Ndi Draft Guidance

Speaker Boehner was receptive to Jarrow Formula's concerns about the FDA's NDI draft guidance during a meeting in LA last month, claim its regulatory attorneys

Jarrow calls for Congressional hearings to address NDI guidance woes

By Elaine Watson

Jarrow Formulas has raised its concerns about the FDA’s draft guidance on new dietary ingredients (NDIs) with House Speaker John Boehner as part of its campaign to alert members of Congress to the dangers the “fatally flawed” document presents to the...

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue

Dispatches from AHPA's Botanical Congress

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue

By Stephen Daniells

The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good manufacturing...

ANH-USA: 'If DMAA is unsafe, it should be removed... If it is an NDI, it should go through the NDI notification process... But let’s stop this nonsense about it being illegal because it’s a synthetic botanical. That is not a requirement of DSHEA...'

Is the DMAA crackdown an enforcement of the NDI draft guidance?

By Elaine Watson

In warning letters sent as part of its recent crackdown on DMAA, the FDA says “synthetically produced DMAA is not a dietary ingredient and, therefore, is not eligible to be used as an active ingredient in a dietary supplement”.

NDI draft guidance release is ‘curious timing’: BI chief

Dispatches from SupplySide West

NDI draft guidance release is ‘curious timing’: BI chief

By Stephen Daniells

The timing of the release of the new dietary ingredient (NDI) draft guidance is “curious” given pressing economic/resource issues and “far more serious issues that FDA should be looking at”, says the chief executive of BI Nutraceuticals.

August 2011 in pictures: Omega-3, NDIs & GNC

August 2011 in pictures: Omega-3, NDIs & GNC

By Stephen Daniells

NutraIngredients-USA looks back at an eventful month of news, with omega-3 innovations and research, NDI draft guidance reaction, vitamin A, and GNC snapping up LuckyVitamin.com.

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