FDA COSMETICS LABELING GUIDE
ATTORNEYS IN DALLAS
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.
U.S. COSMETICS LAWYER
How Can A Cosmetics Lawyer Protect My Business?
The cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and the regulations published by the Food and Drug Administration under the Authority of these two laws.
The FD&C Act was enacted by Congress to protect consumers from unsafe or deceptively labeled or packaged products by prohibiting the movement in interstate commerce of adulterated or misbranded food, drug devices and cosmetics.
Our business attorneys can advise you on a wide range of FDA legal matters, including corporate law, contract law, copyright registration, trademark registration, mergers and acquisitions, corporate governance, and litigation. Our Dallas business lawyers utilize a team-based approach with access to multiple attorneys with substantive years of experience in many practice areas. Whatever your corporate service needs may be, our business attorneys have the talent, resources and expertise to meet them in an efficient, timely, and cost-effective manner.
Click Here to Download Cosmetic Labeling Guidelines from the U.S Food & Drug Administration.
Fair Packaging and Labeling Act
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
The FP&L Act was passed by Congress to ensure that packages and their labels provide consumers with accurate information about the quantity of contents and facilitate value comparisons.
Federal Food, Drug, and Cosmetic Act
The FD&C 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
The FD&C Act prohibits the marketing of cosmetics that are adulterated or misbranded as well as their adulteration or misbranding while in interstate commerce.
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 it is read and understood by consumers under customary conditions of purchase and use
- the container or its fill is misleading
Factors Determining Whether Labeling Is Misleading
Sec. 602, FD&C Act defines the conditions which cause a cosmetic to be deemed misbranded.
Factors Determining Whether Labeling Is Misleading
- Representations made or suggested
- Failure to reveal material facts:
- Material in light of such representations
- Material with respect to consequences resulting from the intended use
Sec. 201(n), FD&C Act
21 CFR 1.21
Labeling may be considered misleading not only because a label statement is deceptive but also because a material fact is not revealed on a label.
A fact may be material in light of a statement made on a label or because certain consequences may result from the recommended use of a product.
What is 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.
Additional Cosmetics Focus
Our Attorneys Can Assist You With All Your Cosmetic Legal Needs
As defined in section 201(i) of the FD&C Act, a cosmetic is a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance.
The raw materials used as ingredients of cosmetic products are by law also cosmetics.
"Intended use" within the meaning of the FD&C Act is determined from its label or labeling.
Senate Report No. 493
73d Cong. 2d Sess. (1934)
U.S. Courts of Appeals Decisions

According to Senate Report No. 493 and court decisions, the term "intended" in the legal definition of the term "cosmetic" or in other definitions means, with respect to the use of a product, its directed or prescribed use as determined from the statements made on a product's label or labeling.
The courts, in deciding whether a product is a "cosmetic", a "drug", or both a "drug" and a "cosmetic", have relied principally on the consumer's perception of the meaning of a label statement and less so on the interpretation of the meaning of a label statement by the labeler or a regulatory agency.
Additional information of FDS Cosmetic Labeling Guidelines can be found with the U.S Food & Drug Administration:
Click Here to Download Cosmetic Labeling Guidelines from the U.S Food & Drug Administration.
CLIENT MATTERS
5,000+
YEARS OF SERVICE
25+
Award Winning
Recognized in the legal industry as dedicated board-certified lawyers and Rising Stars.
Expert Team
Your project will be handled by legal experts every time. You will have the most experienced attorneys working for you.
Quality Representation
