High-dose flushing and skin effects
At doses far above dietary intake, nicotinic acid (but not nicotinamide) causes a flushing reaction: redness, warmth, and itching of the skin, lasting 15 to 60 minutes. This is a pharmacological effect mediated by prostaglandins and occurs at supplemental or therapeutic doses typically above 30 to 50 mg, well above the few milligrams added to food. At intakes achievable from fortified food alone, flushing is not expected.
Nicotinic acid triggers cutaneous flushing via GPR109A receptor activation and prostaglandin D2 release; threshold for this effect in most adults is around 30 to 50 mg as a single bolus dose.
2014Regulatory reviewEFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Scientific Opinion on niacin
Liver effects at very high supplemental doses
Sustained high-dose nicotinic acid (typically 1,000 to 3,000 mg per day in therapeutic contexts) has been associated with liver toxicity, including raised liver enzymes and, rarely, hepatitis. These are pharmacological effects seen in clinical or supplement settings, not from niacin as added to food. The amounts present in fortified foods are several orders of magnitude lower.
Hepatotoxicity has been reported with extended-release nicotinic acid formulations at doses of 1,000 mg per day and above, with raised transaminases resolving on discontinuation.
2010ObservationalRader et al., New England Journal of Medicine
SACN concluded that the tolerable upper intake level for niacin from all sources (food and supplements) is 17 mg per day for adults to avoid flushing, while WHO/FAO upper level is 35 mg per day for nicotinic acid specifically.
2003RegulatoryScientific Advisory Committee on Nutrition (SACN), UK
Colour stabilisation use in meat (not UK-permitted as additive)
Nicotinic acid has been used in some countries to fix the pink colour of fresh meat, acting as a colour stabiliser. This use is not authorised in the UK or EU under food additive law. Its absence from Annex II of EU Regulation 1333/2008 and the UK FSA approved additives list means it cannot legally be added to food as a functional additive in Great Britain or the EU, though it may be added as a nutrient under separate fortification legislation.
E375 does not appear in the UK FSA's approved additives and E numbers list, confirming it is not authorised as a food additive under UK food law.
2024RegulatoryUK Food Standards Agency, Approved Additives and E Numbers list