Transparent, reliable science behind their products is no longer just a "nice-to-have" for brands in the nutraceutical market; it’s a real growth driver.

Representative consumer surveys show that most people want to have scientifically verified information regarding dietary supplements. In a survey by a German consumer monitor, 79% of respondents rated having scientifically verified information as important or very important.

At the same time, there is a lot of uncertainty on the market. According to a recent survey commissioned by the German consumer portal Lebensmittelklarheit.de, 77% of people use dietary supplements. However, nearly half (49%) mistakenly believe these products are tested in advance to ensure their safe to use. For dietary supplements, at least in Germany but also in other countries, this is not the case as such testing isn’t mandatory.

This presents an opportunity for brands. Those that present verifiable, well-explained laboratory findings on the efficacy or way-of-working of their ingredients (from in-vitro or ex-vivo cell models, for example) not only provide guidance but clearly differentiate themselves from competitors who argue based on tradition or testimonials alone.

"Today, you have to show that a product is bioactive. This increases quality and trust, setting brands apart from those that do not invest in scientific evidence," says Dr. Bernd Fiebich, a neuroscientist and the CEO of VivaCell Biotechnology GmbH, a laboratory that specializes in preclinical efficacy research and is a member of 1Q Health GmbH.

It is important to make a clear distinction between legally permissible “health claims” (according to EU Regulation 1924/2006) and scientifically proven health benefits, which do not automatically constitute an EFSA claim.

EFSA health claims are strictly regulated and only permitted in clearly defined cases. Cell-based findings, functional assays, or mechanistic data cannot replace these claims. But they may be communicated in a reputable manner, provided they are accurate, not misleading, and do not promise a cure.

“I would refer to health benefits that are demonstrated in the laboratory and that companies are allowed to communicate, without presenting them as EFSA health claims,” explains Dr. Fiebich.

Preclinical studies provide marketing arguments with substance. Tey prove causal relationships (e.g., anti-inflammatory, antioxidant activity, receptor binding), support product positioning (“for oral health,” “for skin soothing”) and help to formulate strong, legally compliant messages.

From a product development perspective, three levers can be identified:

1. Development: Screening and comparing extracts, fractions, mixtures, and individual substances to identify lead candidates and optimize formulations (e.g., identifying synergies in mixtures and dose-response curves).
2. Quality Assurance: Ensuring reproducible and measurable bioactivity as an additional quality feature (e.g., maintaining consistency from batch to batch and ensuring stability in the end product).
3. Marketing: Tangible, citable data for product documentation, B2B and B2C sales, trade fairs, web dossiers, and package inserts to prove that the formulated benefit expectation is supported by scientific results.

"Both small and large companies benefit equally. Most questions can be tested affordably in cellular models," says Dr. Fiebich.

Preclinical models are practical, fast, and budget-friendly, especially for brands of dietary supplements and natural substances.

For example, in-vitro cell models use primary monocytes (white blood cells), gingival fibroblasts, keratinocytes, or neuronal cells. These are ideal for quantifying mechanistic effects, such as cytokine modulation, ROS, and barrier markers.

Ex-vivo models use human immune cells from blood donations. They bring human biology into the laboratory and increase clinical plausibility.

• Formulation/matrix tests: These tests show whether an efficacy profile is retained in the end product (e.g., toothpaste, cream, or capsules).
• In-vivo models: Useful for addressing specific questions when evaluating systemic effects or pharmacodynamic cascades. However, this is not necessary in developing food supplements.

Note: You can start small with an efficacy claim, a cell line, and two to four meaningful parameters. This often provides reliable signals for go/no-go decisions in product development and sufficient substance for fact-based product communication.

"When it comes to scientific evidence, many people immediately think of expensive clinical trials. That doesn't have to be the case. Well-planned in vitro/ex vivo assays often provide clearer signals than poorly designed small clinics and cost only a fraction of the price," emphasizes Dr. Fiebich. "For simple setups, we're talking about the low four-digit range and a runtime of three to four weeks. That's enough for decision making.”

Oral Health & Inflammation

In an ex-vivo study conducted by VivaCell, the ability of potential probiotics to modulate inflammatory mediators (including IL-1β, IL-6, IL-8, TNF-α, PGE₂, and 8-isoprostane) after LPS stimulation was first tested in human primary monocytes.

Results: Two Lactobacillus strains demonstrated significant, dose-dependent reductions in several mediators and could be used as probiotics in oral care products to reduce gum inflammation.

Tradition Meets Mechanism

Another example is silver linden (Tilia tomentosa). Its traditional use for treating restlessness has been substantiated by pharmacology. A bud extract binds to the GABA binding site of the GABA_A receptor, but not to the benzodiazepine site, which is a plausible mechanism of action for the observed calming effect. Mechanism data like this is invaluable when brands want to translate traditional evidence into modern terms.

These two examples illustrate the guiding principles of the article. Cell studies provide robust, marketable evidence that can be used to formulate precise benefit claims. This can optionally be followed by a larger study (e.g., a clinical trial), but it is not necessary.

The demand for food supplements is concentrated in a few high-growth areas, each of which offers multiple research directions:

• Healthy aging/longevity: Cellular models for mitochondrial function, inflammation, and autophagic flux.
• Women's health: Period, menopause, skin, and microbiome issues with differentiated, gender-specific endpoints.
• Energy and cognitive performance: ATP turnover, mitochondrial respiration, and neurotransmitter modulation as reliable laboratory KPIs.

"Longevity and gender-specific products are popular. It's important to select the right targets and models to ensure the data is relevant for purchasing decisions," says Dr. Fiebich.

An efficient, standardized process for a research project saves time and money. The necessary steps are shortly summarized below:

1. Have a clear focus: What health benefits should be proven (e.g., skin soothing, oral health, regeneration, or focus)?
2. Select the model and markers: Choose indication-related cell models and clinically compatible biomarkers (e.g., cytokines, oxidative markers, and barrier markers).
3. Co-design the study protocol: Dose ranges, positive controls, replicates, and statistics, as well as matrix and stability tests if necessary.
4. Implement and update: Use iterative testing and interim results to refine formulations and claims.
5. Report and transfer: Create audience-friendly graphics and clear narratives (mechanism → benefits), and check advertising texts for legal compliance.
6. Optional expansion: If the signal is strong, conduct a second wave (additional cell types/parameters) or an observational study/pilot clinical study.

A research partner can help with the selection of models and protocols, as well as with health benefits. Therefore, choosing the right partner is crucial for the project's success.

There are a few selection criteria to consider and questions to ask when looking for a research partner:

• Scientific standards: How do they use replicates, statistics, positive controls, and SOPs?
• Experience and team: Do the employees have several years of practical experience? Are there biologists and physicians with the relevant expertise on the team?
• Transparent publication record: Do the employees have peer-reviewed publications? Verifiable methods are markers of quality, so ask for publication and reference lists.
• Industry fit: Is the company a good fit for the NEM, cosmetics, or pharmaceutical industry? Does the company design individual protocols instead of using a “one-size-fits-all” approach?
• Communication: Are there interim reports, data visualization, and support for market transfer?

"There are not many providers who consistently meet all requirements. Always remember to ask for publications, testimonials, and scientific standards," recommends Dr. Fiebich.

• Formulate a hypothesis: What specific problem does the product solve?
• Define one to two cell models.
• Select 2–4 markers.
• Choose realistic doses: Consider galenics and bioavailability. Also, cross-check the end product (e.g., toothpaste, capsule, or cream) at the same time.
• Come up with a clear storyline: Mechanism → marker effect → translated health benefit (without promises of healing).
• Create marketing documents: One-pager, landing page, data sheets, and claim guidelines with permissible wording.

The market for dietary supplements is saturated across the globe. True differentiation can be achieved through scientific evidence behind the products.

Cell and ex-vivo studies are quick and inexpensive tools for demonstrating health benefits, proving quality, and formulating legally compliant marketing claims. In a highly competitive market these can be the make-or-break qualities that gain the attention retailers, press, and most importantly, the consumers.

Sources

• University of Göttingen (2025): Results report on a food supplement study – Consumer Perception & Health Claims/Regulation. (Conclusion: Regulation should ensure that promised effects are verified). Universität Göttingen
• Probiotika & Gingivitis (2018): Ex vivo anti-inflammatory effects of probiotics for periodontal health. J Oral Microbiol. (PMID: 30057719; PMCID: PMC6060379). PubMed
• Tilia tomentosa (2020): Bindung am GABA_A-Rezeptor als plausible Grundlage der traditionellen Anwendung. Zeitschrift für Phytotherapie. Thieme, a magazine for phytotherapy.