2002N-0276 - Small Entity Compliance Guides on Registration of Food Facilities and Prior Notice of Imported Food; Availability
FDA Comment Number : EC367
Submitter : Dr. Chris Rabenda Date & Time: 05/19/2004 08:05:58
Organization : Baskets & Botanicals
Food Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
We operate a small but growing gift basket business in Ontario, Canada. While we registered early in the new year in compliance with the new FDA regulations, we have since that time stopped all shipments to the U.S.

Our gourmet food baskets, which we have in the past shipped to about a dozen different states for both corporate and private clients, are severely impacted by the new regulations. The additional costs of compliance are simply too onerous to be passed on to our clients.

Firstly, there is the annual cost of $750 for retaining the services of an agent in the U.S. Secondly, there is the cost of filing of prior notice on each basket shipment which we have been advised would be a minimum of $20 per basket. When these costs are added to the already significant costs of shipping, plus the fact that we have to factor in the exchange rate on agent services provided in the US, the result is extra charges to our clients which invariably exceed the purchase price of the client's original order.

When we first became aware of the new regulations, we undertook a survey of our clients to determine the degree to which they were willing to pay additional charges. Much as we expected, our clients were virtually unanimous in their refusal to incur such added costs. As a result we have advised our clients that we would no longer be shipping food baskets to the U.S.

We are hearing now that alternative basket choices like those including spa or bath and body products will be subject to similar restrictions.

The net effect of the regulations is that they make it prohibitively expensive for us to continue to do business in the U.S. While the filing of prior notice is something that we could elect to do ourselves, the fact that every individual item in the basket must be documented makes the time factor for doing so as onerous as the cost factor.

We are particularly exasperated that some of the products which we use in our gourmet baskets and have originally been imported into Canada from the U.S., through other Canadian wholesalers, seem to be inadequately labelled. This means, in effect, that some food products which we buy from the U.S. cannot be shipped back because the information contained on the package is not sufficiently complete to comnply with the prior notice filing requirements.

It also seems curious to us that food items made by individuals in their own kitchen are exempt from the filing requirements. In our opinion the risk of biohazard threat or other health risk is much lower from items which have been properly processed in compliance with existing food industry standards than with food items made with virtually no supervision.

We remain hopeful that some compromise can be found between the need to protect public safety in your country and the degree of burden imposed
on businesses like ours which already struggle to survive.

We appreciate the opportunity to comment.