Special edition: Market insights

CPL: The changing face of the US cholesterol-lowering market

By Dr Robert Harwood, CPL Business Consultants

- Last updated on GMT

Related tags: Nutrition

Americans are more interested in functional foods than ever before – a fact that is opening doors for cholesterol-lowering food makers, says Dr Robert Harwood, principal consultant at UK-based CPL Business Consultants.

Cholesterol sits firmly at the forefront of consumers’ minds at present. Lower your cholesterol and you will reduce the likelihood of heart disease​- it’s a simple and easily understood message.

But will cholesterol-lowering food ingredients ever be serious contenders in the cholesterol-lowering market given the competition with drugs and supplements? In particular, statins have quickly risen to prominence as lowering cholesterol has become a national priority.

That market will depend on:

  • how well the ingredient works in lowering cholesterol;
  • the strength of scientific backing;
  • which label claims will be permitted;
  • how much it costs per effective daily dose;
  • its formulation versatility

A good sign for manufacturers is that cholesterol-lowering margarines have held margins of 3-4 times the price of conventional margarines, while high-fiber bread rarely obtains any premium at all.

A cost-elasticity analysis, such as the one we have developed for the US, using a broad range of retail price data, can help predict sales by sector.


According to current US National Cholesterol Education Program (NCEP) guidelines, everyone over 20-years-of-age should have a blood lipoprotein profile at least once every five years to measure total cholesterol, LDL (‘bad’ cholesterol), HDL (‘good cholesterol’) and triglycerides. At present, around one third of all Americans’ cholesterol levels are at or above the recommend maximum.

Consumer awareness data suggests there remains a lot of untapped potential in the market.

Rise of functional foods

Historically, the US ‘health’ market has been based more on supplements than functional food; consumers happily pay high prices for supplements but balk at paying even a little more for enriched foods. However, this may be changing; the recent marketing success of one-shot healthy drinks, coupled with the US accounting for 30 percent of worldwide functional product launches suggests an increased interest in food as a vehicle for healthy ingredients.

Sterols and stanols

Phytosterols and phytostanols dominate the market in a range of products from fruit juices to confectionary chews – they are well researched and were one of the first to gain an FDA-endorsed health claim.

Consumer awareness of other cholesterol-reducing ingredients such as beta-glucan has also increased (as food manufactures have re-badged oats and barley products). Indeed, cholesterol-lowering properties have boosted sales of soy-based products, especially drinks, to health conscious consumers.

Health Claims

In the US, health claims can be made under Health Claims Meeting Significant Scientific Agreement (SSA); Qualified Health Claims (QHCs) and structure/function Claims.

Cholesterol-lowering ingredients meeting SSA standards include Psyllium​ husk, beta glucan from oats and barley, soy protein and stanols/sterols. Ingredients with QHCs include nuts, omega-3 fatty acids, B-vitamins and fatty acids.

Structure/function claims are supported by an individual company’s evidence and are not pre-approved or endorsed by the FDA. A claim that an ingredient ‘lowers cholesterol’ requires FDA approval whereas the claim that and ingredient ‘helps maintain normal cholesterol levels’ can be made as a structure/function claim.

Food manufacturers want ingredients with a sound scientific basis to minimise the risk of losing consumer confidence; this is why ingredients with FDA approval dominate the market. However, there has always been some debate about what works and does not work, regardless of FDA endorsement.


Every day there are reports of new cholesterol-lowering ingredients generally coming from three sources – new research on existing products (e.g. hydrocolloids), extracts from ‘healthy’ plants (e.g. olives) and novel research (e.g. sterols and stanols).

Some of the newer cholesterol lowering ingredients include rye beta glucan, sugar beet fibre, flax, HPMC, policosanol, inulin, oligofructose, hydrocolloids including pectin, guar, konjac and gum arabic, ALA (alpha linolenic acid) and GLA (gamma linolenic acid), as well as various polyphenols.

However, one should be mindful that many studies for new ingredients are in vitro​ or have been carried out in animals; the number translating into positive human clinical trials will be significantly less.

But there is a lot of justified interest and many ingredients companies have cholesterol-lowering products at the top of their ‘wish list’ and those in the right place can capitalise on this.

To see CPL’s view on the EU market, click here​.

For more articles in this series, click here.

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