Cardiovascular Health Claims

According to the United Nations, every year 1.3 million people are killed on the roads. The same organization reports that, annually, 1.8 million people die from AIDS. Those numbers, however, pale into insignificance beside the World Health Organization’s prediction that by 2030, some 23.6 million people will die every year from cardiovascular disease (CVD). In Europe alone, deaths from CVD each year are already running at more than four million-almost half of all deaths.

It came as no surprise, therefore, when Euromonitor reported that in 2009 global sales of heart-healthy foods and beverages reached $3.2 billion and are expected to reach $4.4 billion by 2014. Meanwhile, data from the Innova Database show that product launches positioned on a heart-health platform have nearly tripled over the past five years.

Awareness of the dangers is unquestionably growing among consumers, who are becoming increasingly committed to managing the risk, and they’re being more than ably helped by the ingredients industry.

“The heart-health market will continue to offer significant opportunities for growth and the commercialization of new ingredients,” says Joseph Evans, PhD, manager of pharmacology for Stratum Nutrition (St. Louis). “The heart-health market encompasses products designed to reduce cholesterol, blood pressure, or inflammation-oxidative stress-or to increase blood flow or increase heart energy. The reduction of cholesterol is the most popular and well-established segment, while the others should be viewed as emerging segments.”

Cassie France-Kelly, director of corporate communications at Martek Biosciences (Columbia, MD), claims that heart- and gut-health products have “exploded” onto the market. “Heart health resonates well with consumers both young and old, driving growth in the segment and making it an attractive area for new product development,” she says. “This has been bolstered by the wealth of studies supporting heart-healthy ingredients. For example, omega-3 is well known for its cardiovascular health benefits, and there have been high levels of innovation using the ingredient.”

Cholesterol and Beyond

As the industry is quick to acknowledge, “heart health” is multifaceted-facets include not only cholesterol, but circulation, blood pressure, salt reduction, weight management, and so on-and, as such, a broad spectrum of functional ingredients has been developed to address each aspect.

“Ingredients that address emerging biomarkers for heart health, such as endothelial function and blood flow, also show potential,” says Paul O’Mahony, business development manager at Glanbia Nutritionals (Monroe, WI).

Theodor Graser, MD, PhD, vice president of marketing at DSM Nutritional Products Europe (Basel, Switzerland), marketer of the cardio-health ingredient Fruitflow, also explains that lowering cholesterol isn’t the only target. “There are three major risk factors associated with cardiovascular disease: increased cholesterol, increased blood pressure, and increased platelet aggregation,” he says.

“A number of ingredients target cholesterol and blood pressure levels, but the launch of Fruitflow marks a new scientific breakthrough. Its proprietary technology creates the only functional food ingredient addressing platelet aggregation. By occupying a new space on the market, Fruitflow offers manufacturers massive potential for consumer heart-health products.”

The market for healthy heart ingredients is there, as is a broad range of ingredient solutions. All that remains, it seems, is that food manufacturers be allowed to communicate the heart-health benefits of their products to consumers.

“This expanding market, and the claims attributable to such ingredients, mean that the legislative environment has an important part to play,” says Olivier du Châtelier, business development manager at Cargill Health & Nutrition EMEA in Europe. “It’s worth remembering that, within the European Union, risk assessment and risk management are two separate processes. The European Food Safety Authority [EFSA] takes responsibility for the former; the latter falls to the European Commission, acting on the basis of EFSA’s expert opinion.

“Regarding beta-glucans and plant sterols, EFSA has issued positive scientific opinions in respect of their ability to maintain normal cholesterol levels, while acknowledging that there is clinical evidence pointing to their cholesterol-reducing properties. These scientific opinions are significant steps towards enabling an Article 13 health claim to be made in the European Union.”

Adrian Meyer, sales director at CreaNutrition (Postfach, Switzerland), believes we are seeing a fundamental change in the way companies deal with innovation in sectors related to health communication, leading to fundamental changes in marketing strategies.

“The science that supports claims is becoming ever more crucial,” he says. “Understanding and interpreting the current regulatory environment and developing creative, imaginative, and focused thinking on the future regulatory landscape are now essential.” He is well placed to comment: in December, EFSA issued a positive Article 14 opinion on CreaNutrition’s Oatwell oat beta-glucan.

An EFSA First

DSM is another company to have fared well at the hands of EFSA. “Fruitflow shows great potential for cardiovascular health applications,” says Graser. “This is the first natural, scientifically substantiated solution for healthy blood flow, and it was the first ingredient with an approved health claim from the European Food Safety Authority. The ingredient works by keeping blood platelets smooth to avoid aggregation inside blood vessels.”

In other instances, though, EFSA has proved more of a test. “One of the biggest challenges facing the functional ingredients industry as a whole is the health-claims process,” says Martek’s France-Kelly. “In order to leverage the benefits of a ‘heart healthy’ claim, manufacturers will be expected to use EFSA-approved ingredients.”

She adds that EFSA has permanently changed the European regulatory landscape for all ingredients that provide a health benefit. “Although there is concern within the industry about the number of negative opinions issued, progress is being made on the cardiovascular ingredient front,” she says.

“For example, DHA [docosahexaenoic acid] omega-3 has received a positive opinion that states a cause-and-effect relationship was established between the consumption of DHA and the maintenance of normal (fasting) blood concentrations of triglycerides for heart health-offering the potential for more specific on-pack health claims. Looking forward, it will be important for ingredient manufacturers and EFSA to keep an open relationship in order to better navigate the complicated process.”

In the United States, says Glanbia’s O’Mahony, structure-function claims in CV health and weight management are generally allowed, with appropriate clinical substantiation. “In Europe, EFSA regulations remain challenging, and ingredient manufacturers hoping to make claims have to produce sufficient substantiation to get EFSA approval,” he says.

However, Linwood Riddick, vice president of marketing at Ocean Nutrition Canada (Dartmouth, NS, Canada), sees reasons to be optimistic. “We are looking forward to several events in 2011 that should lead to an improved regulatory environment for omega-3 products,” he says. “In North America, we expect that the Institute of Medicine will initiate a review of omega-3 intakes, which will, ultimately, lead to the establishment of an official DRI (Dietary Reference Intake) for EPA [eicosapentaenoic acid] and DHA in the United States and Canada.

“In the EU, we [saw the] completion of the Article 13 health-claims process for non-botanical ingredients. By the end of June 2011, all omega-3 claim applications should have cleared review by EFSA and the EU member states. This will enable the long-awaited publication of a list of EU-approved Article 13 health claims.  Together, these events will continue to propel the significant growth seen yearly in the omega-3 market.”

This article first appeared in our sister publication, International Food Ingredients magazine. IFI is the authoritative European publication on the food ingredients market.