The request from the main trade associations to extend the period for comments on the NDI draft guidance is ‘reasonable’ and the result of ‘carefully weighing the matter at hand’.
California’s Jarrow Formulas has called for an extension of the comment period on the FDA’s NDI draft guidance to one year, claiming that the current 90 day comment window is ‘insufficient’.
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1994 Dietary Supplement Health and Education Act (DSHEA) does not believe the Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) is consistent with the legislation he co-authored, his office...
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...
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by the dietary supplements industry should the FDA prove unwilling to make substantial changes to its controversial draft guidance on new dietary ingredients (NDIs).
The New Dietary Ingredient (NDI) draft guidance represents ‘rulemaking by guidance’ and should immediately be ‘withdrawn and revised’, says New York-based law firm Ullman, Shapiro & Ullman, LLP.
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is exerted on key members of Congress, it is not beyond the realms of possibility that the FDA might suspend its draft guidance on NDIs (new dietary ingredients) or even withdraw it altogether, according to food law attorney Jonathan...
If stakeholders are granted more time to respond to the FDA’s draft guidance on new dietary ingredients (NDIs), it should be possible to reach a compromise that will satisfy regulators without devastating the dietary supplements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...
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.
The argument that the FDA has overstepped its legal remit in its draft guidance on new dietary ingredients (NDIs) is gaining ground, with one food law expert claiming the FDA is “trying to dismantle” the legislation it is supposed to be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.
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...
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.
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...
Big interview: Daniel Fabricant, Food and Drug Administration (FDA)
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...
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...
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,...
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...
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.
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.
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.
The safety of probiotics should be evaluated at the species and not the strain level when considering possible New Dietary Ingredients notifications, according to a new position paper by three leading probiotic groups.
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.
