Onishchenko will restore order in the badotorgovle?
Resolution of the Chief State Sanitary Doctor of the Russian Federation of May 20, 2009 No. 36 "On supervision of biologically active food additives (dietary supplements)"Rossiyskaya Gazeta – Federal Issue No. 4967 (143) dated 05.08.2009.
Published August 5, 2009
Effective: August 16, 2009
Registered with the Ministry of Justice of the Russian Federation on July 10 , 2009.
Registration Number 14312
I, the Chief State Sanitary Doctor of the Russian Federation G.G. Onishchenko, having analyzed the implementation of the resolution of the Chief State Sanitary Doctor of the Russian Federation dated 06.03.2007 N 8 "On strengthening supervision over the production and turnover of dietary supplements" (registered with the Ministry of Justice of the Russian Federation on 09.04.2007, registration number 9267) and materials of state supervision over the implementation of mandatory requirements for the production and turnover of biologically active food additives (hereinafter referred to as dietary supplements), established by regulatory legal acts of the Russian Federation, I note.
More than 7,500 dietary supplements are in circulation on the consumer market of the Russian Federation. In 2008, the Federal Service for Supervision of Consumer Rights Protection and Human Well–Being registered 1,675 dietary supplements (2004 – 884, 2005 – 1949, 2006 – 1855, 2007 - 1621) of domestic and imported production.
At the end of 2008, there were 182 organizations engaged in the production of dietary supplements in the Russian Federation, 63% of them are located in the Central and Siberian Federal Districts.
38,860 objects are involved in the turnover of dietary supplements: 3506 trade organizations, 783 storage warehouses and 34,385 pharmacy chain facilities.
Among the organizations surveyed in 2008 engaged in the production of dietary supplements, violations of sanitary and epidemiological requirements were detected at 39 out of 87, which amounted to 44.7%.
During the production and turnover of dietary supplements , the following violations are most often detected:
– unsatisfactory sanitary and technical condition of industrial premises;
– lack of documents confirming the safety of incoming raw materials;
– production of dietary supplements without a certificate of state registration;
– lack of production control over manufactured products;
– retail sale of dietary supplements outside the established by clause 7.4.1. SanPiN 2.3.2.1290-03 "Hygienic requirements for the organization of production and turnover of biologically active food additives (dietary supplements)" (registered with the Ministry of Justice of Russia on 15.05.2003, registration number 4536) facilities, including by remote sale and sale through distributors;
– non-compliance with the storage conditions of dietary supplements;
– implementation of dietary supplements without documents confirming their state registration;
– non-compliance of the information applied to the label with the requirements established by the legislative acts of the Russian Federation.
There are cases of absence on the label of the ingredient composition of dietary supplements, information about biologically active substances, the source of which is dietary supplements, contraindications to the use of dietary supplements, information that dietary supplements are not a medicine.
Rospotrebnadzor institutions conduct laboratory studies of dietary supplements for hygienic indicators and for the content of biologically active substances. So, in 2008:
– according to chemical indicators, 13,032 samples of dietary supplements were examined, of which 1.16% did not meet hygienic standards, according to imported dietary supplements, this indicator was 4.92%;
– according to microbiological indicators, 17,953 samples of dietary supplements were examined, of which 3.63% did not meet hygienic standards, according to imported dietary supplements, this indicator was 5.48%;
– according to the definition of biologically active substances, 2,185 samples of dietary supplements were studied, of which 4.5% did not meet the established requirements.
According to the results of the revealed violations, orders were issued to withdraw from the sale of 772 batches of dietary supplements with a volume of 857 kg, 1426 fines were imposed in the amount of 2793545 rubles, the operation of 8 facilities engaged in the production and turnover of dietary supplements was suspended (Rostov Region, Krasnodar Territory, Republic of Adygea, Republic of Tatarstan, St. Petersburg). The departments of Rospotrebnadzor in the Republic of Tatarstan, Altai, Primorsky, Krasnodar, Krasnoyarsk Territories, Penza, Sverdlovsk, Kurgan, Rostov regions and Khanty-Mansi Autonomous Okrug sent materials to law enforcement agencies on 12 cases of violations of legislation related to the production and turnover of dietary supplements.
The Federal Service for Supervision of Consumer Rights Protection and Human Well-Being receives numerous appeals from citizens of the Russian Federation with complaints about the unfair practice of distributing dietary supplements, which has obvious signs of fraud. This, in particular, is expressed in bringing to consumers deliberately false information about various non-existent clinics, medical centers and other false information misleading them. At the same time, consumers have a stable distrust and a clearly negative attitude towards dietary supplements, even despite the fact that in the complaints of citizens, in the vast majority of cases, food products of this group that are in legal circulation and have passed the state registration procedure appear.
Since the deceived purchasers of dietary supplements most often include elderly people, including the disabled, who tend to easily succumb to persistent persuasion, such appeals indicate purposeful and obviously intentional illegal actions against citizens-applicants by persons whose identification in some cases is complicated by the use of fictitious names and addresses, the assessment of which must be given by law enforcement agencies.
Of particular concern are the cases described by the victims of the acquisition of dietary supplements by them within the framework of relations that have nothing to do with the retail sale contract, which caused harm to their health, which may indicate the presence of signs of a criminal offense on the part of persons selling dietary supplements in violation of the established requirements.
The Federal Service for Supervision of Consumer Rights Protection and Human Well-Being sent appropriate appeals to the Prosecutor General's Office of the Russian Federation and the Main Department of Internal Affairs of Moscow to resolve the issue of taking adequate response measures based on the submitted materials.
There remains an urgent problem associated with the illegal sale of dietary supplements containing potent, narcotic drugs and psychotropic substances in their composition. In this regard, the list of biologically active substances and products prohibited for the manufacture of dietary supplements and products that may have a harmful effect on human health has been expanded (SanPiN 2.3.2.2351-08 "Additions and amendments N7k SanPiN 2.3.2.1078-01", approved by the resolution of the Chief State Sanitary Doctor of the Russian Federation dated 05.03.2008 N 17, registered with the Ministry of Justice of Russia 03.04.2008, registration number 11465).
Numerous facts of non-compliance with advertising legislation are noted. A number of economic entities, using the mass media, present to the population deliberately false information about the consumer properties of dietary supplements, indicating the scope of application that does not correspond to the entry in the certificate of state registration.
In accordance with the Federal law of 30.03.1999 N 52-FZ "On sanitary and epidemiological welfare of the population" (collected legislation of the Russian Federation, 1999, N 14, art. 1650; 2002, N 1 (h 1), art 2; 2003, N 2, p. 167; 2003, N 27 (part 1), art 2700; 2004, No. 35, article 3607; 2005, N 19, art 1752; 2006, N 1, p. 10; 2006, N 52 (part 1), article 5498; 2007, N 1 (h 1), art 21; 2007, N 1 (h 1), article 29; 2007, No. 27, article 3213; 2007, N 46, art. 5554; 2007, N 49, p. 6070; 2008, No. 24, item 2801; 2008, N 29 (part 1), art 3418; 2008, N 44, art. 4984; 2008, N 52 (part 1), art 6223; 2008, N 30 (part 2), article 3616; 2009, N 1, article 17) and the Law of the Russian Federation of 07.02.1992 N 2300-1 "On protection of consumer rights" (collected legislation of the Russian Federation, 15.01.1996, N 3, article 140, 20.12.1999, N 51, art 6287, 07.01.2002, N 1 (h 1), art 2, 30.08.2004, No. 35, article 3607, 08.11.2004, N 45, art. 4377, 27.12.2004, N 52 (part 1), art 5275, 31.07.2006, N 31 (1 h), article 3439, 23.10.2006, N 43, art 4412, 27.11.2006, N 48, art 4943, 29.10.2007, N 44, art. 5282, 28.07.2008, N 30 (part 2), article 3616) decide:
1. Legal entities and individual entrepreneurs engaged in the import into the territory of the Russian Federation, production and turnover of dietary supplements:
1.1. To ensure the quality and safety of dietary supplements in accordance with the legislation of the Russian Federation;
1.2. The implementation of dietary supplements should be carried out strictly in accordance with SanPiN 2.3.2.1290-03 "Hygienic requirements for the organization of production and turnover of biologically active food additives (dietary supplements)" in pharmacies and specialized stores or departments of food stores selling dietary products;
1.3. Comply with the requirements for putting information on the label, which is agreed upon during the state registration of dietary supplements;
1.4. Do not allow terms in the names of dietary supplements, and drawings on the packaging that mislead the consumer and indicate the intended effectiveness of dietary supplements;
1.5. Take measures to ensure compliance with the law when preparing promotional materials about dietary supplements.
2. To request the Ministry of Internal Affairs of the Russian Federation, in order to prevent the illegal distribution of dietary supplements, to strengthen measures to curb it within its competence.
3. Recommend to the media:
3.1. Ensure compliance with the established mandatory requirements for the distribution of dietary supplements advertising;
3.2. Recommend to assist the Rospotrebnadzor authorities in carrying out work on informing the population about the implementation of dietary supplements.
4. The heads of the health management bodies of the subjects of the Russian Federation should take measures to prevent the appointment of dietary supplements by medical workers as means that have a therapeutic effect.
5. The institution of the Russian Academy of Medical Sciences Research Institute of Nutrition to finalize the draft guidelines "Guidelines on methods of quality control and safety of dietary supplements for food" taking into account the comments of experts of the Commission on State Sanitary and Epidemiological Rationing at Rospotrebnadzor and submit it to Rospotrebnadzor by 06/15/2009.
6. The chief physicians of the Centers of Hygiene and Epidemiology in the subjects of the Russian Federation should take measures to equip testing laboratories with modern equipment and train specialists in dietary supplement control methods.
7. Heads of Rospotrebnadzor departments in the subjects of the Russian Federation:
7.1. Strengthen state supervision over the production and turnover of dietary supplements, paying attention to the compliance of the content of product information with the established requirements;
7.2. To ensure interaction with the Prosecutor's office and internal affairs bodies on issues of illegal trafficking of dietary supplements;
7.3. To carry out, together with law enforcement agencies, measures for control and supervision of legal entities and individual entrepreneurs engaged in the implementation of dietary supplements;
7.4. To carry out explanatory work in the mass media on the implementation of dietary supplements;
7.5. Report on the work carried out by 01.01.2010.
8. Control over the implementation of this resolution shall be entrusted to the Deputy Chief State Sanitary Doctor of the Russian Federation L.P. Gulchenko.
G. Onishchenko
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Comment:
Who needs supplements?
Dietary supplements are an addition to our diet, but not medicines at all
Gennady Onishchenko, Chief State Sanitary Doctor of the Russian Federation
Prepared by Irina Krasnopolskaya
Today, Rossiyskaya Gazeta publishes a very important document – a resolution that aims to bring order to the market of biologically active additives (dietary supplements).
Biologically active additives – dietary supplements – are a given that cannot be ignored. The dietary supplements market has more than 7,500 names and types. 1775 domestic and foreign enterprises are engaged in their production. But, unfortunately, in the production and turnover of dietary supplements, despite the measures taken, violations are revealed that affect the quality of these products.
One of the main problems is the unfair practice of distributing dietary supplements, a practice that has obvious signs of fraud, to which there are a lot of complaints from citizens.
What do I mean? For example, the consumer is given deliberately false information about various non-existent clinics, medical centers where dietary supplements were allegedly tested and used. Often, medicinal properties are attributed to one or another dietary supplement.
The most vulnerable group of consumers of these products are older people, who are more easily amenable to assurances about the miraculous properties of dietary supplements.
But dietary supplements – let me remind you – are an addition to our diet, but not a medicine.
The problem of the sale of dietary supplements that contain potent and even narcotic and psychotropic substances is still relevant.
Therefore, the resolution part of the document published today is aimed at restoring order in everything related to the production, sale, advertising of dietary supplements.
Portal "Eternal youth" http://vechnayamolodost.ru07.09.2009