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 therefore are 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 the according claim. They have no major role in human biological [http://www.psiram.com/ge/index.php?title=Bioenergetik bioenergetics]. Their use does not | + | '''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 are 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 the according claim. 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. |
| − | In the USA, dietary supplements are over-the-counter(OTC)-products, i.e. they | + | In the USA, dietary supplements are over-the-counter(OTC)-products, i.e. they may be sold in regular shops without prescription. However, the 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 | + | 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 [http://www.psiram.com/ge/index.php?title=MLM Multi-Level-Marketing] (MLM) and the specific advertisement and marketing | + | 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 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]. |
In Germany, dietary supplements are generally bought by an elder clientele: 50% of Germans aged 55 and above use them on a daily basis. | In Germany, dietary supplements are generally 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 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 Germany, the industry producing dietary supplements 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. 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)== | ||
| − | In Germany, dietary supplements are de jure food | + | In Germany, dietary supplements are de jure 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 which are 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 Regulation). |
==Legal situation== | ==Legal situation== | ||
===Germany/EU=== | ===Germany/EU=== | ||
| − | Dietary supplements only must 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 | + | Dietary supplements only must 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 the 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]]-Regulation 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 e.g. the case with [http://www.psiram.com/ge/index.php?title=Superfrucht exotic fruits] and products made of them. |
| − | This regulation | + | This regulation provides that 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 | + | *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 that are not found in comparable existing food and that can influence the health of certain population | + | *substances contained that are not found in comparable existing food and that can influence the health of certain groups of the population; |
| − | *substances contained | + | *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 | + | 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 can 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 the use of accepted scientific findings. |
| − | In Germany, | + | 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>. |
| − | + | German Dietary Supplement Regulation are often deliberately side-stepped by importing such food 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 import in isolated cases. The exact contents of such products usually also remain dubious. | |
==Allowed ingredients== | ==Allowed ingredients== | ||
Revision as of 22:01, 5 November 2010
Dietary supplements are products legally considered as food. In Germany, they are subject to the Dietary supplement Regulation (Nahrungsergänzungsmittelverordnung, NemV) and therefore are 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 the according claim. 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, the 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 area 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 generally 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 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. 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 are de jure 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 which are 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 Regulation).
Legal situation
Germany/EU
Dietary supplements only must 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 the food surveillance authorities maintained by the federal states.
Dietary supplements which were only marketed in insignificant amounts within the EU 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 Council as of January 27th, 1997[1]. This is e.g. the case with exotic fruits and products made of them.
This regulation provides that 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 that are not found in comparable existing food and that 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 can 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 the use of accepted scientific findings.
In Germany, §12 LFGB already banned the use of health-related claims in relation to food[3].
German Dietary Supplement Regulation are often deliberately side-stepped by importing such food 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 import 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, the NemV regulates in appendix 1 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-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 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.
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. 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).[4]
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.
Alleged vitamin deficiency used as marketing argument
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 [5] [3] [4].
Dietary supplement business and volume in Germany
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. 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]. 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).
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 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.[9]
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.[10]
Dietary supplements and Doping
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.
Health Risks
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.[11][12][13]
Examples
German
Some examples of dietary supplements:
- 11-Pflanzen-Schlank-Kur (11-herbs slimming agent)
- Anthocyane
- Avemar
- Chlorophyll
- Ginkgo biloba]
- Ginseng
- Goji-berries
- Haifit shark cartilage
- Maca
- Mangostan
- Mexican Wild Yam
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)
- German version used as base for this article
- http://www.psiram.com/ge/index.php?title=Diätetisches_Lebensmittel
- Nahrungsergänzungsmittel - Revier der Scharlatane
- Nahrungsergänzungsmittel: Verbraucherzentrale NRW warnt vor oftmals gefährlichen Nebenwirkungen
- http://www.bfr.bund.de/cd/945
- http://www.dge.de/modules.php?name=News&file=article&sid=180
- http://www.gesetze-im-internet.de/nemv/index.html
- http://www.krebsinformationsdienst.de/themen/behandlung/nahrungsergaenzungsmittel.php
- http://www.spiegel.de/wissenschaft/mensch/0,1518,624117,00.html
- Eva-Maria Schnurr: Gesunde Ernährung - Leere Versprechen. Fast jeder dritte Deutsche nimmt Vitamintabletten. Doch neue Studien zeigen: Nur die Vitamine in echtem Obst und Gemüse sind gesund, Pillen können sogar schaden, Zeit-Online, 14.6.2010
Weblinks(English)
- Abuse of dietary supplemtn: Example of Matthias Rath
- Report on contamination in US-dietary supplements
- http://jama.ama-assn.org/cgi/reprint/297/8/842.pdf
Sources
- ↑ http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997R0258:de:HTML
- ↑ http://www.efsa.europa.eu/en/scdocs/scdoc/644.htm
- ↑ http://bundesrecht.juris.de/lfgb/__12.html
- ↑ http://www.vz-nrw.de/UNIQ122313037328397/link502181A.html
- ↑ Beat Bächi: Vitamin C für alle! Pharmazeutische Produktion, Vermarktung und Gesundheitspolitik (1933-1953). Chronos Verlag
- ↑ Angaben des Bayerischen Rundfunk, 2008 [1]
- ↑ http://www.vz-nrw.de/UNIQ124099406705519/link556511A.html
- ↑ http://www.bfr.bund.de/cd/945
- ↑ Arzneimitteltelegramm, 2003; 34: 100-2, 111-3
- ↑ "Prävention mit Antioxidanzien: Schaden überwiegt", Arzneimitteltelegramm, 12/2008
- ↑ Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, 14.09.2010 - NPO
- ↑ http://www.scinexx.de/wissen-aktuell-12256-2010-09-14.html
- ↑ http://www.bfr.bund.de/cd/945