What is a Health Statement? It is a statement that indicates, asserts, or implies the relationship between a product or the elements present in the product composition and human health.

What does the Regulation cover? The Regulation governs the rules regarding the inclusion of health statements on the label, promotion, or advertisement of all products (“Product”) except for medicinal products, medical devices, and special medical purpose foods that are supplied to the end consumer.

Health statements cannot be used in Products other than food and dietary supplements, the use of which is subject to the provisions of the “Regulation on the Use of Health Statements in Food and Dietary Supplements”.

In promotions, it is not allowed to state or imply that (i) the elements present in the Product composition are directly or indirectly beneficial to human health, or (ii) the Product is effective, protective, or curative against diseases or their symptoms. Visuals that suggest health statements cannot be used in Product promotions.

The product owner and the promoter are jointly responsible for the health statements used.

Product owner is responsible for:

• Ensuring compliance with relevant legislation regarding the promotion and/or sale of the Product with health statements;
• Keeping records of appropriate information and documents, verifying their accuracy, and assuming responsibility for Product promotions;
• Providing all information and documents related to the Product to the Pharmaceuticals and Medical Device Authority (“Authority”) upon request;

In the case of promotions and sales are conducted via electronic platforms, providing all necessary information about the platforms where the promotions and sales take place to the Authority upon request.

Promoter is responsible for;

• Ensuring compliance with relevant legislation regarding the promotion and/or sale of the Product with health statements;
• Keeping records of appropriate information and documents, verifying their accuracy, and assuming responsibility for Product promotions;
• Providing information and documents related to the Product owner (name, title, contact information, etc.) to the Authority upon request;

In cases where promotions are conducted via electronic platforms, intermediary service providers[1] are responsible for carrying out necessary actions and procedures, as requested by the Authority, to correct, remove, or restrict access to promotional content that violates the relevant regulations regarding the use of health statements.

The Authority is authorized to conduct inspections regarding the promotion and/or sale activities of Products with health statements, as well as promotional materials, on any platform where the promotion and/or sale is conducted. In case of non-compliance, the Authority has the power to take the following actions: (i) ordering the Product owner to cease promotion and sales activities, (ii) rectifying the Product and/or promotional materials, ceasing their market supply, recalling them from the market, (iii) ordering the Product owner to recall the Products, or (iv) deciding to destroy the Products at the expense of the Product owner or by the Authority itself. These measures can be implemented by the Authority or by the competent institution or organization responsible for market surveillance and inspection of the Product.

Those who promote, sell, market, or advertise products in violation of the regulations regarding health statements may be subject to administrative fines in accordance with Article 18 and 19 of Law No. 1262, respectively (i) ranging from ten thousand Turkish Liras to five hundred thousand Turkish Liras, and (ii) administrative fines not less than the total sales amount of the Product in the last year multiplied by five, which shall not be lower than one hundred thousand Turkish Liras. In case the promotion and sale are conducted through electronic platforms, the sanctions specified in (i) and the sanctions stated in Law No. 5651 shall apply.

The Regulation on Health Statements for Products Sold with Health Statements has been repealed.

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[1] Individuals and legal entities that provide the electronic commerce environment for conducting economic and commercial activities on behalf of others.