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~tate of ~ennessee
PUBLIC CHAPTER NO. 108
HOUSE BILL NO. 1157
By Representative Lynn
Substituted for: Senate Bill No. 1031
By Senators Bowling, Crowe, Hensley
AN ACT to amend Tennessee Code Annotated, Title 53 and Title 68, relative to relative
to drug labels.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. This act is known and may be cited as the "Restore Trust in Public Health
Messaging Act."
SECTION 2. Tennessee Code Annotated, Title 68, Chapter 1, is amended by adding the
following as a new part:
68-1-1701. Part definitions.
As used in this part:
(1) "Commissioner" means the commissioner of health;
(2) "Department" means the department of health;
(3) "Emergency use authorized product" means a medical product that
the federal food and drug administration has authorized for use during a public
health emergency under Section 564 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-3);
(4) "FDA" means the federal food and drug administration;
(5) "FDA-approved" means the FDA has granted a product a license
following a comprehensive pre-market clinical trial review process, determined
that the product's benefits outweigh its risks for the intended use, and made the
grant of such license contingent upon ongoing post-marketing surveillance to
assess whether the product maintains its safety and efficacy under real-world
conditions;
(6) "FDA-authorized" means the use of a product is permitted through an
emergency use authorization protocol which allows the use of medical products
during public health emergencies based on available evidence, prior to full
approval;
(7) "Labeling" means the FDA-approved product information and includes
prescribing information, carton and container labeling, medication guides, patient
package inserts, and instructions for use;
(8) "Local health department" means a county or regional health
department in this state;
(9) "Mask" means a face covering, such as a surgical mask, medical
grade N95, or cloth facial covering worn for medical purposes;
(10) "State executive branch" means the governor, members of the
governor's cabinet, the leadership of an executive branch agency or department
of this state other than the commissioner of health, and an executive branch
agency or department of this state other than the department; and HB1157
(11) "Vaccine" means a substance intended for use in humans to
stimulate the body's immune response against an infectious disease or
pathogen, including products intended to provide passive immunity, such as
monoclonal antibodies.
68-1-1702. Prohibition on messaging.
(a) The department, commissioner, an employee or agent of the department, an
employee or agent of a local health department, and the state executive branch shall not
directly or indirectly promote, distribute, or endorse information regarding an FDA
regulated vaccine, mask, or emergency use authorized product that:
(1) Conflicts with or does not accurately reflect the FDA-approved or
FDA-authorized labeling for such vaccine, mask, or emergency use authorized
product; or
(2) Implies that safety or effectiveness has been established for
coadministration of the vaccine, mask, or emergency use authorized product
when adequately powered and well-controlled clinical trials needed to
substantiate such representations have not been completed.
(b) Subsection (a) includes:
(1) The use of any state grants or other funds, federal grants or funds
distributed by this state, or other forms of inducements that may lead to the
dissemination of such information; and
(2) Information concerning general categories or types of FDA-regulated
vaccines, masks, or emergency use authorized products in which a specific
vaccine, mask, or emergency use authorized product is not referenced.
information that references a general category or type must:
(A) Be universally true for all vaccines, masks, or emergency use
authorized products within the general category or type under current
FDA regulations; or
(B) Provide qualifications or disclaimers that highlight the
exceptions or limitations based on the individual label for each vaccine,
mask, or emergency use authorized product.
(c) If the commissioner, an employee or agent of the department, an employee or
agent of a local health department, or the state executive branch refers a healthcare
provider or the general public to information about an FDA-regulated vaccine, mask, or
emergency use authorized product from sources not covered by this part, then the
referral must include a warning that the entity for which the employee or agent is
providing such information is not regulated by this part.
(d) This section does not prohibit the commissioner, the state executive branch,
or another person subject to this part from publicly expressing criticism of or
disagreement with a vaccine, mask, or emergency use authorized product authorization,
approval, or labeling decisions by the FDA.
68-1-1703.
(a) The commissioner and the state executive branch shall:
(1) No later than July 1, 2025, establish an internal review process to
ensure compliance with FDA labeling standards in all communications,
educational materials, and public health campaigns; and
(2) No later than January 15, 2026, and on or before January 15 of each
subsequent year, submit an annual report to the attorney general and reporter,
the clerk of the senate, the clerk of the house of representatives, and the
legislative librarian that details the efforts of the commissioner and the state
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executive branch to comply with this part. The report must include a description
of any violations and corrective actions taken to address such violations.
(b) An individual may report a violation or suspected violation of this part to the
attorney general and reporter.
(c) The attorney general and reporter may:
(1) No later than July 1, 2025, establish a process by which individuals
may submit information concerning violations or suspected violations of this part;
(2) Investigate complaints concerning alleged or suspected violations of
this part and complaints of retaliation against an individual who reported an
alleged or suspected violation of this part;
(3) Upon finding that a violation occurred, notify in writing the violator and
the director or chief executive of the entity for which the violator is an employee
or agent; and
(4) Assess penalties pursuant to§ 68-1-1706(b).
68-1-1704. Corrective action upon notice of violation.
Within ten (10) days of receiving a notice from the attorney general and reporter
pursuant to § 68-1-1703(c)(3) that an entity or an employee or agent of an entity has
violated this part, the director or chief executive of such entity may:
(1) Immediately cease the dissemination of any information deemed to be
in violation of this part; and
(2) Issue a correction notice that:
(A) Clearly states the nature of the violation;
(B) Explains how the entity or employee or agent is correcting the
violation; and
(C) Is disseminated in the same manner, to the same extent, and
to the same recipients as the original information found to violate this part.
68-1-1705. Removal of nonconforming materials.
No later than July 1, 2025, the department; the commissioner; each local health
department; the state executive branch; and each recipient of a federal grant, state
grant, or other funds or inducements distributed by this state shall begin to remove from
public distribution all existing informational materials, whether in printed or electronic
format, that are not in compliance with this part. The removal of such materials must be
completed on or before January 15, 2026.
68-1-1706. Penalties.
(a) An employee or agent of the department, a local health department, or the
state executive branch who violates this part is subject to disciplinary action, which may
include termination of employment or agency agreement.
(b) A violation of this part by an entity that receives state grants or funds, federal
grants or funds distributed by this state, or other forms of financial inducement:
(1) May be subject to a civil penalty not to exceed three (3) times the
amount of state resources misused in the commission of the violation of this part,
or fifty thousand dollars ($50,000), whichever is greater; and
(2) May be ineligible to receive grants, funds, or other inducements for a
period of one (1) to ten (10) years, to be determined by the attorney general and
reporter, based on the severity of the violation.
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SECTION 3. The headings in this act are for reference purposes only and do not
constitute a part of the law enacted by this act. However, the Tennessee Code Commission is
requested to include the headings in any compilation or publication containing this act.
SECTION 4. If any provision of this act or its application to any person or circumstance
is held invalid, then the invalidity does not affect other provisions or applications of the act that
can be given effect without the invalid provision or application, and to that end, the provisions of
this act are severable.
SECTION 5. This act takes effect upon becoming a law, the public welfare requiring it.
4 HOUSE BILL NO. 1157
PASSED: March 17, 2025
CAMER~EXTON,SPEAKER
HOUSE OF REPRESENTATIVES
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RANDY MC)ALL Y
SPEAKER OF THE SENATE
APPROVED this B,?;iL day of (()a /[J fl, 2025
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BILL LEE, GOVERNOR