The EU crackdown on health claims is unlikely to impact on US regulators, but it could provide ammunition to opportunistic plaintiffs’ attorneys this side of the Atlantic, experts have warned.
US firms will face tough questions when the list of general function claims permitted in Europe is finalized this year and it becomes clear that the vast majority of structure/function claims made in the US are regarded as unsubstantiated in the EU, said K&L Gates attorney Tony Pavel.
Pavel, who was speaking at the IFT Wellness 2012 conference in Chicago, said the tough line on general function - or ‘article 13.1’ - health claims taken by the European Food Safety Authority (EFSA) could create issues this side of the Atlantic.
After five years of legal wrangling, just a handful of structure/function-type claims looks set to be approved in the EU this year, mostly related to vitamins and minerals. But scores of others – including most claims about probiotics and weight management ingredients – have been given the thumbs down.
Could plaintiffs’ attorneys in the US start trawling through negative EFSA opinions?
And if an expert scientific panel in Europe has scrutinized these claims and come to the conclusion that they are not supported by the evidence, its conclusions could be a very useful resource for attorneys preparing class action lawsuits in the US, noted Pavel.
“I haven’t seen negative EFSA opinions referred to yet in class action complaints here, but there could certainly be a lot of ammunition there for class action cases.
“The regulations [on health claims] here in the US won’t change, but when it comes to class actions, plaintiffs’ attorneys may well start looking very closely at what is happening in Europe.”
I suspect there will be a rippling effect
Fellow speaker Dr Kathy Musa-Veloso, associate director at consultancy Intertek Cantox, said it would not surprise her if lawyers started quoting from EFSA negative opinions in class action complaints.
Indeed, food and supplement manufacturers this side of the Atlantic will face very difficult questions when it emerges that scores of claims made here have been scrutinized in Europe and found lacking, she said.
“People will ask: How can something be not supported by science in the EU but fine in the US? I suspect there will be a rippling effect.”