Regulation on Inspection of Health Claim Has Been Published

The Regulation on Inspection of Health Claim (“Regulation“) was published in the Official Gazette by the Turkish Medicines and Medical Devices Agency (“Agency“) and entered into force on 13 June 2023.

With the entry into force of the Regulation, the Regulation on Health Claims of Products Offered for Sale with Health Claims published in the Official Gazette dated 7 June 2013 and numbered 28670 (“Repealed Regulation“) was repealed.

Unlike the Repealed Regulation, in addition to human medicinal products and medical devices, foods for special medical purposes are also excluded from the scope of the Regulation.

The general principles regarding health claims within the scope of the Regulation are stated as follows:

• Without prejudice to the provisions of other legislations, health claims cannot be used in products other than food and food supplements.
• In the promotion of products, it cannot be stated or implied that the elements contained in the composition of the product are directly or indirectly beneficial to human health, are effective against diseases or their symptoms, protect or treat them.
• In the promotion of products, visuals that may evoke a health claim may not be used.
• In cases where product promotion is made electronically, the name, title and contact information of the product owner must be included on the website where the promotion is made.
• If deemed necessary by the Agency, scientific advisory commissions or boards may be consulted on whether the statements in the promotion and sale of the product should be considered as health claims.
• The product owner and the promoter are jointly responsible for the health claim made about the products.

The product owner and the promoter are held responsible for ensuring that the promotion and sales are in compliance with the legislation, recording and storing the information and documents and confirming their accuracy.

The Authority is authorised to conduct inspections, examinations and investigations regarding the promotion and/or sales activities of products and promotional materials with health claims. In case it is determined that the provisions of the Regulation have been violated, it may be decided to stop the promotion and sales activities of products, to amend the promotional materials, to stop the supply of products and promotional materials to the market, and to carry out collection and destruction procedures.

The full text of the Regulation can be accessed via this link. (only available in Turkish)