Regulatory Requirements for NMN in Cosmetics in China

β-Nicotinamide mononucleotide (NMN) is a naturally occurring, biologically active nucleotide. In the human body, it is a direct precursor for the synthesis of NAD+ (coenzyme I), and its function is exerted by increasing NAD+ levels. Since nicotinamide belongs to the vitamin B3 family, NMN is considered a vitamin B derivative.

This ingredient is widely involved in biochemical reactions in the human body and closely linked to immunity and metabolism. According to recent studies, NMN's primary function is to improve age-related physiological decline and pathological conditions. As a result, NMN is often considered to have "anti-aging" effects. Given its purported anti-aging effects, NMN has become a popular new cosmetic ingredient (NCI). It has been notified 10 times by different notifiers, becoming the new ingredient with the highest number of notifications.

However, regulatory authorities have maintained a strict stance towards its use in food and medicine products. The China State Administration for Market Regulation (SAMR) has clarified that the use of NMN in food and medicine products is illegal, raising concerns about whether NMN has anti-aging efficacies, as well as whether similar bans may also be brought to the cosmetics field in the future. In this context, this article aims to explore these issues surrounding the use of NMN in the cosmetics industry.

NMN’s Regulatory Status: Notified as a NCI 10 times

Since 2021, NMN has been notified as a NCI 10 times. Based on publicized information, NMN is primarily notified as skin protectant, humectant, antioxidant, and anti-wrinkle agent. Additionally, most NMN that has been notified are those derived from biotechnology. After being authorized by the corresponding notifier, NMN is allowed to be used in cosmetics.

Table: Notified NMN’s Information

The Anti-aging Efficacy of NMN in Cosmetics: Controversy in the Industry

At present, the cosmetics industry is rushing to notify NMN as a NCI. However, the anti-aging efficacy of NMN in cosmetic applications is still under debate within the industry.

Some publicly available research literature suggests that NMN's role in skincare and anti-aging may include alleviating skin cell aging, improving skin immunity, and mitigating metabolic dysfunction caused by inflammation. However, as a NCI, NMN is still in its infancy within the cosmetics field.

Dr. Zhao Haishan, a researcher at Guangdong Provincial People's Hospital, believes that NMN is an important metabolic intermediate in the body. In terms of efficacy, some existing studies support its protective effects against damage from reactive oxygen species, leading to the inference that NMN may possess some anti-aging properties. ¹

However, Dr. Zhao also pointed out that the surging popularity of NMN had been largely driven by marketing, and significant gaps had been existing in its basic research and a lot of work shall be done to fully understand and validate the anti-aging benefits of NMN in cosmetic applications.

Prediction of Future Regulatory Requirements

Given the authorities' strict stance towards the use of NMN in medicines and foods, will the use of NMN in cosmetics be restricted in the future? Industry personnel have divergent views.

According to Guo Qingquan, director of the Guangdong Functional Cosmetics Engineering Technology Center, when NMN is used as a NCI, it primarily act on the skin, and its safety requirements differ from those of food ingredients. Therefore, he predicts that the use of NMN in cosmetics industry will not be affected. ¹

Du Wenbo from Guangzhou Ruby Biotechnology Co., Ltd., believes that the regulatory authorities may impose appropriate regulations on the permitted addition amount of NMN in cosmetics. This is mainly due to the following factors:

• NMN is difficult to directly penetrate the skin barrier, so its effectiveness in topical skin applications still requires further exploration.

• NMN has high requirements for cosmetic production, transportation, and storage conditions.

• There is a lack of robust clinical data related to NMN's skincare benefits.

Under the CSAR framework, NMN is considered a NCI in China and is currently undergoing a three-year safety monitoring period. After this period, the technical review agency will submit an opinion to the National Medical Products Administration (NMPA) on whether NMN meets the safety requirements. If a NCI is ordered to be suspended during the safety monitoring period, the cosmetic registrant/notifier must also suspend the production and operation of cosmetics containing this NCI. In other words, as NMN is a NCI in the safety monitoring phase, the ultimate determination of its suitability for use in cosmetics will hinge on the assessment of its safety profile.

With extensive experience in cosmetic and NCI registration and notification, ChemLinked’s parent company REACH24H Consulting Group offers compliance solutions to assist overseas cosmetic enterprises entering into China. Welcome to contact us at [email protected] for more advice.

Further Reading

• China Clarifies the Use of NMN in Food is Illegal

• Navigating the Availability of NMN in Food Across the Major Countries/Regions