Cuts to the Food and Drug Administration (FDA) budget by the Trump administration meant funding for the Food Contact Notification (FCN) programme was in jeopardy, according to Alistair Irvine, manager for food contact compliance at Smithers Pira.
He pointed to the presidency of George W Bush as another Republican administration under which FDA funding for the FCN system was under threat. On that occasion, the programme survived.
Cut in its taxpayer-funded budget
Some concerns were allayed when the relatively moderate Scott Gottlieb was appointed FDA commissioner in early May. Even so, by late May, the FDA was looking at the prospect of a 30% cut in its taxpayer-funded budget for 2018.
“Faced with budget cuts, it is possible the FDA may choose to prioritise bigger food risks such as bacteriological controls,” Irvine said.
If funding is not renewed on an annual basis, then the FCN programme could be lost, he warned.
“Industry would notice, because it’s a good system, which is state-of-the-art in terms of science and is proportionate to the risks. If new materials aren’t being approved, that can create a roadblock to innovation.”
Claiming exemption from the regulation
Suppliers may avoid registering products with the FDA and could instead seek clearance by claiming exemption from the regulation, Irvine suggested.
“They could do this either by claiming that migration is so low that the new substance is not a part of the food, or through the ‘Generally Recognised as Safe’ [GRAS] route to compliance.”
The risk then might be that, without the sign-off from a regulator that an FDA authorisation confers, the burden of responsibility lies with industry for ensuring that risk assessments and claims of exemption are rigorous, he added.