Why FDA Is Up In Arms with Most Dietary Supplements

Dietary supplements are substances that you consume or imbibe and they include plants, fiber, herbs, vitamins, minerals, amino acids or segments of these substances. They can be in the form of tablets, capsules, pills or liquid. They only enhance the diet and therefore should not be regarded as a substitute for food.

Manufacturers of dietary supplements have no legal basis to claim that dietary supplements are able to diagnose, treat, cure or avert disease but can allege that they add to health sustenance. A dietary supplement is meant to offer nutrients which may not be eaten in adequate quantities. In the US, dietary supplements are defined as foods but in other places they are categorized either as drugs or other products.

Presently, there are more than 50,000 dietary supplements on the market which about half of the adult populations in the US consume. However, the effects of these dietary supplements remain unclear.

These products which are at times referred to as food or nutritional supplements are meant for the prevention or treatment of any ailment or condition, but according to the U.S. National Institute of health, in some situations they can be risky. Note the the agency specifies that certain supplements may have value for those who are unable to eat a balanced diet. Legal and medical experts in other places may have different opinions.

Are dietary supplements necessary?

A person has no need of dietary supplements if he or she eats a balanced diet. Furthermore, a large number of supplements have no tangible effect in their users. For instance, chondroitin and glucosamine are believed to ease joint pain but have not shown any scientifically proven benefit.

Any relief that have been reported resulting from the use of these supplements can probably be the fact that most of the patients who take them on recommendation by a physician use them alongside other pain killers. Similarly, more research is needed about omega-3 fatty acids, which is another common supplement but benefits for healthy people need to be demonstrated.

Sadly a number of supplements are detrimental to health. A good example comes from research funded by the National Institute of Health. It revealed that the rate of prostate cancer was higher in men who took vitamin E supplements than those who did not. In addition, studies have shown that calcium supplements puts people at a bigger risk of heart attacks.

There are various ways in which supplements may create harm, such as excessive consumption, especially fat-soluble vitamins and minerals which can accumulate in the body. These products may also be destructive by their assimilation in a short period, pollution, quality or by simultaneously augmenting their pros and cons.

The 1994 Dietary Supplement Health and Education Act was enacted as a way of deregulation, limiting the Food and Drug Administration’s powers to exercise authority over supplements provided the manufacturers did not make any claims of averting or treating illness. Consequently, the FDA presently controls dietary supplements as a type of food and not drugs.

In comparison with pharmaceutical manufacturers who are required to show proof of the efficacy and safety of their products, makers of supplements have no legal requirement for the same. However, the makers of supplements are required to prove that a product is safe before being marketed. This therefore means that due to the information filed to the FDA, the product cannot be traded for the first 75 days. But this does not really mean that if the FDA has listed the information, then the product is safe for use.

Practically, the FDA has cited lack of funds to examine and determine if the supplements in question should be considered unfit and necessitate their removal from the market. In the case of ephedra, it was due to the strong opposition the agency received from the US congress and the supplement industry that led to its removal from the market.

The FDA was compelled to implement the “good manufacturing practices” policy in 2007 so as a way to force factories manufacturing supplements to follow the right procedures to avoid being contaminated with impurities and with the labelling done appropriately. During the same year, the FDA came up with a regulation forcing supplement producers to provide information about the sided effects associated with their supplements.

Thus because of the legislation enacted in 1994, the FDA should clearly show that any supplement is not fit for use by using the adverse events reporting mechanism, which has the ability to bring out only 1-10% of all the negative side effects associated with the supplement. Based on the audits by the compliance division of the FDA which was completed in 2011 and 2012, an health official gave the astounding revelation that about 70% of operators manufacturing dietary supplements do not follow the set rules of the FDA.

The report also showed that the FDA had issues with most of these companies as they do not provide full information regarding the negative side effects associated with their supplements.