NDI draft guidance

IPA co-founder: EU probiotic approach is “dirty pool”

Disptaches from Microbiota 2011

IPA co-founder: EU probiotic approach is “dirty pool”

By Shane Starling

Jarrow Rogovin, never a man to mince his words, says it is high time the IPA and other trade groups stepped up to the plate to defend a sector that has been under regulatory siege on both sides of the Atlantic for several years.

ABC: Solvents white paper could help inform NDI debate

ABC: Solvents white paper could help inform NDI debate

By Elaine Watson

An authoritative new guide to 23+solvents used in the production of botanical extracts for dietary ingredients could help inform the debate on ‘chemical alteration’ at the heart of the FDA’s draft guidance on new dietary ingredients (NDIs), says the American...

NDI Draft Guidance Comments in brief

Atrium Innovations on NDIs: The system isn’t broken, so why fix it?

By Stephen Daniells

The FDA’s NDI draft guidance sets up a ‘substantial and unprecedented premarket regulatory process’ that is ‘tantamount to obtaining FDA approval for dietary supplement products’, says Atrium Innovations.

AHPA to FDA: Tear up NDI draft guidance and start again

NDI draft guidance comments

AHPA to FDA: Tear up NDI draft guidance and start again

By Elaine Watson

The Food and Drug Administration should tear up its “hugely flawed” draft guidance on new dietary ingredient (NDI) notifications and go back to the drawing board, according to the American Herbal Products Association (AHPA).

ABC: Expert panel should clarify list of grandfathered dietary ingredients

NDI draft guidance comments

ABC: Expert panel should clarify list of grandfathered dietary ingredients

By Elaine Watson

The Food and Drug Administration (FDA) should recognize the existing industry list of ‘grandfathered’ or ‘old’ dietary ingredients (ODIs) sold in the US pre-1994 – but work with an expert panel to clarify its contents, according to the American Botanical...

Trade to FDA: Don’t leave us in limbo on NDI guidance

Trade to FDA: Don’t leave us in limbo on NDI guidance

By Elaine Watson

While the Food and Drug Administration (FDA) will need time to process the expected tidal wave of comments on its draft guidance on new dietary ingredients (NDIs), the supplements industry should not be left in regulatory “limbo” for long, trade associations...

NDI draft guidance release is ‘curious timing’: BI chief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NDI draft guidance release is ‘curious timing’: BI chief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

Readership split on need for new trade association

Readership split on need for new trade association

By Stephen Daniells

NutraIngredients-USA’s readership is torn over the issue of whether the dietary supplements industry needs a new trade association, according to results of a recent poll.

Hatch: 'Alarmed' by NDI draft guidance

DSHEA co-author is ‘alarmed’ by NDI guidance

By Elaine Watson

The chief architect of the 1994 Dietary Supplement Health and Education Act (DSHEA) does not believe the Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) is consistent with the legislation he co-authored, his office...

Rice: Find the middle ground

Supplements trade: NDI guidance can be salvaged, but give us more time

By Elaine Watson

If stakeholders are granted more time to respond to the FDA’s draft guidance on new dietary ingredients (NDIs), it should be possible to reach a compromise that will satisfy regulators without devastating the dietary supplements industry, trade associations...

Siegner: This will shut off innovation

Lawyer on NDI guidance: FDA is trying to ‘dismantle’ DSHEA

By Elaine Watson

The argument that the FDA has overstepped its legal remit in its draft guidance on new dietary ingredients (NDIs) is gaining ground, with one food law expert claiming the FDA is “trying to dismantle” the legislation it is supposed to be clarifying.

Kruger: Think about this from a consumer confidence perspective

Toxicologist: FDA’s NDI guidance is entirely reasonable

By Elaine Watson

Many dietary ingredients used in supplements today bear little resemblance to ingredients that were assumed to be ‘grandfathered in’ post the 1994 Dietary Supplements Health and Education Act, making a fresh safety analysis eminently reasonable if extraction...

ABC's Mark Blumenthal

ABC on NDI guidance: ‘We find this problematic’

By Elaine Watson

The American Botanical Council (ABC) has weighed into the debate over the Food and Drug Administration’s (FDA’s) draft guidance document on new dietary ingredient (NDI) notifications.

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