Regulation: inching beyond implied health claims

As previous articles in this series have demonstrated, the antioxidant area is incredibly diverse in both sources and potential health benefits.

It is also marked out as an area of relatively emerging science, and it is for this reason, scientific agencies and regulators have not exactly been forthcoming with antioxidant-based health claims.

In most places, nutrition claims are all that is permitted – those claims that reference the presence of antioxidants but make no mention to free radical scavenging, skin, heart or any other antioxidant benefit that has showed some significant results in the scientific literature.

As Leatherhead Food Research’s head of regulatory services, Mary Gilsenan PhD, observes: “There is a lot of science coming out in relation to health benefits and it could be said that in some places the regulatory situation is not quite singing from the same hymn sheet,” ​she said.

“Although the science says one thing it is not quite clear if claims will be approved. So there is a lot of ambiguity.”​

Compensating for this claims-making ambiguity is the many years antioxidants have spent in the media spotlight. Before omega-3s and probiotics there were antioxidants, that were for a time picked up as the darlings of the health and nutrition consumer press.

The broad public got to know about antioxidants and some of their benefits and in this way the very mention of antioxidants on-product is an implied health claim related mostly to boosted immunity and heart health to swathes of consumers.

This reality means the 2006 European Union nutrition and health claims regulation includes the term of antioxidant as an implied health claim, although no particular health benefit is specified.

More specifically, vitamin C was linked to cell and DNA protection in a generic article 13.1 opinion from last year. A selenium claim for similar benefits has also been approved.

But no herbal antioxidant claim has yet been approved with the likes of astaxanthin drawing negative opinions from the European Food Safety Authority (EFSA). Nor has any antioxidant-heart health claim won a positive verdict.

EFSA has about 400 antioxidant claims on its books and has completed work on about 190 opinions due for publication this month. These opinions relate to the likes of hops, ginkgo biloba, ginseng, green tea and other herbal extracts. Watch this space.

“If some of these don‘t get the thumbs it will affect claims-making in the EU,”​ said Gilsenen.

Japan may have the most specific, user-friendly claims in the world. There approved claims link vitamin C and maintaining skin mucosa and anti-oxidisation. Vitamin E is linked to protecting fat in the body from oxidisation and maintaining cell health.

The US has approved antioxidant cancer risk reduction claims but they are heavily qualified, perhaps beyond the point where they are that useful to companies, which have tended to opt for structure-function claims instead.

Typical disclaimers include: “​Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”​

Products can bear ‘antioxidant inside’ claims if they contain 20 percent of Institute of Medicine (IOM) recommended levels of, for example, 2000mg for vitamin C and 1000mg for vitamin E.

In Brazil lutein, lycopene, and zeaxanthin can claim to protect cells against free radicals.

In China, vitamin E and C can claim to possess “antioxidant properties”​ but nothing more.

But all eyes for now will be on Parma, Italy, where EFSA is about to produce the largest batch of opinions about antioxidants ever produced.

Those opinions will be felt globally.

The subject of antioxidants and health claims will be discussed in more detail at the upcoming NutraIngredients Antioxidants 2010 Conference​. For more information and to register, please click here​.