United States

More than a year after it was enacted, the US Public Health Security and Bioterrorism Preparedness and Response Act of 2002 will become fully functional on December 12, after which all foodstuffs and dietary supplements entering the US must meet Food and Drug Administration requirements or risk quarantine.

Conceived in the wake of September 11, it is estimated the new law will affect more than 400,000 US and international businesses in the food and supplements industry, although uncertainty about its operation mean its direct and indirect cost to industry has not been ascertained. It requires, among other things, the registration of domestic and foreign food facilities that manufacture, process, pack, transport, distribute, receive, hold or import food or food supplements for human or animal consumption.

"These are very serious rules and the FDA is very serious about enforcing them. It?s crunch time," said the US-based National Nutritional Foods Association?s director of legislative affairs, Kim Smith. She was confident the laws would not be over-burdensome if companies acted quickly and studiously. "US companies should communicate with their international partners to make sure they are up to speed on this."

Loren Israelson, president of LDI Group, a consultancy to the dietary supplements industry, was less optimistic. "At least seven government authorities have co-authority on this. The Customs Service, Postal Service, USDA, and FDA, among others. Are they going to be able to co-ordinate? It doesn?t look like it. You may get an enquiry on the same shipment from five government agencies. That?s a burden."

The UK-based Food and Drink Federation expressed similar concerns. "We are not quite sure if the new Act and existing customs regulations are going to be compatible," said its press officer, Kate Snowden. "The registration process may be low cost but if goods are held up there are likely to be significant costs and we want to make sure this does not happen without proper justification and transparency."

Israelson advised US companies to be prepared for interruptions in supply. "You might want to inventory a little more heavily before the law kicks in, in case your goods get held up or a container load of goods carrying your stock gets held up," he said. "The FDA has X-ray machines that can scan whole containers at once. If you?re dealing in botanicals, for example, you might want to consider the way they are being shipped as this kind of treatment may damage your goods." He added: "Companies will have to work closely with their suppliers to ensure there are no reasons for FDA to assert their new and broadened definition of adulteration against incoming foods and dietary ingredients."