Food and supplements manufacturers have until the end of March to comment on proposed Food and Drug Administration regulations under the Bioterrorism Act that would require companies to register and notify the FDA of food shipments to be imported into the United States.

Under the proposal, FDA must be notified by noon the day before the imported food arrives at the US border or port of entry. FDA anticipates an average of 20,000 'prior notices' every day.

"Everyone in the food and dietary supplements business must make understanding their obligations a top priority," said Tony Young, general counsel for the American Herbal Products Association. "Any company importing raw materials or products needs to set up systems so that these regulations can be complied with once they become final."

All US facilities engaged in 'manufacturing, processing, packing, or holding of food for consumption' must register with FDA by December 12. More than 400,000 companies will be forced to register. Non-US facilities are exempt if food from the facility undergoes further processing or packaging by another foreign facility before it is exported to the US. However, if the processing or packaging activities of the subsequent facility are limited to affixing labels to a package or other minimal activity, both must register.

Non-US producers are worried about the implications for their business. "The logistics sound enormously complicated," said Anthony Bush, chairman of the European Federation of Associations of Health Product Manufacturers. "We are deeply concerned that this new legislation may create a barrier to trade between the two continents. We must ensure that there is some international debate on this and that the requirements are both reasonable and acceptable for manufacturers of food supplements."

The proposals can be accessed, and commented upon, at www.fda.gov/oc/bioterrorism/bioact.html.