The tough line on general function - so-called ‘article 13.1’ - health claims taken by the European Food Safety Authority (EFSA) is already creating ripples this side of the Atlantic, according to Dr Kathy Musa-Veloso from consultancy Intertek Cantox.
“And when it becomes obvious that the vast majority of general function claims made in the US are regarded as unsubstantiated in the EU, it’s going to prompt a lot more debate", added Musa-Veloso, who was speaking to NutraIngredients-USA ahead of a conference dedicated to structure/function claims designed to help firms stay on the right side of the law.
“People will ask: How can something be not supported by science in the EU but fine in the US?”
Would a pre-market approval system be more effective?
While the new pre-market authorization system for health claims in Europe has provoked a storm of controversy – EFSA has given the thumbs down to all but a handful of claims – it has at least clarified exactly what is permitted, said Musa-Veloso.
In the US, by contrast, food and drink manufacturers in particular had far less clarity over what substantiation was needed to support claims, yet were operating in a far more litigious environment, she said.
“Regulations are explicit for dietary supplements in that you can’t claim to diagnose, treat, cure or prevent disease, and must add a disclaimer stating the FDA has not evaluated your claim. You must also be able to prove – if challenged – that your claims are supported by ‘competent and reliable scientific evidence’ – although this is not very clearly defined in the guidance. In FTC case law, the standard of two well-controlled studies has been cited several times, but this is not written into the guidance formally.”
No formal guidance for S/F claims substantiation on foods and drinks
For conventional food manufacturers, by contrast, no substantiation standard applicable to structure/function claims had been defined and no formal guidance had been issued, she said.
While this might sound appealing, it left many firms confused about exactly what was required and what might trigger enforcement action, she added.
Meanwhile, less responsible players seemed to think they could get away with saying whatever they wanted provided they stuck to phrases such as ‘helps maintain’ and avoided words such as ‘treat’, ‘cure’ or ‘prevent’ on pack or in ads, said Musa-Veloso.
“It’s a very risky strategy, because the cost of settling a class action lawsuit is often far more than you would have to pay to put together a couple of decent clinical studies in the first place.
“It is also clear that a lot of supplement companies are not notifying the FDA about claims they are making, even though they are legally required to do so.”
She added: “The health claims Regulation in Europe has wreaked havoc on the industry, but there are people that think a pre-market approval system is what we need in the US too.”
What really triggers enforcement actions?
Speakers at the one-day symposium on November 2 in Arlington, Virginia, include Federal Trade Commission (FTC) assistant director of advertising practices Richard Cleland and Food and Drug Administration (FDA) supplements chief Dr Daniel Fabricant, plus experts from Intertek Cantox.
Fabricant and Cleland would be asked to clarify substantiation standards for structure/function claims, how they should be applied to dietary supplements and foods, what lessons could be learned from FDA warning letters and FTC case law and what triggered enforcement actions, said Musa-Veloso.
As regulators didn’t have the resources to proactively investigate every new product or claim, officials presumably had to adopt a selective approach or rely on third parties to alert them to problem claims, she said.
“What triggers enforcement actions? Is it the wording of claims? Is it complaints? Is it the target population of the claim or the product category, that is, food or dietary supplements?”
Structure/function claims describe the role of a dietary ingredient in the normal structure or function of humans, for example: ‘calcium builds strong bones’.
Click here to find out more about the symposium.