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Splitting tablets in the case of dietary supplements. New resolution.
Dear manufacturers and employees of R&D, regulatory and marketing departments.
The Dietary Supplements Team has defined clear conditions under which dividing a tablet may be indicated in the product instructions for use.
In summary:
- Firstly, safe doses, i.e. the entire tablet must not contain more than the maximum daily amounts of ingredients.
- Secondly, accurate composition, i.e. each ½ part of the tablet, created after division, must contain the declared amount of vitamins, minerals, extracts, etc.
- Thirdly, the tablet must have a clear dividing line (not just decorative) and be breakable.
- Fourthly, simple and unambiguous design, i.e. you must explain to the consumer how and when to divide the tablet in the label/leaflet.
The resolutions of the Dietary Supplements Team are not a source of law, but every practitioner knows that they must be taken into account. Therefore, check today whether splitting will affect the stability of the ingredients or their effectiveness. In addition, ensure good communication. It is not worth risking accusations of mislabelling or misleading consumers.
Do you have questions about how to operate safely? Do you need a checklist or perhaps an audit of your product labelling?
Write to the #kclegal team.
