2004D-0065 - Guidance for Industry: Questions and Answers Regarding the Interim Final Rule on Prior Notice of Imported Food (Edition 2); Availability
FDA Comment Number : EC11
Submitter : Mr. Arthur Ponsonby Date & Time: 06/10/2004 05:06:14
Organization : San-Ei Gen F.F.I., Inc.
Food Industry
Category :
Issue Areas/Comments
Under the current Prior Notice regulations, when consumer food products are sent to the US for business purposes, the manufacturer FDA facility registration number is required. However, if such products are for individual consumption, or are sent as gifts from one individual to another, the manufacturer FDA facility registration is not required. With regard to the manufacturer FDA registration number requirements, we wish to propose that food products sent to the US for business purposes other than that of resale are treated in the same manner as food products sent by individuals.

Under the current rules, a company must obtain the FDA registration number of the manufacturer in order to ship that company products into the US. If a US company wishes to evaluate a food product marketed abroad, particularly is the manufacturer of that product is a rival, the possibility that the manufacturer would not disclose the registration number is high. We believe the regulation as it stands would have a major adverse effect on the abilities of American companies to gather market intelligence on food products marketed in overseas markets.

Risk Assessment:
In developed countries, food products are manufactured for to be safe for consumers. In cases where contamination occurs, legal and voluntary mechanisms are in place to recall products that are a danger to public health, in almost all cases before consumers can be exposed to the dangers. Therefore, mass-marketed products that reach outlet shelves can in general be considered as safe.
While it is impossible to entirely preclude the possibility of criminal tampering with products on supermarket or convenience store shelves, the risk of tampering is almost negligible.
At the very least, the risk of contaminated or tampered product being sent from business to business for internal purposes is certainly no more than that for such a product being sent as a gift from one individual to another.