By: Perry, et al. S.B. No. 261
(In the Senate - Filed November 12, 2024; February 3, 2025,
read first time and referred to Committee on Water, Agriculture and
Rural Affairs; April 1, 2025, reported adversely, with favorable
Committee Substitute by the following vote: Yeas 8, Nays 1;
April 1, 2025, sent to printer.)
Click here to see the committee vote
COMMITTEE SUBSTITUTE FOR S.B. No. 261 By: Perry
A BILL TO BE ENTITLED
AN ACT
relating to the prohibited manufacture, processing, possession,
distribution, offering for sale, and sale of cell-cultured protein.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 431.002, Health and Safety Code, is
amended by adding Subdivision (5-a) to read as follows:
(5-a) "Cell-cultured protein" means a food product
derived from harvesting animal cells and artificially replicating
those cells in a growth medium to produce tissue.
SECTION 2. Section 431.021, Health and Safety Code, is
amended to read as follows:
Sec. 431.021. PROHIBITED ACTS. The following acts and the
causing of the following acts within this state are unlawful and
prohibited:
(a) the introduction or delivery for introduction into
commerce of any food, drug, device, or cosmetic that is adulterated
or misbranded;
(b) the adulteration or misbranding of any food, drug,
device, or cosmetic in commerce;
(c) the receipt in commerce of any food, drug, device, or
cosmetic that is adulterated or misbranded, and the delivery or
proffered delivery thereof for pay or otherwise;
(d) the distribution in commerce of a consumer commodity, if
such commodity is contained in a package, or if there is affixed to
that commodity a label that does not conform to the provisions of
this chapter and of rules adopted under the authority of this
chapter; provided, however, that this prohibition shall not apply
to persons engaged in business as wholesale or retail distributors
of consumer commodities except to the extent that such persons:
(1) are engaged in the packaging or labeling of such
commodities; or
(2) prescribe or specify by any means the manner in
which such commodities are packaged or labeled;
(e) the introduction or delivery for introduction into
commerce of any article in violation of Section 431.084, 431.114,
or 431.115;
(f) the dissemination of any false advertisement;
(g) the refusal to permit entry or inspection, or to permit
the taking of a sample or to permit access to or copying of any
record as authorized by Sections 431.042-431.044; or the failure to
establish or maintain any record or make any report required under
Section 512(j), (l), or (m) of the federal Act, or the refusal to
permit access to or verification or copying of any such required
record;
(h) the manufacture within this state of any food, drug,
device, or cosmetic that is adulterated or misbranded;
(i) the giving of a guaranty or undertaking referred to in
Section 431.059, which guaranty or undertaking is false, except by
a person who relied on a guaranty or undertaking to the same effect
signed by, and containing the name and address of the person
residing in this state from whom the person received in good faith
the food, drug, device, or cosmetic; or the giving of a guaranty or
undertaking referred to in Section 431.059, which guaranty or
undertaking is false;
(j) the use, removal, or disposal of a detained or embargoed
article in violation of Section 431.048;
(k) the alteration, mutilation, destruction, obliteration,
or removal of the whole or any part of the labeling of, or the doing
of any other act with respect to a food, drug, device, or cosmetic,
if such act is done while such article is held for sale after
shipment in commerce and results in such article being adulterated
or misbranded;
(l)(1) forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp,
tag, label, or other identification device authorized or required
by rules adopted under this chapter or the regulations promulgated
under the provisions of the federal Act;
(2) making, selling, disposing of, or keeping in
possession, control, or custody, or concealing any punch, die,
plate, stone, or other thing designed to print, imprint, or
reproduce the trademark, trade name, or other identifying mark,
imprint, or device of another or any likeness of any of the
foregoing on any drug or container or labeling thereof so as to
render such drug a counterfeit drug;
(3) the doing of any act that causes a drug to be a
counterfeit drug, or the sale or dispensing, or the holding for sale
or dispensing, of a counterfeit drug;
(m) the using by any person to the person's own advantage,
or revealing, other than to the department, to a health authority,
or to the courts when relevant in any judicial proceeding under this
chapter, of any information acquired under the authority of this
chapter concerning any method or process that as a trade secret is
entitled to protection;
(n) the using, on the labeling of any drug or device or in
any advertising relating to such drug or device, of any
representation or suggestion that approval of an application with
respect to such drug or device is in effect under Section 431.114 or
Section 505, 515, or 520(g) of the federal Act, as the case may be,
or that such drug or device complies with the provisions of such
sections;
(o) the using, in labeling, advertising or other sales
promotion of any reference to any report or analysis furnished in
compliance with Sections 431.042-431.044 or Section 704 of the
federal Act;
(p) in the case of a prescription drug distributed or
offered for sale in this state, the failure of the manufacturer,
packer, or distributor of the drug to maintain for transmittal, or
to transmit, to any practitioner licensed by applicable law to
administer such drug who makes written request for information as
to such drug, true and correct copies of all printed matter that is
required to be included in any package in which that drug is
distributed or sold, or such other printed matter as is approved
under the federal Act. Nothing in this subsection shall be
construed to exempt any person from any labeling requirement
imposed by or under other provisions of this chapter;
(q)(1) placing or causing to be placed on any drug or device
or container of any drug or device, with intent to defraud, the
trade name or other identifying mark, or imprint of another or any
likeness of any of the foregoing;
(2) selling, dispensing, disposing of or causing to be
sold, dispensed, or disposed of, or concealing or keeping in
possession, control, or custody, with intent to sell, dispense, or
dispose of, any drug, device, or any container of any drug or
device, with knowledge that the trade name or other identifying
mark or imprint of another or any likeness of any of the foregoing
has been placed thereon in a manner prohibited by Subdivision (1);
or
(3) making, selling, disposing of, causing to be made,
sold, or disposed of, keeping in possession, control, or custody,
or concealing with intent to defraud any punch, die, plate, stone,
or other thing designed to print, imprint, or reproduce the
trademark, trade name, or other identifying mark, imprint, or
device of another or any likeness of any of the foregoing on any
drug or container or labeling of any drug or container so as to
render such drug a counterfeit drug;
(r) dispensing or causing to be dispensed a different drug
in place of the drug ordered or prescribed without the express
permission in each case of the person ordering or prescribing;
(s) the failure to register in accordance with Section 510
of the federal Act, the failure to provide any information required
by Section 510(j) or (k) of the federal Act, or the failure to
provide a notice required by Section 510(j)(2) of the federal Act;
(t)(1) the failure or refusal to:
(A) comply with any requirement prescribed under
Section 518 or 520(g) of the federal Act; or
(B) furnish any notification or other material or
information required by or under Section 519 or 520(g) of the
federal Act;
(2) with respect to any device, the submission of any
report that is required by or under this chapter that is false or
misleading in any material respect;
(u) the movement of a device in violation of an order under
Section 304(g) of the federal Act or the removal or alteration of
any mark or label required by the order to identify the device as
detained;
(v) the failure to provide the notice required by Section
412(b) or 412(c), the failure to make the reports required by
Section 412(d)(1)(B), or the failure to meet the requirements
prescribed under Section 412(d)(2) of the federal Act;
(w) except as provided under Subchapter M of this chapter
and Section 562.1085, Occupations Code, the acceptance by a person
of an unused prescription or drug, in whole or in part, for the
purpose of resale, after the prescription or drug has been
originally dispensed, or sold;
(x) engaging in the wholesale distribution of drugs or
operating as a distributor or manufacturer of devices in this state
without obtaining a license issued by the department under
Subchapter I, L, or N, as applicable;
(y) engaging in the manufacture of food in this state or
operating as a warehouse operator in this state without having a
license as required by Section 431.222 or operating as a food
wholesaler in this state without having a license under Section
431.222 or being registered under Section 431.2211, as appropriate;
(z) unless approved by the United States Food and Drug
Administration pursuant to the federal Act, the sale, delivery,
holding, or offering for sale of a self-testing kit designed to
indicate whether a person has a human immunodeficiency virus
infection, acquired immune deficiency syndrome, or a related
disorder or condition;
(aa) making a false statement or false representation in an
application for a license or in a statement, report, or other
instrument to be filed with or requested by the department under
this chapter;
(bb) failing to comply with a requirement or request to
provide information or failing to submit an application, statement,
report, or other instrument required by the department;
(cc) performing, causing the performance of, or aiding and
abetting the performance of an act described by Subsection (x);
(dd) purchasing or otherwise receiving a prescription drug
from a pharmacy in violation of Section 431.411(a);
(ee) selling, distributing, or transferring a prescription
drug to a person who is not authorized under state or federal law to
receive the prescription drug in violation of Section 431.411(b);
(ff) failing to deliver prescription drugs to specified
premises as required by Section 431.411(c);
(gg) failing to maintain or provide pedigrees as required by
Section 431.412 or 431.413;
(hh) failing to obtain, pass, or authenticate a pedigree as
required by Section 431.412 or 431.413;
(ii) the introduction or delivery for introduction into
commerce of a drug or prescription device at a flea market;
(jj) the receipt of a prescription drug that is adulterated,
misbranded, stolen, obtained by fraud or deceit, counterfeit, or
suspected of being counterfeit, and the delivery or proffered
delivery of such a drug for payment or otherwise; [or]
(kk) the alteration, mutilation, destruction,
obliteration, or removal of all or any part of the labeling of a
prescription drug or the commission of any other act with respect to
a prescription drug that results in the prescription drug being
misbranded; or
(ll) the manufacture, processing, possession,
distribution, offering for sale, or sale of cell-cultured protein.
SECTION 3. Section 431.0211, Health and Safety Code, is
amended to read as follows:
Sec. 431.0211. EXCEPTIONS [EXCEPTION]. (a) Any provision
of Section 431.021 that relates to a prescription drug does not
apply to a prescription drug manufacturer, or an agent of a
prescription drug manufacturer, who is obtaining or attempting to
obtain a prescription drug for the sole purpose of testing the
prescription drug for authenticity.
(b) Section 431.021(ll) does not apply to scientific
research using or regarding cell-cultured protein conducted by or
at an institution of higher education or a private or independent
institution of higher education, as those terms are defined by
Section 61.003, Education Code, provided that the research does not
further or relate to the sale or distribution of cell-cultured
protein for human consumption in this state.
SECTION 4. Sections 431.0805(4), (5), (6), (7), (8), (9),
and (10), Health and Safety Code, are amended to read as follows:
(4) "Egg" has the meaning assigned by Section 4(g),
Egg Products Inspection Act (21 U.S.C. Section 1033(g)). The term
does not include an analogue product or [a] cell-cultured protein
[product].
(5) "Egg product" has the meaning assigned by Section
4(f), Egg Products Inspection Act (21 U.S.C. Section 1033(f)). The
term does not include an analogue product or [a] cell-cultured
protein [product].
(6) "Fish" has the meaning assigned by Section 403 of
the federal Act (21 U.S.C. Section 343(q)(4)(E)). The term does not
include an analogue product or [a] cell-cultured protein [product].
(7) "Meat" has the meaning assigned by 9 C.F.R.
Section 301.2. The term does not include an analogue product or [a]
cell-cultured protein [product].
(8) "Meat food product" has the meaning assigned by
Section 1(j), Federal Meat Inspection Act (21 U.S.C. Section
601(j)). The term does not include an analogue product or [a]
cell-cultured protein [product].
(9) "Poultry" has the meaning assigned by Section
4(e), Poultry Products Inspection Act (21 U.S.C. Section 453(e)).
The term does not include an analogue product or [a] cell-cultured
protein [product].
(10) "Poultry product" has the meaning assigned by
Section 4(f), Poultry Products Inspection Act (21 U.S.C. Section
453(f)). The term does not include an analogue product or [a]
cell-cultured protein [product].
SECTION 5. Section 431.081, Health and Safety Code, is
amended to read as follows:
Sec. 431.081. ADULTERATED FOOD. A food shall be deemed to
be adulterated:
(a) if:
(1) it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case the
substance is not an added substance the food shall not be considered
adulterated under this subdivision if the quantity of the substance
in the food does not ordinarily render it injurious to health;
(2) it:
(A) bears or contains any added poisonous or
added deleterious substance, other than one that is a pesticide
chemical in or on a raw agricultural commodity, a food additive, a
color additive, or a new animal drug which is unsafe within the
meaning of Section 431.161;
(B) is a raw agricultural commodity and it bears
or contains a pesticide chemical which is unsafe within the meaning
of Section 431.161(a);
(C) is, or it bears or contains, any food
additive which is unsafe within the meaning of Section 431.161(a);
provided, that where a pesticide chemical has been used in or on a
raw agricultural commodity in conformity with an exemption granted
or a tolerance prescribed under Section 431.161(a), and such raw
agricultural commodity has been subjected to processing such as
canning, cooking, freezing, dehydrating, or milling, the residue of
such pesticide chemical remaining in or on such processed food
shall, notwithstanding the provisions of Section 431.161 and
Section 409 of the federal Act, not be deemed unsafe if such residue
in or on the raw agricultural commodity has been removed to the
extent possible in good manufacturing practice, and the
concentration of such residue in the processed food, when ready to
eat, is not greater than the tolerance prescribed for the raw
agricultural commodity; or
(D) is, or it bears or contains, a new animal
drug, or a conversion product of a new animal drug, that is unsafe
under Section 512 of the federal Act;
(3) it consists in whole or in part of a diseased,
contaminated, filthy, putrid, or decomposed substance, or if it is
otherwise unfit for foods;
(4) it has been produced, prepared, packed or held
under unsanitary conditions whereby it may have become contaminated
with filth, or whereby it may have been rendered diseased,
unwholesome, or injurious to health;
(5) it is, in whole or in part, the product of a
diseased animal, an animal which has died otherwise than by
slaughter, or an animal that has been fed upon the uncooked offal
from a slaughterhouse;
(6) its container is composed, in whole or in part, of
any poisonous or deleterious substance which may render the
contents injurious to health; [or]
(7) it has been intentionally subjected to radiation,
unless the use of the radiation was in conformity with a regulation
or exemption in effect in accordance with Section 409 of the federal
Act; or
(8) it contains, in whole or in part, cell-cultured
protein;
(b) if:
(1) any valuable constituent has been in whole or in
part omitted or abstracted therefrom;
(2) any substance has been substituted wholly or in
part therefor;
(3) damage or inferiority has been concealed in any
manner;
(4) any substance has been added thereto or mixed or
packed therewith so as to increase its bulk or weight, or reduce its
quality or strength or make it appear better or of greater value
than it is;
(5) it contains saccharin, dulcin, glucin, or other
sugar substitutes except in dietary foods, and when so used shall be
declared; or
(6) it be fresh meat and it contains any chemical
substance containing sulphites, sulphur dioxide, or any other
chemical preservative which is not approved by the United States
Department of Agriculture, the Animal and Plant Health Inspection
Service (A.P.H.I.S.) or by department rules;
(c) if it is, or it bears or contains, a color additive that
is unsafe under Section 431.161(a); or
(d) if it is confectionery and:
(1) has any nonnutritive object partially or
completely imbedded in it; provided, that this subdivision does not
apply if, in accordance with department rules, the object is of
practical, functional value to the confectionery product and would
not render the product injurious or hazardous to health;
(2) bears or contains any alcohol, other than alcohol
not in excess of five percent by volume. Any confectionery that
bears or contains any alcohol in excess of one-half of one percent
by volume derived solely from the use of flavoring extracts and less
than five percent by volume:
(A) may not be sold to persons under the legal age
necessary to consume an alcoholic beverage in this state;
(B) must be labeled with a conspicuous, readily
legible statement that reads, "Sale of this product to a person
under the legal age necessary to consume an alcoholic beverage is
prohibited";
(C) may not be sold in a form containing liquid
alcohol such that it is capable of use for beverage purposes as that
term is used in the Alcoholic Beverage Code;
(D) may not be sold through a vending machine;
(E) must be labeled with a conspicuous, readily
legible statement that the product contains not more than five
percent alcohol by volume; and
(F) may not be sold in a business establishment
which derives less than 50 percent of its gross sales from the sale
of confectioneries; or
(3) bears or contains any nonnutritive substance;
provided, that this subdivision does not apply to a nonnutritive
substance that is in or on the confectionery by reason of its use
for a practical, functional purpose in the manufacture, packaging,
or storage of the confectionery if the use of the substance does not
promote deception of the consumer or otherwise result in
adulteration or misbranding in violation of this chapter; and
provided further, that the executive commissioner may, for the
purpose of avoiding or resolving uncertainty as to the application
of this subdivision, adopt rules allowing or prohibiting the use of
particular nonnutritive substances.
SECTION 6. Section 433.0415, Health and Safety Code, is
amended to read as follows:
Sec. 433.0415. LABELING CELL-CULTURED PROTEIN [PRODUCT].
(a) In this section:
(1) "Cell-cultured protein [product]" has the meaning
assigned by Section 431.002 [431.0805].
(2) "Close proximity" means:
(A) immediately before or after the name of the
product;
(B) in the line of the label immediately before
or after the line containing the name of the product; or
(C) within the same phrase or sentence containing
the name of the product.
(b) Cell-cultured protein [A cell-cultured product] must be
labeled in prominent type equal to or greater in size than the
surrounding type and in close proximity to the name of the protein
[product] using one of the following:
(1) "cell-cultured";
(2) "lab-grown"; or
(3) a similar qualifying term or disclaimer intended
to clearly communicate to a consumer the contents of the protein
[product].
(c) The provisions of this subchapter apply to [a]
cell-cultured protein [product], as applicable.
SECTION 7. Subchapter D, Chapter 433, Health and Safety
Code, is amended by adding Section 433.057 to read as follows:
Sec. 433.057. PROHIBITION ON CELL-CULTURED PROTEIN. (a)
In this section, "cell-cultured protein" has the meaning assigned
by Section 431.002.
(b) A person may not manufacture, process, possess,
distribute, offer for sale, or sell cell-cultured protein.
(c) This section does not prohibit scientific research
using or regarding cell-cultured protein conducted by or at an
institution of higher education or a private or independent
institution of higher education, as those terms are defined by
Section 61.003, Education Code, provided that the research does not
further or relate to the sale or distribution of cell-cultured
protein for human consumption in this state.
(d) To the extent another state law conflicts with this
section, this section controls.
SECTION 8. Section 431.0805(2), Health and Safety Code, is
repealed.
SECTION 9. As soon as practicable after the effective date
of this Act, the executive commissioner of the Health and Human
Services Commission shall adopt any rules necessary to implement
the changes in law made by this Act.
SECTION 10. This Act takes effect September 1, 2025.
* * * * *