For a long time, the term “dietary supplement” was used to describe any product that contains one or more essential nutrients (vitamins, minerals, and proteins) used to supplement a diet. Today, the term is used much more broadly. Thanks to the Dietary Supplement Health and Education Act (DSHEA) which became law in 1994. In the law, Congress expanded the definition of the term to include herbs or other botanicals (except tobacco) and other substances that may be used to supplement a diet.
As a result, there are many supplements on the market today that are made with herbs or other botanicals, amino acids, extracts from animal glands, fibers such as psyllium and guar gum, enzymes, and hormone-like compounds. The law has also meant that many substances, previously classified as drugs or unapproved food additives by FDA, are now readily available as dietary supplements with very little regulation.
Yes, the government regulates both drugs and dietary products through the Food and Drug Administration (FDA). However, FDA regulates these two products differently. The Agency is required by law to check the safety and effectiveness of prescription drugs before they are put on the market. The same is true for “over-the-counter drugs” like cold and pain medicines. By contrast, the regulation of dietary supplements is much less strict.
For example, the FDA is not required by law to check the safety or claims of dietary supplements before they are made available to consumers. Instead, it must wait until it receives reports of harmful effects from consumers or consumer advocacy groups. If there is a report of harmful effects linked to a particular supplement, the FDA will then investigate the alleged harm and if confirmed, it will order the product pulled from U.S. market. This is what happened with the herb ephedra (a.k.a. herbal fen-phen) in 2003 when the FDA pulled the supplement from the U.S. market after it was linked to the death of a well-known baseball player.
The Dietary Supplement Health and Education Act has led to exponential increase in the number of dietary supplements on the market. Some of these products like multivitamins contain vitamins and minerals, and are generally considered safe. There are also many products on the market that contain substances potent enough to cause harm alone or when combined with prescription or over-the-counter medicines. The FDA cannot guarantee the safety or effectiveness of these products; therefore, caution is warranted.
If you have doubts about the safety of a supplement, consult with your doctor or pharmacist before taking it. There is hardly any down side to seeking the advice of your doctor or pharmacist. It is necessary to talk to your doctor before taking any supplement if you are pregnant or nursing a baby, have diabetes, high blood pressure, or any other health problems. The same is true if you take medications. Some ingredients found in supplements can certain medical conditions worse. For example, sodium may increase high blood pressure in some individuals. Similarly, kidney problems may be worsened by calcium and magnesium.
So, here are the main points you should know. The Dietary Supplement Health and Education Act (DSHEA) of 1994 expanded the definition of dietary supplements to include products with substances that may be harmful to your health. Therefore, you should never assume that your supplement is safe, especially because the regulation of dietary supplements is less strict compared to drugs. In all cases, but especially if you have a medical condition or take medications, work with your doctor to determine which supplement, if any, you should take and how much.