Weight Loss Pills Containing Banned Substances Sold in Armenia: Shady Business at the Expense of Human Health
For the past few months, Hetq has been researching the weight loss biological supplement market in Armenia. Our investigation shows that in addition to the official market of registered weight loss pills, there is also a “black market” operating in Armenia. Under the guise of 100 % natural capsules, some are freely selling slimming pills that potentially pose health risks.
Investigating both markets, we’ve revealed that in addition to serious legislative shortcomings regarding health supplements, there are people who totally flout the law. Some of these weight loss pills contain the banned ingredient Sibutramine. More interesting is some of these supplements are government-approved.
Prior to this investigation, no Sibutramine had ever been found in slimming biologically active additives in Armenia.
Legislative Shortcomings and Lack of Specialists
Excess weight and obesity are the cause of 5% of all deaths worldwide.
Women are found to be more actively struggling against excess weight. According to data of the last report on “Health System Performance Assessment” of 2017, the number of men and women having excess weight or obesity in Armenia is almost equal - 54% and 46 %.
In Armenia, among people under 40, excess weight and obesity are more often found among males. After 40, the number of overweight women starts to overtake that of men. However, the average distribution continues to remain equal.
Weight loss medications have become a profitable business all over the world. Armenia is no exception. People are sometimes ready to sacrifice their own health to achieve a desired weight, using both medications and supplements.
Biologically active weight loss supplements are especially widespread. They are identified with food and are controlled by the Food Safety Inspectorate. That's why the registration of biologically active supplements is a quick and not so expensive process, unlike the registration of medications serving the same purpose. Moreover, before Armenia became a member of the Eurasian Economic Union, the state registration of biologically active supplements was not mandatory.
Vahe Danielyan, Head of the Food Safety and Quality Control Inspection of the Food Safety Inspectorate.
"We carried out inspections in all the major pharmacies in 2016 and we found that there is a great number of biologically active supplements, which either have no labeling or no state registration certificate, but there was also a casus : there was no such authority in the Republic of Armenia that would make the state registration» - Vahe Danielyan.
Today there are eight certification authorities in the Republic of Armenia entitled to issue registration certificates. However, mandatory state registration is only in the form of documents. Biologically active supplements are not tested. Only the package of documents of these supplements presenetd by their manufacturer is being checked. Based on this, distribution and sales permits are issued. Furthermore, the state registration certificate issued in one member state of the Eurasian Economic Union (EAEU) is mutually acceptable in all member states.
Armenia’s Food Safety Inspectorate (FSI) has only one function in this process - to enter the number of the state registration certificate of the product into the register.
Vahe Danielyan says: "There is no any definition about what should be done in the state registration procedure and often they take advantage of this. Business entities bearing no social responsibility take advantage of this, so to say."
To date, the main part of violations found by FSI referred to labeling or absence of state registration certificate.
Vahe Danielyan confirms this: Technical Regulations 021/2011 "On the Safety of Food Products" of Customs Union, which regulate biologically active supplements, are too weak.
"We have a problem of making clarifications in the field: this doesn’t depend on us. I brought up this issue myself many times in different circles of the Eurasian Economic Union. We have serious discrepancies in the legislation," he says.
Healthcare specialists share the same opinion. Head of the Department of Pharmacognosy at Yerevan State Medical University (YSMU) Naira Chichoyan says that biologically active supplements should also be the domain of healthcare.
"These technical criteria formed within the scope of the Eurasian Economic Union, which only control the safety of the biologically active supplements (heavy metals, radionuclides, microbiological contamination) is not enough and the biologically active supplements must definitely be under control of healthcare experts as well." says N.Chichoyan.
Head of the Ecocenter's Informational-Analytical Center for Food Chain Risk Assessment Davit Pipoyan says that there are no nutritionists in Armenia. “Who is the one that prescribes these products? We have no such specific institute as dietitian.One cannot go and receive training in this field. I have witnessed many cases, when a person calls himself a dietitian or a nutritionist having no idea about nutrigenomics”.
Davit Pipoyan says that people very often don't pay attention to the active ingredient of the biologically active supplement, overdose of which can have a negative effect.
“There are no healing substances and toxic substances in nature. The dose differentiates toxic from medication or healing substance. The problem is with dosage, as one food intake can result in possible exceeding of active ingredients contained in it”.
The «Black Market» of Slimming Pills
During the last four years, the number of biologically active weight loss supplement varieties has increased twofold. 396 types of biologically active supplements have state registration and are being sold in Armenia's pharmacies, this according to 2018 data. Most of them are imported from the USA, Germany, Russia, Slovenia and Italy.
But the market of weight loss remedies is not restricted to legally imported products getting through customs control. The internet also offers us quite “natural” and “safe” medications for weight loss.
“Getting slim is not a dream”, “lose 9-15 kg in a month without harm”, “100% guarantee, 10 years of experience, without diets and workouts, natural and safe”.
You can see such advertisements in social networksin Armenia almost every day. Such posts attract dozens of people and buyers.
Since these remedies for weight loss are described to consumers as quite natural and safe, and not medications that require special license for sale, Hetq decided to study this market as well.
We chose 3 people actively selling such products on Facebook and tried to contact them in order to buy these “magic” medications .
We first turned to Facebook user An Darya (real name – Ani, auth.). She promises “the loss of 15 kg in one month” and certifies that her product is phytogenic and quite harmless.
To lose 15 kg in 1 month is not a dream but a real result.
Ani also promises “the elimination of stored body fat” and “loss of appetite”. We called her and found out that those are American biologically active weight loss supplements Garcinia 3000 Extreme. The active ingredient is Garcinia Cambogia Extract Powder.
A fragment of our conversation with Ani
-The course lasts 20 days; you should take it thrice daily, 20 or 30 minutes before the meal. This is done in order to lose appetite; it is intended to suppress the appetite.
-I have problems with my stomach. Is it OK to take this medicine in this case?
- We had people with stomach diseases - gastritis, gastric erosion, who took this medicine. Actually, they were afraid when buying, but to tell the truth it was interesting for me too. It is contraindicated during pregnancy and lactation and is not recommended to the underaged. There were people, who were afraid as they had stomach problems. However, they took this medicine. Then it was interesting for me, I asked them, and they said that everything was OK.
As Ani said, the product is sold in Vanadzor, but they sell it in Yerevan too. We thus managed to buy this supplement at a price of 16,500 AMD. It normally sells for about 6,000 AMD.
Though there are biologically active supplements containing Garcinia in Armenia that are registered and sold, this product has no registration. It is imported and sold without customs control, is sold illegally, and has no Armenian labeling.
Naira Chichoyan says: “Today, when listing the European information data about biologically active supplements, it is mentioned there that in case of Garcinia side effects have also been registered. So, definitely we can announce that the quality must be under control and attention should be paid to ingredients”.
Next, we turn to Viktorya Khachatryan, who promises to help us lose 9-15 kg in a month “with phytogenic capsules”. She says, “We guarantee safety and result”.
Viktorya Khachatryan, more precisely Captain Viktorya Khachatryan, works in the Ministry of Emergency Situations, in the Special Rescue Team. As she told us, she’s been selling weight loss remedies for seven years.
The first time we phoned her to ask about product licensing she just hung up.
A fragment of our conversation with Viktorya Khachatryan
- Does it have a normal license?
- Yes! I have already said so!
- If necessary, will you bring those documents for me to see, when I buy the product?
- The documents, the licenses, bring them, when I purchase…
- No dear, there is the internet for this. I can send it online. Shall I give you the license now? Or maybe you want me to make a copy for you, and then you will give it to others! Eh! /hangs up, auth./
We didn’t give up, and a bit later tried to contact Viktorya again. In the meantime, we found out that she sells two types of “phytogenic capsules”. As she says, there’s the Russian “Нормомасс” (Normomass), actually made in China, and the so-called “high dose”, variety. Again, as she says, the latter is from abroad, from America, and that it’s of higher quality. Actually, it is also Russian.
Viktorya denied all our requests to reveal the name of this “strong remedy”, to show its packaging, or at minimum the photo of the package, before buying.
A fragment of our conversation with Viktorya Khachatryan
-There is no information about it on the internet You can search it in Armenian, in French, you can write anything you want, and you won’t find it.
-Why? What kind of medicine is this, that there is no information?
-Well, no. If there was available information, it could also be sold in pharmacies.
We decided to buy those “phytogenic capsules” in both low and high doses. One capsule of the latter is 1,500 AMD, it is sold in quantities of at least 10 capsules. The price of 1 capsule of “Нормомасс” (Normomass) is 500 AMD. But, as it has many buyers, we had to wait our turn a few days.
A fragment of our conversation with Viktorya Khachatryan when buying the capsules
-Should she take it for one month?
-One month, at least 9 kg in a month. There are people who lost 15-17 kg. It depends on weight, age, generally it depends on the organism. But for sure it’s impossible to lose 10 kg taking this quantity. Well, she can call me, I will tell her how to take it.
-Is this sold more? Is this a good one? Shall we take this?
-The blue one? Yes, definitely the blue. It is of higher dose and of higher quality. I almost don’t recommend anyone this (shows the green one). I gave this, because she told me. It’s the same for me. Just this one is of higher dose and of good quality (she means the blue one, auth.)
The third person who promises “quick and harmless weight loss and 100% guarantee” is Facebook user Lilarm Gev (real name – Lilit Yeganyan), who presented herself as a doctor during our conversation. We found out that she works in the Department of Otolaryngology of Yerevan Polyclinic #8 as a nurse. She says she’s been selling these products for ten years.
Lose weight quickly and healthy. 100 % result… natural and safe, -she says
Like Viktorya Khachatryan, Lilit Yeganyan also sells two types of weight loss remedies “Нормомасс” (Normomass), which according to her is even prescribed for children above 12 years old, and again “its strong version”, the name of which she refuses to reveal. After prolonged questioning she confesses that it was imported from Kiev and it is “chemical”.
A fragment of conversation with Lilit Yeganyan
-So, I will tell you. They are of two types – chemical and phytogenic. The phytogenic ones are prescribed starting from 12 years of age. They have no contraindications or age limitations. In comparison, its influence is weaker. Well, they do the same thing. They impact the appetite, they suppress appetite, increase metabolism, remove fat and cholesterol.
-That’s “Normomass”. Taking it, you lose up to 5 kg in a month. If you decide to start with it, I can’t say you will lose 10 kg in a month, because for sure you won’t have that result, maximum 5 kg. There are people who don’t hurry, this is for them, so they can lose weight slowly, and I recommend this. And the other one is chemical, i.e. it’s like a medicine, I mean the ingredients… Well I can say that the influence is almost the same, just in this case you will lose weight quicker. You will lose 8-10 kg in a month, for sure. There are people losing even 15 kg, or people losing 7 kg in ten days, that’s just individual. Losing 3-4 kg in 10 days, this is definite.
We ask which one she will recommend as a doctor. Lilit Yeganyan first asked what health problems we have. We answer that have no problem. She recommends taking “the one with higher dose” in order to “have a good effect first”, then to combine it with the “low dose”.
We only buy the chemical ones from Lilit, paying 1,000 AMD for each.
Fragment of conversation with Lilit Yeganyan
-This are «Капсулы для похудения» (capsules for weight loss).They don’t have a particular name that I can tell you. We have ten years experience with it.
-In which country is it produced?
During this period, we also go to pharmacies, to find out what they have for losing weight and which are sold more than others. We buy four types of biologically active weight loss supplements that were mostly recommended by pharmacy employees.
We takethis and all these pills for weight loss bought from pharmacies and private individuals to the “Scientific Center of Drug and Medical Technologies Testing” to find out whether they contain synthetic materials suppressing appetite.
We provide eight weight loss remedy samples for testing - «Турбослим День» (Turboslim Day), «Турбослим Ночь» (Turboslim Night), Apple Cider 600, BioDrain, which were bought from pharmacies and which are registered and Garcinia 3000 Extreme, «Нормомасс» (Normomass) and two types of the so called “higher dose” versions.
Samples Taken for Testing
During the last ten years, the “Scientific Center of Drug and Medical Technologies Testing” found synthetic materials only in the biologically active supplements for male potency sold in the market. In particular, Sildenafil and Tadalafil were found.
Acting Director of the “Scientific Center of Drug and Medical Technologies Testing” Levon Melikyan says: “It is wrong to qualify the biologically active supplements as products having pharmacological activity. Biologically active weight loss supplements have been studied and no orlistat or sibutramine have been found in them”.
Banned Substances in Weight Loss Pills: Test Results
According to the results of the laboratory examination we found out that samples N1,2,3,4 and 5 doesn't contain synthetic materials suppressing appetite.
But in the 6th, 7th and 8th samples we found the psychotropic medication Sibutramine, which suppresses appetite and is banned in Armenia. (N6 – 14,95 mg, N7-5,6 mg, N8- 13,7 mg)
Sibutramine is a strong psychotropic medication, which influences the central nervous system and blocks the centers which are responsible for feeling hunger.
Sibutramine especially negatively impacts the heart. Its use increases the risk of heart disease. It can cause insomnia, stress and mental disorders. Deaths linked to the substance have also been registered.
Because of this and many other side effects, as well as a great number of contraindications, the United States’ Food and Drug Administration has recalled medications containing sibutramine from markets since 2010, and their further sale was banned in a number of countries, such as the USA, Canada, Mexico, European countries, China, India and etc.
In Russia, sibutramine is included in the list of strong medicines and is available only by special prescription.
From these three pills for weight loss containing Sibutramine only “Нормомасс” (Normomass) is considered to be a biologically active supplement. Though it has state registration and can be sold in all the EAEU countries, but it was issued by old normative documents in 2011 with sanitary-epidemiological and hygienic norms. Kazakhstan made the registration.
“Нормомасс” (“Normomass”) is not Russian or American as the sellers try to introduce it, but it is the product of “Green World” Network Company established in China.According to estimates of some pharmacologists the 6th and 8th samples can be identified with Russian weight loss pills «Редуксин» (Reduxin). The anger arising from questions about license or not telling the name of the pills let us conclude that the sellers knew what they were selling.
More than 30 Criminal Cases - Illegal Distribution of Drugs
According to the Law of the Republic of Armenia “On Medicines” it is prohibited to sale medications having no registration and not complying with quality requirements. And in accordance with the Criminal Code the contraband of psychotropic medication through the customs border of the Eurasian Economic Union or the state border of Republic of Armenia is punishable by imprisonment.
In the Investigation Department of Armenia's State Revenue Committee more than 30 criminal cases were launched in 2018 concerning the illegal circulation of drugs and psychotropic medications. They were found in postal parcels sent from abroad – particularly from the USA and European countries. It's necessary to mention that packages for personal use weighting up to 5 kg are not subject to customs clearance in Armenia.
"Do you imagine? Five kg of biologically active supplements in capsules. This can be a serious quantity; it can be about 500 packages. 500 packages are already a commercial quantity and will be sold in the market. We should try to regulate this stage in order to prevent their entrance into the Republic of Armenia," Vahe Danielyan says.
Registered but Counterfeit Biologically Active Supplements: Labeling Violations
Out of 8 samples taken to laboratory expertise only 5 have state registration as biologically active supplements, but only 4 of them are sold in Armenian pharmacies. That’s why we have studied the labeling only of these products and have found breaches in biologically active supplements N1, N2, N4.
In particular, biologically active weight loss supplements «Турбослим День» (Turboslim Day) (serial number 111076) produced by Russian pharmaceutical company “Evalar” (Эвалар) were taken to expertise under N 1. Importer is Armenian «Sia Pharm» company։
According to the original Russian labeling the active ingredients of the supplement are “L Carnitine Tartrate, Guarana extract, gelatin, iron oxide, titanium dioxide, inulin, chromium picolinate, calcium stearate of herbal origin, silicon dioxide - amorphous”.
The requirement concerning the labeling of biologically active supplements is preserved on the original labeling, i.e. not mentioning any healing properties directly, but only mentioning “contributes to” or “helps” something.
However, the Armenian labeling does not correspond to the original labeling: it contains a number of inaccuracies. It's illegible, incomplete and different from the original labeling, which is a breach of the "RA Law On Food Safety" as well as of Technical Regulations 021/2011 of the Customs Union.
In particular, there is no information about ingredients of the biologically active supplement in Armenian labeling. It's only in Russian.
In the Russian version it's noted that «Турбослим День» (Turboslim Day) contributes to:
- Active weight loss in the daytime
- Appetite suppression during the day
In the Armenian labeling we read about the products following "healing properties", which are not mentioned anywhere in the original labeling:
- Lowers cholesterol level in organism
- Improves the functional state of gastrointestinal tract
Contraindications of the biologically active supplement also differ from each other. According to the requirements for biologically active supplements, only the breaches of labeling were enough to forbid the sale of this product in Armenia and in accordance with the "RA Law On Food Safety” to consider it counterfeit (the labeling has been amended without the corresponding amendment of ingredients).
The next labeling infringement is in the biologically active weight loss supplement «Турбослим Ночь» (Turboslim Night) (serial number 112089) produced by the same Russian pharmaceutical company “Evalar” (Эвалар) taken for testing under N 2.
The product has state registration. It’s imported into Armenia again by Armenian «Sia Pharm» company. The pharmacies recommend taking «Турбослим Ночь» (Turboslim Night) in the evening along with «Турбослим День» (Turboslim Day), as if they “complement each other” and so it's possible to have quicker results. Like in the case of the previous biologically active supplement, here the original and Armenian labels also do not correspond.
In the original labeling dealing with ingredients, it's mentioned that the biologically active supplement contains “Garcinia extract, senna extract, gelatin, indigo carmine, titanium dioxide, chitosan, fennel extract, melissa extract, calcium stearate of herbal origin and silicon dioxide - amorphous”.
In the Armenian labeling there is no information about this. It's noted that it contains some B1, B2, E vitamins and L Carnitine. The Armenian importer describes the product as a “source of chromium and zinc”, which is not mentioned in the original labeling. According to the manufacturer the expiration date of the product is three years while according to the importer it's two years. Contraindications are also different. In accordance with RA Law “On Food Safety” «Турбослим Ночь» (Turboslim Night) is also considered counterfeit.
Biologically active supplement BioDrain (manufacturer: «Legosan» AB, Switzerland) again of Danish company «New Nordic» was taken to expertise under N 4. The product has state registration. Importer: “Geniapharm” LLC. It's mentioned among the ingredients that “it is made by Scandinavian herbalists on the basis of famous plants” which “are being used for cleaning the organism and losing weight for more than 10 years”.
Biologically active weight loss supplement BioDrain contains “chicory root powder, citrus peel extract, plantago seed powder, extracts of urtica, asparagus, artichoke, apium, taraxacum and thymus”. There is no any information about ingredients in Armenian labeling. It's only written that “it is made on the basis of 7 herbs and fibers of fruits and plants”, which “are successfully used in Denmark for more than ten years”. It's unknown why only seven herbs are mentioned (in original labeling we can count nine herbs) and why especially in Denmark.
It’s mentioned in original labeling “if you take other medications, consult a doctor”. There is no information about this in Armenian. So, biologically active weight loss supplement «BioDrain» also has a labelling discrepancy - it’s incomplete and violates the "Law On Food Safety” as well as Technical Regulations 021/2011 of the Customs Union.
From non-registered remedies for weight loss we had only the package of the sample N5. It was written in its labeling that “Garcinia 3000 Extreme” contains “100% natural ingredients *” but it was marked with an asterisk (*). Following this mark we see that it’s written “these statements have not been evaluated by the Food and Drug Administration (FDA, Food and Drug Administration, USA)”.
(FDA is one of the United States federal executive departments, responsible for protecting and promoting public health).
In the labeling of this biologically active supplement it’s also mentioned to consult a doctor before using it. However, in Armenia this product is prescribed and sold “not by doctors”.
Video: Ani Sargsyan, Saro Baghdasaryan, Harutyun Virabyan
The investigation was prepared with the financial support of the European Union and supported by the OPEN Media Hub.