Jarrow Formulas FOIA request on NDIs: ‘In sum, FDA has told us to drop dead’

28-Nov-2011 - Jarrow Formulas is still waiting for a “substantive response” from the Food and Drug Administration (FDA) to a Freedom of Information Act (FOIA) request submitted more than two months ago about the FDA’s draft guidance on New Dietary Ingredients (NDIs).

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

10-Nov-2011 - 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 trade associations.

FDA on warning letters: ‘We are going to do more than just hand out paper’

24-Oct-2011 - The dietary supplements industry should keep an eye on GMP compliance, and not be distracted by discussions over NDIs, because enforcement may move beyond handing out paper if warning letters are ignored, said FDA’s Dr Daniel Fabricant.

Herbalife: Six steps to improve functionality of NDI guidance

18-Oct-2011 - 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).

Dispatches from SupplySide West

NDI draft guidance release is ‘curious timing’: BI chief

17-Oct-2011 - The timing of the release of the new dietary ingredient (NDI) draft guidance is “curious” given pressing economic/resource issues and “far more serious issues that FDA should be looking at”, says the chief executive of BI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.

News in brief

NDI guidance prompts unprecedented level of grassroots activism, claims ANH-USA

11-Oct-2011 - Attempts by health advocacy group the Alliance for Natural Health USA (ANH-USA) to drum up ‘grassroots’ support for its campaign against the Food and Drug Administration's (FDA’s) New Dietary Ingredient (NDI) draft guidance have prompted an unprecedented level of activism, the group’s legal director has claimed.

Readership split on need for new trade association

05-Oct-2011 - 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.

AHPA: Work with existing trade associations, a new one isn’t needed

29-Sep-2011 - Dietary supplement companies should work with the existing trade associations to properly address the NDI draft guidance, says the American Herbal Products Association (AHPA), as a new dietary supplement trade association is proposed.

FDA’s Fabricant: ‘Unreasonable risk’ has nothing to do with efficacy

29-Sep-2011 - The issue of ‘unreasonable risk’ in the NDI draft guidance is not about efficacy, despite what some industry personalities have said, the director of the FDA’s Office of Dietary Supplement Programs tells NutraIngredients-USA.

Jarrow Rogovin proposes new supplement trade association: There's no need, say existing associations

28-Sep-2011 - The dietary supplements industry may have a new trade association, as Jarrow Rogovin, founder and president of Jarrow Formulas, proposes the creation of the DSMMA.

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

23-Sep-2011 - 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.

FDA has ‘grossly underestimated’ NDI notification process, CRN tells OMB

20-Sep-2011 - The Council for Responsible Nutrition (CRN) has told the Office of Management and Budget (OMB) that FDA has ‘grossly underestimated the NDI notification process’ burden’.

Jarrow Formulas challenges FDA on NDIs with 128-item Freedom of Information request

16-Sep-2011 - California-based Jarrow Formulas has submitted a 128-item Freedom of Information Request to the US FDA with questions it deems ‘vital’ to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.

FDA grants comment period extension for NDI draft guidance

08-Sep-2011 - The US Food & Drug Administration (FDA) has granted a 60-day extension to the comment period for the New Dietary Ingredient (NDI) draft guidance, NutraIngredients-USA.com can reveal.

Trade associations: 45-day NDI draft guidance extension request ‘reasonable’

07-Sep-2011 - The request from the main trade associations to extend the period for comments on the NDI draft guidance is ‘reasonable’ and the result of ‘carefully weighing the matter at hand’.

Jarrow Formulas calls for 1 year NDI draft comment extension

01-Sep-2011 - 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’.

DSHEA co-author is ‘alarmed’ by NDI guidance

22-Aug-2011 - 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 has confirmed.

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

19-Aug-2011 - 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 has predicted.

Hatch NDI guidance meeting: File comments for now, then explore legal avenues …

18-Aug-2011 - A range of options – “judicial, administrative and Congressional” – is being explored by the dietary supplements industry should the FDA prove unwilling to make substantial changes to its controversial draft guidance on new dietary ingredients (NDIs).

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

11-Aug-2011 - 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.

Emord on NDI guidance: Politics has prevailed over science and common sense

08-Aug-2011 - If sufficient pressure is exerted on key members of Congress, it is not beyond the realms of possibility that the FDA might suspend its draft guidance on NDIs (new dietary ingredients) or even withdraw it altogether, according to food law attorney Jonathan Emord.

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

04-Aug-2011 - 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 have argued.

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

21-Jul-2011 - 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.

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

19-Jul-2011 - 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 to many in the dietary supplements trade.