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Food supplements: what to write on the label

Vitamins, minerals, plant extracts, probiotics, amino acids: on the shelves, food supplements come in very different forms, with different ingredients and functions. They may be sold as capsules, tablets, sachets, powders or liquids to be taken in small quantities. From a regulatory point of view, they are foods, but they have specific characteristics and their labelling follows specific rules as well. A package must explain what the product contains, how much should be taken and which precautions should be followed, but it must also avoid attributing effects to the supplement that it is not allowed to claim. Here the legislation is very clear: nutritional information, health claims and therapeutic claims are very different things and must be kept clearly separate.

What must appear on a food supplement label

The specific European reference is Directive 2002/46/EC, implemented in Italy by Legislative Decree No. 169 of 21 May 2004. These rules are complemented by the general provisions on consumer information laid down in Regulation (EU) No 1169/2011 and those concerning nutrition and health claims in Regulation (EC) No 1924/2006.

The legislation defines food supplements as food products intended to supplement the normal diet and consisting of concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form. The required designation is “food supplement”. Like other prepacked foods, they must include a series of general information, including the list of ingredients, with allergens emphasised, the net quantity, the date of minimum durability or use-by date, any special storage conditions and the name or business name and address of the operator responsible for the information.

Specific information must also be provided. The category of nutrients or other substances characterising the product must be stated, or an indication of their nature must be given. The recommended daily intake is also essential: one tablet, two capsules, one sachet or a specified amount of powder or liquid. The quantities of substances with a nutritional or physiological effect must be expressed numerically and refer specifically to the recommended daily intake. In the case of vitamins and minerals, where required, they are also expressed as a percentage of the nutrient reference values. This is one of the elements that distinguishes food supplements from ordinary foods: products covered by Directive 2002/46/EC are not subject to the standard nutrition declaration required for other prepacked foods.

There are also certain mandatory warnings. The packaging must state that the recommended daily dose should not be exceeded, remind consumers that food supplements should not be used as a substitute for a varied diet and specify that the product should be kept out of the reach of young children. Depending on the composition, additional information required by legislation or by the guidelines of the Italian Ministry of Health may also be necessary. Before being placed on the market in Italy, moreover, the responsible operator must notify the food supplement to the Ministry of Health, also submitting the label used. Products that complete the procedure are entered in the Register of Food Supplements. Notification and registration, however, do not amount to prior authorisation: responsibility for the compliance of the product and the information provided remains with the operator.

Different ingredients, different labelling requirements

There is no standard label suitable for every food supplement. A significant part of the information that must be provided depends on the actual composition of the product.

A significant example is that of supplements containing plant substances and preparations, often referred to as botanicals. In Italy, their use is regulated by the Ministerial Decree of 10 August 2018 and subsequent updates. The plant used must be correctly identified, and the part of the plant used and the characteristics of the preparation must also be taken into account. In the case of extracts, their nature and preparation method may be relevant to accurately identify what the consumer is taking. This is an important distinction because two preparations obtained from the same plant species are not necessarily equivalent. Root, leaf, fruit or seed may have different compositions, and the process used to obtain an extract can also determine its characteristics.

Particular attention must also be paid to supplements containing microorganisms used to support the balance of the intestinal flora. Ministry guidelines establish specific criteria for identifying the microorganisms used and declaring their quantities. In products of this type, as with those containing plant substances, correctly describing the ingredient is therefore a fundamental part of the information provided to the consumer. The composition may also determine the need for specific warnings. Certain substances or particular intake levels require additional wording beyond that generally required for all supplements. For this reason, the label must be developed starting from the actual formulation of the product, rather than simply adapting a graphic template used for other products.

Claims and promises: where the line is drawn

The most delicate aspect is probably the relationship between what a supplement contains and what can be claimed about what it does. Food supplements are not medicines. Their label, presentation and advertising therefore cannot attribute to them properties of preventing, treating or curing a disease. Certain nutrition and health claims may instead be used, but only within the framework established by European legislation.

So-called health claims are not advertising phrases that can be created freely. To use them, it is necessary to verify that the claim is permitted, that it actually refers to the substance present in the product and that the conditions established for its use are met. A scientifically plausible statement, therefore, is not automatically suitable for use on the packaging. The difference may appear subtle, but only at first glance. Stating, in authorised cases and under the required conditions, that a substance “contributes to the normal function” of a specific physiological process is different from claiming that the product prevents or cures a disease. In the latter case, the wording enters the field of therapeutic properties, which cannot be attributed to a food supplement.

Legislation also prohibits suggesting that a balanced and varied diet is generally unable to provide adequate amounts of nutrients. This principle is consistent with the very definition of these products: a supplement is intended to supplement the diet, not replace it. A food supplement label must therefore accommodate a large amount of information in what is often a limited space: ingredients, quantities, daily dose, warnings and information on the product’s characteristics. But the issue is not only finding enough space on the packaging. Above all, the words must be chosen with precision.

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