When people hear the acronym FDA (the Food and Drug Administration), they think about an agency that is responsible for ensuring that all foods and prescription drugs produced in the United States are safe for consumers to purchase and use. And although the FDA is charged with the responsibility of ensuring safety for consumers--in regard to food and drugs, at least--that isn't the case with dietary supplements (vitamins), unfortunately. The authority for vitamin oversight has been given to another, and it isn't the FDA.
1994 Dietary Supplement Health and Education Act
In 1994, the Clinton Administration signed into law the Dietary Supplement Health and Education Act (DSHEA). This Act--regulating the marketing of vitamins--was akin to asking the fox to guard the hen house, since the vitamin manufacturers were the ones entrusted with oversight of safety and effectiveness of vitamins and dietary supplements; not the Food and Drug Administration (FDA), as one might expect. Instead, the FDA was only charged with the responsibility of overseeing the labels on the vitamin bottles; not its safety or effectiveness.
Misconception about the DSHEA and FDA
Unfortunately, many people erroneously thought that the new Act was created to ensure that vitamins would be as stringently monitored and regulated by the FDA as food and drugs are, thus preventing vitamin and dietary supplement manufacturers from putting too much of, too little of, or too detrimental an item in their product(s) for sale. But this was a misconception on the part of some of the public, due to the FDA being involved at least in the regulation of the labels of dietary supplements.
Purpose of the DSHEA and Its Role in Vitamin Oversight
Ensuring safety and effectiveness via the FDA was not the purpose of this Act at all. Instead, this Act was merely put in place to regulate whether vitamin manufacturers labeled their product properly based on the actual ingredients they claimed were in it. The vitamins didn't have to work, or even be in compliance with daily recommended dosages; they just had to state honestly on their label what were the actual ingredients inside the bottle, regardless of whether those ingredients were beneficial nutritionally or not. Therefore, the FDA was only made responsible for oversight regarding vitamin labels; not vitamin safety or effectiveness.
FDA and Vitamin Requirements
Therefore it isn't the FDA that is responsible for ensuring that vitamins are safe (or effective at all) before they are manufactured or put on a store's shelves for consumers to purchase. It is, unfortunately, the vitamin manufacturer who has that responsibility, given to them by the Dietary Supplement Health and Education Act (DSHEA) in 1994.
In addition, there does not exist any minimum or maximum limitations on how much of a nutrient can be present in a vitamin or dietary supplement, or how little. Therefore, some vitamins could contain amounts in excess of the daily recommended dosage and some could be very lacking in that regard, affecting to some degree the consumer who takes them.
Significant
Although the FDA is not responsible for safety of dietary supplements put in the marketplace, it does, however, have the enforcement authority to respond to serious public health emergencies or illness caused by such dietary supplements. Any individual experiencing such a serious medical emergency should seek emergency medical attention first, and then afterward may contact--or have her physician contact--the FDA's MedWatch hotline at 1-800-FDA-1088.
Tags: dietary supplements, safety effectiveness, Dietary Supplement Health, Health Education, Supplement Health, Supplement Health Education, actual ingredients