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Dietary Supplements: The 2026 Regulatory Period
The dietary supplement market in Turkey holds significant commercial potential for entrepreneurs and brands. However, launching a product containing vitamins, minerals, collagen, probiotics, or herbal ingredients in capsule, gummy, effervescent tablet, or sachet form is not merely a commercial decision. Even if your product’s ingredients are legally producible, the brand name, label structure, and health claims are subject to strict regulatory limitations. Furthermore, new regulations coming into effect in 2026 have made the application processes even more critical.
What is the Requirement for the TİTCK Letter as of March 16, 2026?
One of the most important milestones in dietary supplement approval applications began on March 16, 2026. According to this rule, before applying for dietary supplement approval, it is mandatory to obtain an official letter from the Turkish Medicines and Medical Devices Agency (TİTCK) stating that the product’s brand and product name comply with health claim regulations, do not create a perception of medication in the consumer, and do not contain human medicinal product names. Therefore, even when choosing your brand name, obtaining regulatory consultancy is no longer a luxury, but a legal requirement.
Product Ingredients and Correct Classification
The dosage and intended use of the components in a product determine whether it will be classified as food, a food supplement, or under a different regulatory category. Incorrect product classification or incomplete documentation can lead to the rejection of application files or significantly delay the processes.
Responsibility in Contract Manufacturing and Private Label Processes
The biggest mistake made by companies wishing to have their own brand manufactured under private label is leaving the approval process entirely to the manufacturer. However, in the contract manufacturing model, the responsibility structure is shaped according to the legal relationship between the manufacturer, the brand owner, and the company that markets the product. The formulation and brand registration processes must be correctly structured from the outset.
The food supplement approval process, while appearing as a simple application from the outside, is a multi-stage area of expertise, encompassing everything from content suitability to the follow-up of regulatory documents. As OMNIREGULA, we are with you throughout the process to ensure your product is correctly classified, proceeds with the correct application file, and fully complies with current legislation.
