- (a) Dietary supplement--A product a person can consume that has a "dietary ingredient" to add to the diet. A "dietary ingredient" includes vitamins and minerals, herbs, amino acids, enzymes, live bacteria (called "probiotics"), or other substances found in food. The dietary supplement can also be a mix or concentrate of any of these ingredients.
(b) Drug--Articles that are:
- (1) listed in the official United States Pharmacopoeia National Formulary (USP-NF) or any of the USP-NF supplements;
- (2) intended for diagnosing, curing, mitigating, treating, or preventing diseases in humans or animals;
- (3) other than food, meant to influence the structure or any function of the body of humans or animals; and
- (4) intended to be used as a component of any article mentioned in this definition.
- (5) The term does not include devices or their parts, components, or accessories.
- (6) A food for which a claim is made in accordance with Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21 United States Code (U.S.C.) §301), and for which the claim is approved by the United States Secretary of Health and Human Services, is not a drug solely because the label or labeling contains such a claim.
- (c) Food--Any article used by humans for food or drink, including chewing gum and items used as ingredients in other food or drink.
(d) Food manufacturer--A person who combines, purifies, processes, or packages food to sell through a wholesale outlet. This term also includes:
- (1) a retail outlet that packages or labels food before selling it; and
- (2) a person responsible for the purity and proper labeling of a food item by labeling the food with the person's name and address.
- (e) Raw agricultural commodity--Any food in its natural state, including all fruits that can be washed, colored, or treated in their unpeeled form before being marketed. Treatment includes waxing, fumigating, or removing foreign objects or other parts of the plant, such as leaves, stems, and husks. This definition excludes transforming a harvested raw agricultural commodity into processed food by actions such as cutting, cooking, heating, chopping, irradiating, or pasteurizing.
(f) Restaurant--A place where food is made and sold directly to people for immediate consumption, examples include:
- (1) cafeterias;
- (2) lunchrooms;
- (3) cafes;
- (4) bistros;
- (5) fast food places;
- (6) food stands;
- (7) saloons;
- (8) taverns;
- (9) bars;
- (10) lounges;
- (11) catering facilities;
- (12) hospital kitchens;
- (13) day care kitchens; and
- (14) nursing home kitchens.
- (15) "Restaurant" does not include places that provide food for interstate travel, central kitchens, and other similar places that don't serve food directly to the consumer.
(16) For purposes of this subchapter, a restaurant is a food establishment as defined in other department rules, including:
- (A) §229.371 of this chapter (relating to Definitions);
- (B) §229.471 of this chapter (relating to Definitions); and
- (C) §228.2 of this title (relating to Definitions).
(g) Retail food establishment--A place that sells food products directly to consumers as its primary function, like:
- (1) grocery stores;
- (2) convenience stores;
- (3) vending machines; and
- (4) some farm-run businesses.
- (5) "Retail food establishment" includes places that make, process, pack, or store food to sell directly to consumers. The value of food products sold directly to consumers must be higher than the sales of food products to all other buyers. "Consumers" does not include businesses.
(6) For purposes of this subchapter, a retail food establishment is also known as a food establishment as defined in other department rules, including:
- (A) §229.371 of this chapter;
- (B) §229.471 of this chapter; and
- (C) §228.2 of this title.
Source Note:The provisions of this §229.1002 adopted to be effective February 23, 2026, 51 TexReg 1156.