The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Regulated Industries
BILL: SB 196
INTRODUCER: Senator Gruters
SUBJECT: Foods Containing Vaccines or Vaccine Materials
DATE: March 18, 2025
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Baird Imhof RI Pre-meeting
2. AEG
3. RC
I. Summary:
SB 196 sets forth labeling requirements for specific food products containing “vaccine or
vaccine material” and broadens the definition of “drug” in ch. 499, F.S., to include those food
items.
The bill further establishes that any food product containing vaccine or vaccine material without
required labeling is a misbranded drug.
Finally, the bill would deem those food products containing vaccine or vaccine material without
required labeling as misbranded foods under ch. 500, F.S.
The bill provides an effective date of July 1, 2025.
II. Present Situation:
State and Federal Regulation of Drugs, Devices, and Cosmetics
The regulation of drugs is addressed in ch. 499, F.S., which regulates drugs, devices, and
cosmetics by the Department of Business and Professional Regulation (DBPR).
1
The Florida
Drug and Cosmetic Act (the act)
2
is intended to safeguard public health and promote public
welfare by protecting against injuries and merchandising deceit involving drugs, devices, and
cosmetics or the use of such products.
1
The Drug, Device, and Cosmetic program was transferred to the Department of Business and Professional Regulation from
the Department of Health effective November 1, 2012. See ch. 2012-184, Law of Fla., s. 122, at
http://laws.flrules.org/2012/184 (last visited March 18, 2025).
2
See ss. 499.001-499.081, F.S.
REVISED: BILL: SB 196 Page 2
Administration of the act must conform to the Federal Food, Drug, and Cosmetic Act
3
and the
applicable portions of the Federal Trade Commission Act
4
which prohibit the false advertising of
drugs, devices, and cosmetics.
Regulation on Drugs and Devices
General Prohibitions
The act prohibits any person from:
5
• Offering for sale any drug, device, or cosmetic, that is adulterated or misbranded.
• Disseminating any false or misleading advertisement of a drug, device, or cosmetic.
• Refusing from letting the DBPR to enter or inspect an establishment in which drugs, devices,
or cosmetics are manufactured, processed, repackaged, sold, brokered, or held.
• Committing any act that causes a drug, device, or cosmetic to be a counterfeit drug, device,
or cosmetic; or selling, dispensing, or holding for sale a counterfeit drug, device, or cosmetic.
• Committing an alteration, mutilation, destruction, obliteration, or removal of the whole or
any part of the labeling of a drug, device, or cosmetic, or the doing of any other act with
respect to a drug, device, or cosmetic, if the act is done while the drug, device, or cosmetic is
held for sale and the act results in the drug, device, or cosmetic being misbranded.
• Forging, counterfeiting, simulating, falsely representing any drug, device, or cosmetic, or
without the authority of the manufacturer, using any mark, stamp, tag, label, or other
identification device authorized or required by rules adopted under this part.
• Using, on the labeling of any drug or in any advertisement relating to such drug, any
representation or suggestion that an application of the drug is effective when it is not or that
the drug complies with this part when it does not.
• Possessing any drug in violation of part I, ch. 499, F.S.
• Failing to maintain records as required by law and rules adopted under ch. 499, F.S.
• Providing the DBPR with false or fraudulent records, or making false or fraudulent
statements, regarding any matter within the provisions of the act.
• Failing to obtain a permit or registration, or operating without a valid permit when a permit
or registration is required by the act for that activity.
• Obtaining or attempting to obtain a prescription drug or device by fraud, deceit,
misrepresentation or subterfuge, or engaging in misrepresentation or fraud in the distribution
of a drug or device.
Some of these prohibitions will raise to the level of criminal acts under s. 499.0051, F.S.
Misbranding of Drugs
The act specifies that a drug or device is deemed misbranded if:
6
• Its labeling is in any way false or misleading.
• In package form, it does not bear a label containing certain requirements prescribed by law.
3
Section 499.003(20), F.S., defines the federal act referencing 21 U.S.C. ss. 301 et seq. and 52 Stat. 1040 et seq.
4
See 15 U.S.C. ss. 41-58, as amended.
5
See s. 499.005, F.S.
6
See s. 499.007, F.S. BILL: SB 196 Page 3
• Any word, statement, or other information required by the act, that appears on the label or
labeling is not prominently placed with such conspicuousness as to render the word,
statement, or other information likely to be read and understood under customary conditions
of purchase and use.
• It is a drug and is not designated solely by a name recognized in an official compendium and
its label does not bear certain requirements prescribed by the act.
• It purports to be a drug the name of which is recognized in the official compendium and is
not packaged and labeled as prescribed therein. However, the method of packaging may be
modified with the consent of the DBPR.
• It is dangerous to health when used in the dosage or with the frequency or duration
prescribed, recommended, or suggested in the labeling of the drug.
• It purports to be, or is represented, as a drug composed wholly or partly of insulin and it is
not from a batch with respect to which a certificate has been issued pursuant to s. 506 of the
federal act, which certificate is in effect with respect to the drug.
• It purports to be, or is represented, as a drug composed wholly or partly of any kind of
antibiotic requiring certification under the federal act and it is not from a batch with respect
to which a certificate has been issued pursuant to s. 507 of the federal act, which certificate is
in effect with respect to the drug. However, this subsection does not apply to any drug or
class of drugs exempted by regulations adopted under s. 507(c) or (d) of the federal act.
Misbranding or Misrepresenting Food
In Florida a food is deemed to be misbranded:
7
• If its labeling is false or misleading in any particular manner;
• If it is offered for sale under the name of another food;
• If it is an imitation of another food, with exception;
• If its container is so made, formed, or filled as to be misleading;
• If in package form, unless it bears a label containing certain information;
8
• If any word, statement, or other information required by or under authority of ch. 500, F.S.,
• does not meet certain requirements;
9
• If it purports to be or is represented as a food for which a definition and standard of identity
has been prescribed by statute or by rule;
• If it purports to be or is represented as:
o A food for which a standard of quality has been prescribed by rules as provided by s.
500.09, F.S., and its quality falls below such standard unless its label bears a statement
that it falls below such standard; or
o A food for which a standard or standards or fill of container have been provided by rule
as provided by s. 500.09, F.S., and it falls below the standard or fill container unless its
label bears a statement that it falls below such standard.
• Unless the label bears the common or usual name of the food and specific requirements if it
is fabricated from two or more ingredients.
10
7
Section 500.11, F.S.
8
Section 500.11(1)(e), F.S.
9
Section 500.11(1)(f), F.S.
10
Section 500.11(1)(i), F.S. BILL: SB 196 Page 4
• If it purports to be or is represented for special dietary uses, unless its label contains certain
information.
11
• If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative,
unless it bears labeling stating that fact.
• If it is a fresh fruit or vegetable, package of honey, or bee pollen not labeled in accordance
with the provisions of s. 504.012, F.S., or not otherwise labeled in such a manner as to
indicate to an ultimate purchaser the country of origin.
• If it is offered for sale and its label or labeling does not comply with federal requirements
pertaining to nutrition or allergen information.
• If it is offered for sale and its label or labeling does not comply with federal labeling
requirements pertaining to nutritional content claims and health claims.
• If it is bottled water and does not meet certain labeling requirements.
12
• If it is an animal product that fails to have directly thereon or on its container the official
USDA inspection legend.
An operator may not knowingly and willfully misrepresent the identity of any food or food
product to any of the patrons of such establishment. The identity of a food product is
misrepresented if:
• The description of the food or food product is false or misleading;
• The food or food product is served, sold, or distributed under the name of another food or
food product; or
• The food or food product purports to be or is represented as a food or food product that does
not conform to a definition of identity and standard of quality if such standard has been
established by custom and usage.
13
Vaccines
General Regulation
The Advisory Committee on Immunization Practices (ACIP) develops recommendations on the
use of vaccines in the United States.
14
The ACIP is comprised of medical and public health
experts, and works with professional organizations, such as the American Academy of
Pediatrics, the American Academy of Family Physicians, the American College of Obstetricians
and Gynecologists, and the American College of Physicians to develop annual childhood and
adult immunization schedules.
15
11
Section 500.11(1)(j), F.S.
12
Section 500.11(1)(o), F.S.
13
Section 509.292(1), F.S.
14
Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP), General Committee-
Related Information, available at https://www.cdc.gov/vaccines/acip/committee/index.html (last visited March 18, 2025).
Established under Title 42 U.S.C. § 217a, ACIP members are appointed by the Secretary of the U.S. Department of Health
and Human Services and consist of a mix of medical and public health experts from private industry and the public sector.
There are 15 voting members (14 are industry experts and one consumer member), 6 non-voting, ex-officio members
consisting of specific federal government employees, and 30 non-voting representatives from professional health care
organizations.
15
Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP), ACIP
Recommendations, available at https://www.cdc.gov/vaccines/acip/recommendations.html (last visited March 18, 2025). BILL: SB 196 Page 5
The Centers for Disease Control and Prevention (CDC) reviews the ACIP’s recommendations;
once approved by the CDC Director and the U.S. Department of Health and Human Services,
they are published as the CDC’s official recommendations for immunizations of the U.S.
population.
16
New vaccines are considered for addition to the schedule after licensure by the
United States Food and Drug Administration (FDA).
17
The FDA oversees the safety, effectiveness, and quality of vaccines used in the United States.
Once a vaccine is developed, the pre-clinical phase begins, which consists of laboratory research
and testing on animals. If the pre-clinical phase shows the vaccine is likely to be safe and work
well in humans, it is tested on humans through clinical trials. While clinical trials are underway,
the FDA assesses the manufacturing process to ensure that the vaccine can be produced reliably
and consistently. Once a manufacturing process is developed and pre-clinical and clinical trials
are successfully completed, developers submit a Biologics License Application to the FDA,
which includes details on the manufacturing process and data from pre-clinical and clinical trials.
The FDA evaluates the application and decides whether to license the vaccine for use in the
United States. The FDA continues to monitor and regulate vaccines and manufacturers after
licensing.
18
All vaccines must be licensed (approved) by the FDA in order to be marketed in the United
States.
19
However, during public health emergencies, the FDA may authorize vaccines for
emergency use, which speeds up the process of bringing a vaccine to market.
20
Plant-Based mRNA Vaccines
In 2021, scientists at UC Riverside were awarded a $500,000 grant form the National Science
Foundation to study plant-based messenger ribonucleic acid (mRNA) vaccines. The research
projected was charged with covering three concepts:
21
• Showing that DNA containing the mRNA vaccine can be successfully delivered into the part
of plant cells where it will replicate;
• Demonstrating that plants can produce enough mRNA to rival a traditional vaccine shot; and
• If findings prove possible, determining the right dosage.
Prior to the $500,000 grant, Juan Pablo Giraldo, an associate professor at UC Riverside, was
granted over $1,000,000 to develop a project that is using nanomaterials to deliver nitrogen into
16
Id.
17
College of Physicians of Philadelphia, The History of Vaccines: The Development of the Immunization Schedule, available
at http://www.historyofvaccines.org/content/articles/development-immunization-schedule (last visited March 18, 2025).
18
U.S. Food and Drug Administration, Vaccine Development – 101, https://www.fda.gov/vaccines-blood-
biologics/development-approval-process-cber/vaccine-development-101 (last visited March 15, 2025).
19
U.S. Food and Drug Administration, Ensuring the Safety of Vaccines in the United States,
https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Ensuring-the-Safety-of-Vaccines-in-the-United-
States.pdf (last visited March 18, 2025).
20
Food and Drug Administration, Emergency Use Authorization, https://www.fda.gov/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (last visited March 15, 2025). Medical
countermeasures are FDA-regulated products (biologics, drugs, and devices) that may be used in the event of a public health
emergency.
21
UC Riverside, Grow and Eat your own Vaccines?, Jules Bernsein, September 16, 2021, available at
https://www.universityofcalifornia.edu/news/grow-and-eat-your-own-vaccines (last visited March 18, 2025). BILL: SB 196 Page 6
chloroplasts through their leaves and control its release.
22
The $500,000 grant provided by the
National Science Foundation, was awarded to further Giraldo’s original research for repurposing
naturally occurring nanoparticles for gene delivery to plants.
23
If the research proves successful, potential advantages of plant-based mRNA vaccines would be
cheaper costs associated with producing and storage of vaccines. A current challenge that was
well-reported during the COVID-19 Pandemic was the expiration of the mRNA vaccines that
needed to be stored at cold temperatures.
24
(Plant-based mRNA vaccines could be stored at room
temperature).
As of the beginning of 2025, there are no approved plant-based mRNA vaccines.
III. Effect of Proposed Changes:
Section 1 of the bill amends the definition of “drug” to also mean a “food as defined in s. 500.03,
[F.S.] which contains a vaccine or vaccine material.” This would allow foods that contain a
vaccine or vaccine material to be defined as a drug; those foods would have the same regulations
as drugs.
Further, the bill defines a “vaccine or vaccine material” to mean: “a substance authorized or
approved by the United States Food and Drug Administration which is intended for use in
humans to stimulate the production of antibodies and provide immunity against disease and
which is prepared from the causative agent of a disease, its products, or a synthetic substitute and
is treated to act as an antigen without inducing the disease.”
Section 2 of the bill amends what qualifies as a misbranded drug. The bill provides that a drug is
misbranded if “it is a food as defined in s. 500.03,[F.S.] and contains a vaccine or vaccine
material, but its label does not bear, in type of uniform size and prominence, the words “contains
vaccine or vaccine material” and does not specify that the food is classified as a drug under the
Florida Drug and Cosmetic Act.”
Section 3 of the bill amends what qualifies as misbranded food. The bill provides that food is
deemed to be misbranded if “it contains a vaccine or vaccine material as defined in s. 499.003,
[F.S.] unless its label bears, in type of uniform size and prominence, the words “contains vaccine
or vaccine material” and specifies that the food is classified as a drug under the Florida Drug and
Cosmetic Act”
Sections 4 and 5 conform cross-references to amendments made by the bill.
Section 6 of the bill provides an effective date of July 1, 2025.
22
Id.
23
Id.
24
See Mohammad Uddin, Challenges of Storage and Stability of mRNA-Based COVID-19 Vaccines, Vaccines (Basel),
September 2021, available at https://pmc.ncbi.nlm.nih.gov/articles/PMC8473088/pdf/vaccines-09-01033.pdf (last visited
March 18, 2025). BILL: SB 196 Page 7
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
None.
C. Government Sector Impact:
None.
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill substantially amends the following sections of the Florida Statutes: 499.003, 499.007,
and 500.11. BILL: SB 196 Page 8
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.