Buyer questions · Use scenarios
Launching a skincare product (serum or cream) in the United States: what does the OEM factory need to prepare, and how long does notification take?
US skincare products require no pre-market approval or ID number under the MoCRA framework. Factories must complete mandatory facility registration and product listing via FDA's Cosmetics Direct portal. Preparation of responsible person details, INCI labels, and adverse event tracking is essential. Once listed, the product is legally sellable; timelines depend on document readiness rather than an official regulatory review period.
1Mandatory MoCRA Documentation
Requires complete INCI lists, a designated U.S. responsible person, and safety substantiation records. Facilities must maintain an adverse event reporting system and record-keeping protocol active as of July 2024.
2Cosmetics Direct Listing Timeline
FDA's Cosmetics Direct portal has no fixed review wait time. Submissions pass instantly upon document completion, though manufacturers should reserve time for potential FDA verification or additional information requests.
3Labeling & E-commerce
Labels must comply with 21 CFR 701. Prohibited to claim 'FDA Approved' on packaging or listings. Platforms like Amazon require listing data to exactly match regulatory filings to prevent delisting.
Follow-up questions
- Q:Is there a MoCRA exemption for OEMs?
- A:If not selling directly, OEMs don't qualify for the small business exemption but must complete mandatory facility registration.
- Q:Does FDA approve individual ingredients?
- A:No, standard ingredients aren't pre-approved by FDA, but they must not be on FDA prohibited lists and require safety substantiation.
Figures sourced from:各国法规 · 美国美国护肤代工FDA 化妆品禁用与限用成分、色素添加剂配方库
Updated 2026-09-18
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