Posted by Dale Junchang Park
on August 20, 2026
ROKIT NMN® has strengthened its foundation for broader U.S. food ingredient market opportunities through GLP toxicity studies, manufacturing and quality documentation, and expert review led in the U.S.
ROKIT America has been conducting the safety assessment process for its NMN ingredient, ROKIT NMN® (β-Nicotinamide Mononucleotide), as part of its preparation for entry into the U.S. food ingredient market. We are pleased to share that ROKIT NMN® has now reached a Self-Affirmed GRAS (Generally Recognized As Safe) conclusion.
This conclusion represents more than a procedural milestone. It reflects a comprehensive review of the ingredient’s characteristics, manufacturing process, quality control documentation, and toxicological and safety data. In particular, the assessment was supported by toxicity studies conducted by a GLP (Good Laboratory Practice) institution, as well as manufacturing and quality documentation demonstrating a process designed without the use of hazardous solvents, and reviewed by a U.S.-based expert panel in toxicology and food safety.
Through this process, we have further strengthened the scientific foundation supporting the safety and quality of ROKIT NMN®. Based on this foundation, we aim to expand its potential applications beyond dietary supplements and into the broader U.S. food market.
Why this matters
GRAS is a concept under the U.S. FDA regulatory framework that applies to substances used in food when their safety is established through scientific procedures or through general recognition based on publicly available scientific knowledge.
Among these pathways, Self-Affirmed GRAS refers to a process in which qualified experts independently review the intended conditions of use and the available safety data for an ingredient and reach a conclusion regarding its safety.
For ROKIT NMN®, this process involved a comprehensive review of both the safety data and the full set of manufacturing and quality management materials. As a result, it provides a stronger foundation for evaluating the ingredient’s potential use in food and beverage applications in the U.S. market.
What data supported the evaluation
Before initiating the U.S. safety review, ROKIT America conducted toxicity and safety studies on NMN through a GLP institution. These studies included a 90-day repeated-dose toxicity study and genotoxicity-related studies, among others, and were carried out in accordance with internationally recognized guidelines.
In parallel, ROKIT NMN® is produced based on a manufacturing process developed by ROKIT America, and supporting documentation was organized to demonstrate consistent control over both quality and safety. This included review of specifications related to impurities, residual solvents, and related substances, as well as the broader framework covering raw material selection, process conditions, and quality standards.
From a process safety perspective, materials and conditions used throughout manufacturing were also reviewed against standards relevant to the U.S. market. In particular, the process was assessed with consideration of whether solvents of concern from a Proposition 65 perspective were used at any stage. This means that the evaluation was not limited to the safety of the final ingredient alone, but also considered the safety profile and control strategy of the manufacturing process itself.
This is an important point. Safety is not defined by a single test result alone. It becomes more meaningful when toxicological data are supported by a robust manufacturing design and a consistent quality management system. That broader perspective was an important part of this evaluation.
We are continuing to strengthen quality management standards
ROKIT NMN® is manufactured under continuous control of purity and key related substances, with quality standards verified through methods including HPLC analysis.
In particular, we monitor the levels of important NMN-related compounds such as NR (Nicotinamide Riboside) and NAM (Nicotinamide), with a focus on improving batch-to-batch consistency and supply reliability.
This is why we continue to advance our quality management system alongside our safety documentation. In the global ingredient market, competitiveness requires more than simply supplying an ingredient. It requires consistent quality and a management standard that partners can rely on.
The safety review was conducted by U.S. experts.
This Self-Affirmed GRAS evaluation was led by AIBMR Life Sciences, Inc., a U.S.-based scientific and regulatory consulting organization specializing in food, dietary supplement, and ingredient safety. An expert panel in toxicology and food safety participated in the review and conducted a comprehensive evaluation of ROKIT NMN®.
Founded in 1978, AIBMR is recognized as one of the long-established scientific and regulatory consulting firms in North America focused on natural products. Its work includes GRAS Independent Conclusions, FDA GRAS notifications, NDI notifications, regulatory compliance, and toxicology studies. This background adds important context to the review process, underscoring that the evaluation was conducted through an organization with relevant experience and scientific expertise in ingredient safety and regulatory review.
The review of ROKIT NMN® involved experts with credentials and experience such as American Board of Toxicology (DABT) certification, European Registered Toxicologist (ERT) qualification, and experience reviewing toxicological and regulatory submission materials for food ingredients and food-contact substances at the FDA CFSAN Office of Food Additive Safety.
Based on this expertise, the panel reviewed the identity and composition of the ingredient, the manufacturing process, specifications and quality control standards, management of key impurities and related substances, toxicology study findings, stability data, and estimated intake under intended conditions of use. The evaluation was not based on a single study alone, but on an integrated review of nonclinical toxicology data, manufacturing and quality information, relevant scientific literature, and intended use levels.
This comprehensive approach helped ensure that the safety review of ROKIT NMN® was conducted on a structured and multidimensional scientific basis.
The future direction of ROKIT America’s NMN business
With this Self-Affirmed GRAS conclusion, we plan to explore broader opportunities for ROKIT NMN® in the U.S. market.
Beyond its existing potential in dietary supplement applications, we are also evaluating opportunities for expansion into a wider range of categories, including food and beverage, within the scope of relevant use conditions and applicable requirements.
Going forward, we will continue to expand collaboration with food and beverage companies, ingredient suppliers, and product development partners in the U.S., while creating more opportunities for joint product development using ROKIT NMN®. Supported by scientific evidence and quality-focused management, we will continue strengthening the competitiveness of ROKIT NMN® as a trusted ingredient in the global healthy aging and wellness market.
