The Food and Drug Administration (FDA) includes niacinamide and niacin on its list of direct food substances affirmed as Generally Recognized As Safe (GRAS). Both ingredients are also GRAS as nutrients and/or dietary supplements. The safety of niacinamide and niacin has been assessed by the Expert Panel on Ingredient Safety. The Expert Panel evaluated the available scientific data and concluded that niacinamide and niacin were safe in the current practices of use and concentration in cosmetics and personal care products.
The Expert Panel considered niacinamide and niacin sufficiently similar to combine the available data and reach a conclusion on the safety of both cosmetic ingredients. Overall, the available information suggested that niacinamide and niacin were both non-toxic. These ingredients were not significant skin irritants, and were not skin sensitizers or photosensitizers. These ingredients were also not associated with the development of clogged pores. The Expert Panel recognized that certain formulations were marginal to slight ocular irritants and recommended that the industry be aware of this and formulate products to prevent ocular irritation. Niacinamide was not a reproductive or developmental toxin, and has been shown to reduce the toxicity of some known reproductive or developmental toxins. Niacinamide and niacin were not mutagenic. A study of niacinamide alone indicated that it was not carcinogenic. Based on the available data, the Expert Panel concluded that niacinamide and niacin were safe for use in cosmetics and personal care products at the reported practices of use and concentration.
FDA: Link to the Code of Federal Regulations for niacinamide
Link to the Code of Federal Regulations for Niacin
Niacinamide and niacin may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.
Link to the EU Cosmetic Regulation: