Ndi Notifications

CRN urges FDA to put resources behind enforcing supplement master file framework

14-Aug-2023 By Stephen Daniells

The Council for Responsible Nutrition (CRN) has written to the US Food & Drug Administration urging the agency to put resources behind any dietary supplement master file framework, or rethink prioritizing a master files guidance.

NPA submits citizen’s petition demanding resolution on CBD issue

22-Feb-2022 By Hank Schultz

The Natural Products Association has filed a citizen’s petition calling for FDA to either rule that CBD is a legal dietary ingredient or to make a rule allowing enforcement discretion on the substance.

Stakeholders: FDA vacancies will hurt, but agency will weather storm

15-Jan-2020 By Hank Schultz

Industry stakeholders say that while critical vacancies at the US Food and Drug Administration come at an awkward time they believe the agency will fulfill its responsibilities.

Changes to NDI process called for in paper that claims DSHEA no longer adequate to regulate industry

19-Dec-2019 By Hank Schultz

A paper published today in a prominent medical journal asserts that the law governing dietary supplements is no longer adequate to protect consumers and sweeping changes are needed to keep potentially dangerous new ingredients off the market.

Video: In light of FDA's reticence, professional help critical in NDI submissions

10-Jul-2014 By Hank Schultz

The submissions of New Dietary Ingredient notifications seems as fraught as ever, and part of the issue is that regulators are not as communicative as they could be, according to Alex Schauss, senior director of AIBMR Life Sciences.

Dispatches from SupplySide West 2013

NDI trespassers continue to plague market, attorney says

27-Nov-2013 By Hank Schultz

Follow on ingredients that rely on the safety halo provided by New Dietary Ingredient notifications filed by competitors continues to be a serious problem in the marketplace, according to a prominent attorney.

Trade associations urge FDA to issue revised draft guidance on NDI ingredient identity

06-May-2013 By Stephen Daniells

The five associations representing the dietary supplement industry have asked the Food and Drug Administration (FDA) to issue revised guidance on new dietary ingredient (NDI) notifications, with a specific focus on the information to be included to identify...

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.

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...

NDI guidance public comments: Don't revise it, ditch it

03-Aug-2011 By Elaine Watson

The FDA should calculate how much complying with its guidance on new dietary ingredients (NDIs) will cost before forcing the supplements industry to embark on a “giant paperwork exercise” that will not make consumers any safer, according to the first...

‘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.

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,...

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...