New Dietary Ingredients

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.

FDA issues final guidance on NDIN procedures, timeframes

05-Mar-2024 By Stephen Daniells

The Food and Drug Administration (FDA) has finalized guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry".

FDA announces enforcement discretion, amnesty window on missing NDI filings

19-May-2022 By Hank Schultz

FDA announced today that intends to exercise enforcement discretion on missing New Dietary Ingredient Notifications. The Agency also set up a new portal to allow companies to more easily come into compliance by filing the notifications that they should...

Bar association panel takes FDA to task over NDI enforcement

01-Feb-2022 By Hank Schultz

A perplexing attitude towards enforcement on the part of federal regulators leaves the dietary supplement industry with little incentive to file New Dietary Ingredient Notifications, participants in a legal panel asserted recently.

Lawmaker’s letter to FDA demands clarity on NAC issue

29-Oct-2021 By Hank Schultz

Rep. Jeff Duncan, R-SC, sent a strongly worded letter to FDA yesterday requesting clarity on the matter of NAC, NDI enforcement and other matters.

FDA lists NDI update among priorities for coming year

30-Jun-2021 By Hank Schultz

Publishing a revised version of the NDI Draft Guidance has made a list of FDA priorities for the coming year. Industry observers welcomed the news, but questioned how much impact it might have if enforcement priorities remain as they are.

As a result of GRAS process FDA has no idea of what's on market, say paper's authors

08-Apr-2021 By Hank Schultz

A recent paper claims FDA is in the dark as to how many new ingredients have come onto the market via the GRAS process. Only limited progress has been made in the decade since a Congressional report first raised the issue and directed the Agency to make...

NPA urges FDA to stem tide of counterfeit products, move forward on CBD

07-Jan-2021 By Hank Schultz

Federal regulators could do more to protect consumers by using existing import authorities as well as moving forward on hemp/CBD regulation, the National Products Association has said.

Warnings about cesium demonstrate difficulty of getting questionable ingredients off market

26-Oct-2020 By Hank Schultz

The US Food and Drug Administration has sent warning letters to five supplement companies about the sale of cesium chloride products, which the Agency said present significant health risks. The products have been a concern for several years.

FDA’s Tave: Mandatory product listing would be ‘a dramatic step forward in narrowing the regulatory gap’

15-Oct-2020 By Stephen Daniells

“We cannot enforce against what we cannot see or cannot know is there”, said FDA’s Steven Tave, and that’s why mandatory listing requirement for dietary supplement products would be a step forward for enforcement.

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.

Inconsistencies between NDI, GRAS raised in letter to FDA

06-Jan-2020 By Hank Schultz

A letter from a member of Congress to FDA calls into question the inconsistencies between the NDI process and how GRAS submissions are evaluated and the lack of communication between the staffs working on these issues.

Significant change in FDA's approach to ODI list needed, AHPA chief says

09-Oct-2017 By Hank Schultz

The American Herbal Products Association has put forward recommendations on how a list of Old Dietary Ingredients can best be assembled.

PEAs harder to control than were steroids, experts say

30-Mar-2017 By Hank Schultz

The presence and proliferation of phenylethylamines in sports nutrition products continues to be a thorn in the side of the dietary supplement industry.  But trying to regulate these ingredients away is not nearly as straightforward as was the case with...

UNPA brands FDA's finished product focus in NDI guidance as unworkable and unlawful

16-Dec-2016 By Hank Schultz

Requiring NDI notifications on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products Alliance said.

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.

Industry finds new supporter in meeting with Rep. Ted Lieu, D-CA

09-Mar-2015 By Hank Schultz

The dietary supplement industry received a welcome breath of fresh air in a meeting of industry representatives with Rep. Ted Lieu, the newly elected Democrat in California’s 33rd Congressional District.  The meeting was arranged by Jarrow Formulas and...

Guest article

UNPA: On a host of issues, it's back to the future in 2015

08-Jan-2015 By Loren Israelsen, president of the United Natural Products Alliance

On the cusp of its 30th anniversary, there’s been a lot of talk about the look forward provided by the 1985 movie, Back to the Future. A similar look back at the natural health products industry to see the future is not such a far-fetched idea. A number...

Guest article

Goin’ Back in Time with DSHEA

27-Oct-2014 By Steve Mister, president and CEO for the Council for Responsible Nutrition (CRN)

It’s 1994 all over again—The Lion King just came out; everyone is talking about the Nancy Kerrigan incident, and the police are chasing O.J. Simpson’s white Bronco down the L.A. freeway. Meanwhile, back in Washington, Congress is crafting legislation...

Prochnow: GMPs, NDIs and liquid supplements among prominent regulatory concerns for 2014

09-Jan-2014 By Hank Schultz

Attorney Justin Prochnow has made a career of reading the FDA tea leaves for his clients. As the industry enters 2014, he sees a long-term trend of GMP enforcement and nascent guidances on New Dietary Ingredients and liquid dietary supplements as the...

Reaction to CFSAN's priorities for 2013-14

UNPA: Does CFSAN’s plan for GMO labeling guidance signal a change of thinking at FDA?

08-Oct-2013 By Stephen DANIELLS

The Center for Food Safety and Applied Nutrition's (CFSAN) priority to publish guidance to help manufacturers with voluntarily GMO labeling could signal a change in thinking at the agency, says the United Natural Products Alliance (UNPA).

Regulatory blues: 2011 in the dock

19-Dec-2011 By Elaine Watson

While a certain draft guidance document on new dietary ingredients (NDIs) has grabbed all of the headlines, it has not been the only issue keeping the sector’s regulatory affairs experts awake at night.

Exclusive interview

Fabricant: Gap between NDI numbers and submissions is too big 'no matter how you slice it'

13-Oct-2011

It might be controversial, but the FDA's draft guidance on new dietary ingredients (NDIs) does not mean the end of the dietary supplements trade as we know it, insists Daniel Fabricant in an exclusive interview with NutraIngredients-USA at SupplySide...

July 2011 in pictures: Mozart, vitamin D and a certain draft guidance document …

03-Aug-2011 By Elaine Watson

So much for lazily easing into summer. July had barely begin when the FDA dropped a bombshell on the dietary supplements trade just as the holiday weekend kicked off, with the publication of its long-awaited draft guidance on new dietary ingredients ...

Toxicologist: FDA’s NDI guidance is entirely reasonable

13-Jul-2011 By Elaine Watson

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...

Probiotic NDIs: Leading groups argue for genus/species vs strain

08-Jun-2011 By Stephen Daniells

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.

Successful supplement companies fully understand DSHEA

26-Jul-2004

The FDA is fulfilling its role and ensuring that new dietary
ingredients (NDIs) are safe before they reach the market, according
to an article in the Food and Drug Law Journal (FDLJ), but the
supplement industry as a whole still needs...