Florida Senate - 2025 CS for SB 196
By the Committee on Regulated Industries; and Senator Gruters
580-02614-25 2025196c1
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; prohibiting, beginning on a specified
10 date, the manufacture, sale, offer or distribution for
11 sale, or distribution for use of cosmetics that
12 contain specified added chemical ingredients;
13 providing an exception; requiring the Department of
14 Business and Professional Regulation (DBPR), in
15 consultation with the Department of Health, to make
16 certain determinations and make the information
17 publicly available on its website by a specified date;
18 providing construction; providing for disciplinary
19 action; providing applicability; requiring DBPR to
20 adopt rules; specifying requirements for the adoption
21 of such rules; amending s. 500.03, F.S.; defining the
22 term “messenger ribonucleic acid vaccine” or “mRNA
23 vaccine”; amending s. 500.04, F.S.; prohibiting the
24 use of fruits and vegetables to deliver an mRNA
25 vaccine; amending s. 500.11, F.S.; deeming a food
26 misbranded if it contains a vaccine or vaccine
27 material, but its label does not include specified
28 information; amending ss. 499.01 and 499.05, F.S.;
29 conforming cross-references; providing an effective
30 date.
31
32 Be It Enacted by the Legislature of the State of Florida:
33
34 Section 1. Present subsections (47), (48), and (49) of
35 section 499.003, Florida Statutes, are redesignated as
36 subsections (48), (49), and (50), respectively, a new subsection
37 (47) is added to that section, and subsections (17) and (40) of
38 that section are amended, to read:
39 499.003 Definitions of terms used in this part.—As used in
40 this part, the term:
41 (17) “Drug” means an article that is:
42 (a) Recognized in the current edition of the United States
43 Pharmacopoeia and National Formulary, official Homeopathic
44 Pharmacopoeia of the United States, or any supplement to any of
45 those publications;
46 (b) Intended for use in the diagnosis, cure, mitigation,
47 treatment, therapy, or prevention of disease in humans or other
48 animals;
49 (c) Intended to affect the structure or any function of the
50 body of humans or other animals; or
51 (d) Intended for use as a component of any article
52 specified in paragraph (a), paragraph (b), or paragraph (c), and
53 includes active pharmaceutical ingredients, but does not include
54 devices or their nondrug components, parts, or accessories; or
55 (e) Food as defined in s. 500.03 which contains a vaccine
56 or vaccine material.
57 (40) “Prescription drug” means a prescription, medicinal,
58 or legend drug, including, but not limited to, finished dosage
59 forms or active pharmaceutical ingredients subject to, defined
60 by, or described by s. 503(b) of the federal act or s. 465.003,
61 s. 499.007(13), subsection (31), or subsection (48) (47), except
62 that an active pharmaceutical ingredient is a prescription drug
63 only if substantially all finished dosage forms in which it may
64 be lawfully dispensed or administered in this state are also
65 prescription drugs.
66 (47) “Vaccine or vaccine material” means a substance
67 authorized or approved by the United States Food and Drug
68 Administration which is intended for use in humans to stimulate
69 the production of antibodies and provide immunity against
70 disease and which is prepared from the causative agent of a
71 disease, its products, or a synthetic substitute and is treated
72 to act as an antigen without inducing the disease.
73 Section 2. Present subsection (17) of section 499.007,
74 Florida Statutes, is redesignated as subsection (18), and a new
75 subsection (17) is added to that section, to read:
76 499.007 Misbranded drug or device.—A drug or device is
77 misbranded:
78 (17) If it is a food as defined in s. 500.03 and contains a
79 vaccine or vaccine material, but its label does not bear, in
80 type of uniform size and prominence, the words “contains vaccine
81 or vaccine material” and does not specify that the food is
82 classified as a drug under the Florida Drug and Cosmetic Act.
83 Section 3. Section 499.0095, Florida Statutes, is created
84 to read:
85 499.0095 Toxic chemicals in cosmetics prohibited.—
86 (1) As used in this section, the term:
87 (a) “Ortho-phthalates” means esters of ortho-phthalic acid.
88 (b) “Perfluoroalkyl and polyfluoroalkyl substances” or
89 “PFAS” means a class of fluorinated organic chemicals containing
90 at least one fully fluorinated carbon atom.
91 (2) Except as provided in subsection (4), beginning July 1,
92 2026, cosmetics manufactured, sold, offered or distributed for
93 sale, or distributed for use in this state may not contain any
94 of the following intentionally added chemicals or chemical
95 classes:
96 (a) Ortho-phthalates.
97 (b) PFAS.
98 (c) Formaldehyde or any other chemical determined by the
99 department to release formaldehyde.
100 (d) Methylene glycol.
101 (e) Mercury or mercury compounds.
102 (f) Triclosan.
103 (g) M-phenylenediamine or its salt derivatives.
104 (h) O-phenylenediamine or its salt derivatives.
105 (3) Except as provided in subsection (4), beginning July 1,
106 2026, cosmetics manufactured, sold, offered or distributed for
107 sale, or distributed for use in this state may not contain any
108 lead or lead compounds, whether intentionally added or naturally
109 occurring, at 1 part per million or above, or as otherwise
110 determined by department rule.
111 (4) An in-state retailer in possession of cosmetics on the
112 date that restrictions on the sale of the products take effect
113 under this section may exhaust its existing stock through sales
114 to the public until July 1, 2027.
115 (5) By January 1, 2026, the department, in consultation
116 with the Department of Health, shall use existing information to
117 identify and assess the hazards of chemicals or chemical classes
118 that can provide the same or similar function in cosmetics as
119 the chemicals or chemical classes listed in subsection (2). The
120 department shall make the information publicly available on its
121 website.
122 (6) The chemicals in subsection (2) are prohibited in
123 cosmetics regardless of whether the product also contains drug
124 ingredients regulated by the United States Food and Drug
125 Administration.
126 (7) A violation of this section is grounds for disciplinary
127 action under s. 499.066.
128 (8) This section does not apply to ingredients regulated as
129 drugs by the United States Food and Drug Administration.
130 (9) The department shall adopt rules necessary to implement
131 this section.
132 (a) The department’s determinations of chemicals that
133 release formaldehyde must be adopted by rule. The department
134 shall identify a list of chemicals used in cosmetics which
135 release formaldehyde which are subject to restriction under this
136 chapter. In establishing this list, the department shall
137 consider the following:
138 1. Estimated prevalence of use.
139 2. Potential to reduce disproportionate exposure.
140 3. Other information deemed relevant by the department.
141 (b) The department may identify for restriction an initial
142 set of no more than 10 of the listed chemicals used in cosmetics
143 which release formaldehyde. This restriction must take effect on
144 or after July 1, 2026.
145 (c) Restrictions on any remaining listed chemicals used in
146 cosmetics which release formaldehyde may take effect on or after
147 July 1, 2027.
148 (d) In adopting rules under this section, the department
149 shall engage with relevant stakeholders for their expertise and
150 input. The stakeholder process must include, but is not limited
151 to, soliciting input from representatives from independent
152 cosmetologists, businesses offering cosmetology services, such
153 as beauty salons, and manufacturers of cosmetics. The input
154 received from stakeholders must be considered when adopting
155 rules.
156 Section 4. Present paragraphs (t) through (z) of subsection
157 (1) of section 500.03, Florida Statutes, are redesignated as
158 paragraphs (u) through (aa), respectively, and a new paragraph
159 (t) is added to that subsection, to read:
160 500.03 Definitions; construction; applicability.—
161 (1) For the purpose of this chapter, the term:
162 (t) “Messenger ribonucleic acid vaccine” or “mRNA vaccine”
163 means a vaccine that uses laboratory-produced messenger
164 ribonucleic acid to trigger the human body’s immune system to
165 generate an immune response.
166 Section 5. Subsection (12) is added to section 500.04,
167 Florida Statutes, to read:
168 500.04 Prohibited acts.—The following acts and the causing
169 thereof within the state are prohibited:
170 (12) The use of a fruit or vegetable as a delivery
171 mechanism for an mRNA vaccine as defined in s. 500.03.
172 Section 6. Paragraph (q) is added to subsection (1) of
173 section 500.11, Florida Statutes, to read:
174 500.11 Food deemed misbranded.—
175 (1) A food is deemed to be misbranded:
176 (q) If it contains a vaccine or vaccine material as defined
177 in s. 499.003, unless its label bears, in type of uniform size
178 and prominence, the words “contains vaccine or vaccine material”
179 and specifies that the food is classified as a drug under the
180 Florida Drug and Cosmetic Act.
181 Section 7. Paragraphs (a), (b), and (h) of subsection (2)
182 of section 499.01, Florida Statutes, are amended to read:
183 499.01 Permits.—
184 (2) The following permits are established:
185 (a) Prescription drug manufacturer permit.—A prescription
186 drug manufacturer permit is required for any person that is a
187 manufacturer of a prescription drug and that manufactures or
188 distributes such prescription drugs in this state.
189 1. A person that operates an establishment permitted as a
190 prescription drug manufacturer may engage in distribution of
191 prescription drugs for which the person is the manufacturer and
192 must comply with s. 499.0121 and all other provisions of this
193 part and rules adopted under this part. The department shall
194 adopt rules for issuing a virtual prescription drug manufacturer
195 permit to a person who engages in the manufacture of
196 prescription drugs but does not make or take physical possession
197 of any prescription drugs. The rules adopted by the department
198 under this section may exempt virtual manufacturers from certain
199 establishment, security, and storage requirements set forth in
200 s. 499.0121.
201 2. A prescription drug manufacturer must comply with all
202 appropriate state and federal good manufacturing practices.
203 3. A blood establishment, as defined in s. 381.06014,
204 operating in a manner consistent with the provisions of 21
205 C.F.R. parts 211 and 600-640, and manufacturing only the
206 prescription drugs described in s. 499.003(49)(j) s.
207 499.003(48)(j) is not required to be permitted as a prescription
208 drug manufacturer under this paragraph or to register products
209 under s. 499.015.
210 (b) Prescription drug repackager permit.—A prescription
211 drug repackager permit is required for any person that
212 repackages a prescription drug in this state.
213 1. A person that operates an establishment permitted as a
214 prescription drug repackager may engage in distribution of
215 prescription drugs repackaged at that establishment and must
216 comply with all of the provisions of this part and the rules
217 adopted under this part that apply to a prescription drug
218 manufacturer.
219 2. A prescription drug repackager must comply with all
220 appropriate state and federal good manufacturing practices.
221 3. A prescription drug repackager permit is not required
222 for distributing medicinal drugs or prepackaged drug products
223 between entities under common control which each hold either an
224 active Class III institutional pharmacy permit under chapter 465
225 or an active health care clinic establishment permit under
226 paragraph (r). For purposes of this subparagraph, the term
227 “common control” has the same meaning as in s. 499.003(49)(a)3.
228 s. 499.003(48)(a)3.
229 (h) Restricted prescription drug distributor permit.—
230 1. A restricted prescription drug distributor permit is
231 required for:
232 a. Any person located in this state who engages in the
233 distribution of a prescription drug, which distribution is not
234 considered “wholesale distribution” under s. 499.003(49)(a) s.
235 499.003(48)(a).
236 b. Any person located in this state who engages in the
237 receipt or distribution of a prescription drug in this state for
238 the purpose of processing its return or its destruction if such
239 person is not the person initiating the return, the prescription
240 drug wholesale supplier of the person initiating the return, or
241 the manufacturer of the drug.
242 c. A blood establishment located in this state which
243 collects blood and blood components only from volunteer donors
244 as defined in s. 381.06014 or pursuant to an authorized
245 practitioner’s order for medical treatment or therapy and
246 engages in the wholesale distribution of a prescription drug not
247 described in s. 499.003(49)(j) s. 499.003(48)(j) to a health
248 care entity. A mobile blood unit operated by a blood
249 establishment permitted under this sub-subparagraph is not
250 required to be separately permitted. The health care entity
251 receiving a prescription drug distributed under this sub
252 subparagraph must be licensed as a closed pharmacy or provide
253 health care services at that establishment. The blood
254 establishment must operate in accordance with s. 381.06014 and
255 may distribute only:
256 (I) Prescription drugs indicated for a bleeding or clotting
257 disorder or anemia;
258 (II) Blood-collection containers approved under s. 505 of
259 the federal act;
260 (III) Drugs that are blood derivatives, or a recombinant or
261 synthetic form of a blood derivative;
262 (IV) Prescription drugs that are identified in rules
263 adopted by the department and that are essential to services
264 performed or provided by blood establishments and authorized for
265 distribution by blood establishments under federal law; or
266 (V) To the extent authorized by federal law, drugs
267 necessary to collect blood or blood components from volunteer
268 blood donors; for blood establishment personnel to perform
269 therapeutic procedures under the direction and supervision of a
270 licensed physician; and to diagnose, treat, manage, and prevent
271 any reaction of a volunteer blood donor or a patient undergoing
272 a therapeutic procedure performed under the direction and
273 supervision of a licensed physician, as long as all of the
274 health care services provided by the blood establishment are
275 related to its activities as a registered blood establishment or
276 the health care services consist of collecting, processing,
277 storing, or administering human hematopoietic stem cells or
278 progenitor cells or performing diagnostic testing of specimens
279 if such specimens are tested together with specimens undergoing
280 routine donor testing. The blood establishment may purchase and
281 possess the drugs described in this sub-subparagraph without a
282 health care clinic establishment permit.
283 2. Storage, handling, and recordkeeping of these
284 distributions by a person required to be permitted as a
285 restricted prescription drug distributor must be in accordance
286 with the requirements for wholesale distributors under s.
287 499.0121.
288 3. A person who applies for a permit as a restricted
289 prescription drug distributor, or for the renewal of such a
290 permit, must provide to the department the information required
291 under s. 499.012.
292 4. The department may adopt rules regarding the
293 distribution of prescription drugs by hospitals, health care
294 entities, charitable organizations, other persons not involved
295 in wholesale distribution, and blood establishments, which rules
296 are necessary for the protection of the public health, safety,
297 and welfare.
298 5. A restricted prescription drug distributor permit is not
299 required for distributions between pharmacies that each hold an
300 active permit under chapter 465, have a common ownership, and
301 are operating in a freestanding end-stage renal dialysis clinic,
302 if such distributions are made to meet the immediate emergency
303 medical needs of specifically identified patients and do not
304 occur with such frequency as to amount to the regular and
305 systematic supplying of that drug between the pharmacies. The
306 department shall adopt rules establishing when the distribution
307 of a prescription drug under this subparagraph amounts to the
308 regular and systematic supplying of that drug.
309 6. A restricted prescription drug distributor permit is not
310 required for distributing medicinal drugs or prepackaged drug
311 products between entities under common control that each hold
312 either an active Class III institutional pharmacy permit under
313 chapter 465 or an active health care clinic establishment permit
314 under paragraph (r). For purposes of this subparagraph, the term
315 “common control” has the same meaning as in s. 499.003(49)(a)3.
316 s. 499.003(48)(a)3.
317 Section 8. Paragraphs (i) and (l) of subsection (1) of
318 section 499.05, Florida Statutes, are amended to read:
319 499.05 Rules.—
320 (1) The department shall adopt rules to implement and
321 enforce this chapter with respect to:
322 (i) Additional conditions that qualify as an emergency
323 medical reason under s. 499.003(49)(b)2. s. 499.003(48)(b)2. or
324 s. 499.82.
325 (l) The recordkeeping, storage, and handling with respect
326 to each of the distributions of prescription drugs specified in
327 s. 499.003(49)(a)-(v) s. 499.003(48)(a)-(v) or s. 499.82(14).
328 Section 9. This act shall take effect July 1, 2025.