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FDA cosmetic regulations

Summary of FDA Cosmetic Regulations

fda cosmetic regulations

Before implementing the Cosmetic Modernization Act (MoCRA), cosmetic products were regulated by two critical regulations: the Federal Drug and Cosmetic Act and the Fair Packaging and Labeling Act (FPLA).

The new MoCRA regulation requires facility registration and product listing, additional labeling requirements, and GMP compliance.  However, before the MoCRA Act was passed, the Voluntary Cosmetic Registration Program (VCRP) was in place. Now, the FDA has stopped accepting VCRP registrations. 

Even though cosmetic products do not require prior approval, they must comply with several requirements per the FDA Cosmetic Regulations.

What are  FDA  Compliance Requirements for Cosmetics

  1. Label compliance, such as the name of the responsible person, professional use, and contact information for adverse event reporting. The FDA is also developing labeling requirements for allergen declaration on the label.
  2. Facility Registration and Product Listing 
  3. Safety Substantiation
  4. Good manufacturing practice (GMP Compliance)

 

The colors used in cosmetic products require approval from the FDA, and a list of FDA-approved color additives can be found on their website. Cosmetic facilities must also register with the FDA under the MoCRA Act, and the person responsible for them should list all the products. Cosmetic product registration and listing require biennial renewal.

 

The colors used in cosmetic products require approval from the FDA.

 

FDA has also published the list of prohibited ingredients in cosmetic products; apart from this list, several states have their list of banned ingredients. The state of California has Proposition 65 List, which contains list contains a wide range of naturally occurring and synthetic chemicals that are known to cause cancer, birth defects, or other reproductive harm.

 

FDA does not approve the cosmetic products or labels. Also, the cosmetic registration under MoCRA does not denote FDA approval. However, FDA may take enforcement action against adulterated and misbranded products.

 

Companies must know all the applicable regulatory requirements for their cosmetic products to avoid enforcement action by the FDA.

 

FDAbasics can help your company to understand and comply with cosmetic regulations. If you have any questions, get in touch with us.