The Regulation on the Use of Health Claims for Food and Food Supplements (“Regulation”) entered into force as of its publication on the Official Gazette dated 20 April 2023, and numbered 32169; and the requirement for obtaining approval from the Turkish Medicines and Medical Devices Agency ("Agency") under the Ministry of Health for the use of health claims in the labelling, promotion or advertisement of food supplements was abolished.
Following this development, the Agency announced on its official website on 16 January 2024, that despite the removal of the administrative approval process for the use of health claims, companies have continued to submit requests for opinions on health claims and for the Agency to evaluate these requests, a fee of TRY 1,208.19 (approximately EUR 37) will be charged for each health claim evaluation, as it was added to the 2024 fee tariff.
Although the mandatory administrative approval process for the use of health claims has been abolished by the Regulation, it is understood that the Agency will conduct an evaluation and then issue an opinion that is subject to a fee upon companies’ submission of queries to the Agency to prevent potential violations. In this context, it will be assumed that no administrative sanctions will be imposed on the labels and promotional materials for which companies received opinions as a result of this preliminary evaluation stage, which is not included in the Regulation. However, since the Agency review of health claims will not supervise compliance with the rules of other institutions and organizations, it may be possible to face sanctions from other institutions, such as the Advertising Board, which may arise from non-compliance with other principles. Therefore, it should be kept in mind that the opinions to be provided by the Agency will only be limited to the evaluation of the health claims.