The US Food and Drug Administration (FDA) has unveiled its system requiring food manufacturers to report potential problems with their products, online, within 24 hours. While designed to quickly identify and warn the US government, and then consumers, about issues with unsafe food, international law firm Freshfields Bruckhaus Deringer says the new system risks confusing consumers and will have wider repercussions for multinational food manufacturers, who could struggle to reconcile their obligations under differing EU and US regulations.
The new system, an electronic database where manufacturers must notify the FDA if there is a reasonable probability one of their products is likely to cause sickness or death in people or animals, is intended to combat the traditional lag in the reporting of food safety issues, and has been conceived as a means of refocusing the US food safety system on prevention.
However, Freshfields food lawyer Tom Snelling, says the 24 hour system will create dilemmas for large food manufacturers who may be forced into making notifications with an absence of adequate information and proper risk assessment due to the tight FDA timeframe.
He says, ‘Potentially, we have a system that may throw up too many unnecessary red lights because in reality, a large, multijurisdictional food manufacturer may not know the extent to which they have a problem in a 24 hour timeframe, even when taking a precautionary approach. If they report a potential issue, which turns out to be a false alarm, it will create an unnecessary scare which could then be further exacerbated by regulators sharing data immediately on a global basis.’
‘The sharing of data by regulators before proper risk assessment has been completed has serious strategic implications for any manufacturer involved in a product crisis. It requires rapid analysis of regulatory requirements wherever the food is sold, which is supported by sophisticated media and consumer information strategy that extends beyond those countries that are subject to the potential issue,’ he says.
Snelling says that the uncertainty surrounding the ‘reasonable probability’ test now applied by the FDA risks encouraging hurried notifications would have the potential to cause reputational damage from issues that, in the end, do not require government notification and which could then force redundant action from manufacturers on a global scale.
He says: ‘The challenges that the 24 hour online reporting may create for consumers when trying to conduct their own risk assessments about food are increased by the fact that regulators are applying a different criteria of when food is considered ‘unsafe’. A classic example of this is the fact that the EU allows, in certain cases, a limited presence of Listeria monocytogenes in dairy products throughout their shelf-life while the US continues to apply a zero tolerance approach. Basically, the same food sold to the same type of consumer will result in very different regulator reactions. There are plenty of grey areas and these need to be sorted quickly.’
He concludes: ‘The intention of the rules is to protect the consumer from serious health threats, but this is not advanced if the effect of the law is to discourage product testing by food manufacturers.’