The FDA Approval Process — More about What’s NOT Included

4:51 am

The FDA's Web site gives a general description of how it approaches product approval, and the general theme of the explanation is that different products generate different standards by the FDA that must be met in order for a product to be allowed onto the marketplace.

For instance, the following products require the following standards to be met:

  • New drugs and complex medical devices: Must be proven to be "safe and effective."
  • X-ray machines, microwave ovens: Must measure up to "performance standards."
  • Cosmetics/dietary supplements: Generally can be marketed without prior approval.

The list above serves only as a set of examples and not as an exhaustive list. However, we find several problems with the FDA approval process:

  • The FDA does not conduct independent studies on products, but merely analyzes summaries of studies already performed.
  • The FDA's standards appear nebulous at best in certain situations.
  • The FDA's failure to regulate such products as over-the-counter dietary supplements, is, in our opinion, egregious.

 

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