Steven A. Simons, Attorney at Law
9010 Corbin Ave., Suite 17B, Northridge, CA 91324| TEL 818-368-9642, 818-788-LAW1 | FAX 818-975-5032

Consumer Law Newsletter

FDA Authority Over Cosmetics

The Food, Drug, and Cosmetic Act (FDCA) defines “cosmetic” as an article intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting body structure or functions. Soap, however, is generally not considered a cosmetic.

All cosmetics sold in the U.S., whether imported or manufactured domestically, must comply with both the FDCA and the Fair Packaging and Labeling Act (FPLA). While the Food and Drug Administration (FDA) has the authority to enforce both the FPLA and the FDCA, it has limited authority to regulate cosmetics. As a consequence, consumers are cautioned to take care when using cosmetics.

The General Role of the FDA

Prior to a cosmetic’s release to the public, the FDA does not oversee its creation, nor does the FDA test the cosmetic or its ingredients. Furthermore, the FDA has no authority to:

  • Require cosmetic companies to conduct their own testing prior to release
  • Order manufacturers to register their facilities
  • Oblige manufacturers to report the ingredients used in their cosmetics
  • Compel the issuance of reports regarding injuries or health problems resulting from use of cosmetics

The FDA does encourage the testing of cosmetics, however, and maintains a voluntary data collection program for information from manufacturers relating to cosmetics. More importantly, the FDA has the right to conduct examinations and investigations of cosmetics; inspect manufacturing facilities; and seize adulterated (harmful) or misbranded (incorrectly or deceptively labeled) cosmetics. The FDA has also issued guidelines for such inspections and “good manufacturing” procedure suggestions for cosmetics.

Requirements of the Act and the FPLA

Under the FDCA, a cosmetic is deemed adulterated if it:

  • May be injurious, due to a harmful substance, to those using the product in a customary manner
  • Contains a filthy, putrid, or decomposed substance
  • Is stored in a container composed of a harmful substance
  • Is manufactured or stored in unsanitary conditions, such that it may have become contaminated or harmful to consumers
  • Is not a hair dye and contains a non-permitted color additive

Under the FPLA, a cosmetic is deemed misbranded if its label:

  • Is false or misleading
  • Fails to state the name and place of business of the manufacturer, packer or distributor
  • Fails to list all ingredients accurately
  • Does not accurately represent the procedure used to fill the package

The Role of the FDA in a Recall
The FDA, standing alone, has no authority to order a recall of any cosmetic. However, manufacturers may voluntarily recall adulterated cosmetics in response to their own findings, complaints by customers, or a request from the FDA.

The FDA evaluates the health risks associated with a cosmetic’s use and assigns one of the following classifications to indicate the degree of hazard to the public:

  • Class I: A reasonable probability of serious adverse health consequences or death from use of the product
  • Class II: The product may cause temporary or medically reversible adverse health consequences; or the probability of serious consequences is remote
  • Class III: Use or exposure is not likely to cause adverse health consequences

Once the manufacturer initiates a recall, the FDA monitors the process and provides advice and assistance. The FDA seeks to ensure that the public is properly notified and that the product is destroyed or appropriately reconditioned.

Consumers should contact the manufacturer and/or the FDA regarding problems with a cosmetic. In the event an adulterated or misbranded cosmetic reaches the public, particularly when the manufacturer does not conduct a recall, the FDA may bring a court action in federal district court and seek injunctive relief.

© 2013, Inc. All rights reserved.

  • Landlord-Tenant Law Overview
    Landlord-tenant laws govern the rights and liabilities of parties in a landlord-tenant relationship, as well as the transaction that takes place when a commercial or residential property is rented or leased. Landlord-tenant laws involve... Read more.
  • Product Liability and Design Defects
    “Product liability” is the area of the law enabling recovery for those injured by defective products. Some commentators suggest it reflects a balance between the benefits that society as a whole reaps from technological... Read more.
  • Renters Insurance Protects Possessions
    Like homeowners insurance, renters insurance may be purchased to cover specific liabilities associated with renting property. However, renters insurance lacks the same breadth of coverage. The terms, conditions, laws and regulations for... Read more.
  • ILSFDA Protects Individuals from Land Sale Scams
    Prompted by an increase in land sale scams in the 1960’s, Congress passed the Interstate Land Sales Full Disclosure Act (ILSFDA) in 1968. Administered by the Federal Department of Housing and Urban Development (HUD), the ILSFDA... Read more.
Consumer Law News Links
Share This Page: