What is Not Considered a Dietary Supplement? - An Expert's Perspective

The dietary supplement category generally excludes items approved as new drugs, authorized as biological products, or authorized for clinical research pursuant to a new investigational drug application (IND) that has come into effect, unless the item was previously marketed as a dietary supplement or as a food. Dietary supplements are intended to add to or supplement the diet and are different from conventional foods. In general, to the extent that a product is intended to treat, diagnose, cure, or prevent diseases, it is a drug, even if it is labeled as a dietary supplement. Supplements are ingested and come in many forms, such as tablets, capsules, softgels, powders, sticks, gummies and liquids. It is important to understand that dietary supplements are not considered drugs.

The Food and Drug Administration (FDA) regulates dietary supplements under a different set of regulations than foods, pharmaceuticals, and over-the-counter drugs. In 1994, the Dietary Supplement Health and Education Act (DSHEA) created new regulations for the labeling and safety of dietary supplements. Under these rules, the FDA is not authorized to review the safety and effectiveness of dietary supplements before they are marketed. The FDA must prove that the product is unsafe in order to be able to recall it from the market. Once a dietary supplement is on the market, the FDA tracks side effects reported by consumers, supplement companies, and others.

If the FDA believes that a product is unsafe, it can take legal action against the manufacturer or distributor and issue a warning or require the product to be recalled from the market. However, the FDA states that it cannot test all products marketed as dietary supplements that may have potentially harmful hidden ingredients. Under current regulations, the safety of dietary supplements is the responsibility of manufacturers. Unfortunately, manufacturers don't always consider the interests of the public, especially when it comes to making a profit. According to the FDA website, “FDA has discovered that manufacturing problems have been associated with dietary supplements.” The products have been recalled due to microbiological contamination, by pesticides and by heavy metals and because they do not contain the dietary ingredients they are supposed to contain or because they contain more or less of the dietary ingredient that appears on the label. It is essential for consumers to comprehend that taking dietary supplements does not guarantee good health.

You get all the variety of nutrients (vitamins, minerals, antioxidants etc.) in food rather than just in single nutrient supplements; the amounts of different nutrients are balanced so that they don't interfere with digestion, absorption or metabolism; and there's no chance that intake of nutrients from food will cause harm (except for polar bear liver which has toxic levels of vitamin A). On the contrary, high doses of individual nutrients can make things worse. Food also tastes much better than supplements. Certain groups may benefit from taking supplements such as older people, strict vegetarians or vegans, people who restrict their caloric intake, pregnant women or people with food insecurity. If you decide to take supplements consider moderation and follow guidelines to help you choose a supplement. A dietary supplement is not considered a drug and is not subject to pre-marketing approval requirements if its intended use is solely to affect structure or any function of the body and is not intended for therapeutic purposes.

On the other hand if a product claims it can treat diagnose prevent or cure a disease then it would be considered a drug by FDA. What this means for consumers is that they should be careful when considering using a dietary supplement. FDA informed consent and IRB rules do not apply to studies involving dietary supplements that are not considered drugs.

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