What are the steps and timeline for FDA registration under the Voluntary Cosmetic Registration Program for Indonesian cosmetics sold in the United States?

Dokumen yang perlu Anda siapkan untuk pendaftaran dan kepatuhan kosmetik di Amerika Serikat di bawah MoCRA (bukan lagi VCRP). Saya kelompokkan per tahapan agar mudah dipakai sebagai panduan kerja.

1) PRA-REGISTRASI

(Sebelum membuka akun dan mengisi portal FDA)

A. Data Perusahaan & Responsible Person (RP)
1. Legal Entity name (sesuai akta)
2. Alamat lengkap (kantor pusat & operasional)
3. Kontak: telepon, email, website
4. Nama penanggung jawab (regulatory contact)
5. Alamat/kontak di AS (jika tidak punya, biasanya menunjuk US agent/distributor)

B. Data Fasilitas ( di dalam/luar AS)
1. Nama fasilitas (pabrik, repacker, atau (packer)
2. Alamat dan negara
3. Jenis aktivitas (manufacturing, processing, packing, repacking)
4. Denah alur proses (SOP ringkas)
5. Sertifikasi (jika ada: ISO 2276, GMP, Halal, dll).

Jika menggunakan jasa kami sebagai Pengacara perusahaan anda, maka kami dapat melanjutkan Dokumen-dokumen yang perlu anda siapkan. Mohon hubungi kami terlebih dahulu melalui Lawzana.

Dear client,

In the United States, cosmetic facility registration and cosmetic product reporting are voluntary and are not mandatory marketing authorizations such as the cosmetic notification required in Indonesia.

However, following the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), the FDA has encouraged facility registration and product listing (beyond the former Voluntary Cosmetic Registration Program/VCRP). Although such registration is not always explicitly mandatory for all small operators, in the context of international trade practice, this registration is highly recommended.

To be marketed or distributed (including manufacture for export purposes), cosmetic products are required to obtain a marketing authorization in the form of a BPOM Notification, pursuant to Article 4 paragraph (1) of BPOM Regulation No. 21 of 2022.

For many export purposes, importers may require a Certificate of Free Sale (CFS) to be provided.

Under FDA law, cosmetics that are considered “misbranded” (non-compliant labeling) or “adulterated” (containing hazardous substances or contaminants exceeding permitted safety limits) may be subject to refusal of admission at the port of entry, detention, market recall, and may trigger inspections of foreign manufacturing facilities.

The responsible party in the United States (importer/distributor) may be subject to civil or criminal enforcement actions under U.S. federal cosmetic laws.