If you call the FDA “help desk” 1-800-216-7331 and hang up with the feeling of not being helped, you are not alone. Try, for example, calling that number and asking whether the U.S. agent for the foreign facility can be an entity other than individual person (e.g. corporate entity). You will be told that you may not. Basis for such advise are Registration of Food Facilities Step-by-Step Instructions Section Seven, which requires “The first name and last name (surname) of the person acting as U. S. Agent for the foreign facility being registered.”
What about our Congress? “U.S. Agent must be a person (as defined in section 201(e) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 321(e))) that resides or maintains a place of business in the United States whom a foreign facility designates as its agent…” as stated by FDA itself in Summary Report of the U.S. Food and Drug Administration’s Initial Test of the Accuracy of the Emergency Contact. 21 U.S.C 321(e) defines “person” as follows: “The term ‘person’ includes individual, partnership, corporation, and association.”
Please be aware, that if you try to help FDA “help desk” and advise them of such law, do not expect to have them thank you.
