Texas 2025 - 89th Regular

Texas House Bill HB1431 Compare Versions

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11 89R4500 SRA-F
22 By: Gerdes H.B. No. 1431
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77 A BILL TO BE ENTITLED
88 AN ACT
99 relating to the prohibited manufacture, processing, possession,
1010 distribution, offer for sale, and sale of cell-cultured protein.
1111 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1212 SECTION 1. Section 431.002, Health and Safety Code, is
1313 amended by adding Subdivision (5-a) to read as follows:
1414 (5-a) "Cell-cultured protein" means a food product
1515 derived from harvesting animal cells and artificially replicating
1616 those cells in a growth medium to produce tissue.
1717 SECTION 2. Section 431.021, Health and Safety Code, is
1818 amended to read as follows:
1919 Sec. 431.021. PROHIBITED ACTS. The following acts and the
2020 causing of the following acts within this state are unlawful and
2121 prohibited:
2222 (a) the introduction or delivery for introduction into
2323 commerce of any food, drug, device, or cosmetic that is adulterated
2424 or misbranded;
2525 (b) the adulteration or misbranding of any food, drug,
2626 device, or cosmetic in commerce;
2727 (c) the receipt in commerce of any food, drug, device, or
2828 cosmetic that is adulterated or misbranded, and the delivery or
2929 proffered delivery thereof for pay or otherwise;
3030 (d) the distribution in commerce of a consumer commodity, if
3131 such commodity is contained in a package, or if there is affixed to
3232 that commodity a label that does not conform to the provisions of
3333 this chapter and of rules adopted under the authority of this
3434 chapter; provided, however, that this prohibition shall not apply
3535 to persons engaged in business as wholesale or retail distributors
3636 of consumer commodities except to the extent that such persons:
3737 (1) are engaged in the packaging or labeling of such
3838 commodities; or
3939 (2) prescribe or specify by any means the manner in
4040 which such commodities are packaged or labeled;
4141 (e) the introduction or delivery for introduction into
4242 commerce of any article in violation of Section 431.084, 431.114,
4343 or 431.115;
4444 (f) the dissemination of any false advertisement;
4545 (g) the refusal to permit entry or inspection, or to permit
4646 the taking of a sample or to permit access to or copying of any
4747 record as authorized by Sections 431.042-431.044; or the failure to
4848 establish or maintain any record or make any report required under
4949 Section 512(j), (l), or (m) of the federal Act, or the refusal to
5050 permit access to or verification or copying of any such required
5151 record;
5252 (h) the manufacture within this state of any food, drug,
5353 device, or cosmetic that is adulterated or misbranded;
5454 (i) the giving of a guaranty or undertaking referred to in
5555 Section 431.059, which guaranty or undertaking is false, except by
5656 a person who relied on a guaranty or undertaking to the same effect
5757 signed by, and containing the name and address of the person
5858 residing in this state from whom the person received in good faith
5959 the food, drug, device, or cosmetic; or the giving of a guaranty or
6060 undertaking referred to in Section 431.059, which guaranty or
6161 undertaking is false;
6262 (j) the use, removal, or disposal of a detained or embargoed
6363 article in violation of Section 431.048;
6464 (k) the alteration, mutilation, destruction, obliteration,
6565 or removal of the whole or any part of the labeling of, or the doing
6666 of any other act with respect to a food, drug, device, or cosmetic,
6767 if such act is done while such article is held for sale after
6868 shipment in commerce and results in such article being adulterated
6969 or misbranded;
7070 (l)(1) forging, counterfeiting, simulating, or falsely
7171 representing, or without proper authority using any mark, stamp,
7272 tag, label, or other identification device authorized or required
7373 by rules adopted under this chapter or the regulations promulgated
7474 under the provisions of the federal Act;
7575 (2) making, selling, disposing of, or keeping in
7676 possession, control, or custody, or concealing any punch, die,
7777 plate, stone, or other thing designed to print, imprint, or
7878 reproduce the trademark, trade name, or other identifying mark,
7979 imprint, or device of another or any likeness of any of the
8080 foregoing on any drug or container or labeling thereof so as to
8181 render such drug a counterfeit drug;
8282 (3) the doing of any act that causes a drug to be a
8383 counterfeit drug, or the sale or dispensing, or the holding for sale
8484 or dispensing, of a counterfeit drug;
8585 (m) the using by any person to the person's own advantage,
8686 or revealing, other than to the department, to a health authority,
8787 or to the courts when relevant in any judicial proceeding under this
8888 chapter, of any information acquired under the authority of this
8989 chapter concerning any method or process that as a trade secret is
9090 entitled to protection;
9191 (n) the using, on the labeling of any drug or device or in
9292 any advertising relating to such drug or device, of any
9393 representation or suggestion that approval of an application with
9494 respect to such drug or device is in effect under Section 431.114 or
9595 Section 505, 515, or 520(g) of the federal Act, as the case may be,
9696 or that such drug or device complies with the provisions of such
9797 sections;
9898 (o) the using, in labeling, advertising or other sales
9999 promotion of any reference to any report or analysis furnished in
100100 compliance with Sections 431.042-431.044 or Section 704 of the
101101 federal Act;
102102 (p) in the case of a prescription drug distributed or
103103 offered for sale in this state, the failure of the manufacturer,
104104 packer, or distributor of the drug to maintain for transmittal, or
105105 to transmit, to any practitioner licensed by applicable law to
106106 administer such drug who makes written request for information as
107107 to such drug, true and correct copies of all printed matter that is
108108 required to be included in any package in which that drug is
109109 distributed or sold, or such other printed matter as is approved
110110 under the federal Act. Nothing in this subsection shall be
111111 construed to exempt any person from any labeling requirement
112112 imposed by or under other provisions of this chapter;
113113 (q)(1) placing or causing to be placed on any drug or device
114114 or container of any drug or device, with intent to defraud, the
115115 trade name or other identifying mark, or imprint of another or any
116116 likeness of any of the foregoing;
117117 (2) selling, dispensing, disposing of or causing to be
118118 sold, dispensed, or disposed of, or concealing or keeping in
119119 possession, control, or custody, with intent to sell, dispense, or
120120 dispose of, any drug, device, or any container of any drug or
121121 device, with knowledge that the trade name or other identifying
122122 mark or imprint of another or any likeness of any of the foregoing
123123 has been placed thereon in a manner prohibited by Subdivision (1);
124124 or
125125 (3) making, selling, disposing of, causing to be made,
126126 sold, or disposed of, keeping in possession, control, or custody,
127127 or concealing with intent to defraud any punch, die, plate, stone,
128128 or other thing designed to print, imprint, or reproduce the
129129 trademark, trade name, or other identifying mark, imprint, or
130130 device of another or any likeness of any of the foregoing on any
131131 drug or container or labeling of any drug or container so as to
132132 render such drug a counterfeit drug;
133133 (r) dispensing or causing to be dispensed a different drug
134134 in place of the drug ordered or prescribed without the express
135135 permission in each case of the person ordering or prescribing;
136136 (s) the failure to register in accordance with Section 510
137137 of the federal Act, the failure to provide any information required
138138 by Section 510(j) or (k) of the federal Act, or the failure to
139139 provide a notice required by Section 510(j)(2) of the federal Act;
140140 (t)(1) the failure or refusal to:
141141 (A) comply with any requirement prescribed under
142142 Section 518 or 520(g) of the federal Act; or
143143 (B) furnish any notification or other material or
144144 information required by or under Section 519 or 520(g) of the
145145 federal Act;
146146 (2) with respect to any device, the submission of any
147147 report that is required by or under this chapter that is false or
148148 misleading in any material respect;
149149 (u) the movement of a device in violation of an order under
150150 Section 304(g) of the federal Act or the removal or alteration of
151151 any mark or label required by the order to identify the device as
152152 detained;
153153 (v) the failure to provide the notice required by Section
154154 412(b) or 412(c), the failure to make the reports required by
155155 Section 412(d)(1)(B), or the failure to meet the requirements
156156 prescribed under Section 412(d)(2) of the federal Act;
157157 (w) except as provided under Subchapter M of this chapter
158158 and Section 562.1085, Occupations Code, the acceptance by a person
159159 of an unused prescription or drug, in whole or in part, for the
160160 purpose of resale, after the prescription or drug has been
161161 originally dispensed, or sold;
162162 (x) engaging in the wholesale distribution of drugs or
163163 operating as a distributor or manufacturer of devices in this state
164164 without obtaining a license issued by the department under
165165 Subchapter I, L, or N, as applicable;
166166 (y) engaging in the manufacture of food in this state or
167167 operating as a warehouse operator in this state without having a
168168 license as required by Section 431.222 or operating as a food
169169 wholesaler in this state without having a license under Section
170170 431.222 or being registered under Section 431.2211, as appropriate;
171171 (z) unless approved by the United States Food and Drug
172172 Administration pursuant to the federal Act, the sale, delivery,
173173 holding, or offering for sale of a self-testing kit designed to
174174 indicate whether a person has a human immunodeficiency virus
175175 infection, acquired immune deficiency syndrome, or a related
176176 disorder or condition;
177177 (aa) making a false statement or false representation in an
178178 application for a license or in a statement, report, or other
179179 instrument to be filed with or requested by the department under
180180 this chapter;
181181 (bb) failing to comply with a requirement or request to
182182 provide information or failing to submit an application, statement,
183183 report, or other instrument required by the department;
184184 (cc) performing, causing the performance of, or aiding and
185185 abetting the performance of an act described by Subsection (x);
186186 (dd) purchasing or otherwise receiving a prescription drug
187187 from a pharmacy in violation of Section 431.411(a);
188188 (ee) selling, distributing, or transferring a prescription
189189 drug to a person who is not authorized under state or federal law to
190190 receive the prescription drug in violation of Section 431.411(b);
191191 (ff) failing to deliver prescription drugs to specified
192192 premises as required by Section 431.411(c);
193193 (gg) failing to maintain or provide pedigrees as required by
194194 Section 431.412 or 431.413;
195195 (hh) failing to obtain, pass, or authenticate a pedigree as
196196 required by Section 431.412 or 431.413;
197197 (ii) the introduction or delivery for introduction into
198198 commerce of a drug or prescription device at a flea market;
199199 (jj) the receipt of a prescription drug that is adulterated,
200200 misbranded, stolen, obtained by fraud or deceit, counterfeit, or
201201 suspected of being counterfeit, and the delivery or proffered
202202 delivery of such a drug for payment or otherwise; [or]
203203 (kk) the alteration, mutilation, destruction,
204204 obliteration, or removal of all or any part of the labeling of a
205205 prescription drug or the commission of any other act with respect to
206206 a prescription drug that results in the prescription drug being
207207 misbranded; or
208208 (ll) the manufacture, processing, possession,
209209 distribution, offer for sale, or sale of cell-cultured protein.
210210 SECTION 3. Section 431.081, Health and Safety Code, is
211211 amended to read as follows:
212212 Sec. 431.081. ADULTERATED FOOD. A food shall be deemed to
213213 be adulterated:
214214 (a) if:
215215 (1) it bears or contains any poisonous or deleterious
216216 substance which may render it injurious to health; but in case the
217217 substance is not an added substance the food shall not be considered
218218 adulterated under this subdivision if the quantity of the substance
219219 in the food does not ordinarily render it injurious to health;
220220 (2) it:
221221 (A) bears or contains any added poisonous or
222222 added deleterious substance, other than one that is a pesticide
223223 chemical in or on a raw agricultural commodity, a food additive, a
224224 color additive, or a new animal drug which is unsafe within the
225225 meaning of Section 431.161;
226226 (B) is a raw agricultural commodity and it bears
227227 or contains a pesticide chemical which is unsafe within the meaning
228228 of Section 431.161(a);
229229 (C) is, or it bears or contains, any food
230230 additive which is unsafe within the meaning of Section 431.161(a);
231231 provided, that where a pesticide chemical has been used in or on a
232232 raw agricultural commodity in conformity with an exemption granted
233233 or a tolerance prescribed under Section 431.161(a), and such raw
234234 agricultural commodity has been subjected to processing such as
235235 canning, cooking, freezing, dehydrating, or milling, the residue of
236236 such pesticide chemical remaining in or on such processed food
237237 shall, notwithstanding the provisions of Section 431.161 and
238238 Section 409 of the federal Act, not be deemed unsafe if such residue
239239 in or on the raw agricultural commodity has been removed to the
240240 extent possible in good manufacturing practice, and the
241241 concentration of such residue in the processed food, when ready to
242242 eat, is not greater than the tolerance prescribed for the raw
243243 agricultural commodity; or
244244 (D) is, or it bears or contains, a new animal
245245 drug, or a conversion product of a new animal drug, that is unsafe
246246 under Section 512 of the federal Act;
247247 (3) it consists in whole or in part of a diseased,
248248 contaminated, filthy, putrid, or decomposed substance, or if it is
249249 otherwise unfit for foods;
250250 (4) it has been produced, prepared, packed or held
251251 under unsanitary conditions whereby it may have become contaminated
252252 with filth, or whereby it may have been rendered diseased,
253253 unwholesome, or injurious to health;
254254 (5) it is, in whole or in part, the product of a
255255 diseased animal, an animal which has died otherwise than by
256256 slaughter, or an animal that has been fed upon the uncooked offal
257257 from a slaughterhouse;
258258 (6) its container is composed, in whole or in part, of
259259 any poisonous or deleterious substance which may render the
260260 contents injurious to health; [or]
261261 (7) it has been intentionally subjected to radiation,
262262 unless the use of the radiation was in conformity with a regulation
263263 or exemption in effect in accordance with Section 409 of the federal
264264 Act; or
265265 (8) it contains, in whole or in part, cell-cultured
266266 protein;
267267 (b) if:
268268 (1) any valuable constituent has been in whole or in
269269 part omitted or abstracted therefrom;
270270 (2) any substance has been substituted wholly or in
271271 part therefor;
272272 (3) damage or inferiority has been concealed in any
273273 manner;
274274 (4) any substance has been added thereto or mixed or
275275 packed therewith so as to increase its bulk or weight, or reduce its
276276 quality or strength or make it appear better or of greater value
277277 than it is;
278278 (5) it contains saccharin, dulcin, glucin, or other
279279 sugar substitutes except in dietary foods, and when so used shall be
280280 declared; or
281281 (6) it be fresh meat and it contains any chemical
282282 substance containing sulphites, sulphur dioxide, or any other
283283 chemical preservative which is not approved by the United States
284284 Department of Agriculture, the Animal and Plant Health Inspection
285285 Service (A.P.H.I.S.) or by department rules;
286286 (c) if it is, or it bears or contains, a color additive that
287287 is unsafe under Section 431.161(a); or
288288 (d) if it is confectionery and:
289289 (1) has any nonnutritive object partially or
290290 completely imbedded in it; provided, that this subdivision does not
291291 apply if, in accordance with department rules, the object is of
292292 practical, functional value to the confectionery product and would
293293 not render the product injurious or hazardous to health;
294294 (2) bears or contains any alcohol, other than alcohol
295295 not in excess of five percent by volume. Any confectionery that
296296 bears or contains any alcohol in excess of one-half of one percent
297297 by volume derived solely from the use of flavoring extracts and less
298298 than five percent by volume:
299299 (A) may not be sold to persons under the legal age
300300 necessary to consume an alcoholic beverage in this state;
301301 (B) must be labeled with a conspicuous, readily
302302 legible statement that reads, "Sale of this product to a person
303303 under the legal age necessary to consume an alcoholic beverage is
304304 prohibited";
305305 (C) may not be sold in a form containing liquid
306306 alcohol such that it is capable of use for beverage purposes as that
307307 term is used in the Alcoholic Beverage Code;
308308 (D) may not be sold through a vending machine;
309309 (E) must be labeled with a conspicuous, readily
310310 legible statement that the product contains not more than five
311311 percent alcohol by volume; and
312312 (F) may not be sold in a business establishment
313313 which derives less than 50 percent of its gross sales from the sale
314314 of confectioneries; or
315315 (3) bears or contains any nonnutritive substance;
316316 provided, that this subdivision does not apply to a nonnutritive
317317 substance that is in or on the confectionery by reason of its use
318318 for a practical, functional purpose in the manufacture, packaging,
319319 or storage of the confectionery if the use of the substance does not
320320 promote deception of the consumer or otherwise result in
321321 adulteration or misbranding in violation of this chapter; and
322322 provided further, that the executive commissioner may, for the
323323 purpose of avoiding or resolving uncertainty as to the application
324324 of this subdivision, adopt rules allowing or prohibiting the use of
325325 particular nonnutritive substances.
326326 SECTION 4. Subchapter D, Chapter 433, Health and Safety
327327 Code, is amended by adding Section 433.057 to read as follows:
328328 Sec. 433.057. PROHIBITION ON CELL-CULTURED PROTEIN. (a)
329329 In this section, "cell-cultured protein" has the meaning assigned
330330 by Section 431.002.
331331 (b) A person may not manufacture, process, possess,
332332 distribute, offer for sale, or sell cell-cultured protein.
333333 (c) To the extent another state law conflicts with this
334334 section, this section controls.
335335 SECTION 5. As soon as practicable after the effective date
336336 of this Act, the executive commissioner of the Health and Human
337337 Services Commission shall adopt any rules necessary to implement
338338 the changes in law made by this Act.
339339 SECTION 6. This Act takes effect September 1, 2025.