FORM FDA-2511 Registration of Cosmetic Product Establishment - fda-2025

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Qualifications of Applicant for Notification Local company responsible for placing the cosmetic product in the market must has a valid License-to-Operate (LTO), such as AZ Registration, prior to application.
However, before diving into the business of beauty products, its crucial to understand the regulatory landscape and whether you need a license to sell cosmetics online. The short answer is yes, you typically need a license to sell cosmetics, even in the online realm.
FDAs Voluntary Cosmetic Registration Program (VCRP) is a reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.
Do I need to have my cosmetic products or ingredients approved by FDA? The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market. However, cosmetics must not be adulterated or misbranded.
The ingredients (except certain colors) and labeling of cosmetics, such as many perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations do not require FDA approval.
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While not all products require pre-approval by the FDA, the FDA still has regulatory authority in the event of public safety concerns. The FDA has regulatory authority in the event of a public safety issue related to your product.
The good news is that unlike drugs, cosmetics in the US dont require pre-market approval from the FDA. This means you can launch your brand without waiting for FDA green light. As a cosmetic brand owner, youre responsible for ensuring your products are safe.

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