Health Care Newsletter
The Role of the FDA in Regulating 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.
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