| Proper labeling is an important aspect of marketing a cosmetic or personal care product. Labeling is used to help inform consumers of a product's intended use and any related warnings, its ingredients and net quantity of contents, and its place of manufacture or distribution.
The FDA regulates cosmetic labeling under the authority of both the Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices and to help consumers make informed decisions about the personal care products they purchase.
As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that the FDA has approved the product. This applies even if the manufacturing establishment is registered or the product is on file with FDA's Voluntary Cosmetic Registration Program.
All labeling information that is required by US law or regulation must be in English. The only exception to this rule is for products distributed solely in a US territory where a different language is predominant, such as Puerto Rico.
| | | | Summary of FDA Labeling Regulations |
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Principal Display Panel: The Principal Display Panel (PDP) of the label is the part of the label most likely displayed or examined under customary conditions of display for sale. It is on the outer container which usually is a box, folding carton, wrapper etc. holding the inner (immediate) container. If there is no outer container then the PDP is placed on the immediate container holding the cosmetic product.
The area of the PDP is for a rectangular package one entire side, for a cylindrical package 40% of height x circumference, and for any other shape of container 40% of total container surface, excluding top, bottom, neck, shoulder, and flanges. There are specific requirements for the form of stating the required information including panel display, panel size, style and size of letters, background contrast, and obscuring designs. The requirements for the PDP are:Identity statement: An identity statement, indicating the nature and use of the cosmetic product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustrationNet quantity: An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure
§ 740.10 Warning: If the cosmetic product contains an ingredient for which adequate substantiation of safety has not been obtained a warning must be placed on the PDP like "Warning —The safety of this product has not been determined".
Note: If there is an outer and inner package the identity statement, net quantity and 740.10 warning always go on the outer package while on the inner package only the identity statement is required. | | | | Information Panel (IP): The Information Panel (IP) of the label refers to a panel other than the PDP that can accommodate label information where the consumer is likely to see it. The requirements for the IP are:Name and place of business: This may be the manufacturer, packer, or distributor
Distributor statement: If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..."
Warning and caution statements: These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings. Flammable cosmetics such as aerosols are an example of products that require specific warnings
Material facts: Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded. An example is directions for safe use if a cosmetic product has the potential to be misused
Ingredient declaration: The declaration of ingredients shall appear with such prominence and conspicuousness as to render it likely to be read and understood by ordinary individuals under normal conditions of purchase. The declaration shall appear on any appropriate information panel in letters not less than1/16 of an inch in height and without obscuring design, vignettes, or crowding. In the absence of sufficient space for such declaration on the package, or where the manufacturer or distributor wishes to use a decorative container, the declaration may appear on a firmly affixed tag, tape, or card.
Ingredient name: Use the name established by the commissioner as specified in §701.30 which is usually the INCI name. In the absence of an INCI name you may also use the name given in the United States Pharmacopeia, National Formulary, Food Chemical Codex, USAN, and the USP dictionary of drug names
Ingredient listing: The ingredients must be listed in descending order of predominance. Exceptions are active drug ingredients, ingredients with less than 1% concentration, and color additives. Fragrance and flavor compounds may be declared in descending order of predominance as "fragrance" and "flavor." If a fragrance compound also serves as a flavor, it must be declared as "flavor and fragrance". Concentration percentages are only necessary for active pharmaceutical ingredients (APIs) like, for example, salicylic acid, titanium dioxide, and zinc oxide.
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