Niacin

What Is It?

Niacinamide and Niacin are a forms of vitamin B3. In cosmetics and personal care products, Niacinamide and Niacin are used in bath products, shampoos, hair tonics, skin moisturizers and other skin care preparations, and cleansing products.

Why Is It Used?

Niacinamide and Niacin enhance the appearance and feel of hair, by increasing body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment. When used in the formulation of skin care products, Niacinamide and Niacin enhance the appearance of dry or damaged skin by reducing flaking and restoring suppleness.

Scientific Facts

Niacinamide is also called nicotinamide. Nicotinc acid is another name for Niacin. These ingredients are different forms of vitamin B3. Niacin is an essential nutrient required for normal metabolism. The U.S. Recommended Daily Intake (RDI) for Niacin is 20 mg. Niacinamide may also be used for the treatment of high cholesterol. Niacinamide is found in many foods, including yeast, meat, eggs, milk, green vegetables and cereal grains.

Safety Information

The Food and Drug Administration (FDA) includes Niacinamide and Niacin on its list of direct food substances affirmed as Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.). Both ingredients are also GRAS as nutrients and/or dietary supplements. The safety of Niacinamide and Niacin has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR 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.

CIR Safety Review: The CIR 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 CIR 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 CIR 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 UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

More Scientific Information

Niacinamide and Niacin are heterocyclic aromatic compounds also known as vitamin B3. Both compounds are water soluble. In cosmetics and personal care products, these ingredients function primarily as a hair conditioning agents and skin conditioning agents.

Resources

Medline Plus http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-niacin.html

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/