Ndi

Proposed 2007 grandfathered date change: Limited chance of success and distraction from NDI comment deadline?

10-Nov-2011 By Stephen Daniells

A proposed change to the date defining ‘grandfathered’ dietary ingredients to 2007 shows the industry there are options to the NDI issue, but it should not distract attention from FDA and the upcoming deadline for NDI comment submissions, say leading...

Herbalife: Six steps to improve functionality of NDI guidance

18-Oct-2011 By Stephen Daniells

The functionality of the New Dietary Ingredient (NDI) guidance can be improved in only six steps, says direct selling giant Herbalife in its comments to the US Food and Drug Administration (FDA).

Citizens for Health: NDI guidance ‘contravenes spirit and letter of DSHEA'

23-Sep-2011 By Elaine Watson

The Food and Drug Administration (FDA) is “willfully and grossly misinterpreting the law” by making new dietary ingredient (NDI) submissions product-specific rather than ingredient-specific, advocacy group Citizens for Health has argued.

Jarrow Formulas calls for 1 year NDI draft comment extension

01-Sep-2011 By Stephen Daniells

California’s Jarrow Formulas has called for an extension of the comment period on the FDA’s NDI draft guidance to one year, claiming that the current 90 day comment window is ‘insufficient’.

AHPA: FDA will be 'laughed out of court' if it sticks to its guns on supplement-specific NDI notifications

19-Aug-2011 By Elaine Watson

The FDA will be “laughed out of court” if it tries to defend enforcement action against supplement manufacturers based on the argument that new dietary ingredient (NDI) notifications should apply to finished products, not ingredients, one industry leader...

Ullman: NDI guidance creates ‘new dietary supplement’ notification process

11-Aug-2011 By Stephen Daniells

The New Dietary Ingredient (NDI) draft guidance represents ‘rulemaking by guidance’ and should immediately be ‘withdrawn and revised’, says New York-based law firm Ullman, Shapiro & Ullman, LLP.

‘No logic’ to FDA view on product-specific NDI notifications, says lawyer

21-Jul-2011 By Elaine Watson

There is “no logic” to the FDA’s insistence that NDI (new dietary ingredient) notifications are applicable only to the specific manufacturer that submits them, according to one leading food law attorney.

Trade groups line up NDI draft guidance reviews

12-Jul-2011

Leading dietary supplement trade associations are lining up to help industry understand the Food and Drug Administration’s draft guidance for new dietary ingredients (NDI) and the potential implications.

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

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

11-Jul-2011 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...

Big interview: Vasilios Frankos, Herbalife

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

08-Jul-2011

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,...

Big Interview: Vasilios Frankos, Herbalife

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

08-Jul-2011

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...

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

06-Jul-2011 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...

NDI guidance: ‘Absurdly broad, anti-innovative and incredibly burdensome’

01-Jul-2011 By Elaine Watson

Preliminary analysis of draft guidance on new dietary ingredients used in supplements appears to confirm many of the trade's worst fears, according to food law experts.

Special edition: NDI draft guidance reaction

The wait is over: FDA releases NDI draft guidance

01-Jul-2011 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.

NDIs discussed at FDA led public meeting

16-Nov-2004

The Food and Drug Administration (FDA) yesterday held a public
meeting, as announced last month, giving industry and consumers the
chance to discuss the government body's premarket notification
program for new dietary ingredients...