Navigating Cosmetic Regulations in the United States

1. Governing Body:

• 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:

• Voluntary Cosmetic Registration Program (VCRP):
  • Cosmetic registration is not mandatory, but manufacturers are encouraged to file their formulations through the VCRP.
• Pre-Market Approval:
  • Cosmetics do not need pre-market approval, except for color additives.

4. Labeling and Ingredient Disclosure:

• 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).
• 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.