Regulatory Acceptance of Nicotinamide Riboside and TRU NIAGEN®

United States 

  • FDA GRAS no objection for Niagen (nicotinamide riboside chloride) on August 05, 2016 
  • FDA NDIN no objection for Niagen (nicotinamide riboside chloride) on November 03, 2015 
  • FDA NDIN no objection for Niagen (nicotinamide riboside chloride) on March 07, 2018 

Canada

To search for ChromaDex licensed NHPs, visit https://health-products.canada.ca and then select License Holder in the search field and enter ChromaDex as the criterion.

  • Natural Health Product (NHP) License for TRU NIAGEN finished product on October 30, 2018
    • NPN 80088977 – Dose: 125 mg capsules, up to 375 mg/day 
  • Natural Health Product (NHP) License for TRU NIAGEN finished product on May 29, 2019
    • NPN 80092547 – Dose: 150 mg capsules, up to 900 mg/day
  • Natural Health Product (NHP) License for TRU NIAGEN finished product on May 28, 2019 
    • NPN 80092534 – Dose: 300 mg capsules, up to 900 mg/day
  • Natural Health Product (NHP) License for TRU NIAGEN finished product on June 07, 2019 
    • NPN 80092742 – Dose: 300 mg stick packs, up to 300 mg/day
  • Natural Health Product (NHP) License for TRU NIAGEN finished product on August 26, 2021
    • NPN 80092742 – Dose: 500 mg capsules, up to 500 mg/day

European Union (EU)

  • European Food Safety Authority (EFSA) issued a positive opinion of nicotinamide riboside chloride as a novel food on August 07, 2019
  • Authorization for placing nicotinamide riboside chloride on the market by the European Commission in the Official Journal of the European Union on January 10, 2020
  • Nicotinamide riboside chloride was officially included in Annex II of the Food Supplements directive as a permitted Niacin source on March 10th, 2021 and can be used in food supplements across the EU.
  • The EU Commission Regulation 2023/1165 entered into force on June 1, 2023, allowing for the extension of use for nicotinamide riboside chloride as a novel food ingredient for the below listed uses.
    • FSMPs (excluding pregnant and lactating women) in accordance with the particular nutritional requirements of the persons for whom the products are intended
    • Total diet replacement for weight control for the adult population, excluding pregnant and lactating women: max level: 500 mg/day
    • Meal replacements for the adult population, excluding pregnant and lactating women: max level: 150 mg/meal (maximum 2 meals/day up to a maximum of 300 mg/day)
  • Member State notification information can be obtained from the Regulatory Affairs team.

Australia

  • The Therapeutic Goods Administration (TGA) authorized a positive listing for nicotinamide riboside chloride as permissible ingredient in Complimentary Medicines (allowing for use in supplements) in November 2019.
    • Dose: 300 mg/day (230 mg/day in pregnant and lactating women)
    • #3458
  • TRU NIAGEN® was listed on the TGA’s Australian Register of Therapeutic Goods (ARTG) as a Complementary Medicine on January 08, 2020 
  • Food Standards Australia New Zealand (FSANZ) added nicotinamide riboside chloride to Schedule 29 of the Food Standards Code as a form of niacin for use in Food for Special Medical Purposes (FSMPs) on November 3, 2021. A specification for nicotinamide riboside chloride was also included in Schedule 3 of the Code at the same time.  

Last Updated: 10/24/2023

Niagen® (nicotinamide riboside chloride), has achieved virtually unprecedented regulatory acceptance in key markets around the world. Niagen® has been successfully reviewed twice under the US Food and Drug Administration’s (FDA) New Dietary Ingredient Notification (NDIN) program, was successfully notified to the FDA as Generally Recognized As Safe (GRAS), approved as a Novel Food Ingredient by the European Commission, and approved as a permissible ingredient in Complimentary Medicines by the Therapeutic Goods Administration of Australia. As a finished product Tru Niagen® has received approval as a Natural Health Product by Health Canada for 4 different product types. These approvals and acceptance by the world’s leading authoritative regulatory bodies is a clear, unequivocal recognition of the quality of the science, the safety of the ingredient, and the reproducibility of the production process. Please see below for more information on market-specific regulatory status.

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Brazil

  • The Brazilian Health Regulatory Agency (Anvisa) authorized the inclusion of nicotinamide riboside chloride in medical foods on December 8, 2021.

United Kingdom

  • The UK Nutrition, Labelling, Composition, and Standards (NLCS) policy group listed nicotinamide riboside chloride as a form of niacin on UK Statutory Instrument 2019 No. 651 Schedule 2, vitamin and mineral substances which may be used in the manufacture of food supplements in January 2023. The amendment went into force on February 23, 2023.

Turkey

  • The Turkish Ministry of Health (MOH) authorized nicotinamide riboside on the Supplementary Foods Substance List on August 9, 2018. The list can be found here.