Regulation of NMN in Foods in China

Date: 2024-Jul-29 Source: View: 710

NMN stands for β-nicotinamide mononucleotide, a naturally occurring molecule inherent in our human body and other animals. NMN is a precursor of vitamin B3 (nicotinamide adenine dinucleotide, also known as NAD+), and is essential for maintaining NAD+ level in cells. NAD+ is the most widely used coenzyme in the human body, responsible for producing more than 95% of the body's energy, regulating hundreds of metabolic reactions in the human body, and playing a fundamental role in human health.

On December 19, 2018, NMN products passed the US Self-GRAS safety certification for the first time. On November 8, 2022, the Food and Drug Administration (FDA) issued a statement that "NMN cannot be sold as a supplement because it is undergoing clinical trials as a potential drug", overturning the FDA's previous approval that NMN can be sold as a dietary supplement (NDI). The safety and effectiveness of NMN still need more scientific research and clinical trials to confirm.

Antion summarized the application of NMN (β-nicotinamide mononucleotide) in foods in China as of April 2024 for your reference.

In January 2021, the State Administration for Market Regulation issued a Letter on the Investigation of Illegal Operation of "Immortality Drug", clarifying that β-nicotinamide mononucleotide (NMN) has not yet obtained the license for drugs, health food, food additives and novel food ingredients in China, and cannot be produced and sold as food and drug.

On December 30, 2021, the State Administration for Market Regulation issued the Reply to Suggestion No. 1067 of the Fourth Session of the 13th National People's Congress. In the Suggestions on Strengthening the R&D of New Anti-Aging Food (Drug) Products and Supporting the Healthy Development of Related Industries, Representative Hu Jiqiang gave a detailed introduction to the mechanism of action, industrial distribution, development status, etc. of new anti-aging related products using NMN (β-nicotinamide mononucleotide) as raw material. He proposed to accelerate the research on the safety of NMN use and the anti-aging mechanism of action. The State Administration for Market Regulation analyzed from five aspects, including the functional evaluation of health food and the management of the catalogue of health functions, the management of the catalogue of health food raw materials and safety assessments, and the formulation of relevant provisions for food safety standards for NMN. In the next step, the State Administration will work with the National Health Commission, the National Medical Products Administration and other relevant departments to support the basic research of NMN and related products, and guide the standardized development of NMN and related products.

In January 2023, the National Health Commission accepted the application for a new variety of food additive NMN (β-nicotinamide mononucleotide). In May 2023, the National Health Commission issued information on the decision to deny administrative approval for the new variety of food additive NMN (β-nicotinamide mononucleotide).

In April 2023, Douyin listed "NMN" as a high-risk food in the list of product information prohibited from being released on Global Shopping.

Although NMN cannot be produced and sold as food and medicine China at present, there are many health foods purchased through cross-border e-commerce on the market containing this ingredient. The Customs regulates items purchased through cross-border e-commerce as items for personal use, and does not implement the requirements for the first-time import license approval, registration or filing.

In 2023, the General Administration of China Customs deployed a special campaign "Health and Safety 2023" for cross-border e-commerce bonded imported foods, in which health food is listed as a risk monitoring category for the first time and carried out monitoring on cross-border e-commerce imported health foodThis special campaign found that there were problems such as false labeling of active ingredients in health foods such as β-nicotinamide mononucleotide (commonly known as "immortality drug", NMN).

Recently, many media reported that on the evening of May 31, many e-commerce platforms were suddenly informed that the "immortality drug" NMN (β-nicotinamide mononucleotide) could no longer be sold in China through cross-border e-commerce platforms from June 1. At the same time, it was reported that the policy notice issued by the General Administration of China Customs required that foods containing NMN ingredient whose countries (regions) of origin are Taiwan, China, Macau, China, the United States, Australia, Germany, Switzerland, the United Kingdom, Singapore, Spain, the Netherlands, Hungary, Denmark, Sweden, the Czech Republic, Norway, Poland, Austria, France, etc., should not be sold on cross-border e-commerce platforms (1210, direct mail, cc).

As of press time, the relevant departments have not yet given a clear response and specific policy regarding the media reports of "complete ban on sales of NMN". Antion will continue to pay attention to the progress of the application of this substance in foods in China.

Source: Antion

Note: This article is compiled by Antion. Please indicate the source for reprint.