In addition to a business plan, tax issues, organization of distribution channels, and marketing, compliance with food law requirements must be ensured in order for a dietary supplement to be marketed in the EU.
Dietary supplements are food…
Although they are often presented as a separate category (e.g., in online stores), according to regulations, dietary supplements are food. Therefore, dietary supplements must meet the requirements set forth in the food law (levels of contaminants, and applicability of additives).
In addition to general food regulations, specific regulations that apply only to dietary supplements apply also to wholesale supplement distributors. Therefore, for example, the label does not have to include a nutritional table, but a table of active ingredients.
In addition, the regulations for supplements specify the sources of vitamins and minerals that can be added to them.
Dietary supplement – a foodstuff, the purpose of which is to supplement the normal diet, which is a concentrated source of vitamins or minerals or other substances that have a nutritional or another physiological effect, single or combined, marketed in a form that allows dosage, in the form of capsules, tablets, dragees, and in other similar forms, sachets with powder, ampoules with liquid, bottles with droppers,s and other similar forms of liquids and powders intended to be consumed in small measured unit quantities.
Excluding products having the characteristics of a medicinal product within the meaning of the pharmaceutical law (Law of August 25, 2006, on food and nutrition safety).
Supplements vs. other product categories
Dietary supplements are often borderline with other products (herbal teas can be a food for general consumption or a dietary supplement).
A product with added vitamins can be a dietary supplement for fortified food and also a food for special medical purposes (FSMP), a product with a herbal ingredient can be an SD, a food for general consumption, or even a medicinal product.
Depending on the type of ingredients and their dosages, purpose, and form, the product may or may not be a dietary supplement. This should be checked at a possible early stage because the category of the product determines the procedure for its marketing.
Composition of dietary supplements
In order for a supplement to be on the market, it must contain only ingredients permitted for use in that category, in the appropriate quantity and form; including the composition of capsules and shells.
They check in particular additives – that may be appropriate which are provided for use in this category (Regulation (EC) No. 1333/2008 of the European Parliament and of the Council of December 16, 2008, on food additives), plant ingredients – we verify the form, form, type of extract, history of consumption in the EU.
Regulations on supplements vary in the EU
Regulations on supplements are not harmonized at the EU level. The issue is regulated by Directive 2002/46 of the European Parliament and of the Council of June 10, 2002, on the approximation of the laws of the Member States relating to food supplements.
Because of this way of regulation, there are differences between member states with regard to composition, level of active ingredients, marketing rules, and labeling.
Label, labeling, marketing, website, and content in SM
A dietary supplement, like any foodstuff, must be labeled in a certain way.
The regulations include a list of content that must mandatorily appear on the label, e.g. name, ingredient list, expiration date, and allergen information. The presentation of mandatory information is also regulated, e.g. font size, legibility, and placement on the label.
Special regulations also apply to dietary supplements.
Their labeling is rich in marketing content. Content about the health effects of dietary supplements, their quality, and the way they are produced may not violate (numerous) regulations (e.g., regulating the use of health and nutrition claims). Case law in this area is very rich.
Requirements apply to the label, but also to advertising (websites, flyers, online stores, SM, radio, TV).
Online dietary supplement store
The legislation regulates what information wholesale supplements suppliers like PowerBody must provide to the buyer (consumer) if he or she makes a distance transaction. This applies primarily to online stores, but also to mail-order catalogs and supplements, and wholesale distributors.
When planning activities in this area, it is necessary to consider how to solve the issue of updating the information on dietary supplements given on the site and also the consistency of the information given in the online store with the ordered goods.