Ndi

ODSP’s Welch: NDIN 'guidances are not enforceable'

22-Apr-2024 By Danielle Masterson

FDA’s director of the Office of Dietary Supplement Programs (ODSP), Cara Welch, PhD, stopped by SupplySide East to present an overview of the agency’s FY23 activities related to dietary supplements and FY24 plans as well as an update on the pending Human...

CRN’s Steve Mister on NDI enforcement: 'That needs to change'

18-Apr-2024 By Danielle Masterson

SupplySide East just wrapped up, and attendees were buzzing about a number of issues ranging from restrictive laws to NDI guidance to DSHEA. NutraIngredients-USA caught up with CRN’s President and CEO Steve Mister Wednesday in Secaucus, NJ to discuss...

FDA issues draft guidance on NDIN Master Files

03-Apr-2024 By Stephen Daniells

The Food and Drug Administration (FDA) has released draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.”

UNPA’s Israelsen: ‘We’ve really got to get this NDI issue resolved’

26-Mar-2024 By Stephen Daniells

Loren Israelsen, president of the United Natural Products Alliance (UNPA) and one of the key architects of the Dietary Supplement Health and Education Act (DSHEA), is urging the Food and Drug Administration (FDA) to “move along as quickly as they can”...

ODSP’s Cara Welch talks FDA priorities and resources in evolved market

15-Sep-2023 By Asia Sherman

The National Institutes of Health kicked off its annual Office of Dietary Supplements Seminar Series this week with a presentation by Dr. Cara Welch on how the Food and Drug Administration (FDA) regulates the dietary supplement marketplace.

All eyes on Dietary Supplement Master Files

11-Jul-2023 By Danielle Masterson

Fresh off a new Draft Guidance release, many are hopeful that Master Files would provide clarity on NDI filing requirements and provide protections for intellectual property. However, some point to issues with the NDI framework and say that must be solved...

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.

Lawsuit against FDA on NMN ‘certainly being considered’, says NPA CEO

14-Mar-2023 By Stephen Daniells

The Natural Products Association is hoping the US Food & Drug Administration is responsive to its recent Citizen’s Petition on the status of NMN, but if it’s not then other options are being considered, Dr Daniel Fabricant, NPA’s CEO tells NutraIngredients-USA.

Top 8 takeaways from Regulatory Summit

26-Jul-2022 By Danielle Masterson

This year’s Dietary Supplement Regulatory Summit in Washington, DC, featured updates and insights from top FDA officials, including the Office of Dietary Supplement Programs along with top stakeholders and industry experts. Here are a few key takeaways...

7 key takeaways from the CRN-ACI Legal, Regulatory & Compliance Summit

05-Jul-2022 By Stephen Daniells

NDIs, drug preclusions, the CBD stalemate, actions at the State level, and an impending supply chain nightmare around plastics were just some of the highlights from a recent conference in New York City.

Dr Rob Wildman on NDI submissions, implementing MPL

28-Jun-2022 By Danielle Masterson

This year’s International Society of Sports Nutrition Annual Conference & Expo marked its 19th year promoting the science and application of evidence-based sports nutrition and supplementation. NutraIngredients-USA was there to hear about the latest...

FDA working ‘expeditiously’ to finalize NDI draft guidance sections

13-Jun-2022 By Stephen Daniells

The US Food & Drug Administration intends to release multiple draft guidance documents to the industry as smaller, discreet topics relating to New Dietary Ingredients (NDI), a senior figure said recently.

Sixth time still not a charm: FDA again rejects NDIN for kratom

02-Feb-2022 By Stephen Daniells

The FDA has again rejected a new dietary ingredient (NDI) notification for kratom, with one industry lawyer telling us he is not optimistic that anyone will achieve a successful NDI notification for the botanical.

Hofseth Biocare gets NDI nod from FDA for two ingredients

02-Dec-2021 By Stephen Daniells

Norways’s Hofseth BioCare (HBC) has successfully achieved New Dietary Ingredient (NDI) status from the US Food and Drug Administration for its patented CalGo and OmeGo branded products.

NPA’s Fabricant on CBD, NDI-related import alerts, and banned stimulants

01-Apr-2021 By Stephen Daniells

Efforts to move the needle on hemp-CBD at the Federal level are slow, and upcoming exits of key personnel at FDA are unlikely to affect progress much, says NPA’s Dr Daniel Fabricant. “In some ways I think FDA likes the status quo,” he tells NutraIngredients-USA.

STATE OF THE INDUSTRY SURVEY

NutraIngredients-USA survey on the state of the US Dietary Supplements industry in 2020

02-Dec-2020 By Stephen Daniells

How has Covid-19 affected business? Beyond immunity which categories were big winners in 2020? And did we learn anything about delivery formats this year?

FDA rejected oleander constituent as a new dietary supplement ingredient a month ago

09-Sep-2020 By Stephen Daniells

The US Food and Drug Administration rejected mid-August a New Dietary Ingredient notification from Phoenix Biotechnology Inc for oleandrin, a constituent of oleander touted as a COVID-19 cure.

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?

Is FDA open to entertaining an NDI for CBD products?

30-Jul-2020 By Stephen Daniells

The US Food and Drug Administration may be willing to sit down with a company about a possible NDI submission for full-spectrum hemp extracts, says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

NPA Fabricant on CBD, NDIs, FDA resuming inspections

24-Jul-2020 By Stephen Daniells

FDA has stated it is making ‘substantial progress’ with CBD, and a new enforcement guidance could be very significant for the industry, said NPA’s Dr Daniel Fabricant, but he said the Agency needs to ‘get in the game’ for NDIs.

Industry stakeholders lay out safety, regulatory challenges

23-Mar-2020 By Danielle Masterson

The Natural Products Association (NPA) recently held a webinar on political and legislative insights. At the forefront — the expansion of health savings accounts, new dietary new dietary ingredient enforcement, DSHEA, accurate labels, and Cannabidiol...

2020 predictions: Staff changes at FDA, CBD, personalization, and the microbiome

15-Jan-2020 By Stephen Daniells

The year is new and a lot of people are getting out their crystal balls. NutraIngredients-USA is no exception, and here are our top big issues that will impact the dietary supplements industry in this new decade.

30 things we learned at the 2019 IPA DC Workshop

04-Nov-2019 By Stephen Daniells

A booming global market with double digit growth rates, establishing an adequate intake for dietary microbes, and why the impending taxonomic changes to the genus Lactobacillus are like Y2K: These were just some of the topics covered during the fourth...

More enforcement, progress on NDI guidance called for in FDA funding bill

08-Aug-2018 By Hank Schultz

Lawmakers urged FDA to step up its enforcement actions and to finalize the NDI guidance via a funding package that passed the Senate last week.

ChromaDex-Elysium fight highlights glitches in NDI and GRAS processes

01-Sep-2017 By Hank Schultz

The tussle between ChromaDex and Elysium Health highlights again the curious dance between a New Dietary Ingredient Notification and a GRAS affirmation as a way to bring ingredients to market.

NDI draft guidance needs extensive revision, AHPA asserts

15-Dec-2016 By Hank Schultz

The current NDI draft guidance is unlikely to improve compliance or the quality of submissions and should be rewritten. That’s the opinion expressed by the American Herbal Products Association in comments it filed with FDA.

NPA urges FDA to back off in applying food additive standards

14-Dec-2016 By Hank Schultz

The Natural Products Association has urged FDA to cease its attempt to apply  food additive standards to dietary ingredients. To do so would create an undue burden on small business, many of which are represented by NPA.

NAI’s CEO: ‘Sports nutrition has been a wonderful place to act as a crucible for our innovation’

20-Oct-2016 By Stephen Daniells

With an established consumer following in the sports nutrition sector and new sustained release form just launched, Natural Alternatives International is looking at opportunities in seniors and military populations for its blockbuster CarnoSyn beta-alanine.

ChromaDex CEO says new NDI guidance could be tool to clean up marketplace

12-Oct-2016 By Hank Schultz

The NDI draft guidance offers a workable road map for companies willing to provide the safety information already called for by law, according to one ingredient supplier.

FDA extends NDI comment period to Dec. 12

04-Oct-2016 By Hank Schultz

The Food and Drug Administration has extended the comment period on the updated draft version of the New Dietary Ingredients guidance. The new deadline for comments is Dec. 12.

Special edition: botanicals

NDI guidance will dampen innovation in botanicals, experts say

22-Sep-2016 By Hank Schultz

The NDI draft guidance as written will squelch innovation in botanical ingredients, experts have said.

More NDI training needed: A pulse on the dietary supplements industry

20-Sep-2016 By Adi Menayang

More than half (56%) of dietary supplement professionals said they haven’t read the Aug. 11 NDI guidance—and 6% said they haven’t read it, but told their boss that they did.

From nanotechnology to master files, 5 things to think about from FDA's new NDI draft guidance

19-Sep-2016 By Adi Menayang

From ingredient combinations to supercritical CO2 extraction to nanotechnology, here are some things to note from the new NDI draft guidance FDA released Aug. 11.

NDIs: When to file, what FDA wants to see, and how companies can protect themselves

16-Sep-2016 By Dennis Raglin, partner at Rimon, P.C.

Over the last few years, the FDA has zeroed in on the dietary supplement industry.  It has taken numerous actions against dietary supplements where it believes the ingredients pose health risks to the public.  This scrutiny continues with the release...

Focus in NDI draft on supercritical CO2's 'newness' ignores its safety, quality, proponents say

31-Aug-2016 By Hank Schultz

Advocates of supercritical CO2 extraction are dismayed that FDA singled this process out in its updated draft guidance on New Dietary Ingredients. This results from an overzealous adherence to the precise letter of the law rather than a focus on safety,...

FDA’s new NDI draft guidance: ‘Not much that’s surprising’

15-Aug-2016 By Stephen Daniells

The new draft guidance for new dietary ingredient notifications is “more positive than negative”, says Steve Mister, CEO of the Council for Responsible Nutrition.

High NDI failure rate putting more emphasis on GRAS status for new ingredients

09-Feb-2015 By Hank Schultz

The high rate of failure in New Dietary Ingredient notifications has led some companies to seek workarounds. Anecdotal evidence gathered by NutraIngredients-USA shows that companies are increasingly leaning on GRAS status as a way to avoid having to enter...

New online option for NDI notifications could cut basic errors, expert says

17-Nov-2014 By Hank Schultz

The Food and Drug Administration has opened a public comment period on a proposed change that would allow the online submission of New Dietary Ingredient notifications.  The change could help clear up some confusion within the industry about what exactly...

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.

Jury's out whether recent data shows improvement in NDI picture

09-Jun-2014 By Hank Schultz

Preliminary figures from the American Herbal Products Association show that one in four recent New Dietary Ingredient notifications went through without objections from the Food and Drug Administration.  Whether that represents an improvement in the overall...

Warning letter to Exclusive Supplements shows NDI enforcement here to stay, experts say

13-Feb-2014 By Hank Schultz

FDA has again signalled its intention to hold companies’ feet to the NDI fire in a recently-posted warning letter to a company called Exclusive Supplements.  Among the many violations cited in the letter the agency specifically called out the company’s...

Letter from congressman asks FDA to ramp up NDI enforcement

01-Nov-2013 By Hank Schultz

A letter from the office of Texas congressman Steve Stockman to the Food and Drug Administration urges the agency to better police the filing of New Dietary Ingredient notifications.  The letter says that there are some ingredients in the market whose...

Synthetic versions of natural ingredients with NDI notifications crop up in marketplace

02-Oct-2013 By Hank Schultz

The question whether an NDI notification opens the door for follow on ingredients has yet to be definitively answered.  But sources say the question is a lot clearer when the putative follow on ingredient might not even be the same thing.

Does an NDI notification open door for me-too ingredients? Answer: It depends

08-Aug-2013 By Hank Schultz

Let’s assume you’ve done your homework on your new ingredient and have successfully filed a New Dietary Ingredient notification with the Food and Drug Administration.  Can a competitor launching a me-too product come along and trade on that status?  It’s...

House committee admonishes FDA to pick up pace on NDI issue

20-Jun-2013 By Hank Schultz

The US House of Representatives Appropriations Committee has sent a stern message to the Food and Drug Administration on the subject of the draft New Dietary Ingredients guidance.  The message in a nutshell: Get a move on.

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...

‘Uptick’ in GRAS interest suggests industry looking for NDI alternative

16-Jan-2012 By Stephen Daniells

An increase in GRAS (generally recognized as safe) determinations for an ingredient, and particularly self-affirmed GRAS, suggests that industry is looking at the alternatives to NDI notifications, but what are the consequences?

2011 IN PICTURES: DMAA, NDI draft guidance, 'killer' vitamins and SPACE (food), the final frontier

23-Dec-2011 By Elaine Watson

Krill wars, vitamins to send you to an early grave (well who reads beyond the headline, right?), DMAA, microalgae and space food. 2011 was an action-packed year, and with the NDI draft guidance hanging over the trade like the sword of Damocles, 2012 looks...

NDI draft guidance comments

Lawyer: NDI draft guidance raises ‘significant intellectual property issues’

12-Dec-2011 By Elaine Watson

Requiring supplement manufacturers to submit new dietary ingredient (NDI) notifications will force them to seek confidential information from suppliers in order to file submissions, according to law firm Amin Talati.

NDI draft guidance comments

IPA: We do not see NDI draft guidance as 'death sentence' for probiotics industry

09-Dec-2011 By Elaine Watson

The only probiotics that should be subject to new dietary ingredient (NDI) notifications should be “new probiotics derived from GM engineering which have little to no history of safe use”, according to the International Probiotics Association (IPA).