Article: Navigating Cosmetic Regulations in the United States
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Navigating Cosmetic Regulations in the United States
1. Governing Body:
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Food and Drug Administration (FDA):
- The FDA is the main regulatory body for cosmetics sold in the USA.
- The FDA regulates cosmetics under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).
2. Definition of Cosmetics:
- According to the FD&C Act, cosmetics are intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions.
3. Registration and Approval:
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Voluntary Cosmetic Registration Program (VCRP):
- Cosmetic registration is not mandatory, but manufacturers are encouraged to file their formulations through the VCRP.
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Pre-Market Approval:
- Cosmetics do not need pre-market approval, except for color additives.
4. Labeling and Ingredient Disclosure:
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Ingredient Labeling:
- Ingredients must be listed in descending order of quantity.
- Scientific names are often used based on the International Nomenclature of Cosmetic Ingredients (INCI).
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Claims:
- Cosmetic claims must not be false or misleading.
- Claims affecting the structure/function of the body may classify the product as a drug.
5. Prohibited and Restricted Ingredients:
- The FDA has regulations concerning the use of certain ingredients.
- A list of prohibited and restricted ingredients can be found on the FDA's website.
6. Good Manufacturing Practices (GMP):
- Cosmetics must be manufactured in accordance with GMP.
- This includes sanitation standards, quality control, and record-keeping.
7. Adverse Event Reporting:
- Manufacturers are encouraged to report adverse events to the FDA.
- The FDA monitors such reports to identify potential safety concerns.
8. Imported Cosmetics:
- Imported cosmetics must comply with FDA regulations.
- They are subject to inspection at the port of entry.
9. Organic and Natural Claims:
- The USDA regulates organic claims through the National Organic Program (NOP).
- Natural and other marketing claims should comply with the Federal Trade Commission (FTC) guidelines for truth-in-advertising.
10. Cruelty-Free and Animal Testing:
- There is no specific law banning animal testing in cosmetics.
- However, alternative testing methods are encouraged.
Additional Resources:
- FDA Cosmetics - Main page for cosmetics regulations and guidelines.
- VCRP - Information on the Voluntary Cosmetic Registration Program.
- CFSAN Adverse Event Reporting System (CAERS) - Database for adverse event reporting.