FDA provides a cosmetic labeling guide which details the various provisions of the key laws that govern labeling of cosmetics. Violations of these laws and any corresponding regulations can result in severe civil penalties including fines, statutory penalties, and the closing of a business. Experienced FDA and FTC healthcare lawyers work with the manufacturers, distributors, and sellers of cosmetics to help prepare and review the product labels for any compliance issues.
General ways that cosmetic product companies can address compliance needs are:
- Understanding which products meet FDA definition of a cosmetic
- Knowing when cosmetic products may also be classified as drugs
- Understanding what enforcement actions FDA and FTC can take if cosmetic products fail to comply with federal laws and regulations
- Understand some of the key FDA terms such as interstate commerce, adulteration, and misbranding.
- Understand what steps should be taken to show the products comply with product safety requirements
- Showing you are in compliance with precise requirements of cosmetic, cosmetic ingredients, and cosmetic packaging requirements
- Using practical strategies to show compliance with the FD&C Act, the FPLA, and any other relevant laws
Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements. There are […]
The starting point for any compliance review of cosmetic guidelines is to understand the relevant laws and regulations and to show the cosmetic company is meeting the specifics of FDA cosmetic labeling guide.
Federal Food, Drug, and Cosmetic Act of 1938, as amended
The aim of the FD&C Act is to protect consumers from products that are unsafe, labeled deceptively, or packaged deceptively – by forbidding product movement (such as through sales) in interstate commerce. The Act applies to cosmetics, drugs, foods, and devices that are adulterated or misbranded.
Cosmetics must comply with the FD&C Act, the Fair Packaging and Labeling Act (FPLA), and the regulations published by the Food and Drug Administration. The regulations are crafted under the Authority of FD&C Act and the FPLA
Fair Packaging and Labeling Act
The purpose of this law is to “ensure that packages and product labels provide consumers with accurate information about the quantity of contents and facilitate value comparisons”
Federal Food, Drug, and Cosmetic Act – Misbranding
A cosmetic is considered misbranded if…..
- “labeling is false or misleading
- label does not state
- the name and address of the manufacturer, packer, or distributor
- the net quantity of contents
- the required information is not stated prominently, with conspicuousness and in terms that are easy to read and understood by consumers under customary conditions of purchase and use
- the container or [the container’s] fill is misleading”
FD&C Act – factors determining whether labeling is misleading
Representations are misleading if the representations fail to disclose material facts. Materiality is reviewed based on the representations themselves and the consequences that result from the intended use of the cosmetic
FD&C Act – definition of a cosmetic
A cosmetic is a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance…
“In short, one may say that a cosmetic is a product intended to exert a physical, and not a physiological, effect on the human body.” “The raw materials used as ingredients of cosmetic products are by law also cosmetics.”
If cosmetic claims, e.g., moisturizing, deodorizing, skin softening etc., are made on a label, the product is a cosmetic – even when the labels suggest that the product is “soap.”
FD&C Act – When is a cosmetic also a drug?
FDA can categorize a cosmetic as a drug if the produce is “intended to cleanse, beautify or promote attractiveness as well as treat or prevent disease or otherwise affect the structure or any function of the human body.”
Cosmetic product makers need to understand that the categories of drug and cosmetic are not mutually exclusive. In general, for a product to meet FDA laws on drugs, the product must pass rigorous scientific testing.
To paraphrase Freud, sometimes a cosmetic is just a cosmetic – and sometimes it’s a drug…. Which is it—drug or cosmetic? The answer, FDA says, depends on intended use
A package is “A container or wrapping, other than a shipping container or wrapping, in which a consumer commodity is delivered or displayed to retail purchasers.” The definition comes from the FPLA. Basically, a package is the product’s outer container such as a box. The context is critical. When a lotion is sold in a jar which is placed in a box, the box is the package. If there’s no box, then the jar is the package.
FD&C Act – Definition of a label
A labels is a display of information which is in written, printed, or graphic form:
- On the cosmetic container or
- affixed to or appearing on a package containing a consumer commodity
Pursuant to the FD&C Act – “any information required to appear on the label of the immediate container shall also appear on the outside container of the retail package or is legible through the outside container.”
Labeling means al the labels (in written, printed or graphic form) on a product or accompanying a cosmetic product which are in interstate commerce or held for sale. Labeling includes inserts, leaflets, promotions, display packs, and other similar items distributed with the cosmetic product.
FD&C Act – Principal Display Panel (PDP)
This is the part of the label the consumers usually “see or examine” when the product is being sold. Cosmetic products can have multiple labels – including front, back, and side labels. The secondary labels (usually the back and sides) are referred to as information panels.
FD&C Act – Placement and Size of Principal Display Panel
The PDP must be big enough so that all the required label information is clear and conspicuous. When packages have more than one PDP, the required labeling information must be duplicated on each PDP.
“For the purpose of assuring uniform type size for declaring a product’s net quantity of contents, the size of the surface area bearing the PDP, and not the size of the PDP itself, is the determining factor.”
The area of the PDP is for a:
- Rectangular package: One entire side.
- Cylindrical package: 40% of height x circumference.
- Any other shape of container: 40% of total container surface, excluding top, bottom, neck, shoulder, flanges.
For products such as cartridges, pills, compacts, and other special items and items that have ¼ ounce or less – the PDP can be a tear-away tag or tape which is affixed to the container. A card affixed to the container may also be acceptable.
FD&C Act – Placement of Information on Labels – outer containers
“Only the label of the outer container has a PDP.”
Generally, cosmetics labels should include:
- The name of the product
- The net quantity
- A Section 740.120 warning
Information panels should include:
- The name and place of the company business
- A declaration of the ingredients
- Other required information
FD&C Act – Placement of Information on Labels – inner container
Generally, the front panels should include the name of the product.
The information panel should include:
- Directions for safe use
- Name and Place of Business
- Net Quantity of Contents
- Any Other Required Information
FD&C Act – Form of Stating Required Information
Cosmetics are deemed “misbranded” if any word, any statement, or and or label/labeling information which must be placed on the label/labeling – is not prominent and is not conspicuous. Prominent and conspicuous essential means the information is likely to be read by the consumer – or likely to be understood by the consumer. Whether the information is prominent and conspicuous is analyzed for each of the following factors:
- Panel display
- Panel size
- Style and size of letters
- Background contrast
- Obscuring designs and vignettes
For example, “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.”
FD&C Act – Language Requirements
Labels and labeling statements that are required by any law or regulation must be in English. Exceptions may apply for products sold solely in Puerto Rico or a US Territory.
“If the label contains any foreign language representation, all statements required by regulation must also appear on the label in the foreign language. If labeling bears foreign language representations, the required statements must appear on the label or other labeling as required in English.”
FD&C Act – Type Size
There are different size requirements for the ingredients, net contents, warnings, and other information. For example, for ingredient declarations:
“Ingredient Declaration: Generally, in letters not less than 1/16″ in height [21 CFR 701.3(b)]. If surface area available to bear label (excludes surfaces with decorative relief, sculptured surfaces) is less than 12 square inches, letter height may be not less than 1/32″”
FD&C Act – Identity Labeling
The FPLA requires that every consumer commodity have a statement of identity. FDA requires that the identity statement appear on the PDP:
“(a) The principal display panel of a cosmetic in package form shall bear as one of its principal features a statement of the identity of the commodity.
(b) Such statement of identity shall be in terms of:
(1) The common or usual name of the cosmetic; or
(2) An appropriately descriptive name or, when the nature of the cosmetic is obvious, a fanciful name understood by the public to identify such cosmetic; or
(3) An appropriate illustration or vignette representing the intended cosmetic use.”
It may also be expressed in form of an illustration.
“(c) The statement of identity shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.”
Name and Place of Business
The name and business address, on the label, can be the manufacturer, distributor, or the packer. If the identity is not the manufacturer, then there should be a preface such as “Distributed by ….”
The company names must be the corporate name. The address can be the principal place of business. The business address should include:
- The street address
- The name of the city and state
- the ZIP code
If the products are imported, then the Tariff Act of 1930 requires that the country of origin be identified in English.
Additional cosmetic labeling guide information
The compliance guide also covers the following topics:
- Net Quantity of Contents Declaration
- Warning Statements
- Ingredient Labeling
- Ingredient Identification
- Order of Declaration
- Fragrances and Flavors
- Trade Secret Ingredients
- Petitioning for Trade Secrecy
- Drug Ingredients
- Color Additives Added for Color Matching
- Incidental Ingredients
- Dissimilar Product Assortments
- Similar Product Assortments
- Branded Shade Lines
- Direct Mail Cosmetics
- Off-Package Ingredient Labeling
FDA has a compliance labeling guide for cosmetics. Cosmetics that violate the labeling guide may be considered improper for interstate shipment and product on the basis that that the improper labeling causes the cosmetic to misbranded. There are precise requirements for the packaging and the containers which vary depending on the type of packaging or container.
Contact Cohen Healthcare Law Group, PC for legal counsel on healthcare transactions, regulatory compliance, and FDA and FTC law. Our experienced healthcare & FDA attorneys advise healthcare companies and healthcare providers ranging from medical centers, to integrative and functional medicine practices, cosmetics and supplement companies, and medical device manufacturers.