The Role of the US FDA Agent for Cosmetics, OTC and Drug Products

If you’re a foreign manufacturer of Cosmetics and OTC medications and prescription drug products, appointing a US Agent for FDA purposes is crucial. But what exactly does a US FDA agent do?

First of all check here the difference between a cosmetic, OTC and Drug products

The FDA US agent acts as FDA’s primary contact for the foreign cosmetics or drugs manufacturer as it relates to the foreign cosmetics industry. Unlike other regions, an FDA US agent, who is a private person or firm, is not responsible for any registrations for the foreign company. This means it’s not a registration holder similar to other regulatory systems.

FDA Agent Qualifications

The US agent must be a resident of the United States or running and maintaining a business in the state. Keep in mind that a US agent isn’t allowed to use a post office box as a physical address. In addition, they cannot use an answering service alone. They must be available or have a representative on standby to answer the phone during regular business hours.

FDA US Agent Responsibilities

Apart from being a primary contact, an FDA agent serves many essential roles for a foreign manufacturer or distributor. Some of the duties they fulfill include:

• Bridging communications between FDA and the foreign establishment
• Answering questions regarding the foreign firm’s products that are imported or planning to be imported to the United States
• Scheduling inspections of the foreign establishment with the FDA
• Receiving documents in behalf of the foreign establishment in the event that FDA is unable to contact them directly
• Managing import holds or refusals from the FDA

These tasks may sound pretty easy, but FDA processes are strictly time-sensitive. In most cases, the FDA allows only less than seven days to respond after the notice has been served. A professional US FDA Agent will not only submit the notice to the foreign facility on a timely basis but will also be able to suggest the best options to respond.

Our expert FDA Regulatory Consultants is here to help you meet, if not exceed the guidelines of U.S. FDA cosmetic laws and regulations. If you’re in need of a professional US agent for FDA purposes, contact us through email.