Difference between revisions of "Dietary Supplements"

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'''Dietary supplements''' are products legally considered as food. In Germany they are subject to the [http://www.psiram.com/ge/index.php?title=Nahrungsergänzungsmittelverordnung Dietary supplement Regulation] (Nahrungsergänzungsmittelverordnung, NemV) and with this are always governed by the laws regulating food [http://www.psiram.com/ge/index.php?title=LFGB LFGB] and are therefore not meant to have medical effect, work as remedies or prevent illnesses. In the EU they must correspond to guideline 2002/46/EG. In Germany it is not allowed that dietary supplements develop a pharmaceutical effect or claim that they have one and have no major role in human biological [http://www.psiram.com/ge/index.php?title=Bioenergetik bioenergetics]. Their usage does not counter the effects of long-term malnutrition. Dietary supplements overlap with functional food.
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'''Dietary supplements''' are products legally considered as food. In Germany, they are subject to the [http://www.psiram.com/ge/index.php?title=Nahrungsergänzungsmittelverordnung Dietary Supplement Regulation] (Nahrungsergänzungsmittelverordnung, NemV) and therefore always governed by the laws regulating food [http://www.psiram.com/ge/index.php?title=LFGB LFGB], and are thus not supposed to have medical effects, work as remedies or prevent illness. In the EU, they must correspond to guideline 2002/46/EG. According to German law, it is not legal for dietary supplements to develop pharmaceutical effects, or to market them with according claims. They have no major role in human biological [http://www.psiram.com/ge/index.php?title=Bioenergetik bioenergetics]. Their use does not counterbalance the effects of long-term malnutrition. The two terms "dietary supplement" and "functional food" overlap partially.
  
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In the USA dietary supplements are over-the-counter(OTC)-products, meaning that they can be sold in regular shops without having to have a prescription. However, the US-American regulations are more liberal than the German ones: A lot of products sellable as OTC in the states are regarded as pharmaceutical drugs liable to registration. In the USA approval of drugs is in the responsibility of the "Food & Drugs Administration".
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In the USA, dietary supplements are over-the-counter(OTC) products, i.e. they may be sold in regular shops without prescription. However, US-American regulations are more liberal than the German ones: A lot of products sold legally as OTC in the States are regarded as pharmaceutical drugs liable to registration. In the USA, the "Food & Drugs Administration" (FDA) is responsible for their registration.
  
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Dietary supplements are in most cases packaged mimicking pharmaceutical drugs so that most times a layperson can't clearly differ them from drugs. This can lead to confusion. In particular cases even experts can have difficulties to differ them from pharmaceutical drugs, judging the substances and their concentration contained in such products.
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Dietary supplements are often packaged mimicking pharmaceuticals so that laypersons cannot clearly tell them apart from drugs. This can lead to confusion. In particular cases, even experts may have difficulties to distinguish them from pharmaceuticals, judging substances and concentration contained in such products.
  
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Dietary supplements are a typical domain of [http://www.psiram.com/ge/index.php?title=MLM Multi-Level-Marketing] (MLM) and the specific advertisement and marketing methods used there. Also, drastic differences in price for the same substance are not uncommon with dietary supplement. They are most of the time used in the body building area and respective gyms but can also be found in competitive sports. Dietary supplements are also a corner stone of [http://www.psiram.com/ge/index.php?title=Orthomolekulare_Medizin orthomolecular medicine].
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Dietary supplements are a typical domain of [http://www.psiram.com/ge/index.php?title=MLM Multi-Level-Marketing] (MLM) and the specific methods of advertisement and marketing applied there. Drastic differences in price for the same active substance are not uncommon with dietary supplements. They are frequently used in the body building sector and respective gyms, but can also be found in competitive sports. Dietary supplements are also a corner stone of [http://www.psiram.com/ge/index.php?title=Orthomolekulare_Medizin orthomolecular medicine].
  
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In Germany, in general older people buy dietary supplements: 50% of Germans aged 55 and older use them daily.
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In Germany, dietary supplements are largely bought by an elder clientele: 50% of Germans aged 55 and above use them on a daily basis.
  
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In Germany the dietary supplements industry  has a lobby group called "NEM Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten" to represent their interests. It is currently headed by Manfred Scheffler, who is also managing partner of Plantafood. In the internet, this group uses "Freiheit für gesunde Nahrung" (freedom for healthy food) as rallying cry. One of their aims is the "abolishment of 'Abmahnvereine' [associations founded to observe compliance with anticompetion regulations], and the consumer protection should be put in the responsibility of an institute with equal representation of entrepreneur, scientist and consumers (political parties are excluded)".
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In Germany, the industry producing dietary supplements operates a lobby group called "NEM Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten" to represent their interests. It is currently headed by Manfred Scheffler who also is a managing partner of Plantafood. The association makes use of the marketing slogan "Freiheit für gesunde Nahrung" (freedom for healthy food) on the internet. One of their aims is the "abolishment of 'Abmahnvereine' [associations founded to observe compliance with anticompetition regulations], and consumer protection should be entirely in the hands of an institute in which entrepreneurs, scientists, and consumers are equally represented (political parties are excluded)".
  
 
==Definition (Germany)==
 
==Definition (Germany)==
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In Germany dietary supplements are  de jure food that are subject to the LFGB (Lebensmittel- und Futtergesetzbuch, Food and animal feed code). In detail, dietary supplements are food having nutritional or physiological effects that are meant to complement the regular diet. They are sold in the form of capsules, pastilles, tablets, pills, ampoules containing liquids or bottles containing small amounts. Allowed substances are listed in the addendum 1 of Nahrungsergänzungsmittelverordnung (NemV, Dietary supplement Regulation).
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In Germany, dietary supplements de jure are food and therefore subject to the LFGB (Lebensmittel- und Futtergesetzbuch, Food and Animal Feed Code). Dietary supplements, in particular, are foodstuffs with nutritional or physiological effects meant to complement a regular diet. They are sold in the form of capsules, lozenges, tablets, pills, ampoules containing liquids, or bottles containing small amounts. Legal substances are listed in the addendum 1 of Nahrungsergänzungsmittelverordnung (NemV, Dietary Supplement Regulations).
  
  
 
==Legal situation==
 
==Legal situation==
 
===Germany/EU===
 
===Germany/EU===
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Dietary supplements only have to be registered with the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL, Federal Office of Consumer Protection and Food Safety). Supervision of the dietary supplements offered in shops is in the duty of the food surveillance authorities of the states.<br>Dietary supplements that had been marketed within the EU in insignificantly amounts before the [[Novel-Food]]-Regulation became effective are subject to the EC-regulation No 258/97 concerning novel food and novel food ingredients of the European Parliament and of the Council of January 27th, 1997<ref>http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997R0258:de:HTML</ref>. This is e.g. the case with [http://www.psiram.com/ge/index.php?title=Superfrucht exotic fruits] and products made out of them.
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Dietary supplements must only be registered with the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL, Federal Office of Consumer Protection and Food Safety). Supervision of dietary supplements sold in shops is the duty of food surveillance authorities maintained by the federal states.<br>Dietary supplements which were only marketed in insignificant amounts within the EU before the [[Novel-Food]] Regulations became effective are subject to the EC regulation No 258/97 concerning novel food and novel food ingredients of the European Parliament and Council as of January 27th, 1997<ref>http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997R0258:de:HTML</ref>. This is the case with e.g. [http://www.psiram.com/ge/index.php?title=Superfrucht exotic fruits] and products made of them.
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This regulation states that such food has to undergo an approval procedure before it can be marketed. This approval is granted only when in the course of this procedure the product is proven not to pose a health risk.
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This regulation provides such food must pass an approval procedure prior to placing it on the market. This approval is granted only when, in the course of this procedure, the product is proven not to pose health risks.
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Also, there are labeling obligations regarding:
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Certain labeling obligations will have to be observed:
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*all characteristics or nutritional properties like composition, caloric value or nutritional effects, intended use of the food resulting in a novel food or novel food ingredient that is not comparable to an existing food or food ingredient. A novel food is considered to be non-comparable when scientific analyzes has shown that the properties tested show differences to conventional food.
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*All characteristics or nutritional properties like composition, caloric value or nutritional effects, intended use of the food resulting in a novel food or novel food ingredient which is not comparable to an existing food or food ingredient. A novel food is considered to be non-comparable when scientific analyses prove that properties tested show differences to conventional food.
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*the properties modified as well as the procedure used to achieve this modification are to be listed as well as
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*The properties modified as well as the procedure used to achieve this modification are to be listed as well as
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*substances contained that are not found in comparable existing food and that can influence the health of certain population group;  
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*Substances contained which are not found in comparable existing food and which can influence the health of certain groups of the population;  
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*substances contained that are not part of comparable existing food that meet ethical reservations. If no comparable food exists then regulations on proper consumer information have to be enacted.  
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*Substances contained which are not part of comparable existing foodstuffs and meeting ethical reservations. If no comparable food exists, regulations for proper consumer information have to be enacted.  
  
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The EC-Regulation No 1924/2006 of the European Parliament and of the Council of Decembre, 20th, 2006 is put into force by the [http://www.psiram.com/ge/index.php?title=Health_Claims Health-Claims-Regulation] coming into effect. This rules that nutritional- and health- relevant claims are only to be used in advertisement and labeling when they are explicitly allowed by the "Health-Claims-Regulation" and correspond to nutrient profiles issued by the European Food and Safety Authority (EFSA)<ref>http://www.efsa.europa.eu/en/scdocs/scdoc/644.htm</ref>. If a declaration (e.g. an advertisement claim) is not allowed then it can not be used. There is a prohibition principle with reservation on the granting of a permission: „What is not allowed is forbidden.". There is also a strict principle of scientific prove: Allowed is what can be proven using accepted scientific findings.
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The EC Regulation No 1924/2006 of the European Parliament and Council dated December 20, 2006 is put into force by the [http://www.psiram.com/ge/index.php?title=Health_Claims Health-Claims-Regulation] coming into effect. This regulaton provides that nutritional and health-relevant claims may only be used in advertisement and labeling when explicitly approved by the "Health Claims Regulation" and if corresponding to nutrient profiles issued by the European Food and Safety Authority (EFSA)<ref>http://www.efsa.europa.eu/en/scdocs/scdoc/644.htm</ref>. If a declaration (e.g. an advertisement claim) is not approved, it may not be used. A prohibition principle with a caveat is to be observed: „What is not allowed explicitly is forbidden". There is also a strict principle of scientific proof: Approvable is what can be confirmed by accepted scientific research.
  
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In Germany, according to §12 LFGB it was already prohibited to use health-related claims in relation to food<ref>http://bundesrecht.juris.de/lfgb/__12.html</ref>.
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In Germany, §12 LFGB already banned the use of health-related claims in relation to food<ref>http://bundesrecht.juris.de/lfgb/__12.html</ref>.
  
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The German Dietary supplement Regulation are willingly avoided by importing such food from countries having more liberal regulations. Products containing prohibited dietary supplements can be obtained without any problems through sources in the USA, Russia or The Netherlands, the customs being able to block only single cases. Again, in such cases it is totally unclear what the ordered product contains.
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German Dietary Supplement Regulations are often deliberately side-stepped by importing such items from countries with more liberal regulations. Products containing prohibited dietary supplements can be obtained without problem through sources in the USA, Russia or the Netherlands, with authorities only able to prevent such imports in isolated cases. The exact contents of such products usually also remain dubious.
  
 
==Allowed ingredients==
 
==Allowed ingredients==
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Typical ingredients are minerals, vitamins, pseudo-vitamins and antioxidants. In Germany, the NemV regulates in appendix 1 the ingredients allowed in dietary supplements[http://www.gesetze-im-internet.de/nemv/anlage_1_8.html].
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Typical ingredients are minerals, vitamins, pseudo-vitamins and antioxidants. In Germany, appendix 1 of the NemV regulates the ingredients allowed in dietary supplements[http://www.gesetze-im-internet.de/nemv/anlage_1_8.html].
  
 
==Advertising messages used with dietary supplements==
 
==Advertising messages used with dietary supplements==
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Since January 1<sup>st</sup>2007 advertising messages used with dietary supplements are regulated by the new Health-Claims-Regulation. Same like other food, illness-related statements and indications are not allowed and their use can be fined. In practice, this prohibition is disregarded, both regularly and to a great extent. This is particularly true in the internet. Specifically so-called  [http://www.psiram.com/ge/index.php?title=Guerilla-Marketing guerrilla marketing] methods (e.g. marketing on internet boards) are applied to avoid being fined for violating this ban on advertisement. Often, several of such advisers -disguised as regular users- appear who work together and 'complement' each other or a single person starts monologues with her own socket puppets. Usually new board users start threads on health questions and ask for advise. Shortly after that another new board user can offer such advise suprisingly fast and advertises a product she praises for having helped her or some acquaintances. Also, such marketers use private massages or E-mails targeting other users who ask questions.
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Since January 1<sup>st</sup>2007, advertising messages used with dietary supplements are regulated by the new Health Claims Regulations. Same like other food, illness-related statements and indications are not allowed and their use can be fined. In practice, this prohibition is disregarded, not only regularly but to a great extent. This is particularly true in the internet. Specifically so-called  [http://www.psiram.com/ge/index.php?title=Guerilla-Marketing guerilla marketing] methods (e.g. marketing on internet boards) are applied to avoid being fined for violating advertisement bans. Often, several such advertisers - in the disguise of a regular user - cooperate and 'complement' each other, or an individual may soliloquise with their own socket puppets. Usually new board users will start threads on health issues and ask for advice. Shortly after this, another new board member will offer advice surprisingly fast and advertises a product, praising it for allegedly having cured the replier or some acquaintance. Such marketers will also use private messages or e-mails, targeting users who ask questions.
  
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The consumer advice center of Northrhine-Westfalia, after having performed random testing of internet boards, points out that such boards are used ''to stir attention'' for questionable dietary supplements. Such postings, most often written by resellers themselves, would be simply absurd most of the time. Some 30 of such reports on aloe-vera-gels,vitamin- and mineral preparations raised special attention. Half of the authors of these postings came out openly as resellers (5 reports) or offered at least additional information regarding the product or ways to order (10 reports). It should not surprise that 26 of the 30 reports checked claimed irregular and absurd advertisement messages.
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The consumer advice centre of Northrhine-Westfalia, after having performed random tests at internet boards, points out that such boards are used ''to stir attention'' for questionable dietary supplements. Such absurd postings are frequently written by retailers themselves. Some 30 reports on aloe vera gels, vitamin and mineral preparations raised special attention. Every second author of such postings openly admitted they were retailers (5 reports) or offered additional information regarding the product or ways to order it (10 reports). It does not come as a surprise, therefore, that 26 of the 30 reports checked featured irregular and absurd advertisement messages.
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While commercial producers and resellers would violate the prohibition of using health-related advertisement using such claims, the posters in internet boards are obviously of the opinion that they can operate freely. The food expert Angela Clausen of consumer advise centre Northrhine-Westfalia criticizes:”They act in a grey area, largely defying control of the food surveillance and are so far left undisturbed.”. The Higher Regional Court of Cologne decided in February 2008 that dietary supplement producers are also liable for exaggerated or wrong advertisements found on the home pages of their distribution partners(file reference: 6 U 149/07).<ref>http://www.vz-nrw.de/UNIQ122313037328397/link502181A.html</ref>
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While commercial producers and merchants would be in violation of legal provisions prohibition if they used health-related advertisement claims, the posters in internet boards obviously assume they can operate freely. Food expert Angela Clausen of consumer advice centre Northrhine-Westfalia criticizes: ”They operate in a grey area, largely defying controls by food surveillance and so far remain unchallenged”. In February 2008, the Cologne Higher Regional Court decided that producers of dietary supplements are also to be held liable for exaggerated or inaccurate advertisements found on the websites of their distribution partners (file reference: 6 U 149/07).<ref>http://www.vz-nrw.de/UNIQ122313037328397/link502181A.html</ref>
  
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Advertisements of the dietary supplement industry almost always suggest a deficiency of certain substances or active agents. This is usually backed by dubious or biased sources or sources are quote-mined. Also, frequently small-scaled, producer-financed studies are presented as neutral sources.
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Advertisements used by the dietary supplement industry almost always suggest a deficiency of certain substances or active agents. This is usually backed by dubious or biased sources, or sources are quoted distortingly. Another frequent procedure is to present small scale producer-financed studies to suggest these were neutral sources.
  
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==Alleged vitamin deficiency used as marketing argument==
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==Alleged vitamin deficiency used as a marketing argument==
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Often dietary supplements are advertised to overcome an allegedly spreading vitamin deficiency. Vitamin in dietary supplements are not needed for healthy person living on a balanced diet. According to studies on the common dietary situation in Germany, dietary supplements are unnecessary except for special cases like pregnancy (folic acid), alcoholism (vitamin B12), or illnesses requiring a special diet. Such person must seek doctor's advise and should not rely on the recommendations of laypersons. The Deutsche Gesellschaft für Ernährung (DGE, German Nutrition Society) compared the nutritional value of three kinds of food over the last 50 years. According to their findings, oranges have the same amount vitamin C as 50 years ago, same like potatoes. Only apples showed a oscillation over the years. But scientists think this to be due to the influence of the seasons and don't regard this to be an indication of a general loss of nutrients. Food chemists of the University of Kaiserslautern investigated the hypothesis of alleged loss of nutrients. They could not find any evidence indicating vitamin or mineral deficiency in persons living on a balanced diet. Gerhard Eisenbrand, head of the research group conducting this investigation, calls this nutrient deficiency a "myth". Beat Bächli discusses the history of marketing strategies for vitamin C deficiency in his book <ref>Beat Bächi: Vitamin C für alle! Pharmazeutische Produktion, Vermarktung und Gesundheitspolitik (1933-1953). Chronos Verlag</ref> [http://www.zeit.de/2009/21/A-Vitamin-C] [http://orf.at/090625-39701/?href=http%3A%2F%2Forf.at%2F090625-39701%2F38682txt_story.html].
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Dietary supplements are often advertised as a remedy to an allegedly spreading vitamin deficiency. Healthy persons living on a balanced diet, however, do not need additional vitamins in dietary supplements. According to studies on the common dietary situation in Germany, dietary supplements are unnecessary except for special cases like pregnancy (folic acid), alcoholism (vitamin B12), or diseases requiring a special diet. Such persons must seek doctor's advice instead of taking supplements recommended by laypersons. The Deutsche Gesellschaft für Ernährung (DGE, German Nutritional Society) compared the nutritional value of three kinds of food over the last 50 years. According to their results, oranges have the same amount of vitamin C as 50 years ago, same like potatoes. Only apples showed an oscillation over the years. Scientists think this is due to seasonal influence and do not regard this as an indication of a general loss of nutrients. Food chemists of Kaiserslautern University investigated the hypothesis of an alleged loss of nutrients. They could not find any evidence indicating vitamin or mineral deficiency in persons living on a balanced diet. Gerhard Eisenbrand, head of the research group conducting this investigation, calls nutrient deficiency a "myth". Beat Bächli discusses the history of marketing strategies for vitamin C deficiency in his book <ref>Beat Bächi: Vitamin C für alle! Pharmazeutische Produktion, Vermarktung und Gesundheitspolitik (1933-1953). Chronos Verlag</ref> [http://www.zeit.de/2009/21/A-Vitamin-C] [http://orf.at/090625-39701/?href=http%3A%2F%2Forf.at%2F090625-39701%2F38682txt_story.html].
  
 
==Dietary supplement business and volume in Germany==
 
==Dietary supplement business and volume in Germany==
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Dietary supplements often have low production and high retail prices, meaning: they have a high profit margin. Fruit- and vegetable powders are cheap, but packaging very small amounts of it in gelatine capsules makes them quite expensive. Crab shells and grapefruit seeds are waste-products of the food-industry. Packaged in capsules and labeled as dietary supplement they can be sold at quite a high price.
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Dietary supplements often have low production costs and high retail prices, i.e. a high profit margin. Fruit and vegetable powders are cheap, but very expensive when put into small gelatine capsules. Crab shells and grapefruit seeds are waste materials of food industry. Put in capsules and labeled as dietary supplements, they can be sold at quite a high price.
 
Each year dietary supplements worth one billion <ref>Angaben des Bayerischen Rundfunk, 2008 [http://www.br-online.de/bayerisches-fernsehen/faszination-wissen/faszination-wissen-vitamine-nutrigenomik-ID1204988186794.xml]</ref> to 1.3 billion<ref>http://www.vz-nrw.de/UNIQ124099406705519/link556511A.html</ref> Euro are sold in Germany alone.
 
Each year dietary supplements worth one billion <ref>Angaben des Bayerischen Rundfunk, 2008 [http://www.br-online.de/bayerisches-fernsehen/faszination-wissen/faszination-wissen-vitamine-nutrigenomik-ID1204988186794.xml]</ref> to 1.3 billion<ref>http://www.vz-nrw.de/UNIQ124099406705519/link556511A.html</ref> Euro are sold in Germany alone.
  
 
==Criticism==
 
==Criticism==
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The Bundesinstitut für Risikobewertung (BfR, Federal Institute for Risk Assesment) deems dietary supplements unnecessary for healthy persons living on a regular diet<ref>http://www.bfr.bund.de/cd/945</ref>. With such a diet the body would get everything it needs. An additional intake of single nutrients would therefore not be necessary. An unbalanced, one-sided diet wouldn't be balanced by the use of dietary supplements. Only specific situations uncommon in Germany would make a targeted supplementation of one's diet with specific nutrients reasonable. According to the German Nutrition Society supplementation of one's diet is reasonable only regarding iodine (in the form or iodated salt) and folic acid (for pregnant women).
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The Bundesinstitut für Risikobewertung (BfR, Federal Institute for Risk Assesment) deems dietary supplements unnecessary for healthy persons living on a regular diet<ref>http://www.bfr.bund.de/cd/945</ref>. Such a diet will provide the human body with everything it needs. An additional intake of single nutrients therefore was not necessary. An unbalanced, one-sided diet will not become balanced by the use of dietary supplements. Only specific situations uncommon in Germany will necessitate a special supplementation of one's diet with particular nutrients. According to the German Nutrition Society, supplementation is reasonable only regarding iodine (in the form of iodated salt) and folic acid (with pregnant women).
  
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An analyzes of different meta and randomized studies on the current state of knowledge regarding the influence of vitamins A, C and E (which are also promoted as [http://www.psiram.com/ge/index.php?title=Antioxidantien antioxidants]) as well as beta-carotene for treatment or prevention of coronary diseases, cancer, eye illnesses and common cold was distilled. It concluded that the existing randomized studies do not allow to deduce a clear clinical value. Additionally, beta-carotene increases the probability of acquiring lung cancer and the overall mortality rate, especially in smokers.<ref>Arzneimitteltelegramm, 2003; 34: 100-2, 111-3</ref>
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An analysis of different meta and randomized studies evaluated the current state of knowledge regarding the influence of vitamins A, C and E (which are also promoted as [http://www.psiram.com/ge/index.php?title=Antioxidantien antioxidants]) as well as beta-carotene for treatment or prevention of coronary diseases, cancer, eye diseases, and common cold. It concluded that the existing randomized studies do not allow to deduce a clear clinical value. Additionally, beta-carotene increases the probability of acquiring lung cancer and the overall mortality rate, especially with smokers.<ref>Arzneimitteltelegramm, 2003; 34: 100-2, 111-3</ref>
  
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Often, anti-oxidants are used by cancer patients to counter unwanted effects of chemo- or radiotherapy. Experimental as well as clinical data though support the fear that they, to a certain extent, can even protect tumor cells. According to several randomized studies, especially the concurrent intake of high dosages of anti-oxidants together with radiation therapy impairs response and decreases survival time.<ref>"Prävention mit Antioxidanzien: Schaden überwiegt", Arzneimitteltelegramm, 12/2008</ref>
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Anti-oxidants are frequently used by cancer patients to counter unwanted effects of chemo- or radiotherapy. Experimental as well as clinical data, however, support the assumption that they, to a certain extent, may even protect tumor cells. According to several randomized studies, particularly the concurrent intake of high doses of anti-oxidants during radiation therapy impairs response and decreases survival time.<ref>"Prävention mit Antioxidanzien: Schaden überwiegt", Arzneimitteltelegramm, 12/2008</ref>
  
 
==Dietary supplements and Doping==
 
==Dietary supplements and Doping==
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An international study of the Institute of Biochemistry at the German Sport University Cologne, promoted by the IOC, found that approximately 15% of dietary supplements bought in 13 different countries contained anabolics (mainly prohormones) that were not declared on the package. In Germany app. 11% of samples contained prohibited anabolics. These anabolics are probably impurities stemming from the production process and have no doping effect, but they can  lead to positive doping result. This poses a problem both to competitive athletes as well as to producers of dietary supplements. The so-called 'Kölner Liste' of the olympic training center in Cologne-Bonn-Leverkusen offers some guidance regarding doping contamination.
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An international study of the Institute of Biochemistry at the German Sport University Cologne, promoted by the IOC, showed that approximately 15% of dietary supplements bought in 13 different countries contained anabolics (mainly prohormones) which were not declared on the package. In Germany, app. 11% of samples contained illegal anabolics. These anabolics are probably contaminations acquired during the production process and have no doping effect, but may result in positive doping tests. This poses a problem both to competitive athletes as well as to producers of dietary supplements. The so-called 'Kölner Liste' [Cologne catalogue] issued by the Olympic training center in Cologne-Bonn-Leverkusen offers some guidance regarding doping contamination.
  
 
==Health Risks==
 
==Health Risks==
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Freely available dietary supplements can severely damage the liver, especially those sold via the internet. They often contain pollution that damage the liver or contain substances prohibited in Germany because of this danger. This applies especially, next to curcumin extracts, St. Johns wort and slimming agents, to products of the company Herbalife.<ref>Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, 14.09.2010 - NPO</ref><ref>http://www.scinexx.de/wissen-aktuell-12256-2010-09-14.html</ref><ref>http://www.bfr.bund.de/cd/945</ref>
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Freely available dietary supplements can severely damage the liver, especially those sold via the internet. They are often contaminated with substances causing damage to the liver, or may even contain substances which are illegal in Germany because of these effects. This applies to turmeric extracts, St. John's wort, and slimming agents, and in particular to products sold by Herbalife company.<ref>Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, 14.09.2010 - NPO</ref><ref>http://www.scinexx.de/wissen-aktuell-12256-2010-09-14.html</ref><ref>http://www.bfr.bund.de/cd/945</ref>
  
 
==Examples==
 
==Examples==
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*[http://www.psiram.com/ge/index.php?title=Mangostan Mangostan]
 
*[http://www.psiram.com/ge/index.php?title=Mangostan Mangostan]
 
*[http://www.psiram.com/ge/index.php?title=Mexican_Wild_Yam Mexican Wild Yam]
 
*[http://www.psiram.com/ge/index.php?title=Mexican_Wild_Yam Mexican Wild Yam]
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{{OtherLang|ge=Nahrungsergänzungsmittel|en=Dietary Supplements}}
  
 
==Literature==
 
==Literature==
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==Weblinks(German)==
 
==Weblinks(German)==
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*[http://www.psiram.com/ge/index.php?title=Nahrungsergänzungsmittel German version used as base for this article]
 
 
*http://www.psiram.com/ge/index.php?title=Diätetisches_Lebensmittel
 
*http://www.psiram.com/ge/index.php?title=Diätetisches_Lebensmittel
 
*[http://www.vz-nrw.de/UNIQ122313051228656/link21080A.html Nahrungsergänzungsmittel - Revier der Scharlatane]
 
*[http://www.vz-nrw.de/UNIQ122313051228656/link21080A.html Nahrungsergänzungsmittel - Revier der Scharlatane]

Latest revision as of 17:24, 1 March 2013

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Dietary supplements are products legally considered as food. In Germany, they are subject to the Dietary Supplement Regulation (Nahrungsergänzungsmittelverordnung, NemV) and therefore always governed by the laws regulating food LFGB, and are thus not supposed to have medical effects, work as remedies or prevent illness. In the EU, they must correspond to guideline 2002/46/EG. According to German law, it is not legal for dietary supplements to develop pharmaceutical effects, or to market them with according claims. They have no major role in human biological bioenergetics. Their use does not counterbalance the effects of long-term malnutrition. The two terms "dietary supplement" and "functional food" overlap partially.

In the USA, dietary supplements are over-the-counter(OTC) products, i.e. they may be sold in regular shops without prescription. However, US-American regulations are more liberal than the German ones: A lot of products sold legally as OTC in the States are regarded as pharmaceutical drugs liable to registration. In the USA, the "Food & Drugs Administration" (FDA) is responsible for their registration.

Dietary supplements are often packaged mimicking pharmaceuticals so that laypersons cannot clearly tell them apart from drugs. This can lead to confusion. In particular cases, even experts may have difficulties to distinguish them from pharmaceuticals, judging substances and concentration contained in such products.

Dietary supplements are a typical domain of Multi-Level-Marketing (MLM) and the specific methods of advertisement and marketing applied there. Drastic differences in price for the same active substance are not uncommon with dietary supplements. They are frequently used in the body building sector and respective gyms, but can also be found in competitive sports. Dietary supplements are also a corner stone of orthomolecular medicine.

In Germany, dietary supplements are largely bought by an elder clientele: 50% of Germans aged 55 and above use them on a daily basis.

In Germany, the industry producing dietary supplements operates a lobby group called "NEM Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten" to represent their interests. It is currently headed by Manfred Scheffler who also is a managing partner of Plantafood. The association makes use of the marketing slogan "Freiheit für gesunde Nahrung" (freedom for healthy food) on the internet. One of their aims is the "abolishment of 'Abmahnvereine' [associations founded to observe compliance with anticompetition regulations], and consumer protection should be entirely in the hands of an institute in which entrepreneurs, scientists, and consumers are equally represented (political parties are excluded)".

Definition (Germany)

In Germany, dietary supplements de jure are food and therefore subject to the LFGB (Lebensmittel- und Futtergesetzbuch, Food and Animal Feed Code). Dietary supplements, in particular, are foodstuffs with nutritional or physiological effects meant to complement a regular diet. They are sold in the form of capsules, lozenges, tablets, pills, ampoules containing liquids, or bottles containing small amounts. Legal substances are listed in the addendum 1 of Nahrungsergänzungsmittelverordnung (NemV, Dietary Supplement Regulations).


Legal situation

Germany/EU

Dietary supplements must only be registered with the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL, Federal Office of Consumer Protection and Food Safety). Supervision of dietary supplements sold in shops is the duty of food surveillance authorities maintained by the federal states.
Dietary supplements which were only marketed in insignificant amounts within the EU before the Novel-Food Regulations became effective are subject to the EC regulation No 258/97 concerning novel food and novel food ingredients of the European Parliament and Council as of January 27th, 1997[1]. This is the case with e.g. exotic fruits and products made of them. This regulation provides such food must pass an approval procedure prior to placing it on the market. This approval is granted only when, in the course of this procedure, the product is proven not to pose health risks. Certain labeling obligations will have to be observed:

  • All characteristics or nutritional properties like composition, caloric value or nutritional effects, intended use of the food resulting in a novel food or novel food ingredient which is not comparable to an existing food or food ingredient. A novel food is considered to be non-comparable when scientific analyses prove that properties tested show differences to conventional food.
  • The properties modified as well as the procedure used to achieve this modification are to be listed as well as
  • Substances contained which are not found in comparable existing food and which can influence the health of certain groups of the population;
  • Substances contained which are not part of comparable existing foodstuffs and meeting ethical reservations. If no comparable food exists, regulations for proper consumer information have to be enacted.

The EC Regulation No 1924/2006 of the European Parliament and Council dated December 20, 2006 is put into force by the Health-Claims-Regulation coming into effect. This regulaton provides that nutritional and health-relevant claims may only be used in advertisement and labeling when explicitly approved by the "Health Claims Regulation" and if corresponding to nutrient profiles issued by the European Food and Safety Authority (EFSA)[2]. If a declaration (e.g. an advertisement claim) is not approved, it may not be used. A prohibition principle with a caveat is to be observed: „What is not allowed explicitly is forbidden". There is also a strict principle of scientific proof: Approvable is what can be confirmed by accepted scientific research.

In Germany, §12 LFGB already banned the use of health-related claims in relation to food[3].

German Dietary Supplement Regulations are often deliberately side-stepped by importing such items from countries with more liberal regulations. Products containing prohibited dietary supplements can be obtained without problem through sources in the USA, Russia or the Netherlands, with authorities only able to prevent such imports in isolated cases. The exact contents of such products usually also remain dubious.

Allowed ingredients

Typical ingredients are minerals, vitamins, pseudo-vitamins and antioxidants. In Germany, appendix 1 of the NemV regulates the ingredients allowed in dietary supplements[2].

Advertising messages used with dietary supplements

Since January 1st2007, advertising messages used with dietary supplements are regulated by the new Health Claims Regulations. Same like other food, illness-related statements and indications are not allowed and their use can be fined. In practice, this prohibition is disregarded, not only regularly but to a great extent. This is particularly true in the internet. Specifically so-called guerilla marketing methods (e.g. marketing on internet boards) are applied to avoid being fined for violating advertisement bans. Often, several such advertisers - in the disguise of a regular user - cooperate and 'complement' each other, or an individual may soliloquise with their own socket puppets. Usually new board users will start threads on health issues and ask for advice. Shortly after this, another new board member will offer advice surprisingly fast and advertises a product, praising it for allegedly having cured the replier or some acquaintance. Such marketers will also use private messages or e-mails, targeting users who ask questions.

The consumer advice centre of Northrhine-Westfalia, after having performed random tests at internet boards, points out that such boards are used to stir attention for questionable dietary supplements. Such absurd postings are frequently written by retailers themselves. Some 30 reports on aloe vera gels, vitamin and mineral preparations raised special attention. Every second author of such postings openly admitted they were retailers (5 reports) or offered additional information regarding the product or ways to order it (10 reports). It does not come as a surprise, therefore, that 26 of the 30 reports checked featured irregular and absurd advertisement messages. While commercial producers and merchants would be in violation of legal provisions prohibition if they used health-related advertisement claims, the posters in internet boards obviously assume they can operate freely. Food expert Angela Clausen of consumer advice centre Northrhine-Westfalia criticizes: ”They operate in a grey area, largely defying controls by food surveillance and so far remain unchallenged”. In February 2008, the Cologne Higher Regional Court decided that producers of dietary supplements are also to be held liable for exaggerated or inaccurate advertisements found on the websites of their distribution partners (file reference: 6 U 149/07).[4]

Advertisements used by the dietary supplement industry almost always suggest a deficiency of certain substances or active agents. This is usually backed by dubious or biased sources, or sources are quoted distortingly. Another frequent procedure is to present small scale producer-financed studies to suggest these were neutral sources.

Alleged vitamin deficiency used as a marketing argument

Dietary supplements are often advertised as a remedy to an allegedly spreading vitamin deficiency. Healthy persons living on a balanced diet, however, do not need additional vitamins in dietary supplements. According to studies on the common dietary situation in Germany, dietary supplements are unnecessary except for special cases like pregnancy (folic acid), alcoholism (vitamin B12), or diseases requiring a special diet. Such persons must seek doctor's advice instead of taking supplements recommended by laypersons. The Deutsche Gesellschaft für Ernährung (DGE, German Nutritional Society) compared the nutritional value of three kinds of food over the last 50 years. According to their results, oranges have the same amount of vitamin C as 50 years ago, same like potatoes. Only apples showed an oscillation over the years. Scientists think this is due to seasonal influence and do not regard this as an indication of a general loss of nutrients. Food chemists of Kaiserslautern University investigated the hypothesis of an alleged loss of nutrients. They could not find any evidence indicating vitamin or mineral deficiency in persons living on a balanced diet. Gerhard Eisenbrand, head of the research group conducting this investigation, calls nutrient deficiency a "myth". Beat Bächli discusses the history of marketing strategies for vitamin C deficiency in his book [5] [3] [4].

Dietary supplement business and volume in Germany

Dietary supplements often have low production costs and high retail prices, i.e. a high profit margin. Fruit and vegetable powders are cheap, but very expensive when put into small gelatine capsules. Crab shells and grapefruit seeds are waste materials of food industry. Put in capsules and labeled as dietary supplements, they can be sold at quite a high price. Each year dietary supplements worth one billion [6] to 1.3 billion[7] Euro are sold in Germany alone.

Criticism

The Bundesinstitut für Risikobewertung (BfR, Federal Institute for Risk Assesment) deems dietary supplements unnecessary for healthy persons living on a regular diet[8]. Such a diet will provide the human body with everything it needs. An additional intake of single nutrients therefore was not necessary. An unbalanced, one-sided diet will not become balanced by the use of dietary supplements. Only specific situations uncommon in Germany will necessitate a special supplementation of one's diet with particular nutrients. According to the German Nutrition Society, supplementation is reasonable only regarding iodine (in the form of iodated salt) and folic acid (with pregnant women).

An analysis of different meta and randomized studies evaluated the current state of knowledge regarding the influence of vitamins A, C and E (which are also promoted as antioxidants) as well as beta-carotene for treatment or prevention of coronary diseases, cancer, eye diseases, and common cold. It concluded that the existing randomized studies do not allow to deduce a clear clinical value. Additionally, beta-carotene increases the probability of acquiring lung cancer and the overall mortality rate, especially with smokers.[9]

Anti-oxidants are frequently used by cancer patients to counter unwanted effects of chemo- or radiotherapy. Experimental as well as clinical data, however, support the assumption that they, to a certain extent, may even protect tumor cells. According to several randomized studies, particularly the concurrent intake of high doses of anti-oxidants during radiation therapy impairs response and decreases survival time.[10]

Dietary supplements and Doping

An international study of the Institute of Biochemistry at the German Sport University Cologne, promoted by the IOC, showed that approximately 15% of dietary supplements bought in 13 different countries contained anabolics (mainly prohormones) which were not declared on the package. In Germany, app. 11% of samples contained illegal anabolics. These anabolics are probably contaminations acquired during the production process and have no doping effect, but may result in positive doping tests. This poses a problem both to competitive athletes as well as to producers of dietary supplements. The so-called 'Kölner Liste' [Cologne catalogue] issued by the Olympic training center in Cologne-Bonn-Leverkusen offers some guidance regarding doping contamination.

Health Risks

Freely available dietary supplements can severely damage the liver, especially those sold via the internet. They are often contaminated with substances causing damage to the liver, or may even contain substances which are illegal in Germany because of these effects. This applies to turmeric extracts, St. John's wort, and slimming agents, and in particular to products sold by Herbalife company.[11][12][13]

Examples

German

Some examples of dietary supplements:

Versions of this article in other languages

Literature

  • Udo Pollmer, Susanne Warmuth. Pillen, Pulver, Powerstoffe: Die falschen Versprechen der Nahrungsergänzungsmittel. Verlag: Eichborn; (April 2008) ISBN-10: 382185622X ISBN-13: 978-3821856223
  • Cohen PA. American roulette? contaminated dietary supplements. New England Journal of Medicine, 8. Oktober 2009 [5]

Weblinks(German)

Weblinks(English)

Sources

  1. ↑ http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997R0258:de:HTML
  2. ↑ http://www.efsa.europa.eu/en/scdocs/scdoc/644.htm
  3. ↑ http://bundesrecht.juris.de/lfgb/__12.html
  4. ↑ http://www.vz-nrw.de/UNIQ122313037328397/link502181A.html
  5. ↑ Beat Bächi: Vitamin C für alle! Pharmazeutische Produktion, Vermarktung und Gesundheitspolitik (1933-1953). Chronos Verlag
  6. ↑ Angaben des Bayerischen Rundfunk, 2008 [1]
  7. ↑ http://www.vz-nrw.de/UNIQ124099406705519/link556511A.html
  8. ↑ http://www.bfr.bund.de/cd/945
  9. ↑ Arzneimitteltelegramm, 2003; 34: 100-2, 111-3
  10. ↑ "Prävention mit Antioxidanzien: Schaden überwiegt", Arzneimitteltelegramm, 12/2008
  11. ↑ Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, 14.09.2010 - NPO
  12. ↑ http://www.scinexx.de/wissen-aktuell-12256-2010-09-14.html
  13. ↑ http://www.bfr.bund.de/cd/945
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