Are dietary supplements safe? Regulation, security

Are the dietary supplements we take safe? How is their marketing regulated?

Supplements: what are they?

The Italian Ministry of Health has implemented the European Directive 2002/46, which defines food supplements as “food products intended to supplement the common diet and which constitute a concentrated source of nutrients, such as vitamins and minerals, or other substances having a nutritional or physiological effect, in particular but not exclusively amino acids, essential fatty acids, fiber, and extracts of plant origin, whether mono- or multi-compound, in predosed forms”.2

This definition alone clarifies some basic characteristics of supplements: they are compounds-available in predosed forms-intended to supplement normal nutrition, without replacing it, to provide a concentrated source of specific nutrients.2

Therefore, supplements may contain:1

    • Vitamins, such as vitamin C, vitamin E and folic acid
    • Minerals and trace elements, such as calcium, magnesium, iron and zinc
    • other substances such as coenzyme Q10
    • fatty acids, such as omega-3 and omega-6
    • Amino acids, such as L-cysteine and L-carnitine
    • carbohydrates
    • protein compounds
    • Other ingredients, such as probiotics

Supplements are commercially available in the following forms:2

    • capsules
    • tablets
    • sachets
    • vials
    • drinkable vials
    • Bottles of oral solutions or syrups

It should be emphasized that although dietary supplements may come in forms similar to drugs, they should not be confused with medicines; in fact, supplements are not intended to cure or prevent human illnesses or to modify physiological functions, but “only” to supplement the diet thus keeping our body’s functions intact.1

Therefore, a person with a balanced diet including various foods could obtain all the necessary nutrients, and would not, therefore, need to take a supplement.1 There are times in life when for various situations the intake of nutrients and other substances is not sufficient, moreover, often the cultivation methods, storage methods or cooking methods of foods deprive them of many nutrients and other useful substances, so dietary supplementation is needed.

An example of this is folic acid supplementation during pregnancy: in this condition the need for this vitamin to support the child’s development increases. In addition, in some cases dietary intake of folic acid may not be sufficient due to the degradation this nutrient undergoes during the food storage period.3

Another example is the increased need for vitamin D that can occur in winter: during summer, the required amount of vitamin D is generally covered by a balanced diet and by the production that occurs in the skin from sunlight. In winter, on the other hand, the area of skin exposed to the sun and the number of hours in the sun decrease, so support may be useful, especially in certain groups of people such as lactating women or infants.3

Ministry of Health and supplements: regulation

A man taking a supplement pill out of a bottle

The Ministry of Health, Food and Nutrition Department, is the institution in charge of supervising the production and marketing of food supplements, also dealing with food safety, defining, in line with the European Commission and EFSA (European Food Safety Agency), which substances can be used and in what quantity.2,5

All supplements must therefore be notified to the Ministry of Health.

The Ministry may require companies placing the product on the market to make any changes and additional warnings to be displayed on the label and, should the products pose a health hazard, may request their immediate withdrawal from the market.

When the Ministry of Health receives a notification of a supplement, it enrolls the product within the “National Register of Food Supplements” showing the name of the product and the company that notified it, assigning it a specific code whose details can be given on the same label, if the manufacturer wishes.

Dosages and warnings for use

The Ministry of Health, assisted by the peripheral bodies ASL and NAS, verify that the labeling and presentation of the product, as well as its advertising, do not attribute to the supplements effects that they cannot possess, nor capacity to prevent or cure diseases, and that the nutritional or physiological effect attributed to them is among those authorized that can properly guide consumer choices2.

Indicatively, the amount of vitamins and minerals to be provided should be between 15 and 150 percent of the daily requirement set by the European Commission7. This confirms the fact that the supplement, as mentioned above, “supplements” the diet but does not replace it.

Supervision by the Ministry of Health and peripheral control bodies with regard to compliance with current regulationsmake sure that these are safe products that boast correct health claims.

Nonetheless, when taking supplements, especially by individuals who have a medical condition or use medications, or who are in particular physiological situations such as pregnancy or lactation, medical advice is always recommended. Indeed, there are many possible interactions between drugs and supplements, some even for widely used food ingredients.6

In conclusion, dietary supplements are suitable products to help maintain the well-being of a healthy person who follows a varied and balanced diet and a healthy lifestyle.

Bibliography

    1. What are dietary supplements?
    2. LEGISLATIVE DECREE May 21, 2004, no. 169. Implementation of Directive 2002/46/EC on food supplements.
    3. National Health System, NHS. Do I need vitamin supplements? Available online: https://www.nhs.uk/common-health-questions/food-and-diet/do-i-need-vitamin-supplements/. Last updated: October 9, 2023
    4. Wierzejska RE. Int. J. Environ. Res. Public Health (2021); 18: 8897
    5. Commission Regulation (EC) No. 1170/2009 of November 30, 2009 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No. 1925/2006 of the European Parliament and of the Council as regards the lists of vitamins and minerals and their forms that may be added to foods, including food supplements
    6. Know the Science: How Medications and Supplements Can Interact. National Center for Complementary and Integrative Health. (last updated Oct. 19, 2023)
    7. European Regulation 1169/2011

The best supplements for every need

The Principium line adopts all these arrangements: a main active at the highest permissible dosages, in synergy with other substances that enhance its effectiveness combined with the best production technologies.