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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 counter the effects of long-term malnutrition. Dietary supplements overlap with functional food.
'''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 can may 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.
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 pharmaceutical drugs so that laypersons cannot clearly tell them apart from drugs. This can lead to confusion. In particular cases even experts can have difficulties to distinguish them from pharmaceutical drugs, judging the substances and concentration contained in such products.
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 methods used there. Also, drastic differences in price for the same 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].
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 the internet, this group uses "Freiheit für gesunde Nahrung" (freedom for healthy food) as a marketing slogan. One of their aims is the "abolishment of 'Abmahnvereine' [associations founded to observe compliance with anticompetion regulations], and consumer protection should be put in the responsibility of an institute with equal representation of entrepreneurs, scientists and consumers (political parties are excluded)".
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 which is subject to the LFGB (Lebensmittel- und Futtergesetzbuch, Food and animal feed code). In detail, dietary supplements are foodstuffs with nutritional or physiological effects which are meant to complement a regular diet. They are sold in the form of capsules, pastilles, tablets, pills, ampoules containing liquids or bottles containing small amounts. Legal substances are listed in the addendum 1 of Nahrungsergänzungsmittelverordnung (NemV, Dietary supplement Regulation).
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 in the duty of the food surveillance authorities of the federal states.<br>Dietary supplements which were marketed within the EU in insignificant 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.
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 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 health risks.
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 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.
*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
*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 group;
*substances contained that are not found in comparable existing food and that can influence the health of certain groups of the population;
*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.
*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 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.
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, 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>.
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==