Herbal Elements

By | June 24, 2014

Why Are Herbal Remedies Not FDA Approved?

The different herbal remedies that we can all find on the shelves of different drug stores and pharmaceutical companies are not considered by the Food and Drug Administration (FDA) as drugs, but rather treats it as dietary supplements. This means that the different herbal remedies that we buy in order to stay healthy or treat illnesses are not regulated by the FDA as it would with prescription medications, which means that the quality and effectiveness of these herbal remedies can vary from one brand to the next.

The FDA claims that they can only regulate things which fall under the two categories, namely foods and drugs. According to the Food and Drug Act passed in 1906 and 1938, all food additives and drugs should be approved by the FDA before they can be sold in the market. They all need to submit evidences about their health claims or how they can cure an ailment or condition, before they can be legally sold to the public.

Herbal remedies, which are classified under dietary supplements, are composed of processed or unprocessed elements such as plant barks, extracts and essential oils. Since they are considered as dietary supplements, they are not regulated by the FDA like drugs or prescription medications.

They are more likely classified and regulated as food, which helps make it easier for herbal remedies to be sold in the market since there are fewer restrictions in terms of their approval. Unfortunately, since these herbal remedies make health and disease claims, there have been discrepancies as to where they are going to be classified, and how they are going to be regulated.

According to recent debates, FDA do not approve herbal remedies due to the fact that it cannot clearly define the line that separates structure and function claims over disease and health claims. If the line was clearly defined, then herbal remedies would have been easier to regulate. Herbal remedies, which fall under dietary supplements, are not clearly defined and separated from foods. This makes it difficult for the FDA to implement its regulations since it cannot clearly categorize the herbal remedies as to whether it falls under foods or drugs.

One incident that further helped blur the lines in categorizing herbal remedies as foods is when different food companies started making health claims themselves. If this was the case, then these foods should be regulated as drugs. Due to this turn of events, the FDA is now finding it very difficult to further scrutinize the difference on how foods and the dietary supplements should be categorized and regulated.

Ultimately, being able to create a standard for both food and drugs regarding disease and health claims is a step forward, but it is also important to remember that the way consumers think about the different claims that are presented by certain food and drug products, such as dietary supplements, should also be considered. Since dietary supplements are still considered to be in a class of its own, it will continue to be sold legally without restrictions not until it has been categorized by the FDA properly, whereby it can be regulated appropriately.

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