化妝品出口美國前必須知道的FDA認證事項|2026完整說明

Eye shadows and lip glosses, as cosmetic categories, must comply with the regulatory requirements of the U.S. Food and Drug Administration (FDA) if they are planned to be sold in the U.S. market. According to the latest regulatory developments, in particular the MoCRA Modernizing Cosmetics Regulations Act of 2022, cosmetics exported to the U.S. must complete the FDA certification/registration process. This is particularly important for products such as eye shadows and lip glosses, as cosmetics that are not FDA-certified may be at risk of being detained upon entry into the United States.

If the cosmetic products fail to obtain FDA registration before the FBA headway, it may cause the goods to be detained in the U.S. Customs. This will not only delay the launch of the product, but may also bring additional economic burden to the enterprise, such as storage costs, inspection costs, etc. In addition, frequent detention records may be flagged by the FDA system, resulting in the future of the FDA system. In addition, frequent detention records may be flagged by the FDA system, leading to more stringent scrutiny when exporting in the future, affecting the long-term development of the enterprise.

So, how should enterprises apply for FDA registration and what information do they need to prepare? FDA registration of cosmetic products is mainly divided into two parts: business registration and product registration.

1) Business Registration: Businesses need to log in to the FDA's online system for cosmetics and submit relevant company information for reporting. Once the declaration information passes the FDA's manual review and is confirmed to be correct, the company will be given a specific code.

(2) Product Registration: After completing the business registration, the enterprise can submit the product registration application in the same account.

Obtaining an FDA registration can benefit a business in a number of ways:

  • First of all, it is essential for exporting cosmetics to the United States.
  • Secondly, having FDA registration/certification can be a powerful promotional tool for your business.
  • In addition, before selling on e-commerce platforms such as Amazon and Alibaba, it is necessary to certify and test the products, which usually involves uploading information such as the registration receipt and test certificate.
  • Customers may request to see the FDA certificate before placing an order to ensure product safety.
  • Finally, products with FDA approval usually have a smoother customs clearance.

In short, for companies planning to sell cosmetics in the U.S. market, completing FDA registration in a timely manner is a critical step in ensuring a smooth export, avoiding unnecessary financial losses, and building consumer trust.

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