[PRELIMS] PCOS LAB - Cosmetics Labelling Guide Flashcards
A.O. 1938
Federal Food, Drug, and Cosmetic
To protect consumers from unsafe or deceptively labeled or packaged products by prohibiting the movement in interstate commerce of adulterated or misbranded food, drugs, devices, and cosmetics. [21 U.S.C. 321-392]
Federal Food, Drug, and Cosmetic A.O. 1938
To ensure that packages and their labels provide consumers with accurate information about the quantity of contents and facilitate value comparisons. [15 U.S.C. 1451-1460]
Fair Packaging and Labeling Act
Prohibits the marketing of cosmetics that are adulterated or misbranded as well as their adulteration or misbranding while in interstate commerce. [Sec. 301, FD&C Act]
Federal Food, Drug, and Cosmetic Act
A product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. [Sec. 201(i) FD&C Act]
Cosmetic
The Food and Drug Administration (FDA) defines the term “soap” as the product in which the non-volatile portion consists principally of an alkali salt of fatty acids, i.e., the traditional composition of soap; the product is labeled as soap; and the label statements refer only to cleansing. If cosmetic claims, e.g., moisturizing. deodorizing, skin softening etc., are made on label, the product is cosmetic.
Section 701.20 of Title 21 of the Code of Federal Regulations [21 CFR 701.20]
A product customarily distributed for retail sale for use by consumers or for the performance of services at home and usually consumed during such use. [Sec. 10(A), FP&L Act]
Consumer Modality
A container or wrapping, other than a shipping container or wrapping, in which a consumer commodity is delivered or displayed to retail purchasers. [Sec. 10(B), FP&L Act]
Package
This is written, printed or graphic display of information.
Label
All labels and other written, printed or graphic material on or accompanying the product in interstate commerce or held for sale.
Labeling
The required information must be on the panel which is presented or displayed under customary conditions of purchase. This eliminates placement of required information on a bottom panel of the cosmetic unless it is very small and customarily picked up by hand where inspected for possible purchase.
Panel Display
The label must be large enough to provide sufficient space for prominent display of the required information.
Panel Size
The type must be of such size, and at least of the required minimum size, and of such style that the required label statements are easily readable.
Style and Size of Letters
The contrast must be sufficient to make the required label statements conspicuous and easily readable.
Background Contrast
The required statements must not be obscured by vignettes or other designs or by crowding with other printed or graphic matter.
Obscuring Designs, Vignettes
If the cosmetic is sold at retail in an outer container, the net contents statement must appear (1) within the bottom 30% of the PDP of the outer container, generally parallel in line to the base on which the package rests, and (2) on an information panel of the inner container. The bottom location requirement is waived for PDPs of 5 square inches or less.
Location
The declaration must be distinct item, separated from other printed matter by the space equal to at least the height of the lettering used in the declaration and twice the width of the letter “N”
Prominence
The print must be easily legible bold face type in distinct contract to background and other matter on the package. The letter height must be at least that of the lower case letter “o,” and the aspect ratio of height to width must not exceed 3:1.
Conspicuousness
The net quantity of contents (net contents) declaration must accurately reveal the quantity of cosmetic in the container in terms of weight, volume, measure, numerical count, or combinations of count and weight, volume or measure. Reasonable variations due to loss or gain of moisture, or deviations in good manufacturing practice, are acceptable. In case of an aerosol product, the net contents statement must express the net quantity of contents expelled.
Accuracy
Unless there is firmly established, general consumer usage or trade custom to the contrary, the statement must be in terms of fluid measure if the cosmetic is liquid and in terms of weight if the cosmetic is solid, semi-solid, viscous, or mixture of solid and liquid. Fluid measures must express the volume at 68°F (20°C). The customary net contents declaration for aerosol products is in terms of weight.
Product Consistency
Weight is expressed in terms of avoirdupois pound and ounce. Fluid measures are expressed in terms of the U.S. gallon, quart, pint and fluid ounce. Net contents may additionally be stated also in the metric system.
Systems
The term “net weight” or “net wt.” must be used in conjunction with the weight statement, and the term “net contents,” “net” or nothing must be used in connection with liquid statement.
Unit Terms
If the net weight exceeds one pound but is less than 4 pounds, the net contents statement must reveal the total number of ounces followed, in parenthesis, by the number of pounds and ounces or by the number of pounds and fraction thereof. Fluid measures exceeding one pint, but being less than one gallon, must be expressed in terms of the total number of fluid ounces followed, in parenthesis, by the number of quarts, pints and ounces or by the fractions of the quart or pint.
Dual Declaration
Representations of this type are permitted if the firm offers at least one other packaged size of the same brand.
Economy Size
Supplemental statements describing the net quantity of contents are permitted on panels other than the PDP. However, these statements must not be deceptive or exaggerate the amount present in the package.
Giant Pint, Full Quart
Warning: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children. [21 CFR 740.11 (A)]
Cosmetic Aerosols
Caution: For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which physician should be consulted.
Feminine Deodorant Sprays
Caution: Use only as directed. Excessive use of prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.
Foaming Detergent Bath Products
Declaration of ingredients except flavor, fragrance, and trade secret ingredients in descending order of predominance.
Cosmetic Ingredient Labelling
It may consist of any formula, pattern, device or compilation of information which is used in one’s business and which gives one an opportunity to obtain an advantage over competitors who do not know or use it.
Trade Secret
