Why a supplement producer cannot promise treatment – health claims in practice

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Sometimes the most interesting thing on a label is what is not there. A surprisingly careful description is often the result of the law, not a lack of arguments on the producer’s side. Communication about food follows the opposite rule to most industries: you may only say what was permitted before.

What a health claim is

A health claim is any message that states, suggests or implies that there is a link between a food or one of its ingredients and health. Regulation (EC) No 1924/2006 contains this definition.

The key word is “suggests”. A claim is not only a sentence that says something directly. It can also be an image, a trade name or the design of the packaging, if they lead people to this conclusion.

The rules cover all communication, not only the label. This includes the website, the description in a shop, advertising materials and social media.

Nutrition claims and health claims

CriterionNutrition claimHealth claim
What it is aboutThe nutritional properties of the productThe link between food and health
Example of the type of messageInformation about how much of an ingredient the product containsInformation about the role of an ingredient in the body
Basis for permissionConditions set out in the annex to Regulation (EC) No 1924/2006An entry in the list of permitted claims
Who assessesCompliance with the quantity conditions is checked based on the compositionScientific assessment before the claim is permitted

Both types are regulated, but in different ways. A nutrition claim describes the composition. A health claim is about how the body works, so the requirements for evidence are higher.

The principle behind the whole system

The starting point is simple: health claims are not allowed unless they were permitted before. The business that places the product on the market is responsible for making sure that the message meets the law.

Permission is very specific. A claim refers to a specific ingredient. It has a fixed wording or a wording with the same meaning for consumers, and it applies only when the conditions of use are met.

The conditions usually include a significant amount of the ingredient in a portion. A product that contains less than this amount cannot use the claim, even if the ingredient is really in it.

The rules also require additional information. This includes a statement about the importance of a varied diet and a healthy lifestyle, and the amount of product needed to get the described effect.

How an ingredient gets onto the list of authorised claims

The role of scientific assessment

An application to permit a claim goes through a scientific assessment by the European Food Safety Authority. The assessment ends with an opinion, and the European Commission makes the decision.

Claims permitted in this way are added to the list in Regulation (EU) No 432/2012. They are also added to the EU Register of nutrition and health claims kept by the European Commission. The Register is open to the public. It includes both permitted and rejected claims, with the reasons.

A separate procedure applies to claims about reducing the risk of disease and about children’s development and health. These claims need a separate authorisation procedure.

Why many applications are rejected

The reasons for rejection repeat in scientific opinions. These are not arbitrary decisions. They are the result of an assessment of the evidence submitted.

  • The substance is not described well enough. If it is not clear what the application is about, it is not possible to assess cause and effect.
  • The physiological effect is not defined. The described effect must be defined precisely enough so that it can be assessed.
  • Not enough evidence of cause and effect. Observational studies, in vitro work and animal models do not replace data from studies in humans.
  • The tested material is different from the product. A result for one form or one strain does not apply to a different material. More: Postbiotics in scientific research – what we already know and what we do not know yet

A separate category is applications about plant ingredients, whose assessment was put on hold. Always check their status in the EU Register of nutrition and health claims.

What you may never say

Ban on giving medicinal properties

It is not allowed to say that food, including food supplements, can prevent or treat illness or remove symptoms. This rule comes from the law on food information. It applies no matter which studies someone refers to.

The ban also covers indirect messages: a name that refers to a disease, a graphic that suggests treatment or showing the product next to a description of symptoms.

The difference between a supplement and a medicinal product is very important here, because the two categories work under separate legal rules.

More: Food supplements and medicines – why it is worth talking to a doctor or pharmacist

Ban on suggesting that a diet without the product is not enough

The second ban is less well known. The rules do not allow anyone to state or suggest that a balanced and varied diet cannot provide enough nutrients.

This rules out messages based on the idea that modern food is poor in nutrients and that deficiencies are common. This also applies to messages that come from the way material is arranged, not only from what is said directly.

The rules also ban claims that refer to fear or suggest that not eating a product can harm health.

Why many ingredients have no authorised claim

People often misunderstand this part of the system. The lack of a permitted claim is not an official statement that an ingredient has no value.

It can mean several things. Nobody applied, the evidence was not enough or the assessment was put on hold. The research area can also be too new to have data from human studies.

More: Microbiota and the immune system – what research says about this link

However, this does not work the other way either. The lack of a permitted claim does not allow anyone to make promises based on their own reading of studies, press reports or expert opinions.

In practice, this means that a reliable product description is often shorter and more technical than people expect.

How to read marketing messages

The signs below do not decide the quality of a product, but they are a reason to look at the message more closely. We describe mechanisms and do not refer to specific brands.

  1. Promises of fast and certain effects. Statements about a specific result in a specific time go beyond what can be said about food.
  2. References to unnamed studies. “Studies confirm” without naming the publication, the study group and the type of study does not let you check anything.
  3. Medical language around a food product. Clinical terms and descriptions of diseases move the message into an area reserved for medicines.
  4. Images of people in lab coats and medical symbols. A stethoscope, a doctor’s office or a person shown as a specialist create a link with treatment.
  5. Appeals to fear. Messages based on fear of what happens if you do not use the product are directly restricted.
  6. Suggesting common deficiencies. Saying that a diet is never enough falls under the ban described above.
  7. A claim that does not name an ingredient. Permitted claims refer to specific ingredients, not to the product as a whole.

What an honest producer can say

The range of permitted communication is narrower than people think, but it is not empty. A producer can describe accurately what the product is.

  • Ingredients and content. The full list of ingredients and the amount in the recommended daily portion.
  • Description of an ingredient. Origin, form, strain designation or extract standardisation.
  • Technology and process. How the product is made, a description of the product form, storage conditions.
  • Permitted claims. Only claims from the list, for the named ingredients and when the conditions of use are met. An example of such a claim for a specific nutrient is the statement that vitamin C contributes to the normal function of the immune system.
  • Accurate information about studies. The publication, the type of study and the tested material, without turning the results into promises.
  • Regulatory information. Details of the responsible business, the batch number, directions for use. More: How food supplements are supervised in Poland – notification, GIS and producer obligations

Summary

The claims system is based on the principle that you may only use wording that was permitted before, for the named ingredients and when the conditions are met. This covers all communication, not only the label.

Two bans always apply: you may not give food medicinal properties, and you may not suggest that a varied diet cannot provide enough nutrients.

The lack of a permitted claim for an ingredient is not an assessment of its value, but it also does not allow anyone to make promises. This is why a reliable product description is often short and technical. It focuses on what the product is, not on what it should do.

FAQ

Can a producer refer to the results of their own studies?

They can describe studies accurately and name the publication, the type of study and the tested material. However, this does not allow them to make a health claim if the claim was not permitted before through the correct procedure.

Does the ban apply only to the label?

No. The rules cover all commercial communication, including the website, descriptions in shops, advertising materials and posts on social media.

Where can I check if a claim is permitted?

You can use the EU Register of nutrition and health claims kept by the European Commission, available at https://food.ec.europa.eu/food-safety/labelling-and-nutrition/nutrition-and-health-claims_en, and the list set out in Regulation (EU) No 432/2012.

Sources

  1. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods.
  2. Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health.
  3. Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers.
  4. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law.
  5. EU Register of nutrition and health claims kept by the European Commission, https://food.ec.europa.eu/food-safety/labelling-and-nutrition/nutrition-and-health-claims_en

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