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: 39 499.003Definitions 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: 76 499.007Misbranded 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: 85 499.0095Toxic 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 departments 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: 160 500.03Definitions; 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 bodys immune system to 165 generate an immune response. 166 Section 5.Subsection (12) is added to section 500.04, 167 Florida Statutes, to read: 168 500.04Prohibited 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: 174 500.11Food 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: 183 499.01Permits. 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 practitioners 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: 319 499.05Rules. 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.