Guidance & Regulation

This section contains information on laws and regulations that FDA enforces, as well as guidance for industry and Federal Register documents.

Laws & Regulations

FDA enforces laws enacted by Congress and issues regulations as authorized by Congress to implement its statutory authority. The regulations can create binding obligations and have the force of law. Links to laws and regulations that FDA enforces, as well as related overviews and reference materials are posted in this section.

• Federal Food, Drug, and Cosmetic Act
• Fair Packaging and Labeling Act
• Microbead-Free Waters Act of 2015
  • Effective dates for rinse-off cosmetics: For manufacture—July 1, 2017; for introduction or delivery for introduction into interstate commerce—July 1, 2018
  • Effective dates for products that are both rinse-off cosmetics and nonprescription drugs: For manufacturing—July 1, 2018; for introduction or delivery for introduction into interstate commerce—July 1, 2019

• Regulations Related to Cosmetics, Title 21, Code of Federal Regulations
• Key Legal Concepts: Interstate Commerce, Adulterated, and Misbranded
• Prohibited & Restricted Ingredients
• Color Additives Permitted for Use in Cosmetics
• FDA  Authority Over Cosmetics
• Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
• View More Resources on Laws & Regulations

Guidance Documents

Guidance documents represent FDA’s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. Manufacturers can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Links to Federal Register documents, including notices and final rules, are also posted in this section.

• Draft Guidance for Industry: Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level
• Draft Guidance for Industry: Cosmetic Good Manufacturing Practices
• Guidance for Industry: Safety of Nanomaterials in Cosmetics Products
• Guidance for Industry: Labeling for Cosmetics Containing Alpha Hydroxy Acids
• Cosmetics Compliance Program: Import and Domestic – Guidance Manual Chapter 29
• View More Guidance Resources

Industry: Manufacturers, Packagers, Distributors and Emerging Businesses

Links to information and resources for the cosmetics industry

• Cosmetics Registration Program (VCRP)
• Cosmetics Labeling Guide
• Fact Sheet for Small and Home-Based Businesses
• Fact Sheet for Importers & Exporters
• View More Resources for Industry