FDA Agent Service for Cosmetics

For cosmetic manufacturers outside the U.S., appointing a FDA Agent is not optional—it’s a legal requirement. Sobel acts as your trusted representative, connecting your company with the FDA and supporting every step of compliance.

For who?

Count on Sobel as your FDA Agent and maintain full FDA compliance, with seamless communication and representation for your cosmetic business in the American market.

Why do you need this service?

FDA requires every foreign cosmetic establishment to appoint a U.S.-based representative; without one, you cannot register or import products.

A FDA Agent ensures quick and accurate responses to FDA inquiries, reducing compliance risks and avoiding penalties.

Representation guarantees continuity, keeping your company informed and compliant even without local staff in the U.S.

From Appointment to Compliance

Appointing a FDA Agent is a legal step for foreign companies. Sobel ensures your appointment is compliant, efficient, and recognised by the FDA.

Partner with a professional team that protects your business relationship with the FDA.

Appointment contract

We handle the formal steps to appoint Sobel as your recognised FDA Agent before the FDA.

Communication facilitation

We receive and respond to FDA inquiries on your behalf.

Inspection support

We coordinate with the FDA for establishment inspections.

Regulatory updates

We assist with establishment registration and product listing updates.

Related
Services

Sobel supports by managing all FDA-required communications, inspection scheduling, and regulatory follow-up.

Also, our FDA US Agent service is often combined with:

Gap Analysis

Pre-registration review of cosmetic documents to identify gaps and guide compliance.

Safety Substantiation

Compilation of safety data to support cosmetic product compliance with MoCRA requirements.

Cosmetic Registration

Cosmetic Registration and Product Listing according to the FDA regulamentations.

Count on Sobel as your U.S. FDA Agent

Don’t risk delays or non-compliance when entering the U.S. cosmetics market. Let Sobel act as your U.S. FDA Agent!

With Sobel as your official FDA Agent service, you gain a trusted partner for representation, communication, and regulatory alignment.

Still have questions? Checkout our FAQ

1. Is appointing a FDA Agent mandatory?

Yes. Under FDA regulations, every foreign cosmetic manufacturer and distributor must appoint a U.S.-based representative. Without one, your products cannot be registered or imported into the United States, which blocks market access and creates compliance risks.

2. Does the FDA Agent replace the company in regulatory matters?

No. The FDA Agent does not take over your regulatory obligations but serves as an official communication channel with the FDA. This ensures that important notices, inquiries, or inspection requests reach your company quickly and are handled properly.

3. How long is the appointment valid?

The appointment is typically established through a formal agreement with your chosen FDA Agent. As long as the agreement is active, Sobel acts as your legally recognised representative before the FDA, covering all communication and inspection coordination.

4. What happens if the FDA cannot reach my company directly?

If the FDA is unable to contact your foreign establishment, they will send notices or documents to the appointed FDA Agent. Legally, this is considered the same as delivering them directly to you, which makes choosing a reliable partner essential.

5. Does Sobel also manage product registrations?

Sobel’s role as FDA Agent is focused on communication and representation before the FDA. However, Sobel can also support your company with other services—such as facility registration, product listings, or MoCRA compliance!