When the day of reckoning comes - and if you are in the dietary supplements trade, it's going to be some time in January, 2010 - there will be a handful of winners, and scores of losers as the European Commission finally reveals which health claims will be approved under article 13 of the Nutrition and Health Claims Regulation.While officials have been frustratingly vague about the criteria by which claims are being assessed, even the most optimistic observers are predicting Armageddon for large tranches of the supplements sector, where the evidence supporting many claims is woefully lacking.
For those selling long-chain omega-3 fatty acids, however, Armageddon can't come soon enough, says Croda Healthcare's vice president David Cherry. There are so many products currently making claims based on the flimsiest of evidence, he argues, that any legislation that forces firms to support claims with solid science before they hit the market will "put clear water" between the snake oil and the Lorenzo's oil on the market.
When it comes to nutraceuticals, omega-3s have substantially more science behind them than many of the other wonder ingredients currently piled up in EFSA's in-tray, observes Cherry, who assumed his new role in January at the tender age of 38. "There are probably five or six new papers in reputable journals on the health benefits of omega-3s every week, so just deciding which ones to cite [as supporting material for omega-3 applications under the claims Regulation] has been really hard as there is so much good research out there."
The more immediate challenge for Croda is standing out from the crowd now that every Tom, Dick and Harry has jumped on the omega-3 bandwagon in a bid to cash in on the success of the one functional ingredient almost everyone has heard of, he admits. But a crowded market represents an opportunity rather than a threat, he insists. "We are very clear about which section of this market we are competing in. We are offering high purity, highly concentrated omega-3 molecules for the quality end of the market."
Key to this proposition is PureMax, Croda's proprietary ultra-high vacuum, very low residence time, molecular distillation process - using a minimum of three molecular distillation steps - that enables bosses to produce ultra-high purity concentrates of omega-3 fatty acids such as EPA (eicosapentaenoic acid), DPA (docosapentaenoic acid) and DHA (docosahexaenoic acid).
But why is concentration such a USP?
Put it like this, says Cherry: "The percentage of EPA or DHA in fish is in the single digits. We can produce concentrations of up to 80%, which means fewer, smaller, easier to swallow capsules, and the space to add other functional ingredients as well." While large, cheap tubs of omega-3 capsules might look appealing to the uninitiated, he says, you try knocking back three large 1g fish oil capsules a day and see how long it is before you leave them mouldering away on the top shelf of your store cupboard. "Our technology enables manufacturers to produce one, half-gram capsule a day that still gives you everything you need."
As to precisely how much EPA and DHA we do need, this is a moot point, says Cherry. There is still no official recommended daily intake figure for omega-3, a fact exploited by some food manufacturers who have attempted to cash in on the health halo surrounding the ingredient by slapping 'contains omega-3' on their labels, while adding only trifling amounts to their products in order to keep costs down.
"And they get caught out, which has made some consumers quite cynical about omega-3 in foods," says Cherry. "Once you've got an RDI to work with, it's easier. It's like five-a-day for fruit and veg. Manufacturers are then able to put more meaningful terms on packs, like contains 'one of your five a day', just like cereals manufacturers do with vitamins and minerals. We need to do this for omega-3."
While recent moves by Müller to remove omega-3 from its Vitality range have been regarded by some as evidence that consumers have lost interest in omega-3, Cherry sees this merely as proof that the market needs more focus.
While cynics might regard this as a somewhat optimistic reading of the situation, the fact that omega-3 supplements are still showing double-digit growth certainly supports Cherry's view that omega-3 per se still retains consumer confidence.
Historically, Croda has avoided functional foods and focused on supplements, where punters are typically more committed and discerning. However, that may be about to change, hints Cherry. "We are talking to food manufacturers about applications although with highly concentrated omega-3s there are greater technical challenges to overcome, so the delivery system has to be right. But I'd say they are now ready to embrace potency and performance in omega-3s."
Functional foods are also the only means to access the significant numbers of consumers that, for whatever reason, just don't like popping pills, he adds.
"There is also a massive, underexploited opportunity to target people in the prime of life rather than just at the start and the end. We are very assiduous about giving our babies and children the best start in life, which is why there has been such growth in maternal and infant nutrition for omega-3s. But we don't typically start taking action again until we are in our 50s or 60s. It's at this point that the omega-3 market picks up again as cognitive function, joint health and cardiovascular health are suddenly top of mind. There is still a huge amount of work to be done to educate people about the benefits of getting omega-3s across every life stage."
As for cardiovascular health, Croda has a particularly strong position following its pioneering work into two less well-known omega-3 fatty acids: SDA (stearidonic acid) from echium plants, and DPA from salmon oil. DPA, which falls between EPA and DHA on the metabolic pathway, is particularly interesting given its ability to improve the function of the endothelial cells (which line the blood vessels) and inhibit platelet aggregation - which leads to the blood clots responsible for heart attacks and strokes.
Stearidonic acid (SDA), meanwhile, has the unique credentials of being a vegetarian source of omega-3 that is also good for your heart owing to the ease with which it is converted into the more beneficial fatty acid, EPA. Unlike ALA (alpha linolenic acid - the best known plant-sourced omega-3), our bodies convert SDA at a rate of 30% into EPA, he points out. ALA, by contrast, has a conversion rate of just 1-5%, making it "pretty useless" in comparison.
And with Novel Food approval now finally secured, Croda can now actively market SDA both in its own right but also in combination with ALA and GLA under the Incromega V3 brand.
While producers of DHA from microalgae can also make vegetarian claims, they are on shakier ground with heart health, claims Cherry, although he acknowledges that there are some studies demonstrating cardiovascular benefits from DHA in isolation. "The vast body of evidence out there on cardio health involves EPA alone or combinations of EPA and DHA."
As for claims from algal-sourced DHA producers that sourcing omega-3s from fish oil is unsustainable, Cherry is blunt: "The fish we use aren't fished to make omega-3 supplements. They are fished for animal feed and aquaculture; the omega-3s are a by-product." However, crude fish oil prices have rocketed in recent months driven by a combination of higher demand, higher energy prices involved in fish processing, and the rising price of vegetable oil, to which fish oil, bizarrely, is pegged, says Cherry. "You'd think, what has fish got to do with vegetable oil? But all these things are interconnected."
Having spent his formative years working his way up Croda's polymer additives business, suddenly having to wax lyrical about endothelial cell migration was something of a culture shock when he first joined the healthcare business in January, says Cherry, who has a degree and PhD in chemistry under his belt from Oxford University. "I've been on a pretty sharp learning curve. But the good thing about being new is that it's OK to ask stupid questions."