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