The Łódź-headquartered firm applied for novel food approval for 1-Methylnicotinamide chloride (1-MNA) with the UK Food Standards Agency (FSA) back in May 2013.
Although the UK safety opinion was positive, several member states later raised concerns and as a result it has now fallen to EFSA to take a second look.
The vitamin-based substance made from nicotinamide is already used in anti-irritation skin creams marketed to ‘repair and regenerate’ skin.
In the diet, 1-MNA can be found in low levels in foods such as brown seaweed Undaria pinnaatifida and green tea leaves, but the human body is mainly exposed to the substance as a product of the metabolism of the B vitamin niacin.
In its original application to the FSA, the company said it expected the powder ingredient would be used by adult and elderly people in products marketed for circulatory health.
According to Euromonitor International, heart health was the fourth most important positioning for food supplements in Western Europe in 2015, bringing in retail sales of $528.8m (€474.55m).
In Eastern Europe it had a retail value of $122.4m (€109.84m).
The company says the substance could be used to reduce risk factors related to the progression of atherosclerosis – whereby plaque builds up inside the arteries. It said this worked by protecting normal function of the blood vessels' lining endothelium, lowering risk of vascular impairment caused by high cholesterol and stimulating endothelium-dependent repair responses and organ protection.
While the UK novel food committee concluded that proposed daily doses of 58 mg were unlikely to present a health risk to consumers, it “strongly supported” Pharmena’s commitment to post-market monitoring of potential adverse effects.
“The Committee has suggested, and the applicant agreed, that children and pregnant women should not take the product as insufficient data on its safety in these groups is available.”
Yet in the Commission's request for EFSA to take a second look it said "several" member states had later raised objections.
The company did not respond to our requests for comment in time for the publication of this article.