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Pharmaceuticals / Regulatory Affairs

ViGuard Health Petitions FDA to Classify IND as a Supplement

Nov. 15, 2017

ViGuard Health called on the FDA to declare pyridoxamine to be a dietary supplement and no longer authorized for investigation as a new drug.

At issue is a clause in the Dietary Supplement Health and Education Act that seeks to avoid regulatory overlap between drugs and supplements. In 2009, the FDA denied a petition to classify pyridoxamine as a dietary supplement — noting that under DSHEA’s prior market clause, dietary supplements cannot include products authorized for investigation as a new drug, antibiotic or biologic with clinical investigations underway.

ViGuard says pyridoxamine is no longer being investigated as a drug so it should not be excluded from the definition of dietary supplement. However, it’s not clear whether the prior market clause applies once a product is no longer investigational. In its petition, ViGuard argues the statute language, draft guidance and legislative intent all suggest it is not intended to be permanent.

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