U.S. FDA Cosmetic Labeling Requirements

U.S. FDA Cosmetic Labeling Requirements

The cosmetics distributed in the U.S. must comply with the FDA labeling regulations. The U.S. FDA has strict laws regarding labeling and ingredient of cosmetics, and some cosmetic products are regulated in the U.S. as drugs. The cosmetic product laws apply to manufacturers, packers, distributors, importers, advertisers, resellers, and others in the supply chain.

Cosmetic Product Classification

Common cosmetics include perfumes, makeup, lipsticks, skin moisturizers, shampoos, deodorants and any product that is intended for cleansing, beautifying, promoting attractiveness or altering the appearance. However, cosmetic products that are intended for any therapeutic use can be classified as a drug. Such products are fluoride toothpastes and antidandruff shampoos. Many cosmetics that are drugs are sold over the counter.

Does FDA Approve Cosmetic Labels?

FDA does not approve cosmetic labeling however FDA does provide guidance documents for labeing.cosmetic manufacturers or the private labelers must ensure to comply with cosmetic labeling.

U.S. FDA Cosmetic Labeling Requirements

All cosmetics must have;

1. a statement of identity
2. net quantity of contents
3. name and place of business
4. distributor statement
5. warnings and caution statements
6. ingredients.

Labeling means all labels and other written, printed or graphic matter on or accompanying a product. The term ‘accompanying’ is interpreted broadly to mean more than physical association with the cosmetic product. It extends to posters, tags, pamphlets, booklets, brochures, instructions, websites, etc.

For additional information on the requirements of the Cosmetic Principal Display Panel (PDP) and the Information Panel (IP), Check blog post "Cosmetic Labeling, Why is it so important?"

Additional Cosmetic Labeling Regulations

If your cosmetic product can claim that it is Made in USA, the Federal Trade Commission (FTC) has regulations about labeling a product. However, Customs and Border Patrol (CBP) has regulations about how and when to place a foreign country of origin on a product labeling. In addition, All label statements must be in English. If the label contains any foreign language representation, all statements must also appear on the label in foreign language.

What Is An Adulterated Cosmetic?

Cosmetics cannot be adulterated in any way including the cosmetic ingredients or the cosmetic labeling, packing and shipping etc. A cosmetic is adulterated if:

• It has a poisonous or dangerous substance which can be harmful to consumers through standard use or the use detailed in the label.
• It contains a filthy, putrid, or decomposed substance
• It was made or packaged under insanitary conditions
• It contains a non-permitted color additive.

What Is A Misbranded Cosmetic?

Even if the product is valid, A cosmetic can be deemed to be misbranded if :

• False or misleading information,
• Lack of required information,
• Conspicuousness and readability of required information,
• Misleading packaging,
• Improper packaging and labeling of color additives, and
• Deficiencies where the Poison Prevention Packaging Act requires special packaging.

U.S. FDA cosmetics labeling regulations can be complicated and confusing. How FDA cosmetic labeling regulations apply will vary depending on your particular products.

Cosmereg’s cosmetic labeling experts can review current labels and verify if your labeling meets U.S. FDA requirements.

Our Experienced FDA Regulatory Consultants can help guide you through the maze of U.S. FDA cosmetic laws and regulations. For more information, visit our website (www.cosmereg.com) or Call us +1 646 513 2815 for the U.S. and +44 20 3318 2439 for Europe.

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