ThermoLife International, which holds the patent for creatine nitrate, announced the FDA’s decision via press release.
The only FDA document of the ingredient available as of writing dates back to 2014, when the FDA declined ThermoLife International’s first NDIN, stating that it had “significant concerns” about the evidence relayed by the patent holder, mainly due to the lack of studies backing creatine nitrate’s safety and efficacy.
Since then, one PubMed-listed study has been published regarding creatine nitrate’s safety and efficacy, funded by Nutrabolt International, and published in the Journal of the International Society of Sports Nutrition in April 2016.
"The NDI notification process is an important part of the regulatory system and we've always encouraged all of our member companies to submit NDINs, even if they believe their NDI is exempt,” said Daniel Fabricant, president and CEO of trade group Natural Products Association (NPA).
For Jose Antonio, CEO and co-founder of the International Society of Sports Nutrition and editor-in-chief of its journal, the question remains whether creatine nitrate can achieve the same results for users ingesting it as creatine monohydrate can.
“Certainly the 'nitrate' part of it may offer an ergogenic effect, but the data on it, versus CrMono, is sparse—and that's being generous,” he told NutraIngredients-USA.