Archives for July 5, 2011

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Mister on NDI guidance: ‘We are terribly disappointed.’

By Elaine Watson

The amount of safety data the FDA now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified DSHEA and establishes a process “ominously like the one for new food additives”, the Council...

Could the trade mount a legal challenge vs NDI guidance?

By Elaine Watson

If the Food and Drug Administration (FDA) does not revise its draft guidance on new dietary ingredients (NDIs) for supplements to reflect industry concerns, the trade might be stuck between a rock and a hard place, admit lawyers.