Food and Drug Administration (FDA) still has a letter posted on their website advising foreign establishments to register only once: “Contrary to any suggestion by FDA Registrar Corp., food facilities should register only once. The registration does not expire.” This comment, made in response to the agent-principal agreement, fails to appreciate the contractual nature of the relationship.
21 C.F.R. Sec. 1.232(d) of the requires the registration for foreign facilities to include the name, address, phone number, and Emergency Contact phone number of the facility’s U.S. Agent. Additionally, foreign facility may authorize U.S. Agent to register the foreign facility with FDA. 22 C.F.R. Sec. 1.230. The nature of relationship between the U.S. Agent and the foreign facility can be of contractual nature, allowing one party with withdraw from the relationship. Therefore, if a party withdraws from the relationship, FDA must be notified pursuant to 21 C.F.R. Sec. 1.234(a):
“Update requirements. The owner, operator, or agent in charge must submit an update to a facility’s registration within 60 calendar days of any change to any of the information previously submitted under § 1.232 (e.g., change of operator, agent in charge, or U.S. agent), except a change of the owner. The owner, operator, or agent in charge may authorize an individual to update a facility’s registration”
Note, that the foreign facility may authorize U.S. Agent to update a facility’s registration. Thus, if contractually permitted, U.S. Agent may update the facility registration status by noting its withdrawal. The problem occurs, however, if that foreign facility did not find a new U.S. Agent 21 C.F.R. Sec. 1.232(d). It seems that not having a U.S. Agent pursuant to 21 C.F.R. Sec. 1.232(d) is a good reason for cancellation under 21 C.F.R. Sec. 1.235, and therefore a multiple registrations by food establishments.
