U.S. FDA Cosmetics Labeling Requirements
The U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines 'labeling' as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.
The United States has strict laws regarding ingredients and labeling of cosmetics, and some cosmetic products are in fact regulated in the U.S. as drugs. Registrar Corp's Label and Ingredients Review Service helps companies comply with U.S. FDA's extensive labeling requirements by cross-referencing your labeling against thousands of pages within the Code of Federal Regulations as well as the Federal Register, VCRP Cosmetic Ingredient Dictionary, Guidance Documents, the U.S. FDA Labeling Manual, and Warning Letters issued by U.S. FDA. Registrar Corp's label review service provides:
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- A detailed report (typically 30-40 pages) prepared by our team of Cosmetics Regulatory Specialists who scrutinize each element of your labeling (including inner packaging, outer packaging, website, etc).
- A print-ready graphic file of your revised label which incorporates recommended changes.
- A generous revision policy providing additional reports for your revised food label within 90 days at no extra cost.
- Optional reporting assistance to comply with the California Safe Cosmetics Program, which requires any manufacturers, packers, and distributors identified on the cosmetic label to file a list of all their cosmetic products that contain any ingredients identified as known or suspected to cause cancer, birth defects, or adverse developmental or other reproductive toxicity, including colors and fragrances.
- Since failure to comply with the California Safe Cosmetics Program is a criminal offense, Registrar Corp also offers a free year of monitoring during which your product's ingredients will be cross-checked with the growing California list of reportable ingredients.
Learn how FDA cosmetics labeling regulations apply to your cosmetics >>
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U.S. FDA Regulations:
U.S. FDA Cosmetic Labeling: 21 C.F.R. Part 701 et seq.; 15 U.S.C. Chapter 39
Fee:
Cosmetic Labeling Review: US$1495/label
Discounts are available for multiple products. |
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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