Niacin | whatsinit

About

What it is and where it shows up.

Niacin (vitamin B3) is a water-soluble essential B vitamin encompassing nicotinic acid, nicotinamide, and related derivatives such as nicotinamide riboside; all tissues convert it to the coenzymes NAD and NADP, which are required by more than 400 enzymes for cellular energy metabolism and redox reactions. It is added to staple foods and supplements to prevent pellagra-type deficiency and to enrich processed grains.

Safety summary

The regulatory and scientific consensus.

At normal dietary and food-fortification levels niacin is safe and recognized as GRAS by the US FDA (21 CFR §184.1530) with no limits beyond cGMP; however, pharmacological doses of nicotinic acid (≥500 mg/day) can cause skin flushing, hepatotoxicity, impaired glucose tolerance, and—as shown in the AIM-HIGH trial—an increased risk of ischemic stroke when added to statin therapy. The EU Scientific Committee on Food set a tolerable upper intake level of 10 mg/day for nicotinic acid from supplements and fortified foods, and 900 mg/day for nicotinamide; the US Institute of Medicine UL is 35 mg/day (adults). Sensitive populations including those with liver disease, diabetes, or gout should exercise caution with high-dose supplemental use.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Listed as E375 (nicotinic acid). The EU Scientific Committee on Food (SCF, 2002) established a tolerable upper intake level of 10 mg/day for nicotinic acid from supplements and fortified foods (natural food sources excluded); UL for nicotinamide is 900 mg/day. Approved as a permitted nutrient source under Regulation (EC) No 1925/2006 on the addition of vitamins and minerals to foods. EFSA NDA Panel confirmed its role in energy-yielding metabolism (EFSA Journal 2014;12(7):3759).source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Permitted as nicotinamide or nicotinic acid for food fortification under FSS (Fortification of Foods) Regulations, 2018; fortification level for rice and cereal-based foods is 1.3–2.6 mg per 100 g. In health supplements and nutraceuticals, the maximum permitted level is 1 RDA per day (ICMR RDA: ~16 mg/day for adults) under FSS (Health Supplements, Nutraceuticals…) Regulations, 2016. Regulated as a nutrient under FSS (Food Products Standards and Food Additives) Regulations, 2011.source
FDA (Food and Drug Administration) (United States)	Approved	Niacin is GRAS as a direct human food ingredient at current Good Manufacturing Practice levels under 21 CFR §184.1530; no food-use upper limit is codified by FDA. The tolerable upper intake level of 35 mg/day (adults, from supplements and fortified foods only) was established by the Institute of Medicine and is used as a reference for supplement labelling. Daily Value for nutrition labelling is 16 mg.source

Who should approach with care

Whose guidance would steer them away.

Liver Disease — High-dose nicotinic acid supplementation is associated with hepatotoxicity; individuals with pre-existing liver conditions should seek medical guidance before using niacin-enriched products or supplements.

Diabetes — Pharmacological doses of nicotinic acid can impair glucose tolerance and worsen glycaemic control, as documented in clinical literature reviewed by the NIH ODS.

Gout — High-dose niacin supplementation can elevate serum uric acid levels, potentially precipitating gout flares in susceptible individuals.

Heart Disease — The AIM-HIGH randomized trial found that extended-release niacin (1,500–2,000 mg/day) added to statin therapy did not reduce cardiovascular events and was associated with increased ischemic stroke risk, as reported by the NIH ODS.

Pregnancy — High-dose niacin supplementation beyond the established RDA is not recommended during pregnancy without medical supervision, as the safety of pharmacological doses in pregnancy has not been fully established.

Research citations

The sources behind this verdict.

1FDA. 21 CFR §184.1530 – Niacin (GRAS direct food ingredient). ecfr.gov
2other. Niacin – Health Professional Fact Sheet (NIH Office of Dietary Supplements). ods.od.nih.gov
3FSSAI. Food Safety and Standards (Fortification of Foods) Regulations, 2018 – Compendium (Version III, 2021), 2021. fssai.gov.in
4EFSA. Scientific Opinion on Dietary Reference Values for niacin, 2014. efsa.europa.eu
5EFSA. Tolerable Upper Intake Levels for Vitamins and Minerals: Nicotinic Acid and Nicotinamide (Niacin) – SCF Opinion, 2006. efsa.europa.eu

Independently researched5 citations