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Criticism grows over FDA supplement regulations

March 9, 2009 by  

Criticism grows over FDA supplement regulationsIn recent days, critical voices have spoken out against the FDA’s approach to the regulation of dietary supplements which they say overburdens their producers and benefits big pharma.

Commentators have drawn attention to an FDA practice of classifying dietary supplements as drugs if they are an ingredient of newly approved medications, according to Examiner.com.

In January, the agency approved a petition by pharmaceutical company Biostratum to classify Pyridorin as a ‘new drug.’ Since the product contains pyridoxine, a form of vitamin B6, this will effectively prevent natural supplements companies from selling any product that contains it.

In response, food and supplements industry organizations have vowed to challenge the approval as setting a dangerous precedent.

This will mean that "we’re all violating that law each time we eat something with brewer’s yeast, or fish or chicken," because pyridoxine is a naturally occurring compound, says the Examiner.

It also suggests that the price of such supplements is likely to rise once they are only available by prescription, limiting access to them and preventing many consumers from enjoying their beneficial effects.

The FDA has recently met with much criticism from government oversight agencies. A report prepared by the Government Accountability Office and released on March 5 suggested that the FDA does not have the information and resources necessary to adequately regulate dietary supplements.
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