Introduction
Dietary supplements are classified as food, so their sale at a distance (e.g. in online pharmacies) is subject to the regulations for foodstuffs. The key provisions are:
- Food and Nutrition Safety Act (Article 3(3))
- Directive 2002/46/EC of the European Parliament and of the Council (Article 2(a))
The principles of pharmaceutical law do not apply to dietary supplements. These products must meet the requirements of food law, especially those regarding labelling, presentation and advertising. These regulations aim to provide consumers with complete and reliable information, which is crucial in the context of public health.
Since December 13, 2014, Regulation (EU) No 1169/2011 of the European Parliament and of the Council has been in force, which introduces new requirements for providing consumers with information on food, including distance selling. This regulation aims to increase transparency and ensure that the consumer receives all necessary information before making a purchase.
Mandatory information
In the case of distance sales (including online) of dietary supplements, pharmacies must provide consumers with access to the following information before making a purchase:
- Food name: It must be unambiguous and not likely to cause confusion.
- List of ingredients: Including detailed information on allergenic substances.
- Net quantity of food: The exact weight or volume of the product.
- Special storage or use conditions: Information on how to store the product to maintain its quality.
- Name or company name and address of the entity responsible for the product: Kto jest odpowiedzialny za introduction product on market.
- Alcohol content: If it exceeds 1,2% by volume.
- Country or place of origin: In specific cases where origin is important to the consumer.
All this information must be easily accessible on the pharmacy's website. Pursuant to Art. 14 of Regulation No. 1169/2011, only data on the date of minimum durability and use-by date do not have to be indicated in the online information about a food, because the websites present "representatives" of products, not specific items.
New requirements after 2014
Regulation 2018/775 (EC):
- It introduces the obligation to provide information about the country of origin of the main ingredient if it differs from the declared country of origin of the final product. Online pharmacies must now more accurately inform consumers about the origins of dietary supplement ingredients.
Regulation 2019/649 (EC):
- Applies to substances added to food, including dietary supplements. New regulations may affect the composition and presentation of these products.
Update of Regulation No. 1924/2006:
- Additional changes to health claims, including new procedures and requirements for claims for dietary supplements. It is important that all health claims are approved and labeled appropriately.
Directive 2011/62/EU:
- It introduces additional measures to counteract the falsification of medicinal products, which also affects the sale of dietary supplements, especially in the context of their presentation in online pharmacies.
Additional information – marketing texts
Online pharmacies often include additional marketing information to encourage purchases. It is important that these claims meet the requirements of Regulation (EC) No 1924/2006 on nutrition and health claims. Only approved statements entered in the appropriate list and the so-called declarations from the pending list, i.e. declarations waiting for the Commission's approval (see the register available on the website http://ec.europa.eu/nuhclaims/i).
It is also important to remember that any health claim must be supported by appropriate scientific evidence and meet certain conditions, such as:
- A statement about the importance of a balanced diet and a healthy lifestyle.
- Information about the amount of a food and the level of its consumption necessary to obtain a beneficial effect.
- A warning to people who should avoid a given food and a warning about the potential health risk if excessive amounts of the product are consumed.
Legal risks
You should avoid presenting dietary supplements in a way that could suggest that they have medicinal properties. For example, supplements should not be presented in the same category as medications. To avoid legal risks:
- The presentation: Present dietary supplements and medications in separate tabs on the website.
- Terminology: Use terminology appropriate for dietary supplements, e.g. instead of "dosage", use "recommended serving".
Often, on the websites of pharmacies where medicines are also sold, dietary supplements are presented in a similar way to medicinal products. For example, in the tab titled "Medicines and tablets for colds", next to medicinal products, dietary supplements are also presented. Online sellers also commonly use terms such as: "recommended especially during the period of increased incidence of flu and colds." This type of presentation carries a double risk. Firstly, it may be considered as violating Art. 46 section 1 point 2 in connection with joke. 46 section 2 of the Act on Food Safety and Nutrition, which states that the presentation and advertising of a food cannot attribute to the food the properties of preventing or treating diseases, or refer to such properties. Secondly, there is a risk of qualifying a dietary supplement presented in this way as a medicinal product.
In order to minimize the risk of such qualification, efforts should be made to clearly separate the sales descriptions of dietary supplements from medicines, which may occur, among others, by presenting drugs and dietary supplements in separate tabs on websites or clearly specifying both product categories, as well as avoiding terms specific and specific to the presentation of drugs, e.g. instead of the term "dosage" - "recommended portion".
Practical tips
Easily accessible information:
- Make sure all mandatory information is visible on the pharmacy's website before purchasing. Consumers should be able to quickly and easily find all necessary information, such as ingredients, storage conditions and contact details of the manufacturer.
Clear separation of products:
- Separate dietary supplements from medications by using different tabs or categories on the website. This will help consumers find the products they are interested in more easily and avoid mistakes.
Avoiding ambiguity:
- Use terminology specific to dietary supplements to avoid confusion. For example, instead of "dosage", use the term "recommended serving".
Transparent marketing information:
- All health and nutrition claims must comply with applicable regulations and be approved by the relevant authorities. Avoid using unapproved claims that may mislead consumers.
Regular updates:
- Please check and update the information on the website regularly to comply with the latest laws and regulations. The introduction of new regulations may require modifications to the content and presentation of products.
Understandability and readability:
- The information should be presented in a way that is understandable and legible to the consumer. Use simple language and avoid complex scientific terms unless necessary.
Practical examples
Website structure:
- Create a clear website structure where dietary supplements are clearly separated from medicines. You can use different colors or icons to make navigation easier.
Product information templates:
- Use standard product information templates that contain all legally required information. This will ensure consistency and ease of comparison between products for consumers.
Consumer education:
- Include an educational section on your website that explains the differences between dietary supplements and medications and how to use supplements properly. Educating consumers can increase their trust in your pharmacy.
Interactive elements:
- Add interactive elements such as quizzes or tests that help consumers understand which supplements are right for them. This can increase engagement and improve user experience.
Summation
To comply with applicable regulations and improve user experience, online pharmacies must adapt their practices to new legal requirements. It is important that information is presented clearly and transparently to improve user experience and reduce legal risk. Compliance with guidelines for the labeling, presentation and advertising of dietary supplements is crucial to building consumer trust and avoiding potential legal sanctions.