The drugs Sealex Forte and Ali Caps are being withdrawn from circulation

The Federal Service for Supervision of Consumer Rights Protection (Rospotrebnadzor) has banned the sale in Russia of two dietary supplements allegedly intended to strengthen male potency.

As reported on the department's website, on April 26, the Committee for the Protection of Consumer Rights of the Ministry of National Economy of Kazakhstan revoked the state registration of biologically active food additives Sealex Forte and Ali Caps produced by the Russian company LLC "VIS".

Previously, information was received from Belarus and Armenia, as well as from the Moscow department of the Investigative Committee of the Russian Federation, about the identification of individual batches of falsified dietary supplements on sale. They contained the pharmaceutical substance tadalafil, which was not declared during state registration.

“In order to exclude falsified dietary supplements for food from circulation on the territory of the Russian Federation, instructions were given to the territorial bodies of Rospotrebnadzor to strengthen supervision over the production and circulation of dietary supplements for food and to take appropriate measures to stop the sale and withdraw these falsified products from circulation,” noted Rospotrebnadzor .

The president of the RIA Panda company, which produces these supplements, Dmitry Dergachev, told Kommersant that the company learned about the revocation of registration of the drugs the day before from its distributors in Kazakhstan.

“We have not received official notifications, they were not provided upon request, and we have not yet been informed about the seizure of products from pharmacies,” Dergachev said.

He expressed confidence that this situation is a continuation of the competitive war, since the leadership of the Committee for the Protection of Consumer Rights resigned immediately after the revocation of the registration of dietary supplements RIA "Panda" and the products were never produced under the registration certificate numbers indicated by Kazakh specialists.

Some Russian pharmacies no longer sell Sealex and Ali Caps. According to Kommersant's source in the pharmaceutical market, at the beginning of 2015, the manufacturer of Sealex and Ali Caps tried to register these drugs as medicines and submitted an application to Roszdravnadzor. According to DSM Group, Sealex and Ali Caps are among the top 10 dietary supplements in terms of pharmacy sales in Russia (in March, the volume of the entire supplement market exceeded 2.7 billion rubles). In February of this year, Sealex even topped this rating, occupying 2.79% of the market in monetary terms.

Tadalafil is a medication intended to treat erectile dysfunction, that is, the inability to achieve and maintain an erection necessary for sexual intercourse. In Russia, it is a prescription drug not intended for free sale.

Today there are quite a lot of unscrupulous manufacturers in the pharmaceutical field. This can be explained by the high prices for quality medications, especially for drugs that are used for erectile dysfunction and other male problems. Such manufacturers hide the real composition of such drugs. Men who buy such products use components that are truly dangerous to their health. Such drugs include Sealex. Anyone who decides to take it should know why Sealex is banned by Rospotrebnadzor.

Before the audit, Sealex occupied a leading position in sales. This was explained by its effect on potency. Men noted that the effect was visible already 36 hours after starting to take the drug. The DSM Group agency, when monitoring sales in pharmacies, concluded that about 65% of the market in this area was occupied by Sealex Forte and Ali Caps.

Ban

Sealex Forte, as indicated by the manufacturer, is a dietary supplement (dietary supplement). And when additional research was carried out, it was revealed that the composition contains substances such as tadalafil and sildenafil. What is unacceptable for dietary supplements.

The research was started due to the activities of Ria Panda LLC. Organizations such as the Union of Professional Pharmaceutical Organizations, the Association of Manufacturers of Biologically Active Food Supplements, and others have tested dietary supplements.

The scandal began when the Committee for the Protection of Consumer Rights of Kazakhstan canceled the state registration of Sealex. It was under this registration that the drug was sold in Russia. After this, Rospotrebnadzor began to withdraw this drug from pharmacies. Back in September 2015, the investigative committee for the Basmanny district of Moscow opened a criminal case. It described the fact of falsification of dietary supplements. The statement came from the Union of Professional Pharmaceutical Organizations, the Pharmacy Guild and the SRO of dietary supplement manufacturers.

Active substance

In addition to Sealex, Ali Kaps was also completely banned. The scandal over these drugs is the biggest in 10 years. Tadalafil was detected in these products. This substance is not prohibited, but drugs containing it are sold only by prescription. And also the dosage should only be prescribed by a doctor. When taking dietary supplements with it, a person can consume more than is permissible.

The scandal that developed around this active substance was justified, since the permissible threshold for tadalafil in Sealex Forte samples was exceeded tens of times. The samples were taken from different batches and it was found that the dosage of the synthetic substance was not the same in them. That is, manufacturers did not even have a single recipe indicator. Uncontrolled use of such substances can result in dangerous consequences for humans.

All this only proves that the producers of Sialex circumvented all applicable legal norms only for the sake of material profit. At the same time, there was no control over quality and dosage.

Danger

The whole danger of this drug lies in the fact that it is most often taken by men of the older age group. Such men usually already have a history of certain health problems, including with the prostate. This means that they take certain groups of drugs, for example, cardiac and vasodilator drugs. The instructions for dietary supplements do not describe side effects or information about combining them with other drugs.

By consuming dietary supplements, a person without even realizing it harms himself. After all, the components of dietary supplements are always natural and the patient can even increase the dose spontaneously.

Statistics show that about 4 million men in Russia were subjected to such negative influences.

Is it possible to purchase

Of course, the drug Sealex Forte was banned, but it can still be purchased online. Information about this is provided by the DSN Group agency. According to their statistics, already in June and July there were active sales - about 8 thousand packages. And the manufacturer Ria Panda LLC did not confirm this information.

At the same time, site coordinators answer about the legality of such sales that they have not received any documents about the ban. Although there are no new supplies either. So how much does Sealex forte cost? You can order the drug in online pharmacies at a price from 625 to 2450 rubles, it all depends on the number of capsules. Although at the moment there are very few such pharmacies left.

The manufacturer "Ria Panda" immediately after the ban on Sealex forte and Ali Caps released new drugs. Their name is not too different from the previous one - and Ali Caps Plus. Their composition is different and it is noted that they contain only natural extracts. The cost of Sealex forte plus is 712 rubles. for 4 capsules and 1443 rubles. for 12 capsules. This drug can be freely ordered online.

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The male half of humanity goes to any lengths in order to achieve amazing sexual results. Sometimes these actions can be described as stupid and thoughtless. It is this feature that is used by various drug manufacturers to improve the quality of male erection and sexual activity.

Some manufacturers not only add elements that are hazardous to health into their drugs, but also hide this information from consumers. The result is a situation that was played out with the well-known drug for improving erection Sealex Forte. Why was this drug banned for sale?

A modern man suffering from potency problems finds it difficult to find a drug that is sold in pharmacies without a special doctor’s prescription. And this is despite the huge number of products that guarantee not only instant results, but also complete relief from problems with sexual activity.

The process of purchasing a drug usually occurs as follows. First of all, the man visits the attending physician and receives from him a prescription with the name of the medicine for the existing problem, after which the man goes to the pharmacy, where he buys the specified drug.

However, this pattern of action is followed in less than 3% of cases. Other men, faced with the problem of potency dysfunction, trust advertising brochures, advice and articles on the Internet.

It is also worth noting that the price category of medicines also plays an important role in choosing a drug. Those drugs that have not undergone special research and approval by doctors have a cost that is an order of magnitude lower than those that have undergone such testing.

Word of mouth spreads the names of wonderful remedies that eliminate all problems in sexual life. However, not everyone who spreads such rumors imagines how ordinary dietary supplements achieve the ability to treat complex diseases of the reproductive system.

Based on statistical data, Sealex Forte is one of the best-selling drugs in Russia. It is among the top ten popular ones, according to statistics provided by pharmacies. This category of popularity also includes the drug Ali Caps, which has a similar effect on the male reproductive system.

Biologically active additives: harm or benefit?

When making a choice not in favor of certified drugs for the treatment of potency problems, a man should be aware that dietary supplements have a quick effect only by stimulating erection and sexual desire, and not by eliminating the cause of the disease.

Drugs of this type have the ability to increase potency when taking pills for a long time. To a greater extent, the effect of dietary supplements appears due to the self-hypnosis of a man, and only to a small extent - due to the medicinal properties of plant components and chemical compounds.

Their feature does not apply to the treatment of the reproductive system. The fact that a man stopped believing in himself during sexual intercourse is precisely the reason to take a pill that will provide a placebo effect and will not particularly affect health.

Based on international rules, biological additives must contain only natural ingredients. Medicines that do not fall under the category of dietary supplements also contain synthetically derived chemical compounds. In this case, the pills may be intended to treat problems with sexual function.

However, not all manufacturers of dietary supplements are conscientious and reliable. Some may use chemical elements in the tablets without consumers noticing. After taking them, a person begins to notice significant changes in his sexual activity.

This will influence the fact that he will be happy to write a review about this drug and will attract even more clients for the deceiver - the manufacturer of the dietary supplement.

A similar situation occurred with the biologically active additive Sealex Forte, which is why the drug had to be banned. However, manufacturers of dietary supplements find gaps and fill them with their drugs, making huge profits. Such unscrupulous factories are not at all concerned about the consequences that their drugs may cause, nor about the health of their customers.

Some consumers become so dependent on dietary supplements that they are not going to stop taking these pills. If, thanks to pharmacological intervention in dietary supplements, men feel favorable changes in the body, then they do not stop taking the pills. But can chemical additives really be good for people?

Prohibition on the use of Sealex

The increased popularity of Sealex among men attracted attention to the drug. First of all, bona fide manufacturers of pharmaceuticals sounded the alarm, since they need to control the market against the entry of low-quality medicinal products.

An independent examination was appointed and it was found that the composition of Sealex Forte contained deviations from the norm, which allowed the drugs to rise to the pedestal of popularity among drugs sold without a prescription. Sealex Forte really helped men get rid of the signs of impending impotence and problems with erection.

The organization that sounded the alarm and identified the deceivers through expert research is RIA Panda, having enlisted the support of such organizations as:

• Union of Professional Pharmaceutical Organizations;
• Combination of dietary supplements;
• Pharmacy Guild.

These communities made special purchases of dietary supplements in order to identify unscrupulous manufacturers. The purchase was carried out primarily in Moscow pharmacies and was aimed at drugs that affect male potency. After which testing was carried out in three independent laboratories.

Based on the results obtained, it became known that most of the supplement samples taken contained prohibited substances such as tadalafil and sildenafil. This is a category of synthetically derived substances that have a tremendous impact on the body, which under no circumstances should be present in biological supplements.

After such discoveries, it is not surprising that Rospotrebnadzor banned the sale of such dietary supplements as Sealex. But supporters of the drug are still indignant: despite all the research findings, there is no reason to completely block the sale of Sealex.

In fact, Rospotrebnadzor was so concerned about the presence of such dietary supplements on free sale that, in search of gaps in the legislation, it first removed the advertisement, and only after that Sealex itself was banned from sale.

What is dangerous in Sealex?

All the hype about the ban on Cialex lies in the presence of tadalafil in the substance. This chemical compound is not dangerous and is even found in some over-the-counter medications.

However, the only precaution that must be observed when using drugs with tadalafil is compliance with the dosage, namely, no more than 5 mg per day. Therefore, all medicines that contain tadalafil have special indications for use. The substance tadalafil is used in many vasodilators and medications for problems with potency.

In Sealex taken as a sample, tadalafil was contained in proportions inappropriate normal use of dietary supplements. The peculiarity was that in different batches of tablets the content of tadalafil turned out to be different, which testifies O lack of control adding this potent substances

It was found that unscrupulous manufacturers secretly added pharmacological substances in order to obtain greater profits, without any control over the quality and safety of the product.

IMPORTANT! The side effect of Sealex can be either positive, namely, a man will receive a stable and long-lasting erection and sexual arousal, or negative, up to and including complete loss of the ability to arouse.

What are the dangers of taking tadalafil?

The substance that was found in large quantities in Sealex belongs to the group of vasodilators. Typically, men who already have any health problems resort to taking drugs like Sealex.

And they are already taking medications to eliminate their other diseases that are not related to the problem of potency. In some cases, they use a dietary supplement only to give themselves confidence, as a placebo effect.

However, tablets containing an unknown amount of tadalafil in combination with other drugs can cause unpredictable side effects. Men who took Sealex with a prohibited substance did not even think about how much they were risking their own health.

Thus, an active man could become impotent from one pill only because of the unfortunate proportions in the drug.

According to statistics, it was revealed that about four million men in Russia were in such a risk zone, who periodically use biological supplements to improve sexual activity.

The dangers of using unauthorized drugs

Before going on sale in pharmacies, each drug must undergo research and approval by doctors and experts. All of them undergo complex laboratory tests and a lengthy registration system. It can take up to five years to get the tablets approved for sale.

After passing all the necessary procedures, the medicine is issued a certificate of conformity and permission to sell it in pharmacies. At the same time, in the instructions for use, the manufacturer must indicate what possible side effects the drug has and what dosages of use should be observed.

Thus, a pharmaceutical manufacturing company invests huge amounts of money in the production of one drug product. Often, even the inflated cost of selling tablets does not cover the costs incurred.

If biological additives are approved for sale, the entire inspection procedure is significantly simplified. This occurs due to the classification of dietary supplements as food additives, and not as medical products. Manufacturers of dietary supplements are aware that there is no way to gain trust and popularity among consumers if you use only medicinal herbs in the composition. Therefore, many resort to tricks and produce products that do not correspond to their composition indicated on the packaging.

Thus, supplements appear that are diluted with pharmacological substances and which provide the effect of their use. However, are they safe? A drug that acts completely unpredictably and uncontrollably should not be freely sold in city pharmacies. Therefore, it is logical that, having discovered strong foreign substances, Sealex was banned.

Based on the above, we can conclude that Rospotrebnadzor really cares about the health of Russian citizens.

And the ban was not due to the whims of officials. Indeed, lack of control over manufactured biological additives can lead to disastrous consequences. That is why Sealex should be transferred to the category of drugs that are issued by prescription.

The sales ban is largely related to laboratory tests and obtaining permission to sell the product in pharmacies. After establishing a clear formulation and the chemicals contained in the tablets, it will be possible to talk about the return of Sealex Forte to pharmacy shelves.

After all, whatever one may say, many men were really satisfied with the result of the effect of this drug on the reproductive system.

The dietary supplement market is rocked by the biggest scandal in the last 10 years. The protracted story with the discovery of the banned substance tadalafil in the best-selling potency supplements on the Russian market, Sealex and Alicaps, which at first glance appears to be a competitive squabble between manufacturers, actually revealed systemic problems in controlling the circulation of dangerous products and dispelled the myth of the omnipotence of Rospotrebnadzor.

When in May 2015 it first became known about the discovery of prohibited tadalafil in the drugs Sealex and Alicaps, the scenario for the development of events seemed to be the only possible one - a lightning-fast reaction from Rospotrebnadzor, the recall of dangerous products from the market, and the punishment of those responsible. But the all-powerful Rospotrebnadzor seems to have stumbled over Sealex.

The powerful agency, famous for the fact that it can close the market for Moldovan wines or Dutch tulips in a day or even an hour, in this situation seems to have demonstrated inertia and helplessness that was previously unusual for it.

It turned out that analyzes of dubious products for the content of tadalafil, which have been common throughout the world for decades, are illegitimate in Russia due to the lack of an approved special technique. But if there is no methodology, there is no tadalafil, and the fact that every day the health of hundreds and thousands of Russian men is at risk remains outside the brackets of bureaucratic formalities.

It is unknown how long the issue with the methodology would have been in limbo, but Olga Golodets intervened. In the summer of 2015, at a meeting with the Deputy Prime Minister, the issue of the sensational problem with falsified dietary supplements was raised, and immediately after the meeting, the chairman of the State Duma Committee on Health Protection, Sergei Kalashnikov, announced that he was preparing a bill to transfer powers to control the market of dietary supplements from Rospotrebnadzor to Roszdravnadzor, which It will simply register drugs and check each of them for drug content.

After this, Rospotrebnadzor began developing the methodology, and on January 30, 2016, it officially announced that the document had been developed and officially approved.

Rospotrebnadzor, as you can understand, chose to remain silent about the fact that the official method is no different from the unofficial one, which discovered tadalafil back in May 2015. And this is understandable - after all, then it was necessary to explain why it took five months to develop it, while dangerous products continued to be sold unhindered in Russian pharmacies. Be that as it may, Russia has now officially adopted the document MUK 4.1.3331-16 “Methodology for measuring the mass fraction of synthetic phosphodiesterase-5 inhibitors (tadalafil, vardenafil and sildenafil) in dietary supplements using high-performance liquid chromatography with ultraviolet and mass spectrometric detection ", which allows you to accurately determine the presence of the active synthetic substance of the PDE-5 group tadalafil in dietary supplements and food products. Rospotrebnadzor press secretary Anna Brycheva officially confirmed to NG that the methodology adopted by the department makes it possible to determine the presence of tadalafil.

According to NG, immediately after the adoption of the official methodology, a study was conducted in accordance with it, the results of which were published on February 25, 2016. Tadalafil was found in the drug Sealex in amounts from 10.0 to 11.4 mg per capsule, in the drug Alicaps - from 3.9 to 12.4 mg per capsule.

And a month earlier, on December 30, 2015, as part of a criminal case opened regarding the discovery of tadalafil in dietary supplements, the Investigative Committee of Russia conducted its own examination of samples seized from pharmacies and distribution networks. The examination confirmed the content of tadalafil in Sealex and Alicapse.

Based on its results, the Investigative Committee sent an appeal to Rospotrebnadzor with a request to withdraw Sealex and Alicaps from the market.

On February 17, 2016, the Ministry of Health of the Republic of Belarus adopted a resolution to withdraw Sealex and Alicapsa from the market due to the discovery of tadalafil. However, at the time of preparation of the material, Rospotrebnadzor had not yet seen Belarus’ appeal on this issue. “We have not officially received an appeal from Belarus, and accordingly, we cannot yet answer questions regarding further actions,” says the official response from the press service. Let us recall that earlier in a similar situation in July 2015, when the Ministry of Health of the Republic of Belarus decided to recall Togkat Ali Platinum, which also contained tadalafil, a similar decision was made by the Russian Rospotrebnadzor. On July 29, 2015, Rospotrebnadzor of Russia issued an order to terminate the state registration of Togkat Ali Platinum and withdraw it from circulation.

That is, there is already a precedent. Professor, head of the criminal law sector of the Institute of State and Law of the Russian Academy of Sciences Sergei Maksimov believes that if there are free customs borders, “measures to suspend the free circulation of dangerous products should be taken immediately after receiving official notification of the decision of the authorized body.”

Using this story as an example, we become witnesses to a unity of views of a variety of interest groups, very atypical for Russian realities - public organizations, the Investigative Committee, parliamentarians. Surprisingly, the only body that in a different situation would have been the first to take the lead in the fight against unscrupulous producers, Rospotrebnadzor, seems to be in the opposite phase.

“The question arises: why does Rospotrebnadzor not fulfill its direct responsibilities when a number of dietary supplements containing a medical formula are sold, and no measures are taken to remove these drugs from sale?” – asks Sergei Kalashnikov. “Rospotrebnadzor must, by law, impose fines on the manufacturers of these dietary supplements by applying the Code of Administrative Offenses and, of course, prohibit their sale. This is an amazing inaction of Rospotrebnadzor, if not criminal,” he concludes.

The slowness of Rospotrebnadzor in resolving this issue raises the question of whether the once all-powerful agency can protect Russian citizens today. Well, increasingly louder accusations of criminal inaction are often separated from more serious accusations of corruption by just one step.

What will be the incentive for the department under the leadership of Anna Popova to finally apply its own methodology, make an official verdict and put an end to this scandal? Maybe a meeting with the president?

Rospotrebnadzor against potency. The service has banned the sale of dietary supplements for men, Sealex and Ali Caps. Instructions to withdraw funds from the circulation of pharmacies were sent to all distributors. Previously, the manufacturer of dietary supplements, the RIA Panda company, lost state registration for the drugs in Kazakhstan. It was from there that additives were brought to Russia through its subsidiary, explained Rospotrebnadzor spokeswoman Anna Brycheva.

“According to official data from the Committee for the Protection of Consumer Rights, at the end of April this department revoked the state registration of biologically active food additives Sealex Forte and Ali Caps produced by VIS LLC. Thus, these biologically active food additives cannot be in circulation throughout the entire Eurasian Economic Union. Rospotrebnadzor has taken measures to remove these counterfeit products from circulation and has given instructions to strengthen supervision to our territorial authorities and pharmacy chains,” Brycheva explained to Kommersant FM.

The manufacturer of dietary supplements for men refuses to recognize the decision of the regulatory authorities of Kazakhstan. There has been no official information about the revocation of drug licenses, Dmitry Dergachev, president of the pharmaceutical company RIA Panda, told Kommersant FM. The story of the ban on Sialex and Ali Caps in Kazakhstan is the machinations of competitors, the businessman emphasized.

“We received the information from distributors; distributors received information from Eli Lilly’s mailings, which exactly coincided with the release of this information on the website of Rospotrebnadzor of Kazakhstan. Eli Lilly is our competitor in the market of drugs and dietary supplements. In response to our official request to the authorities of Kazakhstan, we did not receive a document, which is currently referenced on the website of Rospotrebnadzor of Kazakhstan and Rospotrebnadzor of the Russian Federation. I would like to draw special attention to the fact that the Kazakhstan website indicates a state registration number under which the products have never been produced,” Dergachev emphasized.

According to Rospotrebnadzor, earlier, in some batches of Sialex and Ali Caps, a substance not declared during registration was found - tadalafil. Such notifications came from the supervisory authorities of Belarus and Armenia. RIA "Panda" was indeed among those manufacturers who themselves violated the conditions of competition, says Leonid Maryanovsky, director of the self-regulatory organization of dietary supplement manufacturers.

“Exactly a year ago, we purchased 29 products from different manufacturers, and found tadalafil in 25 of them. Tadalafil is prohibited for use as part of biologically active food additives, like any other pharmaceutical substance. We were talking here not only about the products of the RIA Panda company - there were products from Malaysia, China, and the United States. On the one hand, this is fraud, and on the other, it is unfair competition, that is, an attempt to make one’s products more effective than those of competitors,” explained Maryanovsky.

According to the analytical company DSM Group, about 4.5 thousand dietary supplements are sold in Russia. There are more than 700 manufacturers on the market. The drugs Sealex and Ali Caps are among the top ten in terms of pharmacy sales. The pharmaceutical company RIA Panda ranks third in the list of the largest manufacturers of dietary supplements - its share in the Russian market is about 6%.