What Should We Consider When Exporting Our FDA Regulated Products to the US?

By Victoria Pankovich

Each month EAS experts answer one question sent in by readers of EASeNews. This month’s question, on considerations for a reliable US Agent, is answered by Victoria Pankovich, Regulatory Specialist, who assists EAS clients with US Agent requirements. If you would like to ask a question of our experts contact us here.

Question: As a firm operating outside of the US, what criteria should we consider when choosing a reliable US Agent for exporting our FDA regulated products to the US?

Pankovich: While most foreign companies engaged in exporting products to the United States understand their regulatory obligation to appoint a US Agent to liaise with the US FDA, what many may not understand is the business benefits that can be gained by working with a professional and reliable US Agent. You should look for a US Agent, who is a proactive partner that can provide guidance on FDA regulations, assist in electronic and paper submission actions and who understands the organization, structure and authorities of the US FDA.

US Agents can be single individuals, or they may be named individuals as part of a larger organization such as the case of consulting firms, like EAS, that provide not only a US Agent service but other regulatory support services as well. The latter provides a depth of capability that allows a firm to be prepared for any eventuality when dealing with the FDA.

Simply put, a US Agent acts as a liaison between the FDA and the foreign company for purposes of communication. This is important in many instances, for example, the case of submitting a food ingredient, medical device or pharmaceutical product application. It is critical for the FDA to have a US-based contact to which they can address any questions or requirements needing clarification prior to the product going to market.

In addition to this basic function, it is not only prudent but extremely beneficial to choose a U.S. Agent with regulatory strength that can assist with any importing issues should they arise. FDA inspects products as they arrive at the US border. Products may be detained for any number of reasons – from lack of prior notice, to product labeling that does not meet US specifications, to products shipped from facilities without an active foreign facility registration or low-acid canned food registration. In the case of detained products, expediting the receipt of required information from the Agency and responding with the missing documentation in a timely manner is critical. Keep in mind, the FDA only allows a certain, generally small, window of time within which to respond to their inquiry. Products waiting for US entry cost manufacturers time and money and a proactive US Agent who understands how to navigate the many bureaucratic layers in order to quickly provide answers to the FDA or US Customs Border Patrol is imperative for business flow.

The FDA copies US Agents on notifications of facility and FSVP inspections. US Agents such as EAS, that possess a broad understanding and capability in all areas of FDA regulatory compliance, can often assist with preparing for these inspections by reviewing documentation and / or conducting a mock-inspection so that plant managers and staff will know what to expect when the Agency arrives. In some cases, a firm may wish to have a consultant familiar with the Agency and their inspection process on site during the inspection itself. After the inspection, should the Agency find violations that need to be addressed, a US Agent knowledgeable in FDA regulations should be able to help the firm makethe needed corrections to bring themselves into full compliance with FDA requirements.

When considering a US Agent, ask important questions to help determine the level of service and competence they will be able to provide. You should also consider how comfortable you are with the clarity of their communications and their ability to represent your firm and its objectives to the FDA, they are after all going to be seen as an extension of your organization. Are they able to meet the most basic requirement of having a named US-based point of contact for US FDA communications? Does the US Agent have the technical know-how to assist with gathering important information in the event of a detained product or a question posed by the Agency? Do they have direct experience in helping firms prepare for a US FDA inspection? Should you wish, are they able to be present and provide support during the US FDA inspection? In the event of a detained product, does that US Agent understand how to interpret the Agency’s requests for documentation so that correct responses can be quickly provided?

EAS provides US Agent assistance with our vast network of independent consultants who specialize in various product areas. We invite you to learn more about our US Agent services on our webpage. Regardless of whether you choose EAS to act as your US Agent, we do recommend that you watch our free on-demand video which discusses the roles that US Agents play. If EAS can answer any questions please feel free to contact us. It is an easy matter to officially change your appointed US Agent.

Posted in 2019, 2019 September, Ask the Expert, EASeNews and tagged .