For normal operation, the human body needs a variety of substances for improve erection that the body itself doesn’t synthesize or synthesize in insufficient quantities. And since the nutritional value of familiar foods is dynamically reduced, a number of these substances can be obtained by taking dietary supplements. But they must consist exclusively of natural raw materials and be primarily safe for the consumer.
Nevertheless, during the existence of the category of dietary supplements accumulated and some problems: for example, scammers began to actively use this term in advertising in the media various miracle pills that can get rid of any ailments.
Along with the development of the dietary supplements market in Russia, legislation also developed. For example, amendments were made to the law on advertising, according to which “advertising of dietary supplements in each case should be accompanied by a warning that the object of advertising is not a medicine”, and “not create the impression that the use of a doctor is unnecessary”, appeared “the responsibility of advertising distributors “. In general, these changes made it possible to almost completely solve the problem of unfair advertising of dietary supplements.
The category of dietary supplements, as well as drugs, has become the object of attention of pharmaceuticals all over the world. Dozens of cases rattled in the US, France and Germany. They were mainly related to the same problem – the latent addition to the supplement of foreign substances that are not declared on the package, up to synthetic medicinal substances.
Russian “Erotic Roulette”
In Russia, such investigations were practically not conducted. And criminal liability for the falsification of dietary supplements appeared only in 2015.
In April, large foreign manufacturers of medicines expressed concern about possible cases of the turnover of their products under the guise of dietary supplements and asked the relevant organizations to conduct appropriate monitoring.
Drugs were purchased in the category of increased potency: samples of purchased drugs were transferred for analysis to three independent laboratories – the center for collective use of the Russian University of Peoples Friendship (RUPF), the laboratory of the Moscow Department of Health and the forensic examination center of the Ministry of Defense.
The study used the standard HPLC technique (high performance liquid chromatography – a method of separating mixtures of substances or particles based on differences in the speeds of their movement in the system of immiscible and moving relative to each other phases). As a 100% proof of finding undeclared substances in dietary supplements, scientists used a set of DART mass spectrometry methods widely used in the West (Direct Analysis in Real Time; a method of researching a substance based on determining the mass-to-charge ratio of ions formed during ionization of sample components of interest performed in real time) and NMR spectrometry (nuclear magnetic resonance; the method uses the fact that the same atomic nuclei in different environments in the molecule show different NMR signals, the difference of the signal from the NMR signal of the standard substance to determine the so-called chemical shift, which is due to the chemical structure of the test substance).
Tadalafil and Sildenafil were found in six preparations, and in two preparations tadalafil was hidden in a gelatin capsule shell. Medications containing these substances should be sold only by prescription and be taken in strict dosage in accordance with the prescription prescribed by the doctor. At the same time, the number of tadalafil in pseudo-dietary supplements exceeds the norm several times.
Such substances have a number of side effects and, according to the conclusion of the chief urologist of the Ministry of Health of Russia Dmitry Pushkar, “potentially can entail serious negative consequences for patients, even life-threatening, especially when used together with nitrate-containing drugs.
At risk are persons with cardiovascular diseases, liver and kidney failure. It is worth noting that Russia ranks first in the world in mortality from cardiovascular diseases, while the above-mentioned supplements are regularly consumed by about 4 million Russian men.
“Tadalafil and Sildenafil are used in small doses in order to combat erectile dysfunction when the“ tools ”don’t work. These substances are necessary in order to expand blood vessels in the penis, “said Sergei Kolesnikov, academician of the Russian Academy of Sciences, honored scientist of Russia. In his opinion, the problem is that people who choose natural biological additives aren’t aware of the fact that they contain dangerous synthetic compounds – tadalafil and sildenafil.
“This is illegal and is considered counterfeit.”
It’s like you sit down to drink tea and want to enjoy a drink, and there is hydrocyanic acid, and you don’t know about it.
The same situation with many dietary supplements, – said the academician. “If a person doesn’t know what he is taking, and the substances contained in the preparation aren’t indicated in the composition, then it is possible to die, especially if taken with alcohol or drugs. You can get a heart attack or stroke. This is such an “erotic roulette”. There is a “Russian roulette”, and this is “erotic”.
Ban and Imprison
Sergey Kolesnikov is sure that it is necessary to fine and judge for such precedents. “There are relevant articles in Russia. For some reason, they still don’t particularly want to apply. And research proving that these substances are in a number of dietary supplements, there are! Therefore, this counterfeit must be urgently withdrawn from circulation, ”said the academician.
In countries such as India and the United States, people found guilty of selling dietary supplements that include banned substances can be sent to jail for life. In Russia, the Ministry of Health is responsible for the drugs, and Rospotrebnadzor is responsible for the dietary supplements.
According to the official report, The ministry is also concerned about the current situation: “… product falsification by unscrupulous market participants in order to obtain commercial benefits by deliberately changing the composition of dietary supplements for food and introducing undeclared components that have medicinal properties creates the prerequisites for misleading consumers.”
The sale of dangerous pseudo-dietary supplements also attended to the State Duma. The parliament believes that the federal law that came into force in January 2015, expanding the powers of Rospotrebnadzor and Roszdravnadzor, as well as adding criminal liability for the falsification of drugs, medical devices and dietary supplements, will allow the supervisory and law enforcement agencies to stop the unlawful activities and remove dangerous products.
In addition, the question of Russia’s accession to the international convention MediCrime was discussed in parliament, which will make it possible to more effectively combat counterfeit medicines at the international level. This convention, initiated by the Council of Europe, is a kind of “pharmaceutical Interpol”. All countries that have ratified the agreement are jointly struggling with scammers in the pharmaceutical market: they exchange data on unscrupulous manufacturers, share new methods, carry out joint operations for the disclosure of criminal schemes. However, this cooperation may be difficult in light of the difficult political situation.