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Regulatory Resources

Here is a listing of useful Regulatory Resources. This page is updated from time to time to include additional resources.

Federal US Resources

Federal Food, Drug & Cosmetics Act FDA Home Page

http://www.fda.gov/Cosmeti cs/default.htm

General Regulatory Compliance

http://www.fda.gov/ForIndustry/ColorAdditives/default.htm

Federal FDA Good Manufacturing Practices Guidelines/Inspection List

http://1.usa.gov/7d7fD

FDA Voluntary Cosmetic Registration Program

http://1.usa.gov/DaTy2

FDA Statement: Is it a Cosmetics, or a Drug, or Both? (Or is it Soap?)

http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm

FDA Statement: Cosmeceutials

http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm127064.htm

FDA Statement: Organic Cosmetics

http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm203078.htm

FDA Statement: Aromatherapy

http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm127054.htm

FDA Statement: New OTC Sunscreen Regulations (6/11)
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm258468.htm#Q1_Why_is_FDA

Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices (scroll down for cosmetics)
http://1.usa.gov/nw4XO

Color Additives that are Exempt from Certification and Permitted For Use in Cosmetics
http://1.usa.gov/WOWHX

International Resources

Obelis European Authorized Representative Center, offering guidance in regard to: European product classification, Product Information File (PIF) compilation, EU pre-market notification, GMP guidance, restricted materials, nano-materials, product claims, labeling/language requirements, serious undesirable effects (SUE), and animal testing.

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