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         499.0095Toxic 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 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.