The Regulation on Health Claims for Food and Food Supplements ("Regulation") entered into force through publication in the Official Gazette dated April 20, 2023 and numbered 32169. Regarding nutrition claims, the Turkish Food Codex Regulation on Nutrition Claims was published in the same Official Gazette and entered into force. The Turkish Food Codex Regulation on Nutrition and Health Claims, which regulated nutrition declarations and health declarations for food and food supplements, was repealed.
In line with these amendments, the Guideline on Health Claims for Food and Food Supplements ("Guideline") was drafted by the Turkish Pharmaceuticals and Medical Devices Authority (“Authority”) and was published on the official website of the Authority on 26 April 2023. The Regulation on Health Claims Used for Products to be Offered for Sale with Health Claims was repealed on 13 June 2023 with the publication of the Regulation on Monitoring Health Claims regulating the procedure and principles with respect to surveillance of health claims used on products offered to end consumers.
The amendments regarding nutrition do not substantially change the respective legal regime, instead, essentially serve to consolidate the regulations on nutrition claims under a standalone regulation separate from those regulating health claims. The Turkish Food Codex Regulation on Nutrition Claims will continue to be enforced by the Ministry of Agriculture and Forestry.
The new regulations on health claims introduced fundamental changes. In particular, enforcing power of the Regulation, which was vested in the Ministry of Agriculture and Forestry prior to the amendments, was transferred to the Authority, and the permission requirement, which had to be followed before the Authority required for the use of health claims, was abolished. Therefore, under the new system, the health claims listed in the Guideline may be used for food and food supplements without the need to have any official permission from the Authority and without the need of making any official declaration thereto, provided that they comply with the provisions of the Regulation and the Guideline. The Authority is also vested with monitoring and supervising powers.
Abolition of the permission requirement that had be followed before the Authority in order to use health claims in promoting of food supplements, enabled the use of health claims set forth in the annexes of the Guideline for food and food supplements covered under the Regulation and produced or imported by companies that are registered before or approved by the Ministry of Agriculture and Forestry without the need for any application for authorization or making any declaration to any administrative institution, provided that health claims are in compliance with the provisions of the Regulation and the Guideline. However, the Authority, when deemed necessary for the protection of public health, may limit the use of health claims and may request necessary information and documents from business enterprises in the food sector. The health claims listed in the annexes of the Guideline may be revisited by the Authority when deemed necessary for public health and may be amended, suspended or cancelled as a result of Authority’s reassessment.
In case of the use of health claims contrary to the provisions of the Regulation, the Authority is authorized to suspend the supply of the product, and to seize, recall and destruct products. Similarly, the Authority may collaborate with other administrative authorities and entities to suspend the promoting activities involving unlawful use of health claims and to remove such promotional content and block access to websites where such use occurs. Additionally, administrative fines and/or judicial fines could be imposed pursuant to the Pharmaceuticals and Medical Preparations Law no. 1262.
Under the current scheme, a versatile monitoring mechanism is deployed to control the use of health claims in promoting food and food supplements. In addition to the Authority's supervision and monitoring powers:
- The Advertisement Board may impose sanctions including warning, suspension, imposing administrative monetary fines.
- Radio and Television Supreme Council (“RTUK”) is also entitled to supervise the advertisements concerning food supplements.
- Besides, administrative fines and judicial fines are among potential sanctions that could be imposed pursuant to the Pharmaceuticals and Medical Preparations Law no. 1262.
As inferred from the existing versatile controlling mechanism, food supplements are subject to highly strict supervision. In this regard, more than one administrative authority is equipped with powers to monitor various aspects of promoting of products accompanied with health claims.
Although it is highly appreciated that ministerial administrative powers regarding the use of health claims are essentially vested in the Authority by eliminating the previous dual structure, effective monitoring and supervision mechanisms must be developed and implemented to prevent advertisements and promotions that may mislead consumers or distort fair competition, especially considering that the official permission procedure has been abolished by the new Regulation.