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Adverse Event Reporting by herbal medicine makers What does it mean to the consumer?

FDA Labels and supplementsThe field of herbal medicines is an integral part of ‘alternative medicines’, which is now a multi billion dollar industry across the world. This kind of therapy regimen takes the help of century-old medicinal formulae using herbs and plant sources for the treatment of common as well as chronic illnesses. These medicines both help in the prevention and cure of several types of ailment. There was a time when herbal supplements and other products did not have the scientific back up of clinical trials, and people were using it purely on the belief that these did cure people of ancient times.

However, the scenario has improved to the extent that several well-known medical and scientific journals are now publishing relevant data regarding the safety and efficacy of some of the most common ingredients used in herbal medicines.

If you have heard about the several risks involved in herbal medicines, you ought to know that while the ingredients may be perfectly safe for use, but the methods used for preparation may not be 100% scientific. This is coupled with the fact, that unlike FDA-approved drugs, which automatically carry a stamp of assurance in terms of safety and Good Manufacturing Practices (GMP), these medicines are not governed by any consumer protection act or law. This means that the consumer is taking the drug at his or her own risk.

Herbal supplements or any other ‘natural’ diet supplements are essentially a combination of plant extracts with natural plant oils and plant-originated solvents. A lot of chemical compounds are contained and synthesized naturally in all herbs. Thus, any herb when consumed may or may not have a beneficial effect on the individual. Sometimes, the chemical compound contained in a herb may adversely react with an individual, depending on his or her own body constitution or existing health conditions. Thus, when the market is full of herbal products containing ingredients which in reality, have no therapeutic effect, but are still actively promoted as the panacea for all illnesses, it has drawn the serious attention of health regulatory authorities in this country.

As a consequence of this concern, the Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed by the federal government which protects the ordinary consumers’ rights for accessing herbal and natural supplements which ought to be safe and effective. Passing of this Act is an important development, since this gave FDA the final nod for ensuring that the herbal supplements and other products which belong to the ‘alternative medicine’ category were indeed safe and were consistently better in quality.

To put a seal on the safety assurance of herbal products, last year the FDA made it mandatory for all herbal product makers to track every data pertaining to safety and follow GMP in their manufacturing processes. This rule is called ‘Adverse Event Reporting’.

To the lay consumer, this essentially means that all herbal products, makers of which are following this rule, would make herbal products which are consistently safe and efficacious.

This is a giant leap forward and those who have started to believe in the fine efficacy of herbal and products of plant-origin can breathe a sigh of relief, provided they buy their supplements, made only by reputed and quality-conscious companies.

 

 

 

 

 

 
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