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Challenges in the Food Supplement Market

In many countries, the food supplement market remains relatively underdeveloped compared to the pharmaceutical market, and it is largely due to bureaucratic constraints.

In most places, those who judge these things tend to view food supplements as dietary components with minimal impact on health.

This simplistic approach has several apparent consequences:

  • Food supplements are rarely the subject of serious scientific study.
  • Clinical trials involving these products are either non-existent or extremely rare.
  • Any claims linking human health to food supplement consumption are prohibited.
  • The standard list of ingredients in food supplements is nearly identical across different countries and remains quite limited. Officials often categorise these components simply as lists of vitamins, minerals, amino acids, and so on.
  • The introduction of a new biologically active ingredient within such a condensed and narrow list is seen not as an achievement or a breakthrough, but as a big problem and a headache. Manufacturers must demonstrate that the new substance qualifies as a food supplement and is not associated with health effects, a process that can take years and requires substantial funding!
  • Intellectual property rights for food supplements are virtually unprotected. This means that a company investing significant resources over many years to prove its novel product can easily have its results replicated by others.

  • The requirements for raw materials and manufacturing processes of food supplements are often less stringent than those for medicinal products and may even be simpler than those for standard grocery items! This leniency allows dishonest entities to flood the market with counterfeit ingredients that could pose health risks.
  • The supply chain for food supplements has minimal legal oversight. Whereas in many countries, conventional foods are monitored all the way from the field to the supplier and ultimately to the point of sale (shop, restaurant), a food supplement can be shipped across oceans via Internet order, like stockings or a stationery item. No one will know whether it was shipped at +45oC or -30оС.  And what happened to its components on the road.
  • The shelf life of food supplements is meticulously determined only by the most responsible manufacturer, requiring thorough laboratory testing and substantial budgets. Many manufacturers simply equate their product's shelf life to that of its ingredients. End of story.

The Challenges and Regulatory Hurdles in the Food Supplement Industry

Unfortunately, this list extends well beyond these points, and it is apparent none of the officials care about this long-established knowledge, for example.
The fact that vitamin C (ascorbic acid) deficiency can lead to scurvy, a potentially fatal condition. It seems to often be ignored.
Similarly, vitamin B deficiency (folic acid) can cause severe birth defects and accelerate atherosclerosis in adults due to its role in metabolising homocysteine, significantly accelerating the development of atherosclerosis.

While experts are aware of these health issues, everyday consumers typically learn about them either from medical professionals or by seeking information from various sources, including the internet.
Leaflets for food supplements are not allowed to openly mention these health connections – the European Union’s regulations forbid health claims in labeling.

Phrases stating that such a particular food supplement is “recommended as a diet component” or “is an additional source of such a vitamin or mineral…” do not provide consumers with meaningful insights into the therapeutic properties of supplements. Oops, we used the banned word “therapeutic”.

While the situation is not so dire with well-known ingredients, as we have experience of their previous use, what about companies that launch a new unique product with no equivalents on the market? Primarily, it concerns food supplements based on plant extracts and ingredients, where EU legislation, with all due respect, is absolutely flawed. And this is where manufacturers face the full circle of the overloaded bureaucracy of this self-important body.

EU legislation currently lacks consistent regulatory guidance regarding the use of plants in food supplements.
There are no specific rules governing herbal substances, nor is there a consolidated list of authorised herbs and their preparations and concentrations. It falls to the companies to demonstrate that their products are safe and provide adequate information for consumers to make informed decisions about the ingredients.

While we wholeheartedly support the goal of consumer safety, developers should also be able to communicate clearly about the advantages and properties of their products without resorting to vague language about authorised health claims.