Changes

[[image:Nem.jpg|300px|thumb]]

[[image:Nem.jpg|300px|thumb]]

'''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.

'''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.

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".

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.

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.

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 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].

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].

In Germany, in general older people buy dietary supplements: 50% of Germans aged 55 and older use them daily.

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 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)".

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)".

==Definition (Germany)==

==Definition (Germany)==

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).

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).

==Legal situation==

==Legal situation==

===Germany/EU===

===Germany/EU===

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.

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.

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.

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.

Also, there are labeling obligations regarding:

Also, there are labeling obligations regarding:

*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 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.