Botanical Safety Consortium Resources

Adulterate: To make unsafe or impure by using contaminated or unneeded ingredients; using a strength or quality that is less than claimed; leaving out or substituting key ingredients; or using inferior manufacturing, processing, packaging, or storage procedures.¹

Also, intentional economically motivated adulteration has been defined as the fraudulent addition of non-authentic substances or removal or replacement of authentic substances without the purchaser’s knowledge for economic gain of the seller.²

¹ “Dictionary of Dietary Supplement Terms.” NIH Office of Dietary Supplements, U.S. Department of Health and Human Services.

² Food Fraud Mitigation Guidance. In: FCC10. Rockville, MD: United States Pharmacopeial Convention; 2017:1586-1621.

A plant, alga, or fungus; a part of a plant, alga, or fungus (e.g., bark, leaves, stems, roots, flowers, fruits, seeds, berries, or parts thereof); or an exudate (secretion) of a plant, alga, or fungus.³

³ Dietary Supplements: New Dietary Ingredient Notifications and Related Issues — Guidance for Industry (Draft). U.S. Food and Drug Administration.

An ingredient of a dietary supplement, personal care, cosmetic, or food product derived from plants, algae, or fungi. Botanical ingredients can be whole, cut, or powdered, or in the form of an extract after further processing using appropriate solvents and methods.

The quantitative study of the absorption, distribution, metabolism, and excretion of botanicals (and their constituents) in living things.⁴

⁴ Defined by the Botanical Safety Consortium.

Whole or physically processed (e.g., cleaned, frozen, dried, or sliced) parts of a single species of plant or a fresh or processed alga or fungus.³ Also referred to as raw agricultural commodities or crude material from which botanical ingredients are made.

³ Dietary Supplements: New Dietary Ingredient Notifications and Related Issues — Guidance for Industry (Draft), FDA.

The study of the actions and interactions of botanicals (and their constituents) within the organism and describes processes at organ, tissue, cellular, and molecular levels.⁴

⁴ Defined by the Botanical Safety Consortium.

A substance that is part of a mixture. Includes substances that cannot be isolated from the whole, as well as those that can. Once isolated, a component of a mixture is also a constituent (see Constituent).³

For example, once combined, hops and valerian extracts cannot be separated though individual constituents can be isolated. The term component also has an FDA regulatory dietary supplement definition meaning any substance used in manufacturing a finished dietary supplement.

³ Dietary Supplements: New Dietary Ingredient Notifications and Related Issues — Guidance for Industry (Draft), FDA.

An article that is a physical part of the whole and can be isolated from the whole.³ Also defined as a component, part, or ingredient of a larger whole. For example, valerenic acid and valepotriate are constituents of the dietary supplement valerian.¹ Phytochemicals are botanical constituents.

¹ “Dictionary of Dietary Supplement Terms.” NIH Office of Dietary Supplements.

³ Dietary Supplements: New Dietary Ingredient Notifications and Related Issues — Guidance for Industry (Draft), FDA.

An ingredient of a dietary supplement that is (A) a vitamin, (B) a mineral, (C) an herb or other botanical, (D) an amino acid, (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in (A) through (E).³

³ Dietary Supplements: New Dietary Ingredient Notifications and Related Issues — Guidance for Industry (Draft), FDA.

A substance that is commonly used as human food or drink.³

³ Dietary Supplements: New Dietary Ingredient Notifications and Related Issues — Guidance for Industry (Draft), FDA.

A product that is intended to supplement the diet. A dietary supplement contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their components; is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is identified on the front label of the product as being a dietary supplement.^1,5

¹ “Dictionary of Dietary Supplement Terms.” NIH Office of Dietary Supplements.

⁵ “Office of Dietary Supplements — Background Information: Botanical Dietary Supplements.” NIH ODS.

A product (ingredient) consisting of a solvent (menstruum) combined with a dietary substance or botanical biomass by a process that physically separates constituents from the dietary substance or botanical and dissolves them into the solvent. The extract can be further concentrated through drying to a dry powder or semi-solid form.³

³ Dietary Supplements: New Dietary Ingredient Notifications and Related Issues — Guidance for Industry (Draft), FDA.

A change in the way a finished product acts in the body when taken with certain other supplements, medicines, or foods, or when taken with certain medical conditions. Interactions may cause the product to be more or less effective, or cause effects on the body that are not expected.¹

¹ “Dictionary of Dietary Supplement Terms.” NIH Office of Dietary Supplements.

All chemical changes that take place in a cell or an organism. These changes produce energy and basic materials needed for important life processes.¹

¹ “Dictionary of Dietary Supplement Terms.” NIH Office of Dietary Supplements.

The study of natural product molecules that are useful for their medicinal, ecological, gustatory, or other functional properties.

Chemical constituents produced by plants, sometimes referred to as primary metabolites when directly involved in the normal growth, development, or reproduction of the organism, and secondary metabolites when not.

Chemical constituents produced by plants not directly involved in the normal growth, development, or reproduction of the organism. See Phytochemical.⁶

⁶ Böttger A, Vothknecht U, Bolle C, Wolf A. (2018). Plant Secondary Metabolites and Their General Function in Plants. Springer.