diagnosis, cure, mitigation,
43 treatment, therapy, or prevention of disease in humans or other
44 animals;
45 (c) Intended to affect the structure or any function of the
46 body of humans or other animals; or
47 (d) Intended for use as a component of any article
48 specified in paragraph (a), paragraph (b), or paragraph (c), and
49 includes active pharmaceutical ingredients, but does not include
50 devices or their nondrug components, parts, or accessories; or
51 (e) Food as defined in s. 500.03 which contains a vaccine
52 or vaccine material.
53 (40) “Prescription drug” means a prescription, medicinal,
54 or legend drug, including, but not limited to, finished dosage
55 forms or active pharmaceutical ingredients subject to, defined
56 by, or described by s. 503(b) of the federal act or s. 465.003,
57 s. 499.007(13), subsection (31), or subsection (48) (47), except
58 that an active pharmaceutical ingredient is a prescription drug
59 only if substantially all finished dosage forms in which it may
60 be lawfully dispensed or administered in this state are also
61 prescription drugs.
62 (47) “Vaccine or vaccine material” means a substance
63 authorized or approved by the United States Food and Drug
64 Administration which is intended for use in humans to stimulate
65 the production of antibodies and provide immunity against
66 disease and which is prepared from the causative agent of a
67 disease, its products, or a synthetic substitute and is treated
68 to act as an antigen without inducing the disease.
69 Section 2. Present subsection (17) of section 499.007,
70 Florida Statutes, is redesignated as subsection (18), and a new
71 subsection (17) is added to that section, to read:
72 499.007 Misbranded drug or device.—A drug or device is
73 misbranded:
74 (17) If it is a food as defined in s. 500.03 and contains a
75 vaccine or vaccine material, but its label does not bear, in
76 type of uniform size and prominence, the words “contains vaccine
77 or vaccine material” and does not specify that the food is
78 classified as a drug under the Florida Drug and Cosmetic Act.
79 Section 3. Section 499.0095, Florida Statutes, is created
80 to read:
81 499.0095 Presence of certain ingredients in cosmetics;
82 notice required.—
83 (1) As used in this section, the term:
84 (a) “Incidental ingredient” means a substance that has no
85 technical or functional effect in the cosmetics but is present
86 by reason of having been incorporated into the cosmetics as an
87 ingredient of another cosmetic ingredient.
88 (b) “Ingredient” means:
89 1. Any chemical or mixture of chemicals intentionally used
90 in the manufacturing of cosmetics. The term does not include any
91 incidental ingredient that is present in cosmetics at
92 insignificant levels or that has no technical or functional
93 effect; or
94 2. A processing aid, including any of the following:
95 a. A substance that is used in the processing of cosmetics
96 but is removed from the cosmetics in accordance with good
97 manufacturing practices before the cosmetics are packaged in
98 their finished form.
99 b. A substance that is used in the processing of cosmetics
100 for its technical or functional effect to produce the cosmetics
101 and is then converted to a substance the same as constituents of
102 a declared ingredient, in accordance with good manufacturing
103 practices, and does not significantly increase the concentration
104 of such constituents before the cosmetics are packaged in their
105 finished form.
106 c. A substance that is used in the processing of cosmetics
107 for its technical or functional effect to produce the cosmetics
108 in accordance with good manufacturing practices, that is present
109 in the cosmetics’ finished form at insignificant concentrations,
110 and that does not have any technical or functional effect in
111 such cosmetics.
112 (c) “Ortho-phthalates” means esters of ortho-phthalic acid.
113 (d) “Perfluoroalkyl and polyfluoroalkyl substances” or
114 “PFAS” means a class of fluorinated organic chemicals containing
115 at least one fully fluorinated carbon atom.
116 (2) Except as provided in subsection (4), beginning July 1,
117 2026, cosmetics manufactured, sold, offered or distributed for
118 sale, or distributed for use in this state must provide notice
119 on such cosmetics’ single-use packaging of the following
120 intentionally added chemicals or chemical classes:
121 (a) Ortho-phthalates.
122 (b) PFAS.
123 (c) Formaldehyde as identified in CAS 50-00-0.
124 (d) Methylene glycol as identified in CAS 463-57-0.
125 (e) Mercury as identified in CAS 7439-97-6.
126 (f) Triclosan as identified in CAS 3380-34-5.
127 (g) M-phenylenediamine or its salt derivatives as
128 identified in CAS 108-45-2.
129 (h) O-phenylenediamine or its salt derivatives as
130 identified in CAS 95-54-5.
131 (3) Except as provided in subsection (4), beginning July 1,
132 2026, cosmetics manufactured, sold, offered or distributed for
133 sale, or distributed for use in this state must provide notice
134 on such cosmetics’ single-use packaging of any lead or lead
135 compounds as identified by CAS 7439-92-1, whether intentionally
136 added or naturally occurring, at 10 parts per million or more,
137 or as otherwise determined by department rule.
138 (4) A retailer in possession of cosmetics that do not
139 comply as of July 1, 2026, may exhaust its existing stock
140 through sales to the public until July 1, 2027.
141 (5) A violation of this section is subject to the penalties
142 and remedies provided in s. 499.066.
143 (6) This section does not apply to cosmetic products
144 regulated as drugs by the United States Food and Drug
145 Administration.
146 (7) The department shall adopt rules necessary to implement
147 this section.
148 Section 4. Present paragraphs (t) through (z) of subsection
149 (1) of section 500.03, Florida Statutes, are redesignated as
150 paragraphs (u) through (aa), respectively, and a new paragraph
151 (t) is added to that subsection, to read:
152 500.03 Definitions; construction; applicability.—
153 (1) For the purpose of this chapter, the term:
154 (t) “Messenger ribonucleic acid vaccine” or “mRNA vaccine”
155 means a vaccine that uses laboratory-produced messenger
156 ribonucleic acid to trigger the human body’s immune system to
157 generate an immune response.
158 Section 5. Subsection (12) is added to section 500.04,
159 Florida Statutes, to read:
160 500.04 Prohibited acts.—The following acts and the causing
161 thereof within the state are prohibited:
162 (12) The use of a fruit or vegetable as a delivery
163 mechanism for an mRNA vaccine as defined in s. 500.03.
164 Section 6. Paragraph (q) is added to subsection (1) of
165 section 500.11, Florida Statutes, to read:
166 500.11 Food deemed misbranded.—
167 (1) A food is deemed to be misbranded:
168 (q) If it contains a vaccine or vaccine material as defined
169 in s. 499.003, unless its label bears, in type of uniform size
170 and prominence, the words “contains vaccine or vaccine material”
171 and specifies that the food is classified as a drug under the
172 Florida Drug and Cosmetic Act.
173 Section 7. Paragraphs (a), (b), and (h) of subsection (2)
174 of section 499.01, Florida Statutes, are amended to read:
175 499.01 Permits.—
176 (2) The following permits are established:
177 (a) Prescription drug manufacturer permit.—A prescription
178 drug manufacturer permit is required for any person that is a
179 manufacturer of a prescription drug and that manufactures or
180 distributes such prescription drugs in this state.
181 1. A person that operates an establishment permitted as a
182 prescription drug manufacturer may engage in distribution of
183 prescription drugs for which the person is the manufacturer and
184 must comply with s. 499.0121 and all other provisions of this
185 part and rules adopted under this part. The department shall
186 adopt rules for issuing a virtual prescription drug manufacturer
187 permit to a person who engages in the manufacture of
188 prescription drugs but does not make or take physical possession
189 of any prescription drugs. The rules adopted by the department
190 under this section may exempt virtual manufacturers from certain
191 establishment, security, and storage requirements set forth in
192 s. 499.0121.
193 2. A prescription drug manufacturer must comply with all
194 appropriate state and federal good manufacturing practices.
195 3. A blood establishment, as defined in s. 381.06014,
196 operating in a manner consistent with the provisions of 21
197 C.F.R. parts 211 and 600-640, and manufacturing only the
198 prescription drugs described in s. 499.003(49)(j) s.
199 499.003(48)(j) is not required to be permitted as a prescription
200 drug manufacturer under this paragraph or to register products
201 under s. 499.015.
202 (b) Prescription drug repackager permit.—A prescription
203 drug repackager permit is required for any person that
204 repackages a prescription drug in this state.
205 1. A person that operates an establishment permitted as a
206 prescription drug repackager may engage in distribution of
207 prescription drugs repackaged at that establishment and must
208 comply with all of the provisions of this part and the rules
209 adopted under this part that apply to a prescription drug
210 manufacturer.
211 2. A prescription drug repackager must comply with all
212 appropriate state and federal good manufacturing practices.
213 3. A prescription drug repackager permit is not required
214 for distributing medicinal drugs or prepackaged drug products
215 between entities under common control which each hold either an
216 active Class III institutional pharmacy permit under chapter 465
217 or an active health care clinic establishment permit under
218 paragraph (r). For purposes of this subparagraph, the term
219 “common control” has the same meaning as in s. 499.003(49)(a)3.
220 s. 499.003(48)(a)3.
221 (h) Restricted prescription drug distributor permit.—
222 1. A restricted prescription drug distributor permit is
223 required for:
224 a. Any person located in this state who engages in the
225 distribution of a prescription drug, which distribution is not
226 considered “wholesale distribution” under s. 499.003(49)(a) s.
227 499.003(48)(a).
228 b. Any person located in this state who engages in the
229 receipt or distribution of a prescription drug in this state for
230 the purpose of processing its return or its destruction if such
231 person is not the person initiating the return, the prescription
232 drug wholesale supplier of the person initiating the return, or
233 the manufacturer of the drug.
234 c. A blood establishment located in this state which
235 collects blood and blood components only from volunteer donors
236 as defined in s. 381.06014 or pursuant to an authorized
237 practitioner’s order for medical treatment or therapy and
238 engages in the wholesale distribution of a prescription drug not
239 described in s. 499.003(49)(j) s. 499.003(48)(j) to a health
240 care entity. A mobile blood unit operated by a blood
241 establishment permitted under this sub-subparagraph is not
242 required to be separately permitted. The health care entity
243 receiving a prescription drug distributed under this sub
244 subparagraph must be licensed as a closed pharmacy or provide
245 health care services at that establishment. The blood
246 establishment must operate in accordance with s. 381.06014 and
247 may distribute only:
248 (I) Prescription drugs indicated for a bleeding or clotting
249 disorder or anemia;
250 (II) Blood-collection containers approved under s. 505 of
251 the federal act;
252 (III) Drugs that are blood derivatives, or a recombinant or
253 synthetic form of a blood derivative;
254 (IV) Prescription drugs that are identified in rules
255 adopted by the department and that are essential to services
256 performed or provided by blood establishments and authorized for
257 distribution by blood establishments under federal law; or
258 (V) To the extent authorized by federal law, drugs
259 necessary to collect blood or blood components from volunteer
260 blood donors; for blood establishment personnel to perform
261 therapeutic procedures under the direction and supervision of a
262 licensed physician; and to diagnose, treat, manage, and prevent
263 any reaction of a volunteer blood donor or a patient undergoing
264 a therapeutic procedure performed under the direction and
265 supervision of a licensed physician, as long as all of the
266 health care services provided by the blood establishment are
267 related to its activities as a registered blood establishment or
268 the health care services consist of collecting, processing,
269 storing, or administering human hematopoietic stem cells or
270 progenitor cells or performing diagnostic testing of specimens
271 if such specimens are tested together with specimens undergoing
272 routine donor testing. The blood establishment may purchase and
273 possess the drugs described in this sub-subparagraph without a
274 health care clinic establishment permit.
275 2. Storage, handling, and recordkeeping of these
276 distributions by a person required to be permitted as a
277 restricted prescription drug distributor must be in accordance
278 with the requirements for wholesale distributors under s.
279 499.0121.
280 3. A person who applies for a permit as a restricted
281 prescription drug distributor, or for the renewal of such a
282 permit, must provide to the department the information required
283 under s. 499.012.
284 4. The department may adopt rules regarding the
285 distribution of prescription drugs by hospitals, health care
286 entities, charitable organizations, other persons not involved
287 in wholesale distribution, and blood establishments, which rules
288 are necessary for the protection of the public health, safety,
289 and welfare.
290 5. A restricted prescription drug distributor permit is not
291 required for distributions between pharmacies that each hold an
292 active permit under chapter 465, have a common ownership, and
293 are operating in a freestanding end-stage renal dialysis clinic,
294 if such distributions are made to meet the immediate emergency
295 medical needs of specifically identified patients and do not
296 occur with such frequency as to amount to the regular and
297 systematic supplying of that drug between the pharmacies. The
298 department shall adopt rules establishing when the distribution
299 of a prescription drug under this subparagraph amounts to the
300 regular and systematic supplying of that drug.
301 6. A restricted prescription drug distributor permit is not
302 required for distributing medicinal drugs or prepackaged drug
303 products between entities under common control that each hold
304 either an active Class III institutional pharmacy permit under
305 chapter 465 or an active health care clinic establishment permit
306 under paragraph (r). For purposes of this subparagraph, the term
307 “common control” has the same meaning as in s. 499.003(49)(a)3.
308 s. 499.003(48)(a)3.
309 Section 8. Paragraphs (i) and (l) of subsection (1) of
310 section 499.05, Florida Statutes, are amended to read:
311 499.05 Rules.—
312 (1) The department shall adopt rules to implement and
313 enforce this chapter with respect to:
314 (i) Additional conditions that qualify as an emergency
315 medical reason under s. 499.003(49)(b)2. s. 499.003(48)(b)2. or
316 s. 499.82.
317 (l) The recordkeeping, storage, and handling with respect
318 to each of the distributions of prescription drugs specified in
319 s. 499.003(49)(a)-(v) s. 499.003(48)(a)-(v) or s. 499.82(14).
320 Section 9. This act shall take effect July 1, 2025.