EFSA OKs new source of niacin for supplements

By Lorraine Heller

- Last updated on GMT

Related tags: Niacin, B vitamins

The European Food Safety Authority (EFSA) has found that inositol hexanicotinate is a safe source of niacin in food supplements, but cautions that safe upper limits must not be exceeded.

Niacin – or vitamin B3 – is used in many supplements as it helps the body to convert carbohydrates into sugar. It is also used in drugs fighting high cholesterol and diabetes.

Following a request from the European Commission, EFSA’s Scientific Panel on Additives and Nutrient Sources added to Food examined the safety and bioavailability of inositol hexanicotinate (inositol hexaniacinate) as a source of niacin in supplements.


The panel confirmed that inositol hexanicotinate is absorbed intact and hydrolysed in the body, releasing free nicotinic acid and inositol. Gastrointestinal absorption of inositol hexanicotinate varies widely, with an average of 70 per cent of an orally ingested dose absorbed into the bloodstream.

It is metabolized slowly, with nicotinic acid levels reaching a peak approximately 6-10 hours after intake. This compares to intake of free nicotinic acid plasma, where levels peak after 0.5-1 hour.

Based on the studies reported, EFSA conclude that nicotinate from inositol hexanicotinate is bioavailable and a source of niacin.


Although no genotoxicity data are available on inositol hexanicotinate, EFSA said this does not raise any concerns as the compound is hydrolysed to inositol and nicotinic acid, which are endogenous compounds and occur in several dietary products.

Safety evaluations of nicotinic acid include an examination by the Scientific Committee on Food (SCF) in 2002, which established a Tolerable Upper Intake Level of 10 mg/day.

In addition, the Expert Group on Vitamins and Minerals (EVM) has established that a dose of 17 mg nicotinic acid/day, for supplementation only, would not be expected to have any significant adverse effects.

As a result, EFSA’s panel concluded that inositol hexanicotinate is a safe source of niacin in supplements “provided that use levels are in compliance with the defined upper safe use level for nicotinic acid (10 mg/day)”.

However, the panel said it was concerned that the use levels of inositol hexanicotinate proposed by the petitioners are 40 and 495 mg/day, which provide levels of nicotinic acid that are 4 to 45 times higher than the tolerable upper intake level.

Vitamin B market

Despite the hurdle of rising costs, a strategic analysis of the European Vitamin B Market by Frost & Sullivan said the market was worth €415m in 2005. This is anticipated to grow to €901m by 2012, equivalent to a compound annual growth (CAGR) of 11.7 per cent for the sector.

Analysts at the firm said the growth of B-complex vitamins was being driven by a consumer interest towards self-medication.

The B vitamins act as coenzymes in numerous biochemical reactions in the body. They are essential for proper growth and maintenance of cells, tissue and organs.

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