Supervision Policy for NMN in Japan, China, America, Australia and Canada
Supervision Policies for NMN in Japan, China, America, Australia and Canada
The mainstream researches of NMN have been conducted since a decade years ago. The United States had already carried out its commercialization of NMN before 1994 based on the announcement of FDA. Japanese government of Ministry of Health, Labor and Welfare released a decision on NMN as a food ingredient in 2019. And in 2023, China National Health Commision publicly accepts proposals for NMN as a food additive.
Supervision Policy for NMN in Japan
The government of Ministry of Health, Labor and welfare released the related policies that there is no item meets the judgement criteria and is inherently present in (contained in) food. It was deemed appropriate to say NMN are not labelled as having the efficacy of a medicinal product and that they are not presumed to be medicinal ingredients.( Figure 1)
That’s to say, NMN is regulated as a food ingredient in Japan. According to related Japanese law, NMN can be sold as a food supplement, but it cannot be marketed for specific health benefits. NMN is not a pharmaceutical drug and does not require approval from the Japanese government before it can be sold. However, manufacturers of NMN products must ensure that their products meet safety and labeling requirements, and that any claims made about the product are accurate and not misleading.
Supervision Policy for NMN in China
In early 2022, China National Medical Product Administration announced the approval of the filing of NMN as a new cosmetic ingredient, which means that it is legal for cosmetic companies in China that have successfully completed the filing to incorporate NMN into the production of cosmetics, while other companies that have not made the filing can use NMN in their cosmetics after a three-year protection period.( Figure 2)
NMN is considered a new food ingredient and is not yet approved for use as a dietary supplement. However, on 28 January 2023, the National Health Commission of China publicly released a notice on the acceptance of new varieties of food additives, indicating that the application for NMN as a food additive had begun to be accepted.( Figure 3)
But Companies producing NMN in China are allowed to establish exporting business and the NMN raw materials manufacturer should ensure that their products meet related exporting standards to obey corresponding law items.
Supervision Policy for NMN in America
The FDA (Food and Drug Adminitration) classifies NMN as a dietary supplement and regulates it under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under DSHEA, dietary supplement manufacturers are responsible for ensuring the safety and labeling of their products, but the FDA does not review or approve these products before they reach the market.
On the other hand, lots of NMN raw materials companies selling NMN can make self-affirmed claims, but these claims are not reviewed or approved by the FDA. So when it comes to NMN as dietary supplements, consumers concern about NMN may not have been thoroughly tested and may have unexpected side effects.
More importantly, in Octerber 2022, on the reply letter to a Chinese company who submit the application for the NDI (new dietary ingredients) of NMN, FDA addressed that NMN is excluded from the dietary supplement definition under the item of FDA has authorized NMN for investigation as a new drug and may not be market as or in a dietary supplement.
Supervision Policy for NMN in Australia
In Australia, the Therapeutic Goods Administration (TGA) is the agency responsible for regulating therapeutic goods, including dietary supplements. Supplements containing NMN are considered to be a type of complementary medicine and are subject to TGA's supervision and regulation. The TGA requires that any claims made about the benefits of a product be supported by evidence and be included on the product label. The TGA also has the power to take action against companies that make false or misleading claims about their products. ( Figure 4)
Specifically, TGA has demonstrated the efficacies of NMN of maintaining energy level, energy production, nervous system function, nervous system health, skin health, body mucous membrane health general health and wellbeing and so on.( Figure 5)
Supervision Policy for NMN in Canada
In Canada, NMN is considered a natural health product and is regulated as such by Health Canada. To be sold as a natural health product, NMN must meet certain requirements, such as having a license and being manufactured in accordance with good manufacturing practices (GMPs). What's more, There is a real case demonstrated on the official website that the NMN products gained the NPN number to marketing related commodities.(Figure 6)
However, the main concern in Canada is that the safety and effectiveness of NMN as a health product have not been extensively studied and there is limited scientific evidence to support its use for anti-aging or other health benefits.