Navigating Complex Claims: Ensuring Regulatory Compliance in Herbal and Botanical Product Labelling

The global market for herbal and botanical products continues to surge, driven by consumer demand for natural health solutions. From traditional remedies and Ayurvedic preparations to adaptogens and plant-based wellness supplements, these products now occupy a significant space in the food supplement, cosmetic, and nutraceutical industries. Yet as popularity rises, so does regulatory scrutiny. Labelling remains one of the most visible and heavily regulated aspects of marketing herbal products alongside their registrations in the correct regulatory category. A label is both a legal document and a powerful marketing tool, and the claims it contains can determine whether a product remains on the shelf or gets pulled by authorities. A label presentation can also determine if your product would be marketed as a medicine or a food supplement / cosmetic for example, and it’s essential in handling borderline cases.

To navigate this space successfully, companies must understand the complex relationship between product claims, scientific substantiation, and country-specific regulatory frameworks. This article explores how businesses can craft compliant, compelling labels while preparing for a regulatory landscape that is becoming increasingly harmonized and science-driven.

Understanding the Stakes: Claims and the Need for Substantiation

Claims on herbal and botanical products must reflect more than branding ambitions. They must be rooted in verifiable science. Whether a product suggests it “supports immune health” or “helps the reduction of fatigue,” these statements are classified as health claims and are subject to strict regulatory review.

In the European Union, health claims fall under Regulation (EC) No 1924/2006, which requires that all health claims made on foods, including food supplements, be authorized by the European Commission after scientific assessment by the European Food Safety Authority (EFSA). EFSA’s evaluation is rigorous and centres on whether a cause-and-effect relationship has been established between the consumption of a substance and the claimed health benefit. Claims like “supports vitality” or “helps with detox” often fall short due to vague terminology or insufficient scientific evidence. To date, EFSA has rejected more than 90 percent of botanical health claims assessed under Article 13.1 due to a lack of substantiation with human intervention studies.

This has led to a peculiar situation. A temporary list of botanical claims (those still under assessment) remains in circulation, and many EU countries allow their continued use as long as they are not misleading and are supported by traditional use or generally accepted data. However, this does not constitute approval. Companies relying on this list must maintain a defensible dossier of evidence in case of inspection or challenge. It’s fair to say that the claims based on the so called “on hold” list do not have a solid legal status, and each EU member state has a different approach in judging their suitability of use when marketing products.

In the United States, the approach is different. The Food and Drug Administration (FDA) does not pre-approve structure-function claims for dietary supplements. However, structure-function claims must be truthful, not misleading, and substantiated by competent and reliable scientific evidence. The Dietary Supplement Health and Education Act of 1994 (DSHEA) allows manufacturers to use claims like “supports joint health” but requires the inclusion of the disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

The situation is different for herbal medicines registered under traditional use pathways, such as the EU Traditional Herbal Medicinal Products Directive (2004/24/EC). These products must demonstrate at least 30 years of traditional use, including 15 years within the EU, to justify claims related to traditional effects. This pathway does not require the same level of clinical data as conventional medicinal products but demands consistency, plausibility, and safety substantiation, with all indications limited to minor health conditions.

Scientific substantiation is not optional. It is a cornerstone of legal compliance, and without it, a THR registration cannot be obtained. If products are marketed without a registration but using medicinal claims based on tradition of use related to botanical ingredients, companies expose themselves to regulatory action, fines, product recalls, or reputational damage. In today’s digital environment, one flagged claim on a label can spark a wider investigation across websites, advertising, and social media channels.

Country-by-Country Variations: A Patchwork of Rules

Despite some global trends, regulatory oversight of herbal and botanical claims varies significantly by region. This is especially relevant for companies operating internationally or selling online.

In the EU, as mentioned, EFSA plays a central role in evaluating the science behind health claims. However, interpretation and enforcement lie with national authorities. Germany’s BfArM, France’s ANSM, and Italy’s Ministry of Health may take different views on borderline cases, including whether a product is classified as a food supplement or a medicinal product. This classification determines the applicable regulatory regime and can shift based on formulation, dosage, presentation, or intended use.

Switzerland, though closely aligned with EU standards, retains its own approach. The Federal Food Safety and Veterinary Office (FSVO) permits certain health claims based on a positive list. Others must follow a notification procedure. Swiss law distinguishes between "nutrition claims," "health claims," and "disease risk reduction claims" in line with Codex Alimentarius principles, but with subtle national nuances in permitted wording and imagery.

In the US, the FDA and Federal Trade Commission (FTC) both exert influence. While the FDA regulates product labelling, the FTC monitors advertising claims. A label claim that passes FDA muster could still prompt FTC enforcement if the supporting evidence is deemed inadequate. FTC guidance requires that advertisers possess “a reasonable basis” for their claims, often interpreted as two randomized controlled trials for products making more significant health benefits.

Canada, Australia, Brazil, and other jurisdictions all offer their own specific requirements. Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) evaluates claims based on monographs and imposes premarket licensing, while Australia's TGA classifies herbal products as "complementary medicines" and restricts higher-risk claims to registered (as opposed to listed) medicines.

This variability makes label harmonization nearly impossible without tailored versions for each market. Companies must carefully map out their global labelling strategy to ensure that a claim accepted in one jurisdiction does not violate laws in another.

Striking a Balance: Compelling Yet Compliant Labels

Crafting a label that satisfies legal standards while appealing to consumers is a balancing act. Marketing teams often want evocative language that resonates emotionally. Regulatory teams need precision and restraint.

The challenge is to communicate benefits without making unauthorized claims. Terms like “natural,” “ancient wisdom,” “rebalances,” or “energy booster” are popular in marketing but can risk misinterpretation. Some regulators view these terms as inherently suggestive of medical or physiological effects. When used, they must be defensible or presented as part of a broader narrative rather than as standalone health claims.

Visual elements also count. Images of organs, medical equipment, or cross-sectional graphics may be deemed suggestive of therapeutic intent. Even font sizes and placement matter. Placing a disclaimer in small print or too far from the claim can render it ineffective in the eyes of regulators.

Some strategies can help navigate this. Using approved structure-function claims where possible, citing traditional use explicitly (“used traditionally for...”), or referencing general wellness support within clearly defined contexts (“as part of a balanced lifestyle”) are methods that reduce risk.

Legal representation during label development, or a comprehensive review by regulatory consultants, can be invaluable. Especially for companies launching across multiple jurisdictions, early-stage regulatory review avoids the costly exercise of relabelling or recall after launch.

Looking Ahead: Where is the Industry Heading?

The herbal and botanical sector is experiencing unprecedented growth. According to Grand View Research, the global herbal supplements market was valued at over USD 100 billion in 2023 and is expected to grow at a CAGR of more than 7 percent through 2030. With this growth comes increasing attention from both regulators and consumers.

Globally, the trend is moving toward greater accountability and harmonization. Regulatory bodies are likely to intensify their focus on evidence-based claims, digital advertising consistency, and cross-border e-commerce compliance. The EU’s forthcoming updates on the status of pending botanical claims, the US’s growing scrutiny of influencer marketing, and China’s push for localized labelling requirements are just a few indicators of this direction.

Technology is also playing a role. With artificial intelligence and natural language processing tools, regulators can now monitor claims across thousands of websites and social media platforms in real-time. Certain organisations, like the UK’s Advertising Standards Authority (ASA) use AI tools to scan the internet for non-compliance and raise complaints. Companies will be expected to maintain consistent messaging not only on packaging but across every consumer touchpoint.

At the same time, consumers are becoming more educated. They are increasingly asking questions about the source, science, and safety behind what they ingest. Brands that respond transparently, avoid hyperbole, and invest in real substantiation will be better positioned to earn trust and sustain long-term growth.

Conclusion: A Path Through Complexity

Labelling for herbal and botanical products goes beyond regulatory compliance, serving as a key element of strategic business planning. The regulatory landscape is fragmented, complex, and rapidly evolving. Claims must be supported by data. Labels must be clear, truthful, and adapted to each market’s requirements. And companies must balance compliance with the need to communicate value to consumers.

To navigate this terrain, businesses need cross-disciplinary collaboration between marketing, regulatory, legal, and scientific functions. With the right strategy, it is possible to tell compelling product stories that respect both consumer intelligence and regulatory frameworks.

As regulatory scrutiny deepens and the market matures, the winners in this space will be those who invest early in compliance, ground their claims in solid evidence, and view the label not only as a piece of packaging but as a reflection of brand integrity.