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Avoiding Common Pitfalls: Tips for Complying with FDA Cosmetics Regulations


MoCRA provides new authorities to FDA including:

MoCRA establishes the following new requirements for industry:

  • FDA has the authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans, and the agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility. If a facility’s registration is suspended, it is a prohibited act to distribute or sell (or otherwise introduce or deliver into commerce) in the United States cosmetic products from the facility.
  • A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data that is already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product.  It’s important, however, that all data used to support the safety are derived from scientifically robust methods.

MoCRA also requires that industry comply with regulations that FDA will establish for:

  1. Labeling is false or misleading
  2. Label does not state
    • The name and address of the manufacturer, packer, or distributor
    • The net quantity of contents
  3. The required information is not stated prominently, with conspicuousness and in terms that it is read and understood by consumers under customary conditions of purchase and use
  4. The container or its fill is misleading