Dietary Ingredients

FDA updates supplements ingredient directory to reflect stakeholder feedback

21-Feb-2024 By Stephen Daniells

The U.S. Food and Drug Administration (FDA) has renamed its Dietary Supplement Ingredient Directory and added classification categories following “some constructive stakeholder feedback”.

CHPA’s MacKay: ‘It’s really important for industry to take a position on proprietary blends’

20-Apr-2023 By Stephen Daniells

A new paper explores the topic of proprietary blends in dietary supplements, with one of the authors noting that industry needs to take a position on an issue that pits transparency on one side against intellectual property protection on the other.

FDA launches directory of ingredients used in products marketed as supplements

07-Mar-2023 By Stephen Daniells

The US Food and Drug Administration (FDA) has unveiled a new Dietary Supplement Ingredient Directory, providing detailed information on 27 ingredients that the Agency states are used in products marketed as dietary supplements.

FDA formally announces NAC enforcement discretion, but legal hangover remains

21-Apr-2022 By Hank Schultz

The US Food and Drug Administration declared today that it will exercise enforcement discretion on the use of NAC. It also said that it is ‘likely’ to make a rule that would formalize the legal use of the compound in finished dietary supplements.

Nuherbs VP: Shipping issues unlikely to work themselves out until April 2022

24-Jun-2021 By Stephen Daniells

With over 80% of global trade transported by sea, ongoing issues and bottlenecks in global shipping will continue to impact international raw material and ingredients supplies, which could drag into Spring of 2022, says Wilson Lau, VP of Nuherbs.

Beauty-from-within Ingredient joins NutraIngredients-USA Awards categories

02-Feb-2021 By The NutraIngredients-USA Team

The prestigious NutraIngredients-USA Awards are back for 2021, and this year we’ve expanded our ‘Ingredient of the Year’ category to include Beauty-from-Within ingredients.

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?

NutraIngredients-USA Awards 2020 Winners Revealed

13-Jul-2020 By Stephen Daniells

WATCH NOW: NutraIngredients-USA Awards 2020 – and the winners are…

NutraIngredients-USA Awards 2020: And the finalists are…

19-May-2020 By Stephen Daniells

NutraIngredients-USA is pleased to announce the finalists for the NutraIngredients-USA Awards 2020... the winners will be announced during a live broadcast on NutraIngredients-USA.com in July.

FDA revises consumer info on CBD, says ingredient is not GRAS, sends 15 CBD warning letters

26-Nov-2019 By Stephen Daniells

The US Food and Drug Administration has stated that it cannot conclude that CBD (cannabidiol) is generally recognized as safe (GRAS) for its use in human food, based on a “lack of scientific information supporting the safety of CBD in food”.

ODI docket comments: Make the list big, or don’t make it at all

06-Dec-2017 By Hank Schultz

Will compiling an official list of Old Dietary Ingredients ultimately be worth the effort? Maybe, but the resulting list must be expansive rather than restrictive to be of much use, most stakeholders agree.

An FDA-approved list of ‘old dietary ingredients’ may not be possible or responsible, warn stakeholders

04-Oct-2017 By Elizabeth Crawford

FDA’s undertaking to create a master list of ‘old dietary ingredients’ that could be sold legally in dietary supplements without first going through the new dietary ingredient notification process likely will fall flat, despite the agency’s best intentions,...

Special edition: Botanicals

Synthetic botanicals standoff likely to continue despite Georgia ruling

22-Jun-2017 By Hank Schultz

Experts expect the existing standoff on synthetic botanicals as voiced by FDA in the most recent draft NDI guidance will continue, despite the consensus from industry being  the agency’s position is not rooted in science.

CRN asks FDA to broaden its view of what constitutes a dietary ingredient

14-Dec-2016 By Hank Schultz

The Council for Responsible Nutrition has urged the Food and Drug Administration to broaden the definition of dietary ingredients in its NDI draft guidance and to step back from requiring filings on new finished products.

Ten things to change about DSHEA

04-Nov-2016 By Stephen Daniells

If you could change one thing about the Dietary Supplements Health & Education Act, what would it be? Ten industry lawyers weighed in…

NDI innovation 'pause' looks more like a freeze, UNPA chief says

19-Oct-2016 By Hank Schultz

According to UNPA president Loren Israelsen there has been plenty of recent innovation within the dietary supplement despite complaints to the contrary. But the NDI draft guidance could bring that to a screeching halt.

NPA to develop ‘safe harbor’ list for dietary ingredients

21-Sep-2016 By Stephen Daniells

In response to the recently re-released NDI draft guidance, the Natural Products Association (NPA) has said it is in the later stages of developing a comprehensive safe harbor list of pre-DSHEA dietary ingredients.

GRAS route will still be popular with hard line taken in NDI draft on synthetic botanicals

12-Aug-2016 By Hank Schultz

The updated New Dietary Ingredients draft guidance, issued yesterday by the Food and Drug Administration, modifies the agency’s stance on the contentious issue of synthetic, nature-identical compounds. But not by much.

CRN asks FDA to reverse stance on synthetic botanicals

25-Oct-2012 By Hank Schultz

The Council for Responsible Nutrition (CRN) has called upon the Food and Drug Administration to reverse its position concerning so-called “synthetic botanicals.”

Updated: FDA cracks down on DMAA - but this is just the start, not the end, of the debate, predicts CRN

27-Apr-2012 By Elaine Watson

It’s official, says the FDA. “Synthetically-produced DMAA (1,3-Dimethylamylamine) is not a dietary ingredient and is not, therefore, eligible to be used as an active ingredient in dietary supplements”.  

ABC: Solvents white paper could help inform NDI debate

21-Dec-2011 By Elaine Watson

An authoritative new guide to 23+solvents used in the production of botanical extracts for dietary ingredients could help inform the debate on ‘chemical alteration’ at the heart of the FDA’s draft guidance on new dietary ingredients (NDIs), says the American...

Novel extraction method should not trigger automatic NDI notification, says USP

08-Dec-2011 By Elaine Watson

Botanical extracts that have been on the market for years should not automatically be treated as new dietary ingredients (NDIs) just because extraction methods have changed, according to the United States Pharmacopeia (USP).

NDI draft guidance comments

NPA to FDA: Ditch product-specific notifications and accept our grandfathered lists … and NDI guidance could be salvaged

01-Dec-2011 By Elaine Watson

The Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) can be salvaged, but only if the agency is willing to substantially rewrite the offending document, the Natural Products Association (NPA) has argued.

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...

Lawyer on NDI guidance: FDA is trying to ‘dismantle’ DSHEA

18-Jul-2011 By Elaine Watson

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.

ABC on NDI guidance: ‘We find this problematic’

13-Jul-2011 By Elaine Watson

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.