Special edition: heart health

Regulation: Science-backed cardio claims quicken sector’s global pulse

By Shane Starling

- Last updated on GMT

Related tags: Fatty acid, Food and drug administration, Epa

Regulation: Science-backed cardio claims quicken sector’s global pulse
In part four of this NutraIngredients heart health special we look at how regulators view those foods, drinks and supplements making cardiovascular claims

It’s no secret that regulators around the world are cracking down on health claims that are not backed by the most robust and specific science, and heart health claims are no exception. But what the sector has in its favour is a level of science that is more robust than most especially in regard to the so-called big four: Plant sterols and stanols, omega-3s, beta-glucans and soy protein.

All of these nutrients have won authorized cardio claims of one persuasion or another, in one jurisdiction or another, approvals that have helped the sector grow to a state of “rude health”​ as Stephen Daniells noted in yesterday’s market summary​. Almost $11bn of rude health according to Leatherhead estimates (in selected major markets in 2009).


But challenges lie ahead. Both the sterol coronary heart disease (CHD) unqualified claim and the qualified omega-3 CHD claim are under FDA review and may lead to major changes in the kind of claims being made; claims that have helped omega-3 supplements become true blockbuster items in supplement aisles.

Just this week existing phytosterol/stanol players breathed a sigh of relief when the Food and Drug Administration (FDA) announced it was extending by a year an ‘enforcement discretion’ period for mooted changes that are set to widen the range of foods and drinks phytosterol ingredients can appear in (on the face of it good), but which may also force a labelling and formulation sea-change if minimum dosage levels rise, as suggested from 400mg to 500mg (less good).

“Irreparable injury,” ​to the sector is how Cargill described the proposed changes if they go through as are.

The Omega-3 claim is being reviewed to take account of the science that has emerged since it was approved in 2004, with industry insiders predicting the current level of 32mg of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) to bear “excellent source”​ of omega-3 claims may be increased.

Trade group GOED (Global Organization for EPA and DHA Omega-3s) has concurrently been lobbying the US Institute of Medicine (IOM) to establish a recommended daily allowance for omega-3 EPA/DHA with a minimum level of 500mg theorized.

Looking further down the FDA page for unqualified health claims and you find a soy-CHD claim (25g/day); soluble fiber (that includes beta-glucan at 3g/day).

In addition to omega-3, approved qualified claims include nuts, B vitamins, monounsaturated fats from olive oil, unsaturated fatty acids from canola oil and corn oil. But rejected heart claims include green tea, omega-3 eggs and vitamin E.


In Europe all claims are under scrutiny from the European Food Safety Authority (EFSA). In a strict system, heart health claims again have come off fairly well.

Beta-glucans won a positive opinion that suppliers have been rejoicing over that backs its ability to fight cholesterol levels, although it is yet to be written into EU law books. However a sterols/stanols cholesterol-fighting claim is law and being utilised by the likes of Unilever and Benecol.

Omega-3 too has gained EFSA backing for its heart science and DHA should be able to claim maintaining normal (fasting) blood concentrations of triglycerides”​ in all 27-member states come year’s end. Both EPA and DHA will be able able to make claims about their importance to “normal cardiac function”.

However the soy ingredients received a blow last year when a soy protein cholesterol-lowering claim was turned down because EFSA said demonstrated cholesterol-lowering effects could have been caused by soy isoflavones, or something else in soy other than its protein content.

The industry is in the process of a resubmission to correct the problem for a claim approved in Japan, the US, the UK, South Africa, the Philippines, Brazil, Indonesia, Korea, Malaysia and Turkey.

Other nutrients to receive EFSA backing in heart health include vitamin B12 and guar gum, but hydrolysed guar gum, green tea, gamma-linolenic acid (GLA), C12-peptide, stearic acid and vitamin D have all received negative EFSA opinions.

Some of these pending rejections as with the approvals, or variations of them, are already granted at member state level and have been in use for some time.

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