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Botanical Healing

Botanical Healing

Sample Answer 

Botanical Healing

FDA Regulation of Standard Medications and Botanicals

In today’s world, both botanicals and standard medications are used for the management of various conditions. Different countries have varying regulations regarding the manufacture and use of these products. In the United States, the Food and Drug Administration (FDA) regulates both botanicals and standard medications. However, the regulations for botanicals fall under a different category from the regulations for prescription and non-prescription drugs.

Whereas standard medications require FDA approval before they can be sold, botanicals do not require FDA approval to be legally sold. The FDA must approve that prescription and non-prescription drugs are safe and effective for the intended indication before they can be sold. The FDA provides that the efficacy and safety of the drugs should be confirmed through clinical trials. The clinical trials should show enough evidence that a particular drug is safe and efficacious before it can be legally sold. Once the FDA approves a drug, it should be manufactured under well-controlled conditions and packaged with all the necessary information (Thaul, 2012). This is not similarly applied to herbal and dietary supplements since they do not have to be proven as safe before they can be taken to the market. The manufacturers of botanicals are not required to carry out clinical trials to determine the safety and efficacy of their products (Zakaryan & Martin, 2012).

However, the FDA monitors the botanicals’ prescription and non-prescription drugs in the market. The Dietary Supplement Health and Education Act (DSHEA) allows the FDA to take action when a dietary and herbal supplement is found to pose a risk to people (Zakaryan & Martin, 2012). The FDA can act against a distributor or manufacturer of a botanical product when the product is found unsafe. It can issue a warning or ask for the product to be removed from the market. The same regulation is applied to prescription and non-prescription medications since the FDA can take action when it is found that counterfeit drugs are being sold in the market (Thaul, 2012). The FDA can take action regardless of whether the drug is a prescription-only drug or an over-the-counter drug.

The way the FDA regulates herbal and dietary supplements is not the same way it regulates over-the-counter and prescription drugs. The FDA requires clinical trials to confirm the safety and efficacy of the standard medications before they can be legally sold. Manufacturers of botanicals do not require FDA approval to sell their products. However, the FDA monitors the botanicals and standard medications in the market. It can request that unsafe products be removed from the market when proven risky.

References

Thaul, S. (2012). How the FDA approves drugs and regulates their safety and effectiveness. FDA Drug Approval: Elements and Considerations, 1–28.

Zakaryan, A., & Martin, I. G. (2012). Regulation of Herbal Dietary Supplements: Is There a Better Way? Drug Information Journal, 46(5), 532–544. https://doi.org/10.1177/0092861512452121

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Question 


Botanical Healing

Question to answer:
Compare and contrast the U.S. FDA regulation of herbal and dietary supplements and standard OTC or prescription medication.

Module 3 – Botanical healing (1)

Botanical Healing

Botanical Healing

 

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