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How to market mushrooms as food supplements

Fungo medicale Cinese

In our culture, mushrooms (“fungi”) are generally considered as foods widely used in traditional cooking, being very versatile and therefore employed in various recipes.

However, an alternative use of mushrooms has lately emerged along with their classic use in cooking, exploiting the properties of medicinal fungi.

Such use comes, in particular, from the East. In China, for instance, medicinal fungi are well-known and have been used in the local traditional medicinal for thousands of years.

According to this tradition, fungi are attributed with different therapeutic properties, both as cure and as prevention, especially in relation to their activity of modulation of the immune system. That is why they are defined as healing fungi. 

What is mycotherapy?

Mycotherapy is defined as an alternative medicine based on the use of some species of fungi to treat specific disorders. According to the supporters of this practice, medicinal fungi can treat and prevent several disorders.

At nutritional level, fungi certainly contains different important elements, such as proteins, group B vitamins, vitamin A and D, folic acid, polysaccharides and polyphenols.

Besides, fungi beneficial properties are associated to a limited calorie supply by these foods, which make them very desirable also for people following controlled diet regimes.

However, it should be reminded that, as for every food, there can be contraindications linked to special conditions of the users, and therefore medicinal fungi can also be contraindicated.

For instance, concomitant use of drugs should be considered as side effects might occur. Special care should also be given to the use of fungi in pregnant or breast-feeding women. The best thing is always to ask for a doctor’s advice before starting to use healing fungi.

The regulations on fungi

What is the regulatory framework of fungi and what should be done to market medicinal fungi legally?

In general, fungi fall in the definition of foods according to Regulation (EC) no. 178/2002. There are also many concentrated forms of fungi taken to integrate the general diet. In the latter case, the reference regulation is the one dealing with food supplements.

This means we are still talking about foods to which no healing property can be attributed, but only claims on the maintenance of good health.

The world of food supplements is well regulated and defines in details any admitted ingredients and the claims that can be attributed to products. Moreover, before marketing a food supplement in Italy, the FBO shall perform an online notification to transmit to the Ministry of Health the label with which the food supplement will be marketed as well as the main information on the product.

As for the products with herbal origin, the Ministry of Health has prepared a list specifying the substances and herbal products that can be used in the formulation of food supplements. In addition, the list also indicates the part of the plants admitted in the formulation as well as the claims that can be attributed to the ingredient.

Therefore, for the same plant species only some parts are admitted while other are forbidden, and the physiologic effects that can be attributed to the ingredients are specific for the part that is used.

The list also reports any warnings or precautions for use to be stated in the label, and also the range for the admitted quantities, if any.

The label of food supplements containing fungi shall therefore report all minimum mandatory information provided for by the regulation, as well as any additional warnings due to the presence of this special ingredient.

Consumers must always be aware of the properties, but also of the precautions to take before consuming a product, and should always consult their doctor, if required.

Authorisation as Novel Food

When a product is formulated, however, the type of fungus to be used should be carefully evaluated, as some types of fungi are not admitted in food supplements. This ban might come from the fact that the fungus is not safe or it has no significant history of consumption.

In the latter case, it can be authorised according to the procedure for novel foods. The concerned company shall submit a real dossier o the new ingredient, including detailed information on the ingredient and its manufacture, as well as document on the safety of the use proposed (with indications on the target population, dose, type of food).

Otherwise, in case of ingredients with a history of consumption in third countries, a notification procedure can be followed instead of a registration: this is faster and less demanding from the point of view of the documentation to be submitted, however does not grant the ingredient exclusivity.

It is then clear that the wording “medicinal fungi”, often used by consumers, is not a definition provided by the regulations, that clearly distinguishes between medicinal products and food supplements.

The former, also called phytotherapic drugs (in case the active substance is an herbal substance) are authorised in Italy by the Italian Medicine Agency that controls their quality, effectiveness and safety: information on these drugs are available in the list published in the Agency portal and they can be bought from pharmacies.

Food supplements, on the other hand, need no authorisation, they should be notified to the Ministry of Health and consumers can buy them from pharmacies, online or in any store selling food supplements.

Written by: Federica Montozzi

Foto di adege da Pixabay