NMN, which stands for β-nicotinamide mononucleotide, can be synthesized naturally in cells and derived from various foods. After entering the human body, NMN can be rapidly converted into NAD+, a substance that can enhance energy generation, damage repair, metabolism, tissue regeneration, etc., thereby achieving anti-aging effects and health enhancement. Due to such magic effect, NMN health supplements are also known as "elixir of youth".

The health potential of NMN has attracted the attention of enterprises. According to data from Global Info Research, the market size of NMN is growing rapidly, with revenue of approximately $214.6 million in 2020 and projected to reach $292.5 million by 2026, at a compound annual growth rate (CAGR) of 8.1% from 2021 to 2026.

However, the regulation of NMN foods is not uniform across different countries. Some countries clearly allow NMN to be used in foods, while some have not yet legislated, creating obstacles for enterprises to develop NMN products. To remove the market access barriers, this article summarizes the use of NMN in food in some major countries/regions.

China

NMN cannot be applied in food in China.

According to the notification issued by National Health Commission on May 9, 2023, China rejected the new food additive application of NMN, which means that NMN cannot be used as food ingredient currently.

Although the disapproval is quite disappointing, some industry insiders think it is good news on the contrary as being a new food additive is the worst choice for NMN among the three ways to legalize its use in China.

1) Registering the substance as a new food additive

National Health Commission takes charge of the registration. The substance should have specific processing functions in the production techniques, such as sweetener, preservative, colorant, etc.

2) Registering the substance as a new food raw material

National Health Commission takes charge of the registration, but it is subject to more stringent requirements comparing with the first way. The criteria for the approval of new food raw materials focus more on the substance's nutrition and safety rather than the benefit to the processing techniques.

3) Registering the substance as a functional nutrition food raw material

State Administration for Market Regulation takes charge of the registration. The application should contain materials proving the substance's safety and healthcare functions. After granted approval, this ingredient can be used in health food (product registration or filing is required).

The best choice for NMN is to be registered as new food raw material, then it can be applied in common food products and enterprises can also promote the function of NMN. Second best is being functional nutrition food raw material, hence NMN can be used in health food with specific healthcare functions. According to industry insiders, around two or three years ago, some companies have submitted this application and it is still undergoing technical review now.

Being the new food additive is the worst choice. On the one hand, the public always have negative impression on food additive, so it will be hard to promote the function of NMN as a food additive. In addition, China's approval of new food raw materials, functional nutrition food raw materials and new varieties of food additives are mutually exclusive. If NMN is listed as a new food additive, it is almost impossible for it to be approved as a new food raw material or functional nutrition food raw material.

The United States

The US FDA previously accepted NMN as a New Dietary Ingredient (NDI) following Syncozymes' application and allowed supplement manufacturers to market it. However, such permission was revoked afterwards. Now NMN is forbidden in dietary supplement in the US.

On July 25, 2022, Inner Mongolia Kingdomway Pharmaceutical Limited submitted an NDI application of NMN. The application was supposed to pass based on historical practices but was rejected by FDA. What is more, FDA even revoked the NDI permit that issued previously. On November 23, 2023, Syncozymes said they received the notification from FDA that NMN NDI 1247 permit they obtained was revoked.

According to Dietary Supplement Health and Education Act of 1994 (DHSEA), dietary supplement cannot contain an ingredient that has been "authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public." FDA's current conclusion for NMN is exactly "NMN has been authorized for investigation as a new drug" and "may not be marketed as a dietary supplement or as a food".

Dietary supplement stakeholders in the US are quite disappointed with FDA's decision. The transparency was questioned because the FDA even has not disclosed when a pharmaceutical company submits an NDI application.

Australia

NMN can be used in health supplement for export only.

In Australia, health supplement is called complementary medicines, which is regulated by Therapeutic Goods Administration (TGA) under the Department of Health and Aged Care. All complementary medicines sold in Australia should be granted approval with TGA after meeting the corresponding requirements of ingredients, production and claims. However, if the product gets close to the standard stipulated by Australian government, the enterprises can apply for export only certificate with TGA.

The European Union

NMN is illegal.

According to EU regulations, any food not consumed "to a significant degree" before May 1997 is considered a novel food. This category includes new foods, food from new sources, new substances used in food, as well as new ways and technologies to produce food. Therefore, only when European Food Safety Authority (EFSA) assesses NMN as safe can this substance be used in food. Actually, in November 2022, the European Commission assessed that NMN was an unauthorized novel food whose safety shall be investigated first.

Japan

NMN is permitted in food.

On March 31, 2020, Ministry of Health, Labor and Welfare (MHLW) included NMN to Directory Distinguishing Food and Drug Ingredients: Non-Drug List, indicating the approval of NMN as a food ingredient. In most cases, NMN can be applied in both health supplement food, which is a type of normal food, and food with function claims, which is a type of health functional food. Japan has no specific limitation for NMN's consumption dosage, but the product should conform to the requirements of dietary supplement.

Based on ChemLinked's research, most countries and regions currently prohibit the use of NMN as a food ingredient due to insufficient safety data. The list of countries and regions also includes South Korea and Taiwan, China. However, we are starting to see increased applications in related industries like cosmetics. With ongoing economic development and the aging population, NMN as a promising anti-aging ingredient undoubtedly has huge market potential. As demand grows, regulatory changes that enable NMN's applications in food are likely on the horizon.

Source: Chemlinked

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