Regulatory Issues of Voluntary Certification of Food Supplements in Russia.

When registering food supplements in Russia, restrictions on the labeling and consumer leaflet contents are tightly controlled by the regulatory agencies. Thus, misleading advertising is the most difficult problem with the turnover of these products if information in the commercials does not correspond to the information on indications for use that were agreed upon during state registration (or sanitary and epidemiologic control). An established procedure of voluntary certification enables additional health claims, thus expanding the information in the label and user leaflet. Voluntary certification is the evidence base for the specific characteristics of the products with regard to their efficacy represented by an independent party. This process allows the manufacturer to inform the consumer about the beneficial properties and efficacy of food supplements and enables the buyer to make an informed choice and to avoid buying counterfeit products by purchasing high-quality safe products with proven efficacy; therefore, the buyer can receive a product that is the best match for his needs and expectations. However, since the mid-2000s, several voluntary certification systems have been developed, approved, and included in the Unified Register of Voluntary Certification Systems maintained by the Federal Agency for Technical Regulation and Metrology, Rosstandart. Thus, manufacturers can choose an authority. In addition to the conventional approach to certification requirements and schemes, various outcomes of approved claims and subsequent certification maintenance are possible. The present article analyzes universal principles of voluntary certification, its legal basis, and authority-specific outcomes of the process.