New regulations published on the Official Gazette numbered 32169 and dated 20 April 2023 have introduced fundamental changes with respect to use of health claims for food and food supplements and use of nutrition claims. In this regard, the Turkish Food Codex Regulation on Nutrition Claims, covering nutrition claims, and the Regulation on Health Claims for Food and Food Supplements (“Regulation”), covering health claims for food and food supplements, have entered into force. Accordingly, the Turkish Food Codex Regulation on Nutrition and Health Claims, which has previously regulated both nutrition and health claims for food and food supplements until the publication of the new regulations, has been repealed.
In line with these amendments, the Guideline on Health Claims for Food and Food Supplements ("Guideline") has been drafted by the Turkish Pharmaceuticals and Medical Devices Authority (“Authority”) and has been published on the official website of the Authority on 26 April 2023. Besides, the Regulation on Health Claims Used For Products to be Offered for Sale with Health Claims have been repealed on 13 June 2023 by the publication of the Regulation on Monitoring Health Claims regulating the procedure and principles with respect to surveillance of health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 consumer.
The amendments made regarding nutrition claims have not substantially changed the respective legal regime, instead, essentially serve to consolidate the regulations on nutrition claims under a standalone regulation separate from those regulating health claims. Accordingly, the Turkish Food Codex Regulation on Nutrition Claims will continue to be enforced by the Ministry of Agriculture and Forestry.
On the other hand, new regulations made on health claims have introduced fundamental changes to the previous system. In particular, enforcing power of the Regulation, which was vested in the Ministry of Agriculture and Forestry prior to the amendments, has been transferred to the Authority, and the permission requirement, which had to be followed before the Authority required for the use of health claims, has been 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 equipped 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. In this regard, it is important to be fully apprised of the provisions of the Regulation and the Guideline in order to be compliant with the current law regulating the use of health claims.
- As per the Regulation, health claims may be used in labelling, promoting or advertising of food and food supplements in a manner that the average consumer can comprehend, provided that the claim is not vague, inaccurate or misleading, and does not cast doubt on the adequacy or safety of other products, and does not promote or encourage the excessive consumption of a particular food, and does not to cause fear in the part of consumers by referring to changes in body functions, and complies with the rules set out in the Guideline.
- Equivalent statements that could be used instead of the health claims specified in the annexes of the Guideline in a manner that does not change and strengthen their meaning shall be determined according to the provisions of the Guideline. For instance, the statement "X contributes to the normal function of the immune system." could be replaced with the statement "X plays a role in the normal function of the immune system.", but not with the statement "X increases the normal function of the immune system.".
- As health claims are exclusively related to the nutrient, other elements, food or food group contained in the product, the health claim should refer only to the relevant ingredient and not to the whole product, and health claims may not be replaced with those with a narrower and more specific meaning since use of a health claim other than those permitted or recommended in the Guideline would risk changing the meaning of that health claim.
- Health claims suggesting that consumer’s health may be adversely affected if not consumed, and claims referring to the amount or rate of loss or gain of weight, and claims that include or imply expressions of gratitude, appreciation, endorsement or approval associated with the experience of the person whose testimony is referred concerning the products for which the health claim is used or with the national and international institutions and organizations, and claims referring to the approval of the product by the Ministry of Health, and claims declaring that the product "can only be sold in pharmacies" are not allowed to be used under any circumstances.
- Health claims may not be used for foods with special medical purposes and for products bearing the same name with human medicinal products, medical devices and foods with special medical purposes, and for beverages containing more than 1.2% alcohol by volume and for infant formulas.
- On the other hand, trademarks, product names, company names, logos or label images containing health claims, could be unreservedly used provided that these are related to and limited to health claims as set under the Regulation, and there is no need to apply to the Authority for such use either. However, use of trade name and logos containing health claims belonging to the companies established prior to the publication date of the Regulation offering their products without using health claims are subject to approval of the Authority.
In general, health claims listed in the Guideline may be used without any permission requirement, provided that they comply with the provisions of the Regulation and the Guideline as summarized above. 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 the food business operators.
The health claims listed in the annexes of the Guideline could be revisited by the Authority when deemed necessary for public health and could be amended, suspended or cancelled as a result of Authority’s reassessment.
Administrative Supervision and Liability Regime
Although the permission requirement that had to be followed before the Authority has been completely abolished, the fact that the used health claims conform to the provisions of the Regulation and the Guideline does not automatically relieve food operators from legal and criminal liability.
The food operator, which is defined in the Regulation as "a natural or legal person responsible for the legal compliance of the activities carried out under its control by public institutions and organizations and natural or legal persons, whether for profit or not for profit, at any stage of the production, importation, processing and market supply of food", continues to remain liable for ensuring that the products for which health claims are used are in compliance with the provisions of the Regulation and the Guideline, and that the ingredients of the products for which health claims are used are produced pursuant to the provisions of the relevant regulations enforced by the Ministry of Agriculture and Forestry, and that information or documents requested by the Authority regarding the products are provided within the specified time. In addition, food operators must confirm the accuracy of all relevant information and documents and keep them in their records and submit them to the Authority upon request.
On the other side, 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 the same. 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 website where such use occurs. Additionally, administrative fine and judicial fine 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 within the body of the Ministry of Trade may impose sanctions including warning, suspension, imposing administrative monetary fine in case of advertising food supplements in a manner contradicting the law on any platform, offering the same for sales or promoting them with unlawful health claims or failing to comply with other advertising laws.
- Radio and Television Supreme Council (“RTUK”) is also entitled per Broadcasting Law No. 6112 to supervise the advertisements concerning food supplements. It is not allowed to broadcast any content concerning sales, marketing and/or promoting of any product, including food supplements and similar supplementary goods, with health claims violating the relevant applicable law.
- Besides, administrative fine and judicial fine 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 some aspects of promoting of products accompanied with health claims.
Transition clause regulating the status of existing products has also been included in the Regulation, stipulating that health claims may be used on the labels of products that have already been supplied to the market with health claim, even if does not meet the criteria set under the new Regulation, until 31 December 2024.
Also, products that have been manufactured prior to 20 April 2023 but have not been launched into the market yet accompanied with a health claim which does not meet the criteria set in the Regulation, may be supplied to the market with use of such health claim on their labels within three months commencing from 20 April 2023 provided that it complies with the requirements specified under the repealed Turkish Food Codex Regulation on Nutrition and Health Claims and the relevant health claim may be used until 31 December 2024.
Number of promoting activities covering food supplements with health claims has been significantly increased, especially in past years throughout coronavirus outbreak. During covid times, some of the food supplements promoted then were not even cleared for sale and some of them were promoted with unlawful health claims contradicting the law without obtaining the required permission from the Authority. Competent public authorities frequently investigated such products and promotions and imposed applicable sanctions. As we have previously examined in our article titled Coronavirus Related Health Claims a versatile monitoring mechanism is deployed with respect to health claims used on food supplements and in relevant promoting activities. However, the previous system was not flawless and it was still an issue that food supplements were nevertheless sold and promoted in a manner violating the law by failing to obtain the necessary permits. In some cases, it was inappropriately concluded by manufacturers or sellers that the authorization obtained from the Ministry of Agriculture and Forestry for manufacturing of the product accompanied with a health claim would also count for the permission required to be obtained from the Ministry of Health for the use of the health claim, and in some other cases, it was observed that the mentioned dual system caused confusion even in the part public institutions as to whether Ministry of Health or Ministry of Agriculture and Forestry was competent to deliver official opinion in cases of violation of the applicable rules on health claims. In that regard, it has been long awaited that the authorization and supervision regime applicable for health claims used on food supplements would be restructured by the Ministry of Health.
In this respect, it is deemed appropriate to regulate the health claims to be used for food and food supplements in detail under a separate legal regime apart from the nutrition claims, which are different in nature, and to grant the exclusive authority to enforce the Regulation to the Ministry of Health.
Moreover, considering that there is no official permission procedure that has to be complied with any longer, necessary monitoring and supervision mechanisms should be developed and implemented by the Authority to prevent any kind of advertisements and promotions that might result in threatening public health and misleading consumers. Accordingly, publication of the Regulation on Monitoring Health Claims drafted by the Authority is deemed an important step to facilitate Authority to exercise its supervision and monitoring powers effectively. In fact, this development is considered as an attempt to build a more solid and strict regime for monitoring and supervision of products accompanied by health claims through expanding the scope of liability of the product owner, promoter and intermediary services provider under the Regulation on Monitoring Health Claims.
Besides, establishment of necessary monitoring and supervision mechanisms is also important for the protection of the fair competition environment in addition to securing public health. Since the permission requirement that was applicable for use of health claims has been abolished, health claims may be used without need to obtain prior authorization as long as they comply with the Regulation and the Guideline. However, use of health claims contradicting the applicable law may constitute unfair competition against the parties that duly use health claims for their products in accordance with the Regulation and the Guideline, as stated under Article 55/1(e) of the Turkish Commercial Code ("TCC"), which reads as follows: "Failure to comply with business conditions; in particular, those who do not comply with business conditions that are imposed on competitors by law or contract or those who do not comply with business conditions that are customary in a profession or environment act in bad faith.”
In conclusion, 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 the fair competition, especially considering that the official permission procedure has been abolished by the new Regulation. Also, considering that both the Authority, the Advertisement Board and the RTUK have monitoring powers on the use of health claims in promoting products, it is deemed important to supervise the lawful use of health claims in terms of establishing a consistent practice regarding procedures and principles of the use of health claims.