Ndis

Progress or a giant nothingburger? Trade associations react to FDA NDI guidance announcement

06-Mar-2024 By Stephen Daniells

FDA's final guidance on New Dietary Ingredient (NDI) notification procedures and timeframes has prompted a range of responses from the dietary supplement industry trade associations, with some more welcoming than others.

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.

ODSP’s director on NDIs, MPL, and NMN

27-Apr-2023 By Danielle Masterson

NutraIngredients-USA caught up with Cara Welch, PhD, Director of FDA's Office of Dietary Supplement Programs. Welch talked inspections, made the case for MPL and hinted NDI guidance is on the way.

Three for three: Hofseth Biocare gets NDI nod from FDA for bioactive peptides

29-Aug-2022 By Stephen Daniells

Hofseth BioCare (HBC) has successfully achieved New Dietary Ingredient (NDI) status from the US Food and Drug Administration for its ProGo bioactive peptides, having already achieved this for its CalGo and OmeGo ingredients.

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.

Cohen team finds unapproved drugs in cognitive support products

24-Sep-2020 By Hank Schultz

A new paper from a prominent industry critic has found a number of unapproved drugs in a suite of cognitive and memory support products purchased online.

Guest article

New Dietary Ingredients: Will FDA protect consumers from pirates and piggybackers?

05-Aug-2020 By Steve Mister, President & CEO, Council for Responsible Nutrition

Why is it so hard to get FDA to enforce the law when it comes to NDIs?

NPA calls for FDA to issue import alerts on imported adulterated dietary supplement ingredients

03-Jun-2020 By Stephen Daniells

The Natural Products Association (NPA) is calling for the US Food and Drug Administration to use import alerts to stop nutritional supplements that fail to comply with New Dietary Ingredient (NDI) regulations.