Evidence-Based Marketing: How Scientific Substantiation is Shaping Brands and the Use of Health Claims

The consumer health market is undergoing a significant transformation. Products like functional foods, nutraceuticals, and cosmetics are no longer judged solely on innovation or appeal, they are expected to prove their worth. Regulators are demanding stronger evidence, and consumers are asking tougher questions. In this environment, marketing cannot rely on broad promises or loosely defined benefits. Scientific substantiation is essential, forming the backbone of any health-related claim that seeks both credibility and regulatory approval.

The Regulatory Imperative for Evidence

Whether in the European Union, the United States, or Asia-Pacific, the regulatory landscape governing health claims has become more sophisticated. In the EU, Regulation (EC) No 1924/2006 governs nutrition and health claims made on foods, requiring that any health claim be supported by generally accepted scientific evidence. Similarly, the FDA in the United States mandates that claims must be “truthful and not misleading,” with structure-function claims requiring substantiation, in the form of competent and reliable scientific evidence.

Anecdotal support or legacy usage is not usually sufficient. Regulatory authorities are expecting structured, well-designed clinical studies. Randomized controlled trials, meta-analyses of peer-reviewed research, and mechanistic studies that demonstrate causality have become central to the approval or at the very least the defensibility of a claim.

Building Marketing on a Scientific Foundation

Aligning marketing strategies with scientific substantiation begins with product development. Teams must collaborate early in the innovation cycle to ensure that ingredient selection, formulation, and intended health benefits are backed by data. If the product is based on ingredients without authorised health claims yet, this means designing clinical trials that not only meet regulatory expectations but are also relevant to real-world consumer outcomes.

When using ingredients which do not have authorised claims yet, companies seeking to make claims such as “supports immune health” or “contributes to normal collagen formation” must go beyond just citing published literature. The studies referenced should mirror the actual product composition, dosage, and route of administration. This relevance, often termed “product-specific substantiation,” carries more weight than general ingredient data and is increasingly becoming the gold standard.

Scientific consultants, regulatory experts, and legal advisors should be involved from the outset. Waiting until a product is ready for launch to consider claim language often results in frustration, delays, or regulatory setbacks. Instead, a cross-functional approach that marries product innovation with regulatory foresight leads to cleaner, more credible outcomes.

Communicating Science with Clarity

Even the strongest data can fall flat if it is not communicated effectively. One of the biggest challenges for marketing teams is translating complex scientific findings into language that is both consumer-friendly and compliant.

This starts with an understanding of what is permissible under local laws. For example, in the EU, terms like “boost,” “prevent,” or “treat” are generally off-limits for food and food supplements. Instead, phrasing must remain within the scope of what the European Food Safety Authority (EFSA) or similar bodies have authorized. Similarly, any graphics or visual elements such as heart symbols or muscle illustrations must not imply a medicinal benefit where one is not legally permitted.

Effective communication is all about framing the findings in a way that connects with consumer priorities while remaining true to the data. If a randomized trial demonstrated that a probiotic reduced the duration of colds in a study population, it may be possible to seek authorisation to say the product “supports immune function,” but not that it “prevents illness.” This distinction is more than semantics; it is often the line between a compliant product and a warning letter.

Language should be concrete and honest. Avoid vague or exaggerated claims. Don’t lean on trendy buzzwords if they have no defined meaning in the regulatory framework. If the evidence supports a benefit, say so clearly. If it doesn't, no amount of creative copywriting will compensate.

The Risk of Overpromising

In the pursuit of market share, the temptation to overstate a product’s benefits is real. But the short-term gain from a bold claim can come at a steep cost: fines, product recalls, reputational damage, and loss of consumer trust. This is particularly true in jurisdictions like Germany, where authorities are proactive and litigation from competitors is common under unfair competition law.

Regulators are not the only audience paying attention. Health professionals, consumer watchdogs, and digital communities now play an active role in calling out unsupported or misleading claims. The reputational fallout from such scrutiny often reaches further than any regulatory penalty.

A Competitive Advantage

When done correctly, evidence-based marketing can become a differentiator. Products that are transparent about their clinical backing, present data in a responsible way, and align their messaging with what is actually proven tend to perform better in the long term. Consumers may not read full study protocols, but they can sense when a brand is grounded in credibility.

If done correctly, reference to scientific substantiation will not only support regulatory compliance, they also foster loyalty and trust—two assets that are hard to earn and easy to lose in today’s market.

Looking Ahead

The trend toward more rigorous scientific substantiation is unlikely to slow down. As regulatory bodies update guidance, consumer demand for transparency increases, and digital tools make clinical information more accessible, companies will need to raise their standards. Those who invest in substantiation as a pillar of brand integrity will be better positioned to lead the next wave of innovation in health and wellness.

Evidence-based marketing relies on clarity, precision, and accountability. By grounding health claims in well-established data, it ensures compliance with regulatory expectations while supporting transparent communication that consumers can trust.