New Study finds Nicotinamide Riboside safe at typical dosages

safetyA clinical study was published January 2016 on the safety and side effects  of Nicotinamide Riboside in the HET Journal (Human and Experimental Toxicology), an international peer reviewed journal.

Although naturally occurring in trace amounts in some foods such as milk and beer, Nicotinamide riboside (NR) is a recently discovered form of vitamin B3. It is being studied for a wide range of potential health benefits due to it’s ability to increase NAD+ levels in human and animal testing.

NAD+ is a co-enzyme found in all animals that enable the mitochondria to perform their role in powering the basic functioning of every cell in our bodies. NAD+ levels naturally drop as we age and is thought to be a key driver in many age related diseases and health problems.

Prior research has shown that increased NAD+ levels in older mice results in improved energy and muscle performance similar to that of young animals.

This study was performed using Niagen, which is the only commercially available brand of Nicotinamide Riboside (NR). They also compared the effects of NR with that of similar dosage of Nicotinamide (also referred to as niacinamide) , a more common and better studied form of B3 vitamin with a long record of safe usage.

In the first phase of the study, mice that were fed 5000 mg per kg of bodyweight exhibited no mortality.

The second phase was a 90 day assessment comparing dosages of 300, 1000, and 3000 mg/kg of bodyweight per day.

Researchers compared the effects on liver, kidneys, ovaries, and testes and found no toxicity at any of the dosages tested.

Their was no adverse effects noted at the 300 mg level. Minor effects at 1000 and 3000 mg levels were similar to that of Nicotinamide.

There are  guidelines used by the FDA to translate the dosages used in mice to the equivalent dosage for the Human Equivalent Dose (HED).

The 300 mg/kg dosage equals 48mg/kg HED, which would be approximately 2880 mg a day for a 132 lb human, which is well over the dosage recommended. However, the FDA requires a 10x safety factor which would result in a dosage of 288 mg, which is at the lower end of recommended dosage.

Comparing results on animals given NR vs Niacinamide, the researchers concluded that NR has a similar toxicity to niaciniamide.

Niacinamide has a long track record of safe use in humans, and is rated as LIKELY SAFE at normal dosages. At dosages above 3 grams per day, Niacinamide can result in serious side effects including liver problems, gout, vision, elevated blood sugar, and other serious problems.

3 grams of Niacinamide per day equals roughly 7 grams per day of Nicotinamide Riboside.

Based partly on the results of this study, Chromadex was able to obtain GRAS status for Niagen.

Niagen (Nicotinamide Riboside) recognized as GRAS (Generally Recognized as Safe)

The company called ChromaDex Corporation, an innovator of nutritional and health ingredients, announced that an independent scientific panel of experts determined that NIAGEN , a patented formula of Nicotinamide Riboside (NR) is Generally Recognized As Safe (GRAS). 

Generally recognized as safe (GRAS) is an American Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.

It is a very strong testimony that Nicotinamide Riboside supplementation is safe without side effect. It should be noted here that the GRAS status was only given to Chromadex’s commercially available form of nicotinamide riboside (NR) called Niagen. This formula is protected by five patents issued and several pending and so far it appears this is the only NR form that is known to be commercially available. Hence when buying NR it seems prudent to ensure oneself of the source to avoid buying false formula’s.

Frank Jaksch Jr., founder and CEO of ChromaDex, commented, “Receiving GRAS status immediately allows NIAGEN to be included as an ingredient in both food and beverages –applications that we believe presents a very substantial opportunity for ChromaDex. Coupled with the recent NDI status, we believe the stage is set for widespread commercialization of NIAGEN as an innovative and compelling ingredient across a myriad of consumer products.”

You can find the press release here.