The production of organic foods has been regulated at European level for quite a long time, EC Regulation 834/2007 of the European Parliament and of the Council (further: Regulation) laying down the principles and rules.

However, since 2007 the organic farming sector of the EU has developed rapidly and as foreseen in the Regulation, a review was needed and conducted to consider the experience gained from the application of the rules.

The results of this review showed that the legal framework governing organic production should be improved to provide rules that correspond to the high expectations of consumers and guarantee sufficient clarity.

To accommodate these needs, a new Council Regulation was negotiated – it took three Council Presidencies (1.5 years) to work out the proposal and 18 trialogues during 4 Council Presidencies (another 2 years) to negotiate the details – and finally in 2018, a new Regulation on organic farming was published: (EU) 2018/848 of the European Parliament and of the Council on organic production and labelling of organic products (further: 2018 Regulation).

So, what changed with this 2018 regulation?

 

 

1. Categories

The 2018 Regulation defines three main categories of products that can be organic certified:

  1. Live and unprocessed agricultural products (such as animals, plants, seeds, mushrooms)
  2. Processed food
  3. Feed

Apart from these, Annex I. of the 2018 Regulation provides a list of products that are not clearly covered by these categories but still can be certified.  This list includes but is not limited to specific yeasts, maté, vine leaves and palm hearts.

It also includes sea salt and other salts for food and feed even if those are not living organisms.

 

2. Objectives and Principles

The 2018 Regulation encourages short distribution channels and the local production.  A new and positive principle is the concept of production connected to the soil, reinforcing the contribution to a non-toxic environment, long fertility and biodiversity.

As for processed food, the exclusion of food containing engineered nanomaterials is new.

 

3. Production Rules for Food Processors

One of the most significant changes will be that whilst now all natural flavours are permitted in organic food production, the 2018 Regulation strongly restricts their use.

From 2021, only natural flavours originating from the mentioned ingredients can be used in organic food processing meaning that for example “natural lemon flavouring” is only allowed if it is at least 95% obtained from lemon.

The rules for obtaining natural flavours are detailed.  Cleaning and disinfection products permitted in organic food production are also listed.

There is slightly increased flexibility regarding the origin indication of ingredients.  Currently, if the producer would like to highlight the origin of an ingredient, at least 95% must be farmed in the indicated place, not 98%.

Other areas where the rules are relaxed a little, include

  • concern group certifications in the EU where a small group of farmers can get certified as a single entity;
  • annual physical inspections will not be mandatory for everyone but will be planned and carried out on a risk based assessment
  • retailers only selling pre-packaged organic products will not need certifications but will be checked as part of the general official controls legislation.
  • Member States have the possibility to exempt farmers selling small quantities of organic products directly to the final consumer from certification.

 

4. Imports

The 2018 Regulation recognises two systems to import organic products from countries outside the EU (a.k.a. third countries):

  1. Trade agreements: Third Countries (13 now) must renegotiate their terms for trade agreement under the 2018 EU procedure.
  2. Certifiers: the Commission established a list of recognised control bodies / authorities authorised to perform controls and certification in Third Countries.

These rules were implemented from the 1st of January 2021.

 

Updates to the Organic Regulation 2018/848

The European Commission published its guidance document that clarifies some of the questions and challenges around the 2018 Regulation.

Below, there are some highlights on several clarifications as they have a direct impact on our business.

 

Can food supplements be organic?

Food supplements are foods in accordance with the General Food Law, Regulation (EC) 178/2002.  The 2018 Regulation defines the scope of the organic regulation, which includes “processed agricultural products for use as food”.

Hence, food supplements produced from agricultural ingredients fall under the scope of the 2018 Regulation and can be labelled as organic.  However, food supplements produced from vitamins and minerals are outside this scope and cannot be labelled as organic.

 

Is it possible to certify algal oil rich in DHA (docosahexaenoic acid) as organic food?

It is possible, but under very strict conditions.

Algae are included as agricultural products in the Annex I of the Treaty of the Functioning of the EU (TFEU), therefore an algae oil rich in DHA is an organic processed food when produced in accordance with the 2018 Regulation.

DHA is also a micronutrient, its use in organic processed food is strictly limited in the 2018 Regulation.  In summary yes, DHA rich algae oil can be certified as organic, but its use, due to the DHA content is limited.

 

Can steviol glycosides (E960) be used as food additive in organic production?

When the 2018 Regulation was introduced, an implementing regulation was created to define the substances that can be used in the processing of organic food products, this is Regulation (EU) 2011/1165.

This regulation lists all substances that may be used as food additives, processing aid or carriers, in organic food production.  Steviol glycosides are not authorised in this regulation and therefore cannot be used as a food additive in organic products.

Although some Member States requested the inclusion of steviol glycosides, the independent Expert Group for Technical advice on Organic Production found that steviol glycosides are not in line with the principles of organic legislation and thus cannot be included there.

 

Could shilajit powder be authorised under Article 25 of Regulation (EU)2018/848 as non-organic agricultural ingredient to be used in organic production?

Shilajit is a natural exudation of rocks and consists of a complex mixture of organic humid substances and plant and microbial metabolites.

This cannot be considered as an agricultural ingredient as it is not covered by any category listed in the TFEU and not listed in the Annex of the New Regulation, therefore it cannot be authorised as a non-organic agricultural ingredient.

 

Could enzymes be used in organic food?

Yes, enzymes can be used in organic food.  The 2018 Regulation specifically mentions food enzymes as a substance that can be used in organic food production, if it would normally be used as a processing aid in food processing and is not produced form Genetically Modified Organisms.

 

What are the flavourings that can be used in organic food processed products?

This is a complex question, as flavourings to be allowed in organic production must comply with several requirements at the same time.

Strictly speaking, only natural flavourings that are obtained exclusively or by at least 95% from the source material that reflects the flavour or the taste of the flavouring component, may be used in organic products – this means that flavourings that would be defined as “natural X flavouring” or “natural X flavouring with other natural flavourings”.

Note that some certification bodies may interpret the 2018 Regulation that natural flavourings can also be used, so this needs to be checked in advance.

A Rise in Botanical Supplements

Walking into a supermarket today or shopping online, it is hard to miss the shift in the types of products for sale such as matcha coffees, lion’s mane teas, ginseng soft drinks and ashwagandha gummies.

All these products stem from the meteoric rise of functionalism in our foods and beverages.  And whilst these products are often supercharged by social media trends, it is more embedded in a population that is seeking to be healthier through what they eat and drink.

Botanicals are part of that uptake.  Previously associated as alternative ancient medicine but now they are continuously sought out by a population seeking to improve their immune health, sleep, cognitive function and overall wellbeing1.

There is no internationally shared definition for the term ‘botanical’; however, according to the European Food Safety Authority (EFSA) a botanical can be seen as herbs, roots, flowers, mushrooms and other plant-derived extracts2.

Other jurisdictions classify these ingredients differently – such as dietary supplements in the US, functional foods or Kampo medicines in Japan, or traditional herbal products in India and China – reflecting the lack of global consensus on how botanicals are categorised3.

Despite this regulatory heterogeneity, the economic significance of botanicals is substantial.  The US saw its botanical supplement industry reach USD 13.57 billion in 20244, while the European herbal market was valued at approximately USD 7.5 billion in 20235.

Latin America’s herbal supplement market stood at USD 3.39 billion in 20246 and Asia-Pacific represents the fastest-growing region globally, driven by deep-rooted traditions in herbal medicine across China, India and Japan7.

As the approach to ageing shifts from living longer to living healthier for longer, botanicals will likely continue to soar in popularity.

This growing demand for botanical dietary supplements stems from positive attitudes toward ‘natural’ products and an expanding body of evidence supporting their beneficial effects on human health.

Plants are rich sources of diverse bioactive compounds, including coumarins, flavonoids, phenolics, alkaloids, terpenoids, tannins, essential oils, lectins, polypeptides and polyacetylenes; and consequently, their potential health benefits are unsurprising8.

Ashwagandha (Withania somnifera) has been shown to reduce perceived stress and anxiety in adults9, giving clinical weight to its reputation as an adaptogen.

Turmeric (Curcuma longa), a curcuminoid-rich plant, has meaningful reductions in pain and improvements in physical function reported among people with knee osteoarthritis10.

Elderberry (Sambucus nigra), rich in flavanols, has been found to reduce duration and severity of common cold and flu symptoms11.

Despite these positives, caution is warranted when botanicals are used for medicinal purposes.  Their “natural” origin often leads consumers to perceive them as inherently benign, fostering assumptions of safety that are not always justified.

This perception has contributed to widespread misunderstanding surrounding botanical products and their appropriate use.

 

 

A Credibility Issue

Consider Emily.  Like many Americans, she has begun to struggle with knee pain linked to chronic inflammation.

On the advice of friends and a growing body of academic research, she adds turmeric to her routine as part of a broader holistic approach.

The label states a meaningful dose of curcuminoids, the “active ingredient” most often linked to turmeric’s health benefits.

Weeks later, little has changed and independent testing reveals that the product contains far less curcuminoids than advertised.  Emily does not blame processing choices or the environmental conditions in which the turmeric was grown.

She blames the plant itself, stops trusting botanical supplements altogether and possibly takes to social media where it can amplify distrust far beyond a single purchase.

Emily’s story, while hypothetical, reflects a real and measurable problem.

Large-scale global assessments of nearly 6,000 commercial herbal products across 37 countries have found roughly 27% were adulterated in some way, illustrating how unmanaged variability and poor verification can erode confidence across the category12.

The answers to seemingly simple questions, what exactly is in the product, how consistent it is batch to batch and whether it reflects what the label claims are not always clear and the solutions are more complex.

Plants are characteristically intricate organisms and their biological makeup is inherently linked to the abiotic and biotic factors it experiences during growth13.

For example, anyone who has tasted oranges grown in different parts of the world will recognise the effect of geography.

Fruits from warmer, sunnier regions often taste sweeter, while those grown in cooler environments can be sharper or more acidic – despite all being, unequivocally oranges. Soil composition, rainfall, temperature and harvest timing subtly but consistently shapes flavour.

The same principle applies to botanical supplements; species such as ashwagandha or ginseng, which are cultivated across multiple geographic regions, can differ meaningfully in their chemical profiles depending on where and how they are grown.

Lan et al.14 showed that Panax ginseng cultivated under different forest canopies, coniferous, broad-leaved and mixed forests exhibited statistically significant differences in both total ginsenoside content and individual ginsenosides.

These subtle changes matter when products are expected to deliver certain health outcomes.

The challenge is compounded by the way botanical products are processed.  Raw materials are often sourced from multiple growers and processed in different ways, even within the same supply chain.

For example, Kumar et al.15 in Withania somnifera (Ashwagandha) the principal bioactive compounds such as withaferin A, withanones and withanosides are unevenly distributed across plant parts, with leaves enriched in certain withanolides and roots in withanosides.

This means products made from roots, leaves or whole plants can contain markedly different profiles of these compounds.

As a result, two products derived from the same plant but processed differently can vary meaningfully in both composition, potential benefit and therefore quality.

 

Figure 1 – From plant to product: where botanical variability enters the supply chain. At each stage from genetics, through growing conditions and sourcing to processing – new sources of variability are introduced and compound through to the finished product.

 

When identity and composition are not carefully verified, variability can slide into misidentification or even deliberate substitution.

Cheaper materials may be used to imitate more valuable ingredients, such as peanut skins being substituted for the A-type proanthocyanidins associated with cranberries16.

These practices do more than mislead consumers: they risk undermining efficacy claims and, in some cases, introduce safety concerns that neither the label nor the user expects.

Managing these risks calls for a different way of thinking about quality.  Modern analytical science offers the tools to make that complexity manageable.

 

Overview of Analytical Techniques

For much of history, botanical quality was judged by eye and by a small number of simple tests.

A root or leaf was inspected to see if it “looked right,” and one or two marker compounds were measured to suggest identity or strength.  These methods are still useful and, in many settings, perfectly adequate.

However, modern botanical supply chains are far more complex.  Ingredients are grown in different regions, across seasons and under subtly different environmental and processing conditions.

In this context, analytical techniques play a critical role in reducing uncertainty about raw materials, verifying authenticity of source ingredients and supporting regulatory compliance across different markets.  These techniques increasingly fall into two broad categories:

  1. Targeted methods, which measure predefined metabolites
  2. Untargeted methods, which characterise the overall bio-chemical system.

 

1. Targeted Analytical Techniques

Targeted approaches are designed to answer focused questions: Is compound X present?  Is it within specification?

They rely on prior knowledge of marker compounds, specific chemical constituents used to verify the identity, purity or potency of a botanical material, as well as reference standards.

As such, they are central to regulatory compliance and routine quality control.

Gas Chromatography–Mass Spectrometry (GC–MS)

GC–MS examines the volatile fraction of a botanical.  The sample is vapourised and carried by an inert gas through a narrow column, where compounds separate based on their interaction with the stationary phase.

As each compound exits the column, it is ionised and fragmented, producing a characteristic mass spectrum17.

This combination of separation and structural identification makes GC-MS ideal for aroma profiling, characterisation of residual solvents and small volatile adulterants.

Its limitation is fundamental: larger bioactive phytochemicals (BAPs) including glycosides, polyphenols, curcuminoids, ginsenosides and withanolides are non-volatile and thermally unstable.

This means they fall outside the analytical scope of GC-MS unless chemically derivatised17.

High-Performance Liquid Chromatography (HPLC)

HPLC uses high pressure or ultra-high pressure (UPLC) to push a liquid sample through a packed column, separating compounds based on their polarity due to the interaction between the stationary and mobile phases.

Detection is most often optical (e.g., UV/Visible) and methods are engineered around compounds with known chromatographic behaviour18.

Its strengths are precision, reproducibility and scalability across laboratories (Figure 2).  By design, however, it only detects chemistry the method defines; compounds outside that analytical window remain undetected.

 

Figure 2 – Illustrative HPLC-UV chromatogram of an ashwagandha (Withania somnifera) root extract at 227 nm, showing separation of six withanolides marker compounds. Retention times and peak heights are simulated for illustrative purposes and do not represent real analytical data.

 

Liquid Chromatography Mass Spectrometry (LC–MS)

When liquid chromatography is coupled to mass spectrometry, chromatographic peaks gain molecular specificity.  Features are defined not only by retention time but by their mass-to-charge ratio and fragmentation pattern.

When a photodiode array (PDA) detector is also coupled, UV/visible absorbance data can provide additional confirmation.  In practice, this configuration is most applied as a targeted technique used to confirm and, depending on the type of mass analyser, quantify predefined analytes18.

 

2. Untargeted Analytical Techniques

Untargeted techniques shift the analytical question.  Rather than confirming the presence of specific compounds, they aim to capture the overall chemical composition of a botanical.

High-Resolution (LC–MS)

When liquid chromatography is paired with high-resolution mass analysers — such as Time-of-Flight (ToF), Orbitrap, or hybrid Q-ToF instruments — the analytical window opens significantly.

These platforms measure mass with enough accuracy to infer molecular formulas directly from the data19.

Depending on how they are configured, high-resolution LC/MS systems can operate in both targeted and untargeted modes: confirming known compounds or scanning broadly for hundreds to thousands of features without preselecting what to look for20.

This flexibility makes them especially valuable in botanical quality assessment, where the question is not just “is compound X present?” but “does this material look like the real thing?”.

The resulting datasets are complex, but they become meaningful when compared against well-characterised reference profiles of genuine plant material.

NMR (Nuclear Magnetic Resonance) Spectroscopy

NMR places a prepared extract – whose composition reflects the extraction protocol used – in a strong magnetic field and probes how atomic nuclei respond to radiofrequency energy.

Each chemical functional group produces a distinct resonance and the resulting spectrum integrates signals from all major molecular populations at once21.

Because signal intensity is directly proportional to concentration, NMR is inherently quantitative and highly reproducible for major metabolites above its detection threshold, though sensitivity limits its ability to quantify trace-level components.

The result is a holistic chemical portrait that shifts with any meaningful change in composition, making it powerful for assessing overall integrity.

Modern analytical techniques make it possible to measure botanical chemistry in detail.  Yet, when used in isolation, each still answers only a narrow question.

In practice, no single method can fully describe a living system shaped by species, soil, climate and processing.  What has emerged in response is metabolomics: an approach that treats botanical ingredients not as collections of isolated compounds, but as integrated bio-chemical systems.

 

Metabolomics: Beyond Markers to Fingerprints

Metabolomics describes the comprehensive measurement of all small molecules present in a biological system at a given moment.

In plants, this means capturing the full spectrum of sugars, organic acids, amino acids, phenolics, terpenoids and countless other metabolites that collectively define a species and reflect how it has grown, been harvested and processed18.

Unlike traditional quality control, which reduces a complex extract to the concentration of one or two “marker” compounds, metabolomics treats each botanical as a multidimensional chemical fingerprint.

Using an untargeted approach, thousands of features are measured simultaneously.

This shift also changes the underlying question being asked.  Rather than asking whether a predefined compound falls within an acceptable range, metabolomic approaches ask whether the overall chemical behaviour of a material is consistent with that of an authentic plant.

In a conventional single‑marker framework, an extract is evaluated against one target analyte — for example, whether compound X meets specification.  As illustrated in Figure 3a, an authentic botanical extract and a deliberately spiked product can both pass this test, even though their underlying chemistry is fundamentally different.

 

Figure 3 – From single markers to system-level identity. Left: A traditional single-marker test asks whether a target compound (e.g., compound X) falls within the expected concentration range. Both an authentic extract and a spiked product (Product X) pass, illustrating how this approach can fail to distinguish genuine material from engineered imitations. Right: A Principal Component Analysis (PCA) score plot based on untargeted metabolomic profiling reveals the full chemical picture. Authenticated botanical samples (triangles) cluster within a coherent fingerprint space defined by natural variation, while spiked products (circles) fall outside this region — even when they meet a single-marker specification. Identity is defined by pattern, not a single value. 

 

Untargeted metabolomic profiling resolves this limitation by capturing the full chemical composition of the extract and interpreting it using multivariate statistical methods such as Principal Component Analysis (PCA).

As shown in Figure 3b, genuinely authenticated botanical samples cluster within a coherent chemical space shaped by natural biological variation, while materials that have been diluted, substituted or engineered to satisfy a narrow marker specification fall outside this region, even when they comply with single‑compound criteria.

In this framework, identity is no longer defined by the presence or concentration of an isolated compound, but by whether the pattern of chemistry aligns with that of real plant material.

 

Overcoming Variability, Processing and Adulteration

By shifting quality from single measurements to whole-pattern behaviour, metabolomics directly addresses the core problems that undermine botanical credibility: environmental and seasonal variability, processing effects and adulteration.

Earlier we saw how geography alters plant chemistry, how different plant parts and extraction methods reshape composition and how products can be engineered to satisfy a narrow specification.  Fingerprinting reframes these challenges.

Instead of forcing complex biology into a fixed number, metabolomic models learn how authentic plants vary and define the natural “cloud” they occupy.  This allows regional/environmental conditions to be differentiated as well as adulteration.

This principle is already playing out in practice.  In Panax ginseng, LC–MS metabolomics showed that roots grown under different forest canopies formed distinct but overlapping clusters, capturing the chemical impact of environment while still separating genuine ginseng from non-ginseng material20.

In Saw Palmetto, 1H NMR fingerprinting grouped commercial products by extraction method and exposed samples that were diluted with cheaper vegetable oils, an artefact invisible to fatty-acid testing alone22.

In black cohosh, metabolomic profiles reliably distinguished Actaea racemosa from closely related Asian species in finished supplements, even where DNA barcoding failed due to processing21.

Turmeric shows the same vulnerability: products can meet curcuminoid specifications while diverging from authentic Curcuma chemistry through the addition of dyes or foreign starches; untargeted LC–MS places these materials outside the natural chemical space defined by real rhizome extracts23.

Each case reflects a problem described earlier: geography, processing, substitution and engineered compliance – each demonstrates how fingerprinting restores meaning to identity.

 

Regulation, Traceability and Ethical Sourcing

Metabolomics sits awkwardly within most current regulatory frameworks, which remain grounded in fixed identities and single-parameter specifications.

In the US, the FDA’s approach under DSHEA relies on declared species, GMP compliance and targeted identity tests 24.

In the UK, botanical products are assessed through MHRA and food standards pathways that similarly depend on pharmacopeial methods and marker compounds 25.

EFSA’s evaluations across the EU are anchored to known constituents and safety thresholds.  On the other hand regulators in South America, such as ANVISA in Brazil or CONAL in Argentina, operate through monographs, species declarations and defined assays23,26,27.

In the Asia-Pacific region, regulatory approaches are equally varied.  Japan separates traditional medicines, regulated as drugs, from functional foods assessed under its FOSHU system28.

China’s State Administration for Market Regulation overseas both traditional Chinese medicine and health food registration29, while India’s FSSAI governs botanical supplements as part of its broader food safety framework30.

Australia’s Therapeutic Goods Administration takes a comparatively stringent approach, requiring listed or registered product status for complementary medicines31.

Figure 4 shows the global regulatory landscape for botanical supplements.  These systems are effective for ingredients that behave like chemicals.

They are less equipped to accommodate evidence that expresses authenticity as a multivariate pattern rather than a single value.

 

Figure 4 – Global regulatory landscape for botanical supplements. Compiled from national regulatory authority publications and comparative reviews 3,27,31–35.

 

Yet that very difference is what gives metabolomics its broader significance.

When reference libraries are built from well-documented plant material, chemical fingerprints can link finished products back to biological and geographic origin, creating continuity across the supply chain.

This capability aligns closely with the aims of the Nagoya Protocol, which seeks fair and equitable benefit-sharing from the use of genetic resources36.

By anchoring products to authentic plant populations and documented provenance, metabolomic frameworks can reinforce claims of origin, deter substitution and support sourcing models in which value flows back to the communities and ecosystems from where these botanicals originate from37.

 

Future Perspectives: From Verification to Design

Looking forward, metabolomics is poised to reshape how botanicals are verified, but also how they are developed and applied.

As datasets expand and chemical fingerprints are increasingly linked to biological outcomes, it becomes possible to move beyond generic claims toward evidence-based designs, identifying which metabolic patterns correlate with cognitive resilience, immune modulation or stress adaptation.

Emerging work already shows that subtle shifts across networks of metabolites, rather than single “actives,” underpin many of these effects, particularly in complex systems such as the gut–brain and immune axes38.

In this context, metabolomics becomes a bridge between traditional botanicals and modern biotechnology: enabling targeted cultivation, optimised processing and, ultimately, more personalised nutrition strategies that align plant chemistry with individual physiology.

The KHNI sponsored a sold out ‘Lunch and Learn’ session at Vitafoods Europe, held in Barcelona on 21st May 2025.

Key experts from the industry discussed the journey of bringing nutraceuticals from niche positionings to the mass market.

The opening keynote was impactfully delivered by Teddy Levenfiche, Co-Founder of the UK’s fastest growing energy drink, PerfectTed.  Teddy urged those who are building a nutrition centric brand to start small and go deep into a market niche, before trying to expand the solution to the masses.

For PerfectTed, this meant making matcha more accessible and appealing with positive energy, both within the canned drink, and through their product positioning.

Key milestones for the £300million brand were also shared with the audience, from supermarket listings, to securing funding on the TV show ‘Dragons Den’, explaining the power of community, clarity and conviction when developing the product.

PerfectTed is now the largest matcha brand in Europe, setting a clear example of moving from niche to mass market and this set the tone for the KHNI sponsored Lunch & Learn.

 

 

The 3 hour session then switched to a panel of subject matter experts, each sharing their unique experiences in the nutraceuticals industry bringing a diverse viewpoint to the day.

 

Panelists:

    • David Lemley, President & Head of Strategy (Retail Voodoo).  Expertise: Brand strategy, storytelling, launches/failures, consumer-brand alignment
    • Johan Hellmor, Commercial lead, Supplements (Kerry).  Expertise: Supplements, regulatory strategy, European market experience and expansion, scientific substantiation, product development
    • Riccardo Accolla, Director of Innovation (Thimus).  Expertise: Sensory neuroscience, product testing, consumer emotional response, adoption psychology•
    • Rick Miller, Associate Director, Specialised Nutrition (Mintel).  Expertise: Consumer data, trend forecasting, scientific nutrition & dietary knowledge, market entry strategy
    • Lucy Whittaker, Senior Content Producer (Vitafoods Europe)

 

Nutraceutical Market Trends and Consumer Demand

Rick Miller from Mintel opened the session with market trends leading to consumer demand for functional food and supplements, highlighting that nearly 70% of consumers are actively seeking function-specific nutrition.

Regarding category specific growth, Rick pointed out that functional drinks, yoghurt and cereals are saturated in the functional foods market, whereas spreads, confectionery and daily staples e.g. baked goods are showing potential as breakout categories for innovation with functional ingredients.

Trends with huge opportunity for growth are Hormonal health, Edible Beauty, Personalised Nutrition to tailor supplementation.

Furthermore only 1 in 5 niche products that try to scale to the mainstream achieve measurable market share.

Common blind spots in these scaling attempts include poor pricing strategy, lack of efficacy, and under innovation.  Brands sometimes respond too literally to trends and don’t creatively customise to their product to their consumer.

Transparency and authenticity of products and brands are needed to connect with consumer.

 

Brand Strategy and Communications

Next David Lemley, President & Head of Strategy (Retail Voodoo), discussed the power of brand strategy and communications.  David has helped build breakthrough brands like KIND, Essentia, and Starbucks.

According to Gartner, 45% of new innovations fail due to poor market fit.  What truly separates successful brand breakthroughs from those that flop is building a brand that resonates with consumers, choosing a consumer category and going narrow and deep with that message.

Mission-led messaging is in high demand but is often overplayed.  To authentically build brand stories around values like sustainability or clean label, without greenwashing or virtue signalling, it’s about people, ensuring the employees and buyers believe in the purpose before the consumer does.

This was demonstrated through the example shared of PerfectTed at the start of the session.

 

 

Product Development and Scientific Validation

The biggest challenge facing the industry in the next five years was identified as balancing the speed of innovation with scientific and regulatory integrity.  Johan Hellmor from Kerry delved into the importance of regulatory and scientific validation of nutraceutical products.

Kerry’s research shows 64% of consumers trust products with clinically validated ingredients.  Clinical validation isn’t optional anymore, it’s the price of entry for long-term success.

It should be viewed as both a credibility driver and an innovation enabler.  Building a framework where R&D, regulatory, and commercial are aligned from day one, allows creation of novel formats and ingredient combinations without falling into the ‘post-launch substantiation scramble’ that derails many innovations.

Regarding the EU regulatory landscape, Europe is one of the most challenging markets for health claims.  For companies to navigate the fine line between science-backed claims and regulatory approval when developing new products it is recommended to involve regulatory experts in R&D early on in the process, not as gatekeepers, but co-creators.

Cross-functional teams are critical. R&D, legal, and marketing must work hand-in-hand from idea to launch to avoid costly reformulations or retractions.

In Europe, scepticism around functional claims is higher, therefore building consumer trust through education and proof of efficacy is vital.

The discussion highlighted the novel food and ingredients assessment processes from EFSA and the limited resources that could potentially slow down approval times and limit growth.

With regards to the trends that are currently shaping innovation pipelines, the convergence of personalisation, cognitive wellness, and proactive aging, are areas with potential to go from niche to mainstream.

Taste and texture are also scaling fast as differentiators in supplements.

If a product doesn’t taste great, it won’t become mainstream, no matter how effective it is.  Taste masking and flavour innovation is one example of how we scale sensory science alongside efficacy.

 

Sensory Science in Product Development

Riccardo Accolla, Director of Innovation (Thimus), discussed how he uses neuroscience and biometric testing to decode how consumers emotionally and physically respond to products.

According to Innova, 70% of consumers are more likely to repurchase products that deliver a memorable sensory experience.

Neuroscience is intrinsically involved in product consumption and purchase.

Sensory cues e.g. taste, smell, and emotional memory define whether a consumer likes the product, driving consumption and repurchase.  Increasing quality of consumer neuroscience insights reduces the product failure rate, reducing time to market.

 

Learning from Failure, Scaling and Continuous Innovation

What are some of the most common causes of failure brands face when moving from niche to mass market?

      • Underfunding and moving too quickly without understanding the consumer.  Due diligence is more important than speed to market.
      • We can often over rely on trend analysis rather than authenticity and connection to consumers.
      • One common cause of failure is the lack of regulatory foresight.  Brands often overlook the importance of early regulatory consultation, leading to delays and additional costs. Integrate regulatory strategy from the outset to avoid these pitfalls.  Importance of cross-functional “go/no-go” checkpoints early in product development.
      • Compliance doesn’t have to be a constraint; it can be a catalyst.  When science and storytelling are in sync, it unlocks real innovation.
      • Consumer education is always key here and having consumer facing websites showcasing the strength of the science is a key advantage.

 

Future Nutraceutical Market Outlook

    • The session wrapped up exploring the future market outlook with advice for brands aiming to scale from niche to mass market in the next 3–5 years.
    • Invest in clinical validation early on.  This not only builds consumer trust but also strengthens your market position.  Evidence, transparency, and taste matter more than ever.
    • One emerging trend or consumer segment that’s underhyped but ripe for breakout, is the integration of nutraceuticals with digital health tools, offering personalised nutrition solutions.
    • The greatest challenge facing the industry in next 5 years is balancing innovation speed with scientific and regulatory integrity, especially as AI, synthetic biology, and personalized nutrition explode.
    • In 2030, consumers will demand nutraceuticals that are not only effective but also personalised to their unique health profiles, are clinically proven, taste amazing, and align with their personal values.

The ‘Lunch and Learn’ session at Vitafoods Europe provided a wealth of insights and strategic advice for industry professionals.

By addressing common pitfalls, exploring future market opportunities, identifying upcoming challenges, and envisioning the future of nutraceuticals, the session offered a comprehensive guide for brands looking to scale from niche to mass market.

The expert speakers’ insights underscored the importance of authenticity, regulatory foresight, innovation, and consumer education in achieving long-term success in the nutraceutical industry.