NMN Novel Food Status: UTHEVER® NMN Leads the EU Compliance Race

In late February 2025, UTHEVER NMN, the world’s first large-scale, human clinically proven NMN brand, completed the EU Novel Food Public Consultation phase. UTHEVER^® is pioneering the EU novel food application process, becoming the first NMN brand to enter the risk assessment stage, and is now pending approval. If approved, UTHEVER^® NMN will be the first NMN ingredient to receive EU Novel Food certification, granted with the green PASS in the EU market.

What Is Novel Food, and Why Does It Matter?

In Europe, NMN is legally classified as a Novel Food, meaning it’s a substance that was not significantly consumed before May 15, 1997, and must undergo strict safety assessment by EFSA before being sold. These may include new food sources, substances derived from advanced biotechnology, or ingredients produced via fermentation, cell culture, or other innovative methods. Each application must undergo a strict safety and toxicological evaluation by the European Food Safety Authority (EFSA).

For reference, EFSA Novel Food evaluation involves assessing safety data such as:

• 90-day animal toxicology results
• ADME pharmacokinetics
• Stability and degradation profiles

Only about 30% of submissions pass this rigorous process, especially in high-risk categories like anti-aging bioactives. This reflects the EU’s strict regulatory standards aimed at safeguarding public health and highlights the significant credibility and market value associated with being recognized by EFSA.

Why NMN Novel Food Certification Is a Game-Changer

With EU approval underway, UTHEVER® NMN will soon be able to reach a much broader group of consumers. Once certified, it can be sold in 28 EU countries—not just online, but also in major stores like Boots, Sephora, and Carrefour. This marks a big step forward: a shift from a cross-border e-commerce model to a full mix of online and in-store access.

Once the certification is finalized, more trustworthy NMN brands—like UTHEVER®—will be available both online and in physical stores across Europe. This gives cautious consumers easier access to 100% traceable, 99.9% purity NMN, while offering pharmacy and beauty retailers a clear path to expand their product offerings legally and safely.

Entrance to a Larger EU Market: Pharmacies and Beauty Retail Channels

With Novel Food certification, UTHEVER^® NMN enters the nutraceutical and functional food market in 28 EU countries, expanding into the $5 billion global anti-aging market and increasing its presence in Europe, thereby supporting international distribution and regulatory development.

The Novel Food provides a strategic path for UTHEVER^® NMN to transition from cross-border trade and online sales to mainstream retail channels. Subject to regulatory approval, UTHEVER^® NMN can be integrated into physical retail chains such as Boots, Sephora, and Carrefour. The shift from an “online-only” retail strategy to a dual-channel retail strategy will drive significant sales growth. The new combination system of in-store and online availability will drive market growth by expanding consumer access and enhancing UTHEVER^® NMN’s brand recognition. As a trusted NMN provider, UTHEVER^® NMN will support our clients—pharmacies, and beauty retailers—in capturing the growing demand for longevity and wellness products, ultimately strengthening their market position in the EU.

Legal Debate in the US: Medication or Dietary Supplement?

Being the pioneer of the market for healthy aging supplements, the United States has played a key role in shaping global consumer confidence in NMN. The popularity among customers in the United States further confirms that NMN is safe for consumption as a dietary supplement.

However, while NMN has been extensively studied for its safety and consumed for years, legal disputes have emerged in the US regarding its classification. Concerns over new drug protections have raised the possibility of NMN being banned as a supplement. With EU Novel Food approval moving forward, Europe could soon become a major place to buy NMN, opening up new chances for both brands and shoppers.

For everyday consumers, that means easier access to reliable NMN products in local pharmacies and health stores—not just online.It also gives cautious buyers more options to choose from, including trusted global brands like UTHEVER®, which offers 100% traceable, 99.9% purity NMN.

The controversy arises from the FDA’s stance on NMN’s status in light of new drug exclusivity regulations. As the regulatory landscape in the US remains uncertain, consumers are awaiting the FDA’s response in late July. Meanwhile, recent positive progress in the EU New Food certification process shows hope for the adoption of NMN’s global regulations. It reinforces its potential as a compatible and easily accessible worldwide NAD booster.

For the latest information regarding the legal status of NMN, visit: Effepharm NMN Legal Dispute Updates.

Leading Innovation with Clinical Evidence

Effepharm is committed to advancing anti-aging ingredients by integrating advanced biotechnology with solid clinical validation. UTH’s flagship range of NAD+ boosters is designed to improve longevity and well-being, ensuring that each product is backed by rigorous scientific research. Since our founding in 2017, we have continually transformed breakthrough discoveries into effective healthcare solutions, prioritizing safety and effectiveness to set new industry standards in the pursuit of innovation.

Other Frequently Asked Questions

Is NMN allowed in food supplements in Europe?

Not yet. NMN is considered a Novel Food in the EU. As it wasn’t widely consumed before 1997, it must first receive approval from EFSA. UTHEVER® NMN is currently undergoing assessment and is the first NMN brand to enter this final risk evaluation phase. As one of the most promising NMN supplements, UTHEVER® represents the frontier of functional NMN in food applications designed to promote longevity and cellular vitality with clinical evidence.

Why is NMN considered a “novel food”?

Because NMN wasn’t part of the regular EU diet before 1997. As such, any product classified as NMN in food must undergo strict testing for safety, absorption, and stability before being cleared for use. This classification helps ensure consumer safety and product quality across the European market.

Why did some stop taking NMN?

Some stopped taking NMN not because of safety concerns—it remains a well-tolerated supplement—but due to regulatory uncertainty in the U.S. market. Additionally, newer alternatives, such as NMN-H (NMNH, the reduced NMN), have emerged, showing even greater potential in boosting NAD+. In many cases, people also had unrealistic expectations about immediate effects, leading them to discontinue use.
Read more about what changes NMN can bring to you

Start Your Compliance Journey with UTHEVER® NMN

Now is the time to plan for success in the European market. Whether you’re looking to buy bulk NMN, develop private label products, or distribute through EU retail, UTHEVER® NMN provides the regulatory readiness and scientific validation you need.

Explore the UTHEVER® Whitepaper for detailed scientific data and keep up to date with NMN Legal Status Updates. Join Effepharm—the global expert in NMN novel food innovation and compliance.