The Regulatory Landscape of the Food Supplement Industry in Türkiye - Healthcare Series 15

The rapid change in people's living and working circumstances is reflected in their daily routines and requirements. We have a desire to feel stronger and more energetic throughout the day or to boost our immunity for a variety of reasons: stress, unbalanced diet, lack of sleep, or illnesses. As a consequence, an industry has grown that claims to fulfill this demand, and whose recognition and reliability are increasing day by day: the food supplements industry.

In this article, we will outline the general organizational and regulatory landscape of the food supplements industry in Türkiye in terms of registration and manufacturing, production and distribution, labeling, advertising and marketing, and inspection.

What is a Food Supplement?

A food supplement is defined under Law 5996 on Veterinary Services, Plant Health, Food and Feed (“Law”) as a foodstuff for the purpose of supplementing a normal diet and which is a concentrated source of vitamins or minerals or other substances with a nutritional or physiological effect. A food supplement can be alone or in combination, placed on the market in dosage forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop-dispensing bottles, and other similar forms of liquids and powders designed to be taken in small, measured-unit quantities.

Since the beginning of the COVID-19 pandemic, the industry has experienced explosive growth. Aside from exercising to enhance health, individuals are also interested in consuming vitamins and supplements. Reports and market surveys reveal that there has been an unusual movement toward the usage of supplements as individuals seek protection against the virus. Even after the epidemic has passed, the tendency is likely to persist. According to the Market Analysis Report[1], the global market size was valued at USD 140.3 billion in 2020 and is expected to expand at a compound annual growth rate of 8.6 percent from 2021 to 2028.

It can easily be said that comparable to the global market, a similar emerging trend is seen in Türkiye. According to the Pharmaceutical Manufacturers Association of Türkiye(“IEIS”), the industry grew by 51 percent in 2020 and exceeded TRY 2 billion.

Organization

The industry in Türkiye is governed principally by the Ministry of Agriculture and Forestry (“Ministry”) and its subsidiaries. The manufacture, advertising and sales of supplementary foods are regulated under the Regulation on Import, Production, Processing, and Market Supply of Supplementary Foods (“Regulation”) and the Turkish Food Codex Food Supplements Communique 2013/49 (“Communique”).

As supplements are not evaluated as pharmaceuticals, statements requiring scientific evidence, misleading or deceptive claims, and health claims other than those allowed in the legislation cannot be included in advertisements for these foodstuffs. Additionally, according to the most recent version of the Commercial Advertising and Unfair Commercial Practices Regulation, comparative advertising for supplementary foods is completely prohibited. In this regard, the Advertising Board and the Radio and Television Supreme Council (“RTÜK”) act scrupulously on food supplement advertisements.

Furthermore, the Turkish Medicines and Medical Devices Agency (“TITCK”) also monitors and inspects the supplemental food industry.

The Regulatory Landscape

The food supplement industry in Türkiyeis primarily governed by several pieces of legislative and administrative legislation, such as:

• the Law which protects and ensures food and feed safety, public health, plant and animal health, animal breeding and welfare, including consumer benefit and environmental protection,
• the Regulation which manufacturers and distributors are required to follow for the import, production, and processing of food supplements and their placement on the market,
• the Turkish Food Codex Regulation on Food Labelling and Consumer Information aims to provide accurate and up-to-date information to consumers in the promotion and presentation of foods,
• the Turkish Food Codex Communique on Supplementary Foods determines product qualities in order to ensure that food supplements are produced, prepared, processed, preserved, stored, transported and put on the market hygienically,
• the Regulation on Registration and Approval Procedures of Food Businesses determines the procedures and principles regarding the registration and approval procedures for food businesses.

The Regulation and the Communique contain comprehensive provisions on supplementary foods. According to the regulations, supplementary foods refer to capsules, tablets and similar dosed products that are used to support a person’s diet and contain vitamins, minerals, amino acids, herbs, or bioactive substances.

1. Registration and Manufacturing

According to Article 10 of the Regulation, food supplements cannot be produced, processed, imported, or placed on the market without the approval of the Ministry. Prior to being placed on the market, the product must be registered according to the procedures and processes which are specified under Articles 11 and 12 of the Regulation.

Approval should be obtained from the competent provincial directorates of the Ministry by submitting the necessary information and documentation related to the composition and manufacturing of the product. As an exception to this, the Food Supplement Commission approves food supplements for the 2-4 age group.

2. Production, Storage and Distribution

If all of the requirements are met following the relevant provincial directorate examination, an official letter authorizing the registration and manufacture of the product in Türkiye is issued.

The production, storage and distribution of food supplements are carried out by institutions and organizations that have received approval in accordance with the Law and Regulations. Facilities where one or more of the operations or processes of storage, classification, processing, evaluation, fortification, and packaging are carried out, starting from the raw material, and all the places complementary to these facilities are considered as the workplaces of production.[2]

In Türkiye, since March 2019, over 6,000 food supplements have been approved and registered, bringing the total number of accessible food supplements to 11,828. This demonstrates how rapidly the sector has expanded and progressed.

3. Placement on the Market

According to Article 13 of the Regulation, food supplements must be marketed from the importer, producer, and processor's facilities, as well as the wholesale storage premises, using the domain name and URL address(es) specified by the food operator in its application for authorization.

As per the Regulation, a direct seller is an independent person who purchases food supplements from food supplement businesses with whom they have a contract and supplies them to consumers on their account without being bound by an employment contract.

Lastly, pursuant to Article 5/14 of the Implementation Instruction on Import, Production, Processing and Placing on the Market of Food Supplements, pharmacies can only sell supplements that they have obtained through pharmaceutical warehouses.

4. Labelling

Labelling of supplements is of great importance. Several strict rules govern what must be written on a label.

Labels, presentations, or advertisements for supplementary foods cannot state that they have a preventive or curative effect. This provision is included in Article 12 of the Communique. Likewise, presentations or advertisements for supplementary foods cannot claim that a balanced and natural diet will not meet all of a person’s daily nutrition needs.

5. Advertising and Promotion

Advertising has an important role in establishing communication with the consumer in a competitive supplementary food market.

When a food supplement business makes an application for approval for any food supplement, the processing of this application is subject to a commitment to take the necessary measures to terminate advertisements/promotions made on the domain names/URL addresses under its control.

Health declarations in advertisements for supplementary foods must be in accordance with the rules in the Turkish Food Codex Labelling Regulation. If an advertisement does not comply with these rules, the TITCK may request that sales be stopped and that the products in question be recalled or destroyed.

As mentioned above, the RTÜK monitors advertisements for supplementary foods. Within this scope, recently, companies have been penalized for advertising slimming drugs and supplements that claimed to be effective against COVID-19. The penalties were issued because the advertisements erroneously promoted the products as drugs and contained misleading information. Advertisements containing such misleading information are considered to be deceptive advertisements, for which the Advertising Board and RTÜK can impose fines on advertisers and media channels.

6. Inspection

As per Article 28 of the Law, the procedures and principles regarding the production, official controls, import, and export of food supplements are executed by the Ministry. Therefore, approval and inspection processes for food supplements are made by the Ministry. Audit and control procedures are stipulated in Articles 39 and 42 of the Law.

In addition, according to the Regulation on Health Declarations of Products Available with Health Declarations, TITCK is the competent authority in terms of cease, recall, collection, and disposal of products if the promotion of food supplements fails to comply with the Turkish Food Codex Regulation on Food Labelling.

Conclusion

The food supplement industry has gained greater importance and market volume due to the COVID-19 outbreak. Accordingly, the industry, which was already competitive by nature, is being examined more closely by both producers and consumers. Given its growing importance both locally and internationally the industry has been under the spotlight for years and seemingly this will continue in years to come.

Regulations for the industry govern many areas in detail, from production to advertising. Turkish regulations on food supplements cover a wide range of topics within the industry. And that being the case, legislative regulations will become more of an issue.

This article has aimed to highlight the key points without including all aspects. You can find more detailed information by following our article series.

With thanks to Omer Caktu for his assistance on this article.

[1] https://www.grandviewresearch.com/industry-analysis/dietary-supplements-market

[2] Law on the Amendment of the Decree-Law on the Production, Consumption and Inspection of Foods numbered 5179 dated 27 May 2004.