Dietary Supplements

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 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 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 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 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 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. 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 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). 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 the use of accepted scientific findings.

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

German Dietary Supplement Regulations 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 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 1^st2007, 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 the advertisement ban. 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 suprisingly fast and advertises a product praised 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 center 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 advise centre Northrhine-Westfalia criticizes: ”They operate in a grey area, largely defying controls by food surveillance and so far remain unchallenged.”. The Cologne Higher Regional Court in February 2008 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).

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 frequently 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 the University of Kaiserslautern 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 [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 to 1.3 billion 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. 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 in 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.

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.

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 contamined 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 of Herbalife company.

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

Versions of this article in other languages

• Deutsch: Nahrungsergänzungsmittel

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)

• 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