Definitions

 

DEFINITIONS

DSHEA: Dietary Supplement Health and Education Act of 1994 Public Law 103-417 103rd Congress enacted to amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes.

HEALTH BENEFIT STATEMENT: A statement which identifies a potential benefit to health from a product. This is not to be construed to mean a drug claim, a NLEA health claim, or a DSHEA statement of nutritional support.

LABELS: Include all packaging and any written materials attached to or accompanying the product.

LABELING: Includes all packaging, promotional materials, brochures, and any other written materials attached to or accompanying the product; verbal or visual representations including video, audio- tapes, signage and websites.

LITERATURE: Includes educational materials such as advertisements, brochures, magazine articles, books and other printed or visual matter that may not be specific to the exhibitor’s branded product and is not physically attached to the product or product labeling.

NLEA: Nutrition Labeling and Education Act of 1990 enacted to amend the Federal Food, Drug, and Cosmetic Act to prescribe nutrition labeling for foods, and for other purposes.

QUALIFIED MEDICAL PRACTITIONER: A graduate of an accredited institution of higher learning.

STANDARD: A minimum requirement exhibitors must meet to participate in a NATURAL PRODUCTS EXPO.

ARTIFICIAL:  A substance not derived solely from mineral, plant or animal matter or that undergoes a synthetic process. In most cases, these substances are synthetically derived and are not bio-identical to a substance found in nature. Certain artificial substances are prohibited at Natural Products Expo in accordance with the Ingredients Standards & Guidelines. Products containing artificial ingredients may not be labeled as natural.

BIO-IDENTICAL/NATURAL IDENTICAL: A synthetically derived substance that is identical or similar to a substance found in nature. Products, substances/ingredients, or products containing bio-identical substances may be acceptable for exhibit and advertisements, HOWEVER, they may not be labeled or promoted as natural.  

BIOTECHNOLOGY*:  Biotechnology describes the alteration or creation of novel organisms using in-vitro nucleic acid techniques or the fusion of cells beyond an organism’s taxonomic family. Products of biotechnology may be agricultural crops, or microorganisms used to produce materials for pharmaceuticals, crops, livestock, fuels, industrial products such as plastics, and for environmental applications. Biotechnology in food production may include genetic engineering or gene editing, whereby organisms’ DNA is modified for specific applications using a number of technologies, including CRISPR, TALEN, and other genetic engineering techniques. Products, substances/ingredients, or products containing substances produced using the application of biotechnology may be acceptable for exhibit and advertisements, HOWEVER, they may not be labeled or promoted as natural. 

BIOSYNTHESIS: The generation of natural products or chemical compounds by enzymatic reactions or living organisms. When the biosynthesis process includes the application of modern biotechnology* as defined here, the substances produced are considered synthetic. Products, substances/ingredients, or products containing substances made using biosynthesis that includes modern biotechnology* may be acceptable for exhibit and advertisements, HOWEVER, they may not be labeled or promoted as natural.

SYNTHETIC: A substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from naturally occurring plant, animal or mineral sources, or by a process whereby an organism that would not otherwise produce the substance is intentionally engineered to do so, except such term shall not apply to substances created by naturally occurring biological processes†. Synthetic processes may include and are not limited to the application of biotechnology* (as defined here), synthetic biology, and precision fermentation. Some common ingredients produced through biosynthetic fermentation include vanillin, chymosin, astaxanthin, resveratrol, whey (dairy) proteins, collagen. Products, substances/ingredients or products containing synthetically produced substances may be acceptable for exhibit and advertisements, HOWEVER, they may not be labeled or promoted as natural. A natural claim may be specific to particular ingredients in a product, but the term may not apply to the product itself. 

SYNTHETIC BIOLOGY: A type of biotechnology* that involves designing new biological entities or redesigning existing biological systems by engineering them to meet specific performance criteria, for instance, producing a substance the organism is unable to make naturally. Synthetic biology relies on biomolecular, genome, and metabolic engineering techniques. These processes often use chemically synthesized DNA to introduce novel genes, functionalities, and pathways in other organisms.” Products, substances/ingredients, or products containing substances produced using synthetic biology may be acceptable for exhibit and advertisements, HOWEVER, they may not be labeled or promoted as natural. 

PRECISION FERMENTATION: Precision fermentation is a form of synthetic biology that uses microbial hosts as "cell factories" for producing specific functional ingredients. Precision fermentation can produce enzymes, flavoring agents, vitamins, pigments, and fats. Products, substances/ingredients, or products containing substances made using precision fermentation may be acceptable for exhibit and advertisements, HOWEVER, they may not be labeled or promoted as natural.  

GENETICALLY MODIFIED ORGANISMS (GMO) / GENETICALLY ENGINEERED: Products or substances/ingredients derived using the application of biotechnology* as defined here. Pertains to plants, animals, fungi, microorganisms. Refer to Section 7 of the Ingredients Standards & Guidelines.

USDA BIOENGENEERED (BE) LABELING: Requires entities that label foods for retail sale to disclose the presence of foods and food ingredients that contain genetic material that has been detectably genetically modified. If genetically modified material is not detectable it does not need to be labeled as BE. 

CULTIVATED ANIMAL CELLS: Animal meat, seafood, or secreted food products (e.g., milk) produced via the growth of animal cells in a controlled and aseptic bioreactor environment. Cultivated animal cells are compositionally similar to products derived from their original sources and may be used as a standalone product or ingredient in other food products. Products, substances/ingredients, or products containing cultivated animal cells are prohibited for exhibit at Natural Products Expos at this time. 

HYBRIDIZATION /CONVENTIONAL BREEDING: Traditional agricultural and livestock breeding methods which do not include the application of biotechnology* as defined here. Traditional breeding methods are intended to improve characteristics such as increased resistance to disease, pests, higher tolerance to environmental extremes such as drought, excessive water or heat, increase crop yield or growth, improve nutrition profile, etc. 

VEGAN: Product contains no animal-derived ingredients in its production or supply chain including those sourced from or processed with the use of any animal-derived materials (e.g., sugar filtered with bone char), by-products, or derivatives, or genetic materials. Ingredients that are bio-identical to animal derived nutrients (e.g., whey protein, collagen, gelatin) are excluded and may not be labeled as vegan.