- Adulterated (Cosmetic)
- A cosmetic which is or contains a filthy, putrid, or decomposed substance; which contains an unapproved color additive or a color additive in a way for which it hasn’t been approved; which has been prepared, held, or packed under insanitary conditions; or which has a container that is composed partly or completely of a poisonous substance which may make the cosmetic injurious. [21 USC 361]
See What does ADULTERATED mean?
- Color Additive
- Any material … that is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived,… from a vegetable, animal, mineral, or other source and that, when added or applied to a food, drug, or cosmetic or to the human body or any part thereof, is capable (alone or through reaction with another substance) of imparting a color thereto. [21 CFR 70.3(f)]
For a material otherwise meeting the definition of color additive to be exempt … on the basis that it is used (or intended to be used) solely for a purpose or purposes other than coloring, the material must be used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned. (It is not enough to warrant exemption if conditions are such that the primary purpose of the material is other than to impart color.) [21 CFR 70.3(g)]
- The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap. [21 USC 321(i)]
See What is a COSMETIC?
- B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals [21 USC 321(g)(1)]
See What is a DRUG?
- A list of the standardized and internationally accepted names (called “INCI Names”) that should be used in the declaration of ingredients on cosmetic and personal care products (with some specific exceptions for the United States).
See What is INCI?
- Incidental Ingredient
- An ingredient or component present at insignificant levels and which has no technical or functional effect in the product. Incidental ingredients may be omitted from the ingredient declaration.
See What are INCIDENTAL INGREDIENTS?
- Any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity. [21 USC 321(k), 21 CFR 1.3(b), 15 USC 1459(c)]
See What is a LABEL?
- Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. [21 CFR 1.3(a)]
See What is LABELING?
- Misbranded (Cosmetic)
- A cosmetic is misbranded if: a)it has labeling which is false or misleading in any way; b) its labeling which does not include the name and place of business or the net contents; c) required information is not placed clearly and conspicuously on the label; the container is formed or filled to be misleading; it has does not have appropriate hazardous substance labeling if required. [21 USC 362]
- Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. [7 USC 136(u)]
- Principal Display Panel
- The front of the outer container which the customer is most likely to see when looking at the product sitting on a shelf ready for purchase. [15 USC 1459(f), 16 CFR 500.2(h), 21 CFR 701.10]
See What is the PRINCIPAL DISPLAY PANEL?
- [To be exempt from the definition of a cosmetic] the FDA interprets the term “soap” to apply only to articles that meet the following conditions:
(1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and
(2) The product is labeled, sold and represented only as soap. [21 CFR 701.20(a)]