United States

The US government's so-called 'war on terrorism' could have far-reaching consequences both real and unintended for the functional foods industry. The Bio-Terrorism Act is intended to minimise the risk of food being subjected to tampering or criminal or terrorist actions.

All manufacturers and distributors that export food ingredients, supplements and animal feed into the US face FDA registration and potential 30-day detention of adulterated products under the bill. Domestic companies also must register.

The registration process, which must be completed by December 2003, requires the owner, operator or agent in charge of a domestic or foreign facility to submit an application. Foreign facilities are defined as those that manufacture, process, pack or hold food to be exported to the US. Importers in the US will also have to register food-holding premises.

The procedure for the products themselves is not expected to be costly or intrusive—probably just filling out a one-page form detailing the products and ingredients to be shipped into the country, according to Anthony Young, partner in Piper Rudnick, a Washington, DC, law firm. But while it sounds simple, Young has some concerns.

"It's going to be a problem because there may be a disruption of trade just by the sheer volume of notifications and the way they'll be handled," he said.

The most significant change is the FDA's new 'administrative detention authority,' which has never been directed toward the food or supplements industry before, although the pharmaceuticals industry has had to comply since 1972.

"This certainly expands FDA's inspection authority of records and product seizure authority—they call it 'administrative detention'," said Michael McGuffin, president of the American Herbal Products Association. "This language—which has no footnote whether anything's the result of terrorist activity—clearly gives FDA authority to look at paperwork if they have a reasonable belief a product has adverse health consequences. There is a concern the possibility of detention authority could be interpreted more broadly than Congress intended," he said.

www.fda.gov/oc/bioterrorism/bioact.html