1-1 By: Armbrister S.B. No. 558
1-2 (In the Senate - Filed March 2, 1993; March 3, 1993, read
1-3 first time and referred to Committee on Health and Human Services;
1-4 March 31, 1993, reported favorably by the following vote: Yeas 9,
1-5 Nays 0; March 31, 1993, sent to printer.)
1-6 COMMITTEE VOTE
1-7 Yea Nay PNV Absent
1-8 Zaffirini x
1-9 Ellis x
1-10 Madla x
1-11 Moncrief x
1-12 Nelson x
1-13 Patterson x
1-14 Shelley x
1-15 Truan x
1-16 Wentworth x
1-17 A BILL TO BE ENTITLED
1-18 AN ACT
1-19 relating to food labeling requirements under the Texas Food, Drug,
1-20 and Cosmetic Act.
1-21 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-22 SECTION 1. Subdivision (14), Section 431.002, Health and
1-23 Safety Code, is amended to read as follows:
1-24 (14) "Drug" means articles recognized in the official
1-25 United States Pharmacopoeia National Formulary, or any supplement
1-26 to it, articles designed or intended for use in the diagnosis,
1-27 cure, mitigation, treatment, or prevention of disease in man or
1-28 other animals, articles, other than food, intended to affect the
1-29 structure or any function of the body of man or other animals, and
1-30 articles intended for use as a component of any article specified
1-31 in this subdivision. The term does not include devices or their
1-32 components, parts, or accessories. A food for which a claim is
1-33 made in accordance with Section 403(r) of the federal Act, and for
1-34 which the claim is approved by the secretary, is not a drug solely
1-35 because the label or labeling contains such a claim.
1-36 SECTION 2. Section 431.060, Health and Safety Code, is
1-37 amended to read as follows:
1-38 Sec. 431.060. Initiation of Proceedings. (a) The attorney
1-39 general, or a district, county, or municipal attorney to whom the
1-40 commissioner, an authorized agent, or a health authority reports a
1-41 violation of this chapter, shall initiate and prosecute appropriate
1-42 proceedings without delay.
1-43 (b) The commissioner, the commissioner's authorized agent,
1-44 or the attorney general may, as authorized by Section 307 of the
1-45 federal Act, bring in the name of this state a suit for civil
1-46 penalties or to restrain a violation of Section 401 or Section
1-47 403(b) through (i), (k), (q), or (r) of the federal Act if the food
1-48 that is the subject of the proceedings is located in this state.
1-49 (c) The commissioner, the commissioner's authorized agent,
1-50 or the attorney general may not bring a proceeding under Subsection
1-51 (b):
1-52 (1) before the 31st day after the date on which the
1-53 state has given notice to the secretary of its intent to bring a
1-54 suit;
1-55 (2) before the 91st day after the date on which the
1-56 state has given notice to the secretary of its intent to bring a
1-57 suit if the secretary has, not later than the 30th day after
1-58 receiving notice from the state, commenced an informal or formal
1-59 enforcement action pertaining to the food that would be the subject
1-60 of the suit brought by the state; or
1-61 (3) if the secretary is diligently prosecuting a suit
1-62 in court pertaining to that food, has settled a suit pertaining to
1-63 that food, or has settled the informal or formal enforcement action
1-64 pertaining to that food.
1-65 SECTION 3. Section 431.082, Health and Safety Code, is
1-66 amended to read as follows:
1-67 Sec. 431.082. Misbranded Food. A food shall be deemed to be
1-68 misbranded:
2-1 (a) if its labeling is false or misleading in any
2-2 particular or fails to conform with the requirements of Section
2-3 431.181;
2-4 (b) if, in the case of a food to which Section 411 of
2-5 the federal Act applies, its advertising is false or misleading in
2-6 a material respect or its labeling is in violation of Section
2-7 411(b)(2) of the federal Act;
2-8 (c) if it is offered for sale under the name of
2-9 another food;
2-10 (d) if it is an imitation of another food, unless its
2-11 label bears, in prominent type of uniform size, the word
2-12 "imitation" and immediately thereafter the name of the food
2-13 imitated;
2-14 (e) if its container is so made, formed, or filled as
2-15 to be misleading;
2-16 (f) if in package form unless it bears a label
2-17 containing:
2-18 (1) the name and place of business of the
2-19 manufacturer, packer, or distributor; and
2-20 (2) an accurate statement, in a uniform location
2-21 on the principal display panel of the label, of the quantity of the
2-22 contents in terms of weight, measure, or numerical count; provided,
2-23 that under this subsection reasonable variations shall be
2-24 permitted, and exemptions as to small packages shall be
2-25 established, by rules adopted by the board;
2-26 (g) if any word, statement, or other information
2-27 required by or under the authority of this chapter to appear on the
2-28 label or labeling is not prominently placed thereon with such
2-29 conspicuousness (as compared with other words, statements, designs,
2-30 or devices in the labeling) and in such terms as to render it
2-31 likely to be read and understood by the ordinary individual under
2-32 customary conditions of purchase and use;
2-33 (h) if it purports to be or is represented as a food
2-34 for which a definition and standard of identity has been prescribed
2-35 by federal regulations or rules of the board as provided by Section
2-36 431.245, unless:
2-37 (1) it conforms to such definition and standard;
2-38 and
2-39 (2) its label bears the name of the food
2-40 specified in the definition and standard, and, in so far as may be
2-41 required by those regulations or rules, the common names of
2-42 <optional> ingredients, other than spices, flavoring, and coloring,
2-43 present in such food;
2-44 (i) if it purports to be or is represented as:
2-45 (1) a food for which a standard of quality has
2-46 been prescribed by federal regulations or rules of the board as
2-47 provided by Section 431.245, and its quality falls below such
2-48 standard unless its label bears, in such manner and form as those
2-49 regulations or rules specify, a statement that it falls below such
2-50 standard; or
2-51 (2) a food for which a standard or standards of
2-52 fill of container have been prescribed by federal regulations or
2-53 rules of the board as provided by Section 431.245, and it falls
2-54 below the standard of fill of container applicable thereto, unless
2-55 its label bears, in such manner and form as those regulations or
2-56 rules specify, a statement that it falls below such standard;
2-57 (j) <if it is not subject to the provisions of
2-58 Subsection (h),> unless its label bears:
2-59 (1) the common or usual name of the food, if
2-60 any; and
2-61 (2) in case it is fabricated from two or more
2-62 ingredients, the common or usual name of each such ingredient, and
2-63 if the food purports to be a beverage containing vegetable or fruit
2-64 juice, a statement with appropriate prominence on the information
2-65 panel of the total percentage of the fruit or vegetable juice
2-66 contained in the food; except that spices, flavorings, and colors
2-67 not required to be certified under Section 706(c) of the federal
2-68 Act <colorings>, other than those sold as such, may be designated
2-69 as spices, flavorings, and colors <colorings>, without naming each;
2-70 provided that, to the extent that compliance with the requirements
3-1 of this subdivision is impractical or results in deception or
3-2 unfair competition, exemptions shall be established by rules of the
3-3 board;
3-4 (k) if it purports to be or is represented for special
3-5 dietary uses, unless its label bears such information concerning
3-6 its vitamin, mineral, and other dietary properties as the board
3-7 determines to be, and by rule prescribed, as necessary in order to
3-8 fully inform purchasers as to its value for such uses;
3-9 (l) if it bears or contains any artificial flavoring,
3-10 artificial coloring, or chemical preservative, unless it bears
3-11 labeling stating that fact; provided that, to the extent that
3-12 compliance with the requirements of this subsection is
3-13 impracticable, exemptions shall be established by rules of the
3-14 board. The provisions of this subsection and Subsections (h) and
3-15 (j) with respect to artificial coloring do not apply in the case of
3-16 butter, cheese, and ice cream;
3-17 (m) if it is a raw agricultural commodity that is the
3-18 produce of the soil and bears or contains a pesticide chemical
3-19 applied after harvest, unless the shipping container of the
3-20 commodity bears labeling that declares the presence of the chemical
3-21 in or on the commodity and the common or usual name and the
3-22 function of the chemical, except that the declaration is not
3-23 required while the commodity, after removal from the shipping
3-24 container, is being held or displayed for sale at retail out of the
3-25 container in accordance with the custom of the trade;
3-26 (n) if it is a product intended as an ingredient of
3-27 another food and if used according to the directions of the
3-28 purveyor will result in the final food product being adulterated or
3-29 misbranded;
3-30 (o) if it is a color additive, unless its packaging
3-31 and labeling are in conformity with the packaging and labeling
3-32 requirements applicable to the color additive as may be contained
3-33 in regulations issued under Section 706 of the federal Act;
3-34 (p) if its packaging or labeling is in violation of an
3-35 applicable regulation issued under Section 3 or 4 of the Federal
3-36 Poison Prevention Packaging Act of 1970 (15 U.S.C. 1491 et seq.);
3-37 (q) if it contains saccharin, unless its label and
3-38 labeling and retail display comply with the requirements of
3-39 Sections 403(o) and 403(p) of the federal Act; <or>
3-40 (r) if it contains saccharin and is offered for sale,
3-41 but not for immediate consumption, at a retail establishment,
3-42 unless the retail establishment displays prominently, where the
3-43 food is held for sale, notice that is provided by the manufacturer
3-44 of the food under Section 403(o)(2) of the federal Act for
3-45 consumers concerning the information required by Section 403(p) of
3-46 the federal Act to be on food labels and labeling;
3-47 (s)(1) if it is a food intended for human consumption
3-48 and is offered for sale, unless its label or labeling bears
3-49 nutrition information that provides:
3-50 (A)(i) the serving size that is an amount
3-51 customarily consumed and that is expressed in a common household
3-52 measure that is appropriate to the food; or
3-53 (ii) if the use of the food is not
3-54 typically expressed in a serving size, the common household unit of
3-55 measure that expresses the serving size of the food;
3-56 (B) the number of servings or other units
3-57 of measure per container;
3-58 (C) the total number of calories in each
3-59 serving size or other unit of measure that are:
3-60 (i) derived from any source; and
3-61 (ii) derived from fat;
3-62 (D) the amount of total fat, saturated
3-63 fat, cholesterol, sodium, total carbohydrates, complex
3-64 carbohydrates, sugar, dietary fiber, and total protein contained in
3-65 each serving size or other unit of measure; and
3-66 (E) any vitamin, mineral, or other
3-67 nutrient required to be placed on the label and labeling of food
3-68 under the federal Act; or
3-69 (2)(A) if it is a food distributed at retail in
3-70 bulk display cases, or a food received in bulk containers, unless
4-1 it has nutrition labeling prescribed by the secretary; and
4-2 (B) if the secretary determines it is
4-3 necessary, nutrition labeling will be mandatory for raw fruits,
4-4 vegetables, and fish, including freshwater or marine fin fish,
4-5 crustaceans, mollusks including shellfish, amphibians, and other
4-6 forms of aquatic animal life, except that:
4-7 (3)(A) Subdivisions (1) and (2) do not apply to
4-8 food:
4-9 (i) that is served in restaurants or
4-10 other establishments in which food is served for immediate human
4-11 consumption or that is sold for sale or use in those
4-12 establishments;
4-13 (ii) that is processed and prepared
4-14 primarily in a retail establishment, that is ready for human
4-15 consumption, that is of the type described in Subparagraph (i),
4-16 that is offered for sale to consumers but not for immediate human
4-17 consumption in the establishment, and that is not offered for sale
4-18 outside the establishment;
4-19 (iii) that is an infant formula
4-20 subject to Section 412 of the federal Act;
4-21 (iv) that is a medical food as
4-22 defined in Section 5(b) of the Orphan Drug Act (21 U.S.C. Section
4-23 360ee(b)); or
4-24 (v) that is described in Section
4-25 405, clause (2), of the federal Act;
4-26 (B) Subdivision (1) does not apply to the
4-27 label of a food if the secretary determines by regulation that
4-28 compliance with that subdivision is impracticable because the
4-29 package of the food is too small to comply with the requirements of
4-30 that subdivision and if the label of that food does not contain any
4-31 nutrition information;
4-32 (C) if the secretary determines that a
4-33 food contains insignificant amounts of all the nutrients required
4-34 by Subdivision (1) to be listed in the label or labeling of food,
4-35 the requirements of Subdivision (1) do not apply to the food if the
4-36 label, labeling, or advertising of the food does not make any claim
4-37 with respect to the nutritional value of the food, provided that if
4-38 the secretary determines that a food contains insignificant amounts
4-39 of more than half the nutrients required by Subdivision (1) to be
4-40 in the label or labeling of the food, the amounts of those
4-41 nutrients shall be stated in a simplified form prescribed by the
4-42 secretary;
4-43 (D) if a person offers food for sale and
4-44 has annual gross sales made or business done in sales to consumers
4-45 that is not more than $500,000 or has annual gross sales made or
4-46 business done in sales of food to consumers that is not more than
4-47 $50,000, the requirements of this subsection do not apply to food
4-48 sold by that person to consumers unless the label or labeling of
4-49 food offered by that person provides nutrition information or makes
4-50 a nutrition claim;
4-51 (E) if foods are subject to Section 411 of
4-52 the federal Act, the foods shall comply with Subdivisions (1) and
4-53 (2) in a manner prescribed by the rules; and
4-54 (F) if food is sold by a food distributor,
4-55 Subdivisions (1) and (2) do not apply if the food distributor
4-56 principally sells food to restaurants or other establishments in
4-57 which food is served for immediate human consumption and the food
4-58 distributor does not manufacture, process, or repackage the food it
4-59 sells;
4-60 (t) if it is a food intended for human consumption and
4-61 is offered for sale, and a claim is made on the label, labeling, or
4-62 retail display relating to the nutrient content or a nutritional
4-63 quality of the food to a specific disease or condition of the human
4-64 body, except as permitted by Section 403(r) of the federal Act; or
4-65 (u) if it is a food intended for human consumption and
4-66 its label, labeling, and retail display do not comply with the
4-67 requirements of Section 403(r) of the federal Act pertaining to
4-68 nutrient content and health claims.
4-69 SECTION 4. Section 431.083, Health and Safety Code, is
4-70 amended by amending Subsection (a) and adding Subsection (c) to
5-1 read as follows:
5-2 (a) Except as provided by Subsection (c), the <The> board
5-3 shall adopt rules exempting from any labeling requirement of this
5-4 chapter:
5-5 (1) small open containers of fresh fruits and fresh
5-6 vegetables; and
5-7 (2) food that is in accordance with the practice of
5-8 the trade, to be processed, labeled, or repacked in substantial
5-9 quantities at establishments other than those where originally
5-10 processed or packed, on conditions that the food is not adulterated
5-11 or misbranded under the provisions of this chapter when removed
5-12 from the processing, labeling, or repacking establishment.
5-13 (c) The board may not adopt rules under Subsection (a) to
5-14 exempt foods from the labeling requirements of Sections 403(q) and
5-15 (r) of the federal Act.
5-16 SECTION 5. Section 431.182, Health and Safety Code, is
5-17 amended to read as follows:
5-18 Sec. 431.182. FALSE ADVERTISEMENT. (a) An advertisement of
5-19 a food, drug, device, or cosmetic shall be deemed to be false if it
5-20 is false or misleading in any particular.
5-21 (b) The advertising of a food that incorporates a health
5-22 claim not in conformance with or defined by Section 403(r) of the
5-23 federal Act is deemed to be false or misleading for the purposes of
5-24 this chapter.
5-25 SECTION 6. Section 431.244, Health and Safety Code, is
5-26 amended to read as follows:
5-27 Sec. 431.244. Federal Regulations Adopted as State Rules.
5-28 (a) A regulation adopted by the secretary under the federal Act
5-29 concerning pesticide chemicals, food additives, color additives,
5-30 special dietary use, processed low acid food, acidified food,
5-31 infant formula, bottled water, or vended bottled water is a rule
5-32 for the purposes of this chapter, unless the board modifies or
5-33 rejects the rule.
5-34 (b) A regulation adopted under the Fair Packaging and
5-35 Labeling Act (15 U.S.C. 1451 et seq.) is a rule for the purposes of
5-36 this chapter, unless the board modifies or rejects the rule. The
5-37 board may not adopt a rule that conflicts with the labeling
5-38 requirements for the net quantity of contents required under
5-39 Section 4 of the Fair Packaging and Labeling Act (15 U.S.C. 1453)
5-40 and the regulations adopted under that Act.
5-41 (c) A regulation adopted by the secretary under Sections
5-42 403(b) through (i) of the federal Act is a rule for the purposes of
5-43 this chapter unless the board modifies or rejects the rule. The
5-44 board may not adopt a rule that conflicts with the limitations
5-45 provided by Sections 403(q) and (r) of the federal Act.
5-46 (d) A federal regulation that this section provides as a
5-47 rule for the purposes of this chapter is effective:
5-48 (1) on the date that the regulation becomes effective
5-49 as a federal regulation; and
5-50 (2) whether or not the department has fulfilled the
5-51 rulemaking provisions of the Administrative Procedure and Texas
5-52 Register Act (Article 6252-13a, Vernon's Texas Civil Statutes).
5-53 (e) <(d)> If the board modifies or rejects a federal
5-54 regulation, the board shall comply with the rulemaking provisions
5-55 of the Administrative Procedure and Texas Register Act (Article
5-56 6252-13a, Vernon's Texas Civil Statutes).
5-57 SECTION 7. This Act takes effect September 1, 1993.
5-58 SECTION 8. The importance of this legislation and the
5-59 crowded condition of the calendars in both houses create an
5-60 emergency and an imperative public necessity that the
5-61 constitutional rule requiring bills to be read on three several
5-62 days in each house be suspended, and this rule is hereby suspended.
5-63 * * * * *
5-64 Austin,
5-65 Texas
5-66 March 31, 1993
5-67 Hon. Bob Bullock
5-68 President of the Senate
5-69 Sir:
5-70 We, your Committee on Health and Human Services to which was
6-1 referred S.B. No. 558, have had the same under consideration, and I
6-2 am instructed to report it back to the Senate with the
6-3 recommendation that it do pass and be printed.
6-4 Ellis,
6-5 Vice-Chair
6-6 * * * * *
6-7 WITNESSES
6-8 FOR AGAINST ON
6-9 ___________________________________________________________________
6-10 Name: R. D. (Dan) Sowards x
6-11 Representing: Tx Dept of Health
6-12 City: Austin
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