Essential Reading for Corporations Selling NMN Supplements Under Their Own Brand: Practical Guidelines for Pharmaceutical Affairs Act, Consumer Protection Act, and Advertising Regulations, and a Checklist for Preventing Violations

When manufacturing and selling NMN supplements under your own brand, one aspect that many companies tend to overlook is compliance with "advertising and labeling regulations." In Japan, multiple laws, such as the Pharmaceuticals and Medical Devices Act (PMD Act) and the Act against Unjustifiable Premiums and Misleading Representations (Act on Premiums and Representations), govern the labeling and advertising of supplements. Violations can not only result in administrative actions and penalties but also damage brand credibility. This article explains the essential regulatory knowledge for corporations selling NMN supplements, along with a practical checklist.

The Pharmaceutical and Medical Devices Act and NMN: "Medicinal Language" is Absolutely NOT Allowed

The Pharmaceutical and Medical Device Act (PMD Act) prohibits the display and advertising of "drug-like efficacy and effects" for foods (including supplements). Specifically, expressions suggesting "treatment," "prevention," or "diagnosis" of diseases are not allowed.

Examples of representative forbidden words (from the perspective of the Pharmaceutical and Medical Device Act):

• "Treating cellular aging" -> Claiming therapeutic efficacy
• Disease prevention claims
• "Replenish NAD+ with NMN and stop aging" → Assertive claim of efficacy
• "Doctor recommended" - NG if it suggests certification or approval

The claims that can be made for supplements are limited to the statutory nutritional function claims for "foods with nutrient function claims" or health claims submitted as "foods with function claims" as described below. In the general category of "health foods," claims about the efficacy and effectiveness of the product itself are generally prohibited.

Act on False Representations Regarding Premiums and Representations: Pitfalls of "Misleading Superiority" and "Misleading Advantage"

The Act against Unjustifiable Premiums and Misleading Representations (also known as the Premium Labeling Act or Keihyoho) prohibits representations that mislead consumers into believing that a product or service is "significantly superior or more advantageous than it actually is." The following points require particular attention in advertisements for NMN supplements.

Examples of Misleading Representations (in the absence of objective grounds)

• "Uses NMN of the world's highest purity"
• With XXmg formulation for maximum effect
• "Twice the NMN absorption compared to other companies' products" (Unsubstantiated comparative claim)

Examples of misleading advertising

• "For subscription purchases, use 90%OFF" (if the actual pricing differs significantly)
• Special price for a limited time (when the price is always the same)

Superlative expressions without basis (e.g., "best," "strongest," "No. 1") carry a high risk of violating the Premiums and Representations Act unless accompanied by objective evidence (e.g., test data, third-party certifications, survey results).

Functional Food System: Possibility of Application to NMN

The Foods with Function Claims system is a food category that allows claims about its function (health benefits) based on scientific evidence. It requires notification to the Consumer Affairs Agency, and once approved, claims related to its function can be used. While research papers on NMN are accumulating, when considering the utilization of this system, it is important to recognize that substantial costs and time are required for the development of scientific evidence (conditions, quality, and quantity of papers) and the notification procedures to the Consumer Affairs Agency.

Additional risks in SNS and e-commerce sales

Regulations under the Pharmaceutical and Medical Device Act (Yakkiho) and the Consumer Protection Act (Keihyoho) apply equally to sales of NMN supplements on social media platforms such as Instagram, X (formerly Twitter), and YouTube, as well as on proprietary e-commerce sites and various online marketplaces. Examples requiring particular attention:

• Claims of efficacy in influencer "experience" posts
• Prohibited expressions in e-commerce product descriptions
• Addressing efficacy in review responses

The stealth marketing regulations (amendment to the Premiums and Representations Act) that came into effect in October 2023 prohibit companies from not clearly indicating that content is an advertisement, even when they are aware that the content is being displayed as an advertisement by a third party. When utilizing influencer marketing,Strict enforcement of advertising identifiers such as "\#PR" and "\#AD"is necessary.

Violation Prevention Checklist

• "treatment", "prevention", or "improvement" are not used
• Is a disease name (cancer, diabetes, high blood pressure, etc.) being used?
• Are there any unsubstantiated superlative expressions such as "the best," "the strongest," or "No. 1"?
• In comparative advertising, are objective grounds presented?
• Are we using the labels for Foods with Function Claims or Foods with Nutritional Function Claims without notification?
• Is there an advertisement identification display on the influencer's post?
• Is the e-commerce product description compliant with the latest regulations?

Regarding advertising claim regulations in the United States (Structure/Function Claim)NMN Supplement Advertising: US Labeling Regulations Guideis explained in detail.

For an overview of FDA regulations for the US marketUS FDA NMN Regulation TimelinePlease also refer to.

Summary

To sell NMN supplements under your own brand, understanding the regulations of the Pharmaceutical Affairs Act and the Act on Premiums and Representations is the first step in avoiding legal risks. Unjustified claims of efficacy are not only subject to administrative action but also lead to a loss of social credibility. Honest advertising that is not exaggerated and is based on evidence contributes to the long-term brand value. Even when collaborating with OEM manufacturers, having quality certifications and sharing information on appropriate expressions are the foundation for sound supplement brand management.