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Dietary supplements cannot be placed on the Turkish market solely because they are manufacturable or importable. Product formulation, ingredient composition, dosage, delivery format, brand name, labeling information, health claims, and regulatory application files must all be evaluated together in accordance with applicable legislation.
For products such as vitamins, minerals, herbal supplements, collagen, glucosamine, amino acids, probiotics, effervescent tablets, capsules, gummies, liquids, powders, and sachets, the regulatory pathway may vary depending on the formulation, intended use, and market positioning of the product.
OMNIREGULA supports companies throughout dietary supplement approval and licensing processes by helping ensure accurate product classification, compliant label structures, appropriate health claim evaluations, and properly prepared regulatory application documentation.
Key Client Profile
- Ideal for entrepreneurs planning to establish a dietary supplement brand in the Turkish market.
- Supports companies seeking to import dietary supplements into Türkiye from international manufacturers or suppliers.
- Designed for brands aiming to align their existing products with current regulatory requirements.
- Suitable for companies developing vitamins, minerals, collagen products, capsules, tablets, gummies, and similar supplement formats through contract manufacturing.
- Provides expert guidance for businesses requiring professional evaluation of dietary supplement labels, health claims, or brand name compliance.
- Assists manufacturers seeking support with export certification procedures, FDA facility registration processes, and FDA-compliant labeling requirements.
Key Areas Evaluated During the Process
- Evaluation of product formulation and ingredient compliance.
- Assessment of product format and intended use.
- Review of brand names and product names from a regulatory perspective.
- Verification of health claims and labeling statements.
- Provides expert guidance for businesses requiring professional evaluation of dietary supplement labels, health claims, or brand name compliance.
- Identification of the documentation required for the regulatory application file.
- Assessment of import pre-notification and export certification requirements.
- Follow-up of official correspondence and applicable compliance procedures.
Why Is This Process Important?
At first glance, dietary supplement approval may appear to be a straightforward product authorization procedure. In practice, however, a single ingredient within the formulation, a health claim used on the label, a statement included in the brand name, or missing labeling information may significantly affect the outcome of the application process.
As of March 16, 2026, dietary supplement approval applications in Türkiye require an official statement from the Turkish Medicines and Medical Devices Agency confirming that the brand name and product name comply with health claim legislation and do not contain references associated with human medicinal products. This development has made pre-application evaluation of brand names and health claims considerably more critical.
Frequently Asked Questions
Although different terms are commonly used within the industry, the essential requirement is that the product successfully completes the regulatory approval process and becomes eligible for commercialization in accordance with applicable legislation. This process involves the evaluation of the product formulation, labeling, brand name, health claims, and regulatory application documentation as a whole.
A brand name should not conflict with health claim regulations, contain or imply the name of a human medicinal product, or create a pharmaceutical perception among consumers. For this reason, brand names should be carefully evaluated before the application process begins.
Labeling is one of the primary elements that defines how a product is presented to consumers. If the formulation details, directions for use, warnings, claims, or product name are not compliant with applicable legislation, the market authorization process may be delayed.
In contract manufacturing models, regulatory responsibilities should be evaluated according to the relationship between the manufacturer, the brand owner, and the company placing the product on the market. For this reason, regulatory obligations and application responsibilities should be clearly defined before production begins.
