SENATE BILL 1031
By Bowling
HOUSE BILL 1157
By Lynn
HB1157
002259
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AN ACT to amend Tennessee Code Annotated, Title 53
and Title 68, relative to relative to drug labels.
WHEREAS, the Food and Drug Administration (FDA) is the federal agency responsible
for protecting public health by ensuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and
products that emit radiation; and
WHEREAS, a 2024 Congressional Report titled "We Can Do This: An Assessment of the
Department of Health and Human Services' COVID-19 Public Health Campaign" recommended
that, in order to prevent a recurrence of communication failures that undermine public health,
"HHS and its agencies should abide by the FDA's product labeling guidelines" and "HHS and its
agencies should be barred from promoting information regarding an FDA-regulated product that
does not reflect the FDA-approved label"; and
WHEREAS, to restore and maintain trust in public health messaging, all communications
from public health agencies about FDA-approved products must be grounded in verified data
and scientific research, free from unproven claims or promotional language that could mislead
consumers; now, therefore,
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.
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As used in this part:
(1) "Commissioner" means the commissioner of health;
(2) "Department" means the department of health;
(3) "FDA" means the federal food and drug administration;
(4) "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;
(5) "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;
(6) "Local health department" means a county or regional health
department in this state; and
(7) "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.
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-
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regulated product in a manner that conflicts with or does not accurately reflect the FDA-
approved or FDA-authorized label for such product.
(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
products where no specific product is referenced. Information that references a
general category or type must:
(A) Be universally true for all 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 individual product labels.
(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 FDA-regulated products 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 product authorization, approval, or labeling decisions by the FDA.
68-1-1703.
(a) The commissioner and the state executive branch shall:
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(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 campaign; and
(2) No later than January 15, 2026, and on or before January 15 of each
subsequent year, submit an annual report to the comptroller of the treasury, 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 executive
branch to comply with this part. The report must include, but is not limited to, 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
comptroller of the treasury.
(c) The comptroller of the treasury shall:
(1) On or before 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.
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Within ten (10) days of receiving a notice from the comptroller of the treasury
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 shall:
(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:
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(1) Is 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) Is ineligible to receive grants, funds, or other inducements for a period
of one (1) to ten (10) years, to be determined by the comptroller of the treasury,
based on the severity of the violation.
SECTION 3. 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 4. This act takes effect upon becoming a law, the public welfare requiring it.