The Federal Food, Drug, and Cosmetic Act prohibits the introduction or delivery for introduction into interstate commerce of cosmetics that are adulterated or misbranded (Sec. 301).
A cosmetic may be deemed adulterated (Sec. 601) for essentially four reasons, namely:
- It may be injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance.
- It contains filth.
- It contains a non-permitted, or in some instance non-certified, color additive.
- It is manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.
A cosmetic may be deemed misbranded (Sec. 602) for reasons of:
- False or misleading labeling.
- Failure to state prominently and conspicuously any information required by or under authority of this act.
- Misleading container presentation or fill.
To determine whether cosmetic firms manufacture, hold or deliver for introduction into interstate commerce cosmetics that are adulterated or misbranded, and to prevent these and other practices violating Sec. 301 of the FD&C Act, the law gives the agency the authority to enter the establishments of such firms and inspect their facilities as well as all pertinent equipment, finished and unfinished materials, containers and labeling therein. See Sec. 704(a) of the FD&C Act.
Rigorous adherence to good manufacturing practice minimizes the risk of adulteration or misbranding of cosmetics. The following cosmetic establishment instructions, excerpted from FDA's Inspection Operations Manual, may serve as guidelines for effective self-inspection. A good inspection score means that an establishment follows good manufacturing practice.
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