Florida Senate - 2025 CS for CS for CS for SB 196
By the Committee on Rules; the Appropriations Committee on
Agriculture, Environment, and General Government; the Committee
on Regulated Industries; and Senators Gruters and Calatayud
595-03665-25 2025196c3
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; prohibiting, by a specified date, cosmetics
15 that release formaldehyde from being manufactured,
16 sold, offered or distributed for sale, or distributed
17 for use in this state, unless it is a natural
18 byproduct with no functional or technical purpose;
19 providing an exception; providing construction;
20 providing penalties and remedies; providing
21 applicability; authorizing the Department of Business
22 and Professional Regulation to adopt rules; amending
23 s. 500.03, F.S.; defining the term “messenger
24 ribonucleic acid vaccine” or “mRNA vaccine”; amending
25 s. 500.04, F.S.; prohibiting the use of fruits and
26 vegetables to deliver an mRNA vaccine; amending s.
27 500.11, F.S.; deeming a food misbranded if it contains
28 a vaccine or vaccine material, but its label does not
29 include specified information; amending ss. 499.01 and
30 499.05, F.S.; conforming cross-references; providing
31 an effective date.
32
33 Be It Enacted by the Legislature of the State of Florida:
34
35 Section 1. Present subsections (47), (48), and (49) of
36 section 499.003, Florida Statutes, are redesignated as
37 subsections (48), (49), and (50), respectively, a new subsection
38 (47) is added to that section, and subsections (17) and (40) of
39 that section are amended, to read:
40 499.003 Definitions of terms used in this part.—As used in
41 this part, the term:
42 (17) “Drug” means an article that is:
43 (a) Recognized in the current edition of the United States
44 Pharmacopoeia and National Formulary, official Homeopathic
45 Pharmacopoeia of the United States, or any supplement to any of
46 those publications;
47 (b) Intended for use in the diagnosis, cure, mitigation,
48 treatment, therapy, or prevention of disease in humans or other
49 animals;
50 (c) Intended to affect the structure or any function of the
51 body of humans or other animals; or
52 (d) Intended for use as a component of any article
53 specified in paragraph (a), paragraph (b), or paragraph (c), and
54 includes active pharmaceutical ingredients, but does not include
55 devices or their nondrug components, parts, or accessories; or
56 (e) Food as defined in s. 500.03 which contains a vaccine
57 or vaccine material.
58 (40) “Prescription drug” means a prescription, medicinal,
59 or legend drug, including, but not limited to, finished dosage
60 forms or active pharmaceutical ingredients subject to, defined
61 by, or described by s. 503(b) of the federal act or s. 465.003,
62 s. 499.007(13), subsection (31), or subsection (48) (47), except
63 that an active pharmaceutical ingredient is a prescription drug
64 only if substantially all finished dosage forms in which it may
65 be lawfully dispensed or administered in this state are also
66 prescription drugs.
67 (47) “Vaccine or vaccine material” means a substance
68 authorized or approved by the United States Food and Drug
69 Administration which is intended for use in humans to stimulate
70 the production of antibodies and provide immunity against
71 disease and which is prepared from the causative agent of a
72 disease, its products, or a synthetic substitute and is treated
73 to act as an antigen without inducing the disease.
74 Section 2. Present subsection (17) of section 499.007,
75 Florida Statutes, is redesignated as subsection (18), and a new
76 subsection (17) is added to that section, to read:
77 499.007 Misbranded drug or device.—A drug or device is
78 misbranded:
79 (17) If it is a food as defined in s. 500.03 and contains a
80 vaccine or vaccine material, but its label does not bear, in
81 type of uniform size and prominence, the words “contains vaccine
82 or vaccine material” and does not specify that the food is
83 classified as a drug under the Florida Drug and Cosmetic Act.
84 Section 3. Section 499.0095, Florida Statutes, is created
85 to read:
86 499.0095 Presence of certain ingredients in cosmetics;
87 notice required.—
88 (1) As used in this section, the term:
89 (a) “Incidental ingredient” means a substance that has no
90 technical or functional effect in the cosmetics but is present
91 by reason of having been incorporated into the cosmetics as an
92 ingredient of another cosmetic ingredient.
93 (b) “Ingredient” means:
94 1. Any chemical or mixture of chemicals intentionally used
95 in the manufacturing of cosmetics. The term does not include any
96 incidental ingredient that is present in cosmetics at
97 insignificant levels or that has no technical or functional
98 effect; or
99 2. A processing aid, including any of the following:
100 a. A substance that is used in the processing of cosmetics
101 but is removed from the cosmetics in accordance with good
102 manufacturing practices before the cosmetics are packaged in
103 their finished form.
104 b. A substance that is used in the processing of cosmetics
105 for its technical or functional effect to produce the cosmetics
106 and is then converted to a substance the same as constituents of
107 a declared ingredient, in accordance with good manufacturing
108 practices, and does not significantly increase the concentration
109 of such constituents before the cosmetics are packaged in their
110 finished form.
111 c. A substance that is used in the processing of cosmetics
112 for its technical or functional effect to produce the cosmetics
113 in accordance with good manufacturing practices, that is present
114 in the cosmetics’ finished form at insignificant concentrations,
115 and that does not have any technical or functional effect in
116 such cosmetics.
117 (c) “Ortho-phthalates” means esters of ortho-phthalic acid.
118 (d) “Perfluoroalkyl and polyfluoroalkyl substances” or
119 “PFAS” means a class of fluorinated organic chemicals containing
120 at least one fully fluorinated carbon atom.
121 (2) Except as provided in subsection (5), beginning July 1,
122 2026, cosmetics manufactured, sold, offered or distributed for
123 sale, or distributed for use in this state must provide notice
124 on such cosmetics’ single-use packaging of the following
125 intentionally added chemicals or chemical classes:
126 (a) Ortho-phthalates.
127 (b) PFAS.
128 (c) Formaldehyde as identified in CAS 50-00-0.
129 (d) Methylene glycol as identified in CAS 463-57-0.
130 (e) Mercury as identified in CAS 7439-97-6.
131 (f) Triclosan as identified in CAS 3380-34-5.
132 (g) M-phenylenediamine or its salt derivatives as
133 identified in CAS 108-45-2.
134 (h) O-phenylenediamine or its salt derivatives as
135 identified in CAS 95-54-5.
136 (3) Except as provided in subsection (5), beginning July 1,
137 2026, cosmetics manufactured, sold, offered or distributed for
138 sale, or distributed for use in this state must provide notice
139 on such cosmetics’ single-use packaging of any lead or lead
140 compounds as identified by CAS 7439-92-1, whether intentionally
141 added or naturally occurring, at 10 parts per million or more,
142 or as otherwise determined by department rule.
143 (4) Except as provided in subsection (5), beginning July 1,
144 2026, cosmetics manufactured, sold, offered or distributed for
145 sale, or distributed for use in this state may not release
146 formaldehyde as identified in paragraph (2)(c) unless it is a
147 natural byproduct with no functional or technical purpose.
148 (5) A retailer in possession of cosmetics that do not
149 comply with the requirements of this section as of July 1, 2026,
150 may exhaust its existing stock through sales to the public until
151 July 1, 2027.
152 (6) A violation of this section is subject to the penalties
153 and remedies provided in s. 499.066.
154 (7) This section does not apply to cosmetic products
155 regulated as drugs by the United States Food and Drug
156 Administration.
157 (8) The department may adopt rules necessary to implement
158 this section.
159 Section 4. Present paragraphs (t) through (z) of subsection
160 (1) of section 500.03, Florida Statutes, are redesignated as
161 paragraphs (u) through (aa), respectively, and a new paragraph
162 (t) is added to that subsection, to read:
163 500.03 Definitions; construction; applicability.—
164 (1) For the purpose of this chapter, the term:
165 (t) “Messenger ribonucleic acid vaccine” or “mRNA vaccine”
166 means a vaccine that uses laboratory-produced messenger
167 ribonucleic acid to trigger the human body’s immune system to
168 generate an immune response.
169 Section 5. Subsection (12) is added to section 500.04,
170 Florida Statutes, to read:
171 500.04 Prohibited acts.—The following acts and the causing
172 thereof within the state are prohibited:
173 (12) The use of a fruit or vegetable as a delivery
174 mechanism for an mRNA vaccine as defined in s. 500.03.
175 Section 6. Paragraph (q) is added to subsection (1) of
176 section 500.11, Florida Statutes, to read:
177 500.11 Food deemed misbranded.—
178 (1) A food is deemed to be misbranded:
179 (q) If it contains a vaccine or vaccine material as defined
180 in s. 499.003, unless its label bears, in type of uniform size
181 and prominence, the words “contains vaccine or vaccine material”
182 and specifies that the food is classified as a drug under the
183 Florida Drug and Cosmetic Act.
184 Section 7. Paragraphs (a), (b), and (h) of subsection (2)
185 of section 499.01, Florida Statutes, are amended to read:
186 499.01 Permits.—
187 (2) The following permits are established:
188 (a) Prescription drug manufacturer permit.—A prescription
189 drug manufacturer permit is required for any person that is a
190 manufacturer of a prescription drug and that manufactures or
191 distributes such prescription drugs in this state.
192 1. A person that operates an establishment permitted as a
193 prescription drug manufacturer may engage in distribution of
194 prescription drugs for which the person is the manufacturer and
195 must comply with s. 499.0121 and all other provisions of this
196 part and rules adopted under this part. The department shall
197 adopt rules for issuing a virtual prescription drug manufacturer
198 permit to a person who engages in the manufacture of
199 prescription drugs but does not make or take physical possession
200 of any prescription drugs. The rules adopted by the department
201 under this section may exempt virtual manufacturers from certain
202 establishment, security, and storage requirements set forth in
203 s. 499.0121.
204 2. A prescription drug manufacturer must comply with all
205 appropriate state and federal good manufacturing practices.
206 3. A blood establishment, as defined in s. 381.06014,
207 operating in a manner consistent with the provisions of 21
208 C.F.R. parts 211 and 600-640, and manufacturing only the
209 prescription drugs described in s. 499.003(49)(j) s.
210 499.003(48)(j) is not required to be permitted as a prescription
211 drug manufacturer under this paragraph or to register products
212 under s. 499.015.
213 (b) Prescription drug repackager permit.—A prescription
214 drug repackager permit is required for any person that
215 repackages a prescription drug in this state.
216 1. A person that operates an establishment permitted as a
217 prescription drug repackager may engage in distribution of
218 prescription drugs repackaged at that establishment and must
219 comply with all of the provisions of this part and the rules
220 adopted under this part that apply to a prescription drug
221 manufacturer.
222 2. A prescription drug repackager must comply with all
223 appropriate state and federal good manufacturing practices.
224 3. A prescription drug repackager permit is not required
225 for distributing medicinal drugs or prepackaged drug products
226 between entities under common control which each hold either an
227 active Class III institutional pharmacy permit under chapter 465
228 or an active health care clinic establishment permit under
229 paragraph (r). For purposes of this subparagraph, the term
230 “common control” has the same meaning as in s. 499.003(49)(a)3.
231 s. 499.003(48)(a)3.
232 (h) Restricted prescription drug distributor permit.—
233 1. A restricted prescription drug distributor permit is
234 required for:
235 a. Any person located in this state who engages in the
236 distribution of a prescription drug, which distribution is not
237 considered “wholesale distribution” under s. 499.003(49)(a) s.
238 499.003(48)(a).
239 b. Any person located in this state who engages in the
240 receipt or distribution of a prescription drug in this state for
241 the purpose of processing its return or its destruction if such
242 person is not the person initiating the return, the prescription
243 drug wholesale supplier of the person initiating the return, or
244 the manufacturer of the drug.
245 c. A blood establishment located in this state which
246 collects blood and blood components only from volunteer donors
247 as defined in s. 381.06014 or pursuant to an authorized
248 practitioner’s order for medical treatment or therapy and
249 engages in the wholesale distribution of a prescription drug not
250 described in s. 499.003(49)(j) s. 499.003(48)(j) to a health
251 care entity. A mobile blood unit operated by a blood
252 establishment permitted under this sub-subparagraph is not
253 required to be separately permitted. The health care entity
254 receiving a prescription drug distributed under this sub
255 subparagraph must be licensed as a closed pharmacy or provide
256 health care services at that establishment. The blood
257 establishment must operate in accordance with s. 381.06014 and
258 may distribute only:
259 (I) Prescription drugs indicated for a bleeding or clotting
260 disorder or anemia;
261 (II) Blood-collection containers approved under s. 505 of
262 the federal act;
263 (III) Drugs that are blood derivatives, or a recombinant or
264 synthetic form of a blood derivative;
265 (IV) Prescription drugs that are identified in rules
266 adopted by the department and that are essential to services
267 performed or provided by blood establishments and authorized for
268 distribution by blood establishments under federal law; or
269 (V) To the extent authorized by federal law, drugs
270 necessary to collect blood or blood components from volunteer
271 blood donors; for blood establishment personnel to perform
272 therapeutic procedures under the direction and supervision of a
273 licensed physician; and to diagnose, treat, manage, and prevent
274 any reaction of a volunteer blood donor or a patient undergoing
275 a therapeutic procedure performed under the direction and
276 supervision of a licensed physician, as long as all of the
277 health care services provided by the blood establishment are
278 related to its activities as a registered blood establishment or
279 the health care services consist of collecting, processing,
280 storing, or administering human hematopoietic stem cells or
281 progenitor cells or performing diagnostic testing of specimens
282 if such specimens are tested together with specimens undergoing
283 routine donor testing. The blood establishment may purchase and
284 possess the drugs described in this sub-subparagraph without a
285 health care clinic establishment permit.
286 2. Storage, handling, and recordkeeping of these
287 distributions by a person required to be permitted as a
288 restricted prescription drug distributor must be in accordance
289 with the requirements for wholesale distributors under s.
290 499.0121.
291 3. A person who applies for a permit as a restricted
292 prescription drug distributor, or for the renewal of such a
293 permit, must provide to the department the information required
294 under s. 499.012.
295 4. The department may adopt rules regarding the
296 distribution of prescription drugs by hospitals, health care
297 entities, charitable organizations, other persons not involved
298 in wholesale distribution, and blood establishments, which rules
299 are necessary for the protection of the public health, safety,
300 and welfare.
301 5. A restricted prescription drug distributor permit is not
302 required for distributions between pharmacies that each hold an
303 active permit under chapter 465, have a common ownership, and
304 are operating in a freestanding end-stage renal dialysis clinic,
305 if such distributions are made to meet the immediate emergency
306 medical needs of specifically identified patients and do not
307 occur with such frequency as to amount to the regular and
308 systematic supplying of that drug between the pharmacies. The
309 department shall adopt rules establishing when the distribution
310 of a prescription drug under this subparagraph amounts to the
311 regular and systematic supplying of that drug.
312 6. A restricted prescription drug distributor permit is not
313 required for distributing medicinal drugs or prepackaged drug
314 products between entities under common control that each hold
315 either an active Class III institutional pharmacy permit under
316 chapter 465 or an active health care clinic establishment permit
317 under paragraph (r). For purposes of this subparagraph, the term
318 “common control” has the same meaning as in s. 499.003(49)(a)3.
319 s. 499.003(48)(a)3.
320 Section 8. Paragraphs (i) and (l) of subsection (1) of
321 section 499.05, Florida Statutes, are amended to read:
322 499.05 Rules.—
323 (1) The department shall adopt rules to implement and
324 enforce this chapter with respect to:
325 (i) Additional conditions that qualify as an emergency
326 medical reason under s. 499.003(49)(b)2. s. 499.003(48)(b)2. or
327 s. 499.82.
328 (l) The recordkeeping, storage, and handling with respect
329 to each of the distributions of prescription drugs specified in
330 s. 499.003(49)(a)-(v) s. 499.003(48)(a)-(v) or s. 499.82(14).
331 Section 9. This act shall take effect July 1, 2025.