BodyRestored.com: How much do you know about Nutritional Supplements ?

Do you take a supplement ?

Simple question but do you mean a nutritional supplement or something else ?

Most people must take something because sales of supplements in the USA now exceed $200 million a year. I'll admit to taking Omega 3 capsules - usually 2 or 3 capsules spread through the day for about 1 gram of Omega 3 in total. Read this for a detailed analysis of supplement usage in the USA.

How safe are these supplements ?

Charles Corbin (Professor Emeritus at Arizona State University) has come up with a quiz to test everyone's knowledge about the regulation of supplements.

Try these questions and then look at the answers.

1. Dietary supplements are tested by the FDA for effectiveness and safety ?

2. The FDA requires manufacturers to evaluate the identity, purity, quality, strength, and composition of dietary supplements ?

3. Recommended doses for most dietary supplements have been scientifically established ?

4. Dietary supplements, unlike medicines, do not have side effects or interactions with medicines or other supplements ?

5. By law, dietary supplements must include labels similar to labels on foods in the grocery store ?

6. Sellers of dietary supplements must have a license to sell them ?

7. Sellers of dietary supplements must have completed an educational program in nutrition to sell them ?

8. Dietary supplement labels legally may not make unsubstantiated claims about disease prevention, treatment, or diagnosis ?

9. The FDA regulates and systematically enforces claims made for dietary supplements ?

10. Information is available to help consumers evaluate claims made for dietary supplements sold on the Web and in other locations ?

Now see how much you really know about how well we are protected:

1. Dietary supplements are tested by the FDA for effectiveness and safety.

False. The truth is that the FDA does NOT test dietary supplements to assure that they are effective and safe. In 1994, the Dietary Supplement Health and Education Act (DSHEA) was passed by the congress and signed into law. Under this act, manufacturers, not the FDA, are responsible for the safety of the products manufactured or distributed. Furthermore, the manufacturer is responsible for determining that claims made about them are substantiated by scientific evidence. This means that dietary supplements do not need approval from the FDA before they are marketed, nor is a product prevented from reaching the market if no evidence exists concerning its effectiveness.

2. The FDA requires manufacturers to evaluate the identity, purity, quality, strength, and composition of dietary supplements.

True. On June 22, 2007, the FDA announced a new rule that “...will help ensure that dietary

supplements are manufactured with controls that result in a consistent product free of contamination, with

accurate labeling.” The rule, effective in September 2007, requires supplement manufacturers to provide labels to ensure that a supplement is what it is purported to be, that it does not contain too much or too little of the ingredient, and that it is not contaminated. This is important because more than a few cases of contaminated supplements have been reported, and in some cases, severe illness and death have occurred (8). The manufacturer, not the FDA, will test products to ensure that they meet the requirements of the new rule. The consumer should understand that the FDA evaluates safety of supplements through “adverse events monitoring.” In other words, it relies on consumers to report adverse reactions to supplements. When such reports are received, the FDA investigates. The new rule is a step in the right direction. Nevertheless, it is still possible for supplements to contain ingredients other than those on the new labels. This is because products with incorrect contents may go unnoticed until complaints are brought against the manufacturer. It is important for consumers to report adverse effects so that unscrupulous manufacturers can be identified (report adverse effects at www.fda.gov/medwatch/how.htm). The new FDA rule does require manufacturers to report adverse reactions to their products. Currently, some dietary supplements carry the USP label. USP is an independent group that tests supplements to make sure that they are what they claim to be.

3. Recommended doses for most dietary supplements have been scientifically established

False In fact, recommended doses have been established for some supplements, but for most, scientific evidence is NOT yet available. The Institute of Medicine has developed dietary reference intake values for both macronutrients and micronutrients for foods. This includes recommendations for vitamins and minerals (in the diet). Other organizations have made recommendations concerning other supplements such as creatine and vitamins . Still, for many other supplements (such as herbs/botanicals and other substances listed in the definition previously presented), no standard doses have been scientifically established. In some cases, very large doses have been advocated for supplements including vitamins, although there is little or no scientific support for these megadoses. No rules currently exist concerning the serving size or recommended dose of dietary supplements.

4. Dietary supplements, unlike medicines, do not have side effects or interactions with medicines or other supplements

False. The truth is that dietary supplements CAN have side effects and can interact with medicines and other supplements. Ephedra is a dietary supplement that enjoyed wide sales before April 2004, when its sale was banned because of adverse effects reported by users and medical personnel. It is important to consider all supplements (as well as medicines) when making decisions about supplements. Some can cause irregular heart beats (e.g., Ginkgo and kava), some interact with medicines (e.g., St. John92s wort interacts with birth control pills and HIV medications), and some can affect medical procedures (e.g., St. John92s wort increases risk of bleeding and should not be taken before surgery). Supplements often contain ingredients also found in medicines (many medicines are made from plants) and can have the same side effects as medicines.

5. By law, dietary supplements must include labels similar to labels on foods in the grocery store

False. Current law requires supplements to have a label, but the law does NOT require the same detail on

food supplements that is currently required for packaged foods sold in grocery stores. As indicated in answer 2, the FDA will soon require new labels. These labels must describe the exact content of the supplement. The manufacturer must continue to supply (as required by current law) the "descriptive.., net contents of the product. Even with the new rule, supplements will not be required to include the more complete information contained on food labels".

6. Sellers of dietary supplements must have a license to sell them

False. Under current law, “Manufacturers do NOT need to register themselves nor their dietary supplement products with FDA before producing or selling them.”

7. Sellers of dietary supplements must have completed an educational program in nutrition to sell them

False. There is NO current requirement that people who sell dietary supplements have any special training or education.

8. Dietary supplement labels legally may not make unsubstantiated claims about disease prevention, treatment, or diagnosis

True “A product sold as a dietary supplement and promoted on its label or in labeling as a treatment,

prevention, or cure for a specific disease or condition would be considered an unapproved . . . and thus illegal drug”.

9. The FDA regulates and systematically enforces claims made for dietary supplements

False. The truth is that the FDA does NOT regularly regulate and enforce claims made for dietary supplements. “FDA has limited resources to analyze the composition of food products, including dietary supplements. It focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law”. The FDA “monitors the marketplace” with occasional lab content analyses or selected products and checks of Internet and consumer information. The Federal Trade Commission(FTC) regulates advertising of dietary supplements in national or regional newspapers and magazines; in radio and TV commercials, including infomercials; through direct mail to consumers; or on the Internet. The FTC requires that all information about supplements be truthful and not misleading. However, it is impossible for the FTC to monitor all claims. For this reason, a person cannot assume that claims made in the media and on the Internet concerning supplements are true.

10. Information is available to help consumers evaluate claims made for dietary supplements sold on the Web and in other locations

True. Information is available to help consumers evaluate claims made for dietary supplements sold on the Web and in other locations.