Herbal medicines vs. dietary supplements
The regulatory requirements for plant-based products differ significantly depending on their classification as medicines, cosmetics, foods, or food supplements. This distinction determines which legal requirements apply to the products, manufacturers, and distributors, how high the barriers and efforts for market entry are, and which claims about their effects are permitted. Especially in the field of plant-based products, this differentiation is often challenging, as many plants can be used both as food ingredients and as medicinal substances. For consumers, this difference is often difficult to recognize.
Medicinal products are defined as products intended for medical use or marketed as such. Food supplements are foods intended to supplement the normal diet. While medicinal products claim pharmacological effects, those of food supplements are of a nutritional or physiological nature. Food supplements, like medicinal products, are also marketed in a dosed form.
The composition of food supplements and medicinal products can be very similar or even identical, meaning that ultimately only the dosage, presentation, and marketing determine the difference. To distinguish between medicines, foods, and consumer goods, the competent authorities establish criteria. Food supplements are classified as medicinal products if they are considered “functional medicinal products” due to their composition and dosage, regardless of their presentation and marketing, because they demonstrably exert pharmacological, immunological, or metabolic effects. At the same time, products are considered “presentation medicinal products” if, due to their presentation, they give the impression of being medicinal products or are described or marketed as such, regardless of their actual effect. This classification can vary between different countries.
Medicinal products require authorization in Switzerland, and manufacturers, importers, exporters, or wholesalers must hold an operating license. Even though simplified authorization procedures exist in Switzerland for so-called phyto- or complementary medicinal products, these still involve significant requirements and effort. This creates binding standards for quality and safety but can also limit innovation, reduce overall product availability, and raise questions of economic viability. In contrast, foods can be placed on the market very easily by registered companies without authorization, provided they comply with food law requirements, with self-control playing a central role.
Pharmaceutical manufacturers face a challenge: they operate in a market environment in which numerous providers offer comparable plant-based products as food supplements - often much faster and with significantly lower overall effort. This creates an imbalance in competition. In practice, it is also repeatedly observed that advertising claims and product descriptions are formulated at the edge of what is legally permissible. Health-related claims sometimes fall into grey areas, although the European Court of Justice has already clarified that health claims for botanical substances in foods and food supplements are generally not permitted unless they are authorized under the Health Claims Regulation or fall under transitional provisions.
For medicinal product manufacturers, this creates a tension: on the one hand, they invest heavily in regulatory dossiers, quality documentation, and approval procedures. On the other hand, they compete in the same market segment with products that appear similar to consumers but belong to a different legal category. This can lead to the perception that strictly regulated products are disadvantaged in competition, even though they meet higher standards. This situation also illustrates that regulatory frameworks are not only about safety, but also have a direct impact on market structure, innovation, and consumer trust.
The Swissmedic report on the authorization of complementary and herbal medicinal products in 2025 notes that the number of approved herbal medicinal products has declined significantly in recent years, identifying the increasing importance of food supplements and medical devices as key influencing factors.
A central difference between medicinal products and food supplements lies in quality requirements and quality control. While herbal medicinal products are subject to binding regulatory standards, this applies only to a limited extent for food supplements. Medicinal products must be manufactured according to Good Manufacturing Practice (GMP) and meet the requirements of the relevant pharmacopoeias (e.g., the European Pharmacopoeia). This ensures that identity, purity, and content are tested in a standardized way. Manufacturers are subject to regular inspections by authorities.
For consumers, this means that authorized medicinal products generally offer reliable, tested, and consistent quality. Medicinal products can be identified by their dispensing category or authorization number. In contrast, food supplements are legally considered foods, which are also subject to certain safety requirements but not equivalent GMP obligations in the pharmaceutical sense. The scope and depth of quality testing are not comparable.
Recent studies confirm these differences clearly. In a national inspection campaign by the Association of Cantonal Chemists in Switzerland, 127 products containing plant-based ingredients—mostly food supplements—were examined. 125 of the 127 were found to be non-compliant; in 89% of cases, distribution was prohibited, and 38% were withdrawn from the market because they contained, for example, prohibited botanical ingredients or substances. The authorities explicitly described the overall results as alarming. These findings show that significant quality and labeling deficiencies can occur, that self-regulation in parts of the market is insufficient, and that purchasing via online shops does not currently provide consumers with the desired level of protection, given the many unregistered operators and non-compliant or potentially harmful food supplements.