A FDA spokesperson confirmed that the "decision date for omega-3 will now be August 17 as the documents are still in clearance with the FDA." Providing there are no objections a decision will then be taken.
Scott Van Winkle, managing director of Adam, Harkness & Hill, thought that giving omega-3 the green light could be one of the most significant decisions of 2004 for the functional foods industry, opening the way for further health claims.
"We have in the US right now a much more favorable environment for the FDA to activate health claims than we had in the past," said Van Winkle.
Of all the functional food ingredients available, the future looks most promising for omega-3 polyunsaturated fatty acids (PUFAs), particularly in the US, according to recent research by consultancy firm Frost & Sullivan.
The research commented that while the more mature European omega-3 PUFA market was likely to stabilise at an annual growth rate of eight percent, some key market participants in the US are experiencing growth rates of over 20 percent.
Kathy Brownlie, an industry analyst from Frost & Sullivan, explained omega-3 has such growth potential because of the health benefits it is regularly purported to bring.
"Increased media coverage and product availability have helped differentiate omega-3 and omega-6 PUFAs from saturated fats, promoting omega-3 PUFAs as 'good fats', which are an essential part of the diet," she said. "Most industry experts agree that more omega-3 PUFAs need to be incorporated into our diets."
Scientific evidence is growing to substantiate the role of omega-3 PUFAs not only for protecting heart health but also prevention of cancer and other diseases.
The ingredient is moreover seeing support from low-carb diets such as Atkins, which promotes omega-3 fatty acids as part of their eating plans.
On Thursday (1 July) PBM Pharmaceuticals (PBM) will bring a new omega-3 product to the market when it launches Animi-3 at a conference entitled "Increased Consumption of Omega-3 Fatty Acids may lower the risk of Cardiovascular Disease, Dementia, and Inflammatory Disease" at Weill Medical College of Cornell University in New York.
Animi-3 contains folic acid, vitamins B6 and B12, as well as pharmaceutical grade, DHA (docosahexaenoic acid)dominant omega-3 fatty acids.