NDI draft guidance

NDI Draft Guidance Comments in brief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The FDA’s NDI draft guidance sets up a ‘substantial and unprecedented premarket regulatory process’ that is ‘tantamount to obtaining FDA approval for dietary supplement products’, says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AHPA to FDA: Tear up NDI draft guidance and start again

NDI draft guidance comments

AHPA to FDA: Tear up NDI draft guidance and start again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The Food and Drug Administration should tear up its “hugely flawed” draft guidance on new dietary ingredient (NDI) notifications and go back to the drawing board, according to the American Herbal Products Association (AHPA).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NDI draft guidance comments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While the Food and Drug Administration (FDA) will need time to process the expected tidal wave of comments on its draft guidance on new dietary ingredients (NDIs), the supplements industry should not be left in regulatory “limbo” for long, trade associations...

NDI draft guidance release is ‘curious timing’: BI chief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NDI draft guidance release is ‘curious timing’: BI chief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The timing of the release of the new dietary ingredient (NDI) draft guidance is “curious” given pressing economic/resource issues and “far more serious issues that FDA should be looking at”, says the chief executive of BI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Hatch: 'Alarmed' by NDI draft guidance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

It might not be legally binding, but ignore the FDA's draft guidance at your peril...

NDI guidance poll verdict: It’s catastrophic ...

By Elaine Watson

A seemingly innocuous draft guidance document outlining the FDA's views on new dietary ingredient (NDI) notifications has provoked almost as much hysteria as Campbell Soup's move to put some salt back into its soups. But with good reason, according...

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.

Lawyer: FDA line on grandfathered ingredients was not made clear

Lawyer: FDA line on grandfathered ingredients was not made clear

By Elaine Watson

A leading food law expert and the Food and Drug Administration’s (FDA’s) dietary supplements chief agreed to disagree over several key aspects of the FDA’s draft guidance on new dietary ingredients (NDIs) during a spirited conference call with stakeholders...

Fabricant:

Big interview: Daniel Fabricant, Food and Drug Administration (FDA)

FDA on NDI guidance: This is ‘not a doomsday scenario’ for supplements trade

By Elaine Watson

The trade can rail against the Food and Drug Administration's new dietary ingredient (NDI) guidance as much as it likes, but it cannot honestly pretend to be shocked or even surprised by it, according to the man in charge of the FDA’s dietary supplements...

Doing nothing and hoping it will all go away is not a good plan ...

Big Interview: Vasilios Frankos, Herbalife

Frankos on NDI guidance (part two): This really isn’t a big surprise

While many stakeholders warn that the FDA’s controversial NDI draft guidance will stifle innovation and bury the supplements trade (and the FDA itself) under a hellish mountain of paperwork, they cannot pretend they didn’t see it coming, Herbalife’s Vasilios...

Frankos: You don't have to go out and spend millions on new tox studies...

Big interview: Vasilios Frankos, Herbalife

Frankos on NDI guidance (part one): Take a deep breath and don’t panic

While many stakeholders seem to believe that the Food and Drug Administration’s (FDA’s) controversial draft guidance document on NDI (new dietary ingredient) notifications could spell Armageddon for the supplements trade, this is actually quite unlikely,...

CRN: NDI guidance will stifle innovation

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?

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.

The wait is over: FDA releases NDI draft guidance

Special edition: NDI draft guidance reaction

The wait is over: FDA releases NDI draft guidance

By Stephen Daniells

The Food and Drug Administration (FDA) has released the much anticipated New Dietary Ingredient (NDI) draft guidance, meeting its statutory deadline for the release of the document.

Ullman & Mackay: Not happy

Dispatches from SupplySide East

NDI guidance could be 'gamechanger' for supplements trade

By Elaine Watson, Secaucus, New Jersey

Fears are mounting that the Food and Drug Administration’s (FDA’s) long-awaited guidance on new dietary ingredients (NDIs) could prove a “game changer” for the industry, and not in a good way.

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