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What Does "Novel Food" Mean for NMN?

By Mathew Stuckey, Founder of Longevity Formulas
Last Updated: December 29, 2025
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The short answer: NMN is classified as a "novel food" in the UK, which means it wasn't widely consumed before 15 May 1997 and requires regulatory approval before being sold in food supplements. Currently, NMN is "under assessment" - applications for approval have been submitted, but no final decision has been made. Products on the market before certain dates can continue being sold during this assessment period.

This isn't a ban, but it's regulatory limbo. Companies selling NMN should be complying with specific requirements whilst this assessment continues.

⚠️ Important: This information is for educational purposes only and should not be considered legal advice. Regulations can change. For current official information, check the Food Standards Agency (FSA) website directly.


What "Novel Food" Actually Means

The Definition

Under UK law, a novel food is any food or ingredient that:

  • Wasn't consumed to a significant degree in the UK or EU before 15 May 1997
  • Falls into one of several categories (new ingredients, new production processes, foods from other countries not historically eaten here, etc.)

The date (15 May 1997) is when the first EU novel food regulation came into force. It's arbitrary but legally significant.

Why This Classification Exists

The purpose is consumer safety. If an ingredient hasn't been widely consumed historically, regulatory authorities want to assess:

  • Is it safe for the general population?
  • Are there specific groups who shouldn't consume it?
  • What are appropriate maximum doses?
  • Is it stable when stored normally?
  • Could it interact with common medications?

This is fundamentally about risk assessment, not about proven danger. Novel food status doesn't mean something is unsafe - it means safety hasn't been formally established through the regulatory process.


Why NMN Is Classified as Novel Food

The History

NMN exists naturally in small amounts in foods like broccoli, avocado, and edamame. Your body produces it as part of normal metabolism. So why is it a novel food?

Because whilst NMN exists in nature and in your body, concentrated NMN as a supplement ingredient wasn't consumed in significant amounts before May 1997. The distinction is between:

  • Trace amounts in regular foods (not novel)
  • Purified NMN at supplement doses of 250-1000mg (novel)

This might seem like splitting hairs, but it's how food regulation works. Caffeine exists naturally in coffee, but if someone started selling pure concentrated caffeine as a supplement in 1995 (which they did), that concentrated form would have gone through safety assessment.

My Perspective on This

Having sold NMN for several years, I understand why this frustrates both companies and consumers. NMN is naturally occurring, your body makes it, and research suggests it's safe. The regulatory process feels bureaucratic and slow.

But I also understand the regulatory caution. NAD+ precursors affect fundamental cellular processes. Doses used in supplements (500mg) are hundreds of times higher than you'd get from food. Ensuring this is safe for long-term use across diverse populations isn't unreasonable, even if the pace is frustrating.

The regulatory system isn't designed for speed - it's designed to prevent another supplement safety scandal. That's probably appropriate for substances affecting core metabolism, even if it creates business uncertainty for companies like mine.


Current Status: "Under Assessment"

What This Means

When you check the UK Novel Foods Catalogue, NMN is listed as "under assessment." This status means:

Applications submitted: Companies have filed novel food applications with supporting safety data

Assessment ongoing: The Food Standards Agency (FSA) is reviewing these applications

No final decision: Neither approval nor rejection has been issued

Transitional arrangements: Products that were on the market before certain dates can continue being sold whilst assessment continues

Timeline uncertain: No public indication of when decisions will be made

The Application Process

Novel food applications require extensive documentation:

  • Comprehensive safety studies (including toxicology data)
  • Manufacturing specifications and quality controls
  • Stability data showing the ingredient remains safe during storage
  • Proposed uses and maximum dose levels
  • Assessment of exposure (how much people might consume)

These dossiers can cost hundreds of thousands of pounds to compile. For small companies, this creates significant barriers. For established supplement companies, it's an expensive but manageable process.


What "Under Assessment" Allows

Products Can Still Be Sold

This is the part that confuses people: if NMN is awaiting approval, why is it available for purchase?

The answer is transitional provisions. Products that were already on the UK market before certain key dates can continue being sold whilst applications are assessed. This prevents market disruption whilst allowing the assessment process to proceed.

However, these products must:

  • Be labelled as food supplements, not medicines
  • Not make unauthorised health claims
  • Meet general food safety requirements
  • Come from compliant manufacturing facilities

What Companies Should Be Doing

Responsible companies selling NMN during this period should:

  • Have engaged with the novel food process appropriately
  • Maintain comprehensive quality documentation
  • Avoid making medicinal claims
  • Provide transparent information about regulatory status
  • Be prepared to comply with whatever requirements emerge from the assessment

At Longevity Formulas, we've engaged with this process and maintain GMP manufacturing with published testing. We acknowledge the novel food status openly rather than ignoring it.


Possible Outcomes of the Assessment

Scenario 1: Full Approval

NMN receives novel food authorisation with conditions like:

  • Maximum daily dose limits
  • Specific labelling requirements
  • Warnings for certain populations
  • Restrictions on what claims can be made

Likelihood: Moderate to high, given existing safety data

Timeline: Unknown - could be months or years

Impact: Regulatory clarity, continued market access with defined rules

Scenario 2: Conditional Approval

Authorisation granted with more stringent conditions:

  • Lower maximum doses than currently used
  • Additional safety warnings
  • Requirements for ongoing monitoring
  • Restrictions on who can use it

Likelihood: Possible, if regulators have specific concerns

Impact: Products would need reformulation or restriction

Scenario 3: Assessment Continues Indefinitely

The current "under assessment" status persists for years without resolution.

Likelihood: Unfortunately quite possible given regulatory timelines

Impact: Ongoing uncertainty for businesses and consumers

Scenario 4: Rejection or Restrictions

Assessment concludes NMN shouldn't be authorised, or requires prescription-only status.

Likelihood: Lower, given existing research, but not impossible

Impact: Significant market disruption, products would need reformulation or removal

My Honest Assessment

Based on watching this space for several years: I expect eventual approval with conditions, but the timeline is anyone's guess. Regulatory processes are notoriously slow, and novel food assessment is particularly complex.

The safety data for NMN is reasonably robust for studies up to 12 months. The challenge is that regulators want longer-term data and assessment across broader populations. Gathering this takes time.

What frustrates me is the lack of clear communication about timelines. Companies are left operating in uncertainty, unable to plan properly. Consumers don't know whether products will remain available long-term. Transparency about process and timeline would help everyone.


What This Means for Consumers

Can I Buy NMN Legally?

Yes, as of December 2025, NMN products are legally available for purchase in the UK. The novel food status doesn't make them illegal - it means they're in regulatory assessment.

Should I Be Concerned?

The novel food classification itself shouldn't concern you - it's a regulatory category, not a safety warning. However, you should:

Choose quality products: With regulatory uncertainty, quality matters even more. Look for:

  • Published Certificates of Analysis
  • GMP manufacturing
  • Companies that acknowledge the regulatory situation openly
  • Transparent labelling about novel food status

Understand the uncertainty: The regulatory situation could change. Products might be reformulated, restricted, or (less likely) removed from the market depending on assessment outcomes.

Consider your risk tolerance: Some people prefer to wait for full regulatory approval before trying new supplements. Others are comfortable using supplements with existing safety data even without final regulatory authorisation. Neither position is wrong.

What About Safety?

Novel food status is about regulatory approval, not proven danger. Current evidence suggests:

Short-term safety: Studies up to 12 months show NMN is well tolerated in healthy adults at typical doses

What's unknown: Very long-term safety (beyond 12 months), effects in specific populations (pregnant women, children, people with certain conditions), potential medication interactions

My view: The existing safety data is reassuring for healthy adults using NMN as studied in research. But the unknowns are real, which is why consulting your healthcare provider makes sense, especially if you have medical conditions or take medications.


What This Means for the Industry

Compliance Challenges

Companies face difficult decisions:

  • Invest heavily in novel food applications with uncertain timelines
  • Continue selling during assessment period whilst maintaining compliance
  • Navigate marketing restrictions to avoid medicinal claims
  • Manage inventory and supply chains with regulatory uncertainty

Market Impact

The novel food situation affects:

Smaller companies: May struggle with application costs, leading to market consolidation

Pricing: Compliance costs inevitably affect retail prices

Innovation: Regulatory uncertainty may slow development of new NAD+ precursor products

Consumer trust: How companies handle this situation affects long-term credibility

My Perspective as a Business Owner

Operating in regulatory limbo is genuinely challenging. I've invested in maintaining quality, engaging with the novel food process, and being transparent with customers. But I can't tell customers with certainty what the regulatory landscape will look like in two years.

This creates difficult business decisions. Do I invest in expanding the NMN range knowing regulations might change? How do I price products when regulatory costs are uncertain? How do I communicate honestly about status without either overstating risks or pretending uncertainty doesn't exist?

I've chosen transparency as the best approach - acknowledge the situation openly, maintain quality regardless of regulatory status, and trust that customers appreciate honesty over marketing spin.


How Novel Food Differs from Medicine Regulation

A Common Confusion

People sometimes confuse novel food assessment with medicine approval, but they're completely different:

Medicines (MHRA regulated):

  • Must prove efficacy for specific medical conditions
  • Require extensive clinical trials
  • Need marketing authorisation for therapeutic claims
  • Subject to prescription requirements or pharmacy-only sales

Novel foods (FSA regulated):

  • Must prove safety for general consumption
  • Don't need to prove health benefits
  • Cannot make therapeutic claims
  • Sold as food supplements

NMN's novel food status means it's being assessed as a food ingredient, not as a medicine. It can't make medical claims regardless of approval status.


Comparing to Other Novel Foods

NMN Isn't Unique

Many ingredients have gone through novel food assessment:

  • Chia seeds
  • Various algae products
  • CBD (cannabidiol)
  • Numerous plant extracts
  • Alternative protein sources

Some have been approved, some rejected, some remain under assessment for years. NMN's situation isn't unprecedented.

What Other Cases Tell Us

Looking at other novel foods:

  • Assessment timelines vary enormously (months to many years)
  • Initial applications are often rejected and require resubmission
  • Approval typically comes with specific conditions
  • The process is expensive and administratively complex
  • Outcomes aren't always predictable

This context suggests patience is required. The system moves slowly.


Practical Guidance

If You're Currently Taking NMN

  • Continue purchasing from reputable suppliers with published testing
  • Stay informed about regulatory developments
  • Don't rely solely on any supplement for health concerns
  • Consult your healthcare provider with questions

If You're Considering Starting NMN

  • Research supplier credentials thoroughly
  • Understand the regulatory uncertainty
  • Consult your healthcare provider, especially if you have medical conditions
  • Make an informed decision based on available evidence and your risk tolerance

If You're Selling NMN

  • Engage appropriately with novel food requirements
  • Maintain comprehensive quality documentation
  • Avoid medicinal claims in all marketing
  • Be transparent about regulatory status
  • Prepare for potential regulatory changes

The Bigger Picture

Why This Matters

The NMN novel food situation highlights broader questions about supplement regulation:

  • How should naturally occurring compounds at concentrated doses be assessed?
  • How do we balance safety assessment with innovation and access?
  • What timelines are reasonable for regulatory decisions?
  • How much evidence should be required before approval?

These aren't simple questions, and reasonable people disagree on answers.

My Hope for Resolution

What I'd like to see:

  • Clear timelines communicated by regulators
  • Transparent criteria for approval decisions
  • Reasonable safety thresholds based on evidence
  • Streamlined processes for small companies
  • Continued market access during assessment

Whether that's realistic remains to be seen.


Key Takeaways

  1. Novel food status means NMN requires regulatory approval as a food supplement ingredient
  2. "Under assessment" means applications are being reviewed, but no decision has been made
  3. Products can currently be sold during the assessment period
  4. Eventual approval seems likely but timeline is uncertain
  5. The classification reflects regulatory process, not proven danger
  6. Consumers should choose quality products from transparent companies
  7. The situation could change as assessment progresses

Related Information

For official information on novel food regulations in the UK, see the Food Standards Agency Novel Foods Guidance.

For the authorised regulated products register, visit the FSA Regulated Products Register.

Our NAD+ supplement range includes NMN products manufactured under GMP standards. We acknowledge the novel food status and operate in accordance with current UK requirements.


Legal Disclaimer: This article provides general information about UK novel food regulations as of December 2025. It is not legal advice. Regulations can change, and this information may become outdated. For current requirements, consult the Food Standards Agency directly or seek professional legal advice.

Regulatory Notice: NMN is classified as a novel food in the UK and is available for purchase whilst under review for full authorisation. These products are food supplements and are not intended to diagnose, treat, cure, or prevent any disease.

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Mathew Stuckey

About the Author

Mathew Stuckey is the founder of Longevity Formulas and a longevity researcher focused on NAD⁺ biology, NMN, and evidence-based supplement science. He has spent years reviewing peer-reviewed studies, regulatory updates, and manufacturing standards to provide clear, research-backed educational content on longevity supplements.

Mathew is not a medical doctor. His work is educational, highlighting what is known, emerging, and still under investigation, particularly for ingredients like NMN that are under regulatory review in the UK.

👉 View full author profile: https://longevityformulas.co.uk/pages/about-mathew-stuckey

Content Accuracy & Review
This article has been reviewed for scientific accuracy, clarity, and alignment with publicly available research. It includes regulatory context, safety considerations, and transparent discussion of uncertainties. This content is educational and does not constitute medical advice.