Proper reading of food labels, including those on dietary supplements and foods for special medical purposes (FSMP), is crucial for consumer health. Accurate labeling and health claims on packaging help consumers make informed dietary choices and ensure their safety.
Properly reading a food product label is an essential skill — it enhances our safety and supports maintaining health through conscious planning of a balanced daily diet. Correctly interpreting the information provided by the manufacturer is particularly important in the case of dietary supplements — products that, by definition, are intended to complement a normal diet and help address deficiencies of nutrients necessary for maintaining good health.
In this text, we will discuss:
- the importance of proper labeling and health claims;
- why this topic is important for both consumers and manufacturers;
- the current practices and consequences of incorrect labeling of dietary supplements.
Dietary supplements
It is a concentrated source of vitamins, minerals, or other substances with nutritional or physiological effects, meaning that the ingredients, which are also present in other food products, are contained in a dietary supplement in a concentrated form, tailored to specific health needs (the so-called recommended daily intake).
Moreover, it comes in a form that allows for precise dosing, such as capsules, tablets, lozenges, sachets with powder, ampoules with liquid, bottles with droppers, and other similar liquid or powder forms intended to be consumed in small, measured single doses.
The main purpose of a dietary supplement is to complement a normal diet.
Therefore, dietary supplements are concentrated sources of vitamins, minerals, or other substances with nutritional or physiological effects. Their main purpose is to complement a normal diet. Dietary supplements must meet specific legal requirements regarding labeling, which are regulated, among others, by Regulation (EC) No 1924/2006 and Regulation (EC) No 1169/2011.
More specifically, the most important regulations are:
- Regulation (EC) No 1924/2006: Governs nutrition and health claims related to food in the EU.
- Regulation (EC) No 1169/2011: Concerns the provision of food information to consumers, including labeling, packaging, and advertising.
- The list of vitamins and minerals, as well as their permitted forms for use in dietary supplements, is included in Annexes 1 and 2 of the Directive of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.
- Regulation of the Minister of Health of 9 October 2007 on the composition and labeling of dietary supplements.
Legal requirements for labeling dietary supplements
It is worth noting the list of authorized health claims, i.e., the statements that may be used on packaging (as well as in advertising), included in the Annex to the Commission Regulation (EU) of 16 May 2012, establishing the list of permitted health claims made on foods, other than those referring to the reduction of disease risk and the development and health of children.
The rules and conditions for using health claims are regulated by the Regulation of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods.
Positive lists / pending claims lists are being developed and updated based on the latest opinions of EFSA (European Food Safety Authority) experts for other specific chemical compounds, for example, derived from plants, which may be included in dietary supplements. The evaluation primarily focuses on causal relationships between the consumption of specific foods and health.
- Health claims: Health claims must be approved by EFSA (European Food Safety Authority) and can only be used when there is scientific evidence supporting a relationship between the consumption of a particular substance and health.
- Nutrition claims: Nutrition claims regarding the content of vitamins and minerals must meet specific criteria; for example, “Source of vitamin C” can be used when the product contains at least 15% of the recommended daily allowance (RDA) of vitamin C per serving.
A health claim is any statement that asserts, suggests, or implies a relationship between a food category, a specific food, or one of its components, and health. It is important to remember that health claims cannot be used freely. They are subject to evaluation by EFSA – the European Food Safety Authority. Interestingly, among health claims, there are also claims related to plant-derived ingredients, which appear on the so-called “pending list.” These are claims awaiting EFSA evaluation or Commission decision. Pending claims may be used at the manufacturer’s own responsibility, which is important to keep in mind.
Examples of approved health claims
Vitamin C:
- “Vitamin C contributes to the normal functioning of the immune system.”
- “Vitamin C contributes to the protection of cells from oxidative stress.”
Vitamin D:
- “Vitamin D contributes to the maintenance of healthy bones.”
- “Vitamin D supports the normal functioning of the immune system.”
Folic acid:
- “Folic acid contributes to the reduction of tiredness and fatigue.”
- “Folic acid supports normal amino acid synthesis.”
Dietary supplement labeling may also include so-called nutrition claims — statements suggesting that a particular food has specific nutritional properties. A nutrition claim is any statement that asserts, suggests, or implies that a food has particular nutritional characteristics due to:
a) energy (caloric value), which it:
i. provides,
ii. provides in reduced or increased amounts, or
iii. does not provide,
or
b) nutrients or other substances:
i. that it contains,
ii. that it contains in reduced or increased amounts, or
iii. that it does not contain.
Vitamin C
“Source of vitamin C”
It can be used when the product contains at least 15% of the recommended daily allowance (RDA) of vitamin C per serving.
For example, for “High in vitamin C” — it can be used when the product contains at least 30% of the recommended daily allowance (RDA) of vitamin C per serving.
The packaging must include:
- The designation “dietary supplement”;
- The name of the category of nutrients or other substances characterizing the product, or an indication of their properties;
- The recommended daily portion of the product;
- A warning not to exceed the recommended daily portion;
- A statement that dietary supplements should not be used as a substitute for a varied diet;
- A statement that dietary supplements should be stored out of reach of small children;
- The content of vitamins, minerals, and other substances with a nutritional or other physiological effect present in the dietary supplement, declared in numerical form per the manufacturer’s recommended daily portion (for vitamins and minerals, also expressed as a percentage of the so-called Reference Intake “RI”).
Additionally, on the product label or in the presentation and advertising of the product, it is necessary to include:
- A statement highlighting the importance of a balanced diet and a healthy lifestyle;
- The daily portion of the product required to achieve the beneficial effect of the product;
- Where applicable: a statement indicating which individuals should avoid the product, as well as an appropriate warning for products that may pose a health risk if consumed in excess.
Dietary supplements must not contain information (including in graphic form) that attributes to them the properties of preventing or treating diseases, nor refer to such properties.
(Based on Regulation (EC) 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, Chapter 4, Article 10.)
Summary
Proper labeling and claims on dietary supplement packaging are essential for ensuring consumer safety and enabling informed product choices. Compliance with legal labeling requirements is crucial for both manufacturers and consumers.
Do you have any questions? Are you marketing, labeling, or advertising dietary supplements?
We invite you to get in touch!
Attorney Aleksandra Diskau
adiskau@ajlaw.pl