New Dietary Ingredient

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.

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...

FDA seizes Chinese imports over NDI status

16-Mar-2021 By Hank Schultz

The US Food and Drug Administration has issued an import alert and seized products from two firms that were deemed to be offering New Dietary Ingredients that have not gone through the notification process.

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.

NAXA attacks Cardax’s synthetic astaxanthin via citizen’s petition

29-Nov-2017 By Hank Schultz

The Natural Algae Astaxanthin Association has filed a citizen’s petition that seeks regulatory action by FDA against a synthetic form of astaxanthin marketed by Cardax.

Study finds 'next DMAA' in tainted sports, weight loss products

09-Nov-2017 By Hank Schultz

A research report by a group led by prominent supplement industry critic Dr Pieter Cohen MD, found DMAA and three similar stimulant-like compounds in dietary supplement-like products purchased on the open market.

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.

FDA continuing to drill down to provenance of ingredients

07-Jul-2017 By Hank Schultz

Recent warning letters show the Food and Drug Administration continues to hone in on the provenance of ingredients, and demonstrate that the tempo of enforcement remains unchanged despite the moves by the Trump Administration to roll back regulations...

Acacia rigidula still popping up on market

31-Mar-2017 By Hank Schultz

Acacia rigidula-containing products continue to find a place in the market, as a recent warning letter shows. 

NPA requests one-year extension to vinpocetine comment period

05-Oct-2016 By Stephen Daniells

The Natural Products Association has called on the US Food and Drug Administration to extend the comment period on the status of vinpocetine until September 6, 2017.  

UNPA on the NDI draft guidance: ‘The economic cost to industry could be billions of dollars’

22-Aug-2016 By Stephen Daniells

In addition to the areas that require clarification, the dietary supplement industry should look carefully and cautiously at the revised draft guidance for new dietary ingredient notifications, specifically at the economic impact of the FDA's new...

US Marshals seize $150,000 of kratom

05-Aug-2016 By Stephen Daniells

US Marshals Service have seized over 100 cases of products labeled as containing kratom in California, the US Food and Drug Administration has announced.

DMAA: Almost 40 products still commercially available with the controversial ingredient

16-Oct-2015 By Stephen DANIELLS

Thirty nine products containing controversial ingredient DMAA are commercially available in the US, according to the Human Performance Resource Center.

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...

Nutrition 21 self-affirms GRAS status of its inositol-stabilized arginine silicate (Nitrosigine)

03-Oct-2014

An expert panel has affirmed the generally recognized as safe (GRAS) status of Nutrition 21’s Nitrosigine ingredient for use in nutritional bars and beverages at daily doses up to 1,500 mg.

Rock Creek suspends Anatabloc sales while it tries to resolve NDI issue

13-Aug-2014 By Hank Schultz

Rock Creek Pharmaceuticals, formerly doing business as Star Scientific, has suspended the sale of its Anatabloc antioxidant dietary supplement based on anatabine, a molecule found in cauliflower and other foods. The company said it is attempting to clear...

Nascent 100% confident in the quality and safety of its PQQ, despite FDA safety concerns

05-May-2014 By Stephen DANIELLS

Nascent Health Sciences has resubmitted a New Dietary Ingredient notification (NDIN) for its PureQQ pyrroloquinoline quinone ingredient following a negative response from the FDA first time around, and the company stands by the safety of its product....

Kratom distributor recalls all products in wake of FDA import alert

18-Mar-2014 By Hank Schultz

SNI National has voluntarily recalled all of its products that contain kratom, an ingredient whose legality has been questioned by the Food and Drug Administration.

Warning letter underscores FDA view of extraction and concentration as factors in NDI status

03-Jan-2014 By Hank Schultz

A warning letter from FDA to Star Scientific, makers of an antioxidant supplement called Anatabloc, underscores again the agency’s focus on the status of New Dietary Ingredients.

Mitsubishi's open letter to industry on PQQ

02-Oct-2013

Dear colleague, With a vested interest in the viability of the industry, we believe that you want to be well informed, and it is in that spirit that we are writing to you today.

House Energy & Commerce Committee members call on FDA to ‘re-examine’ NDI draft guidance

30-Mar-2012 By Stephen Daniells

Select members of the highly influential House Energy & Commerce Committee have written to FDA calling for a 'significant reworking' of the controversial new dietary ingredient (NDI) draft guidance.

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.

FDA passes 12 mg New Dietary Ingredient petition for astaxanthin

16-Sep-2011 By Stephen Daniells

The US Food and Drug Administration (FDA) has issued permission for an increase in the daily serving for astaxanthin from 7.8 mg to 12 mg, following a successful petition by Cyanotech.

FDA grants comment period extension for NDI draft guidance

08-Sep-2011 By Stephen Daniells

The US Food & Drug Administration (FDA) has granted a 60-day extension to the comment period for the New Dietary Ingredient (NDI) draft guidance, NutraIngredients-USA.com can reveal.

Aker BioMarine gets NDI notification from FDA for krill oil

24-May-2011 By Stephen Daniells

The US Food & Drug Administration (FDA) has no objections regarding Aker BioMarine’s New Dietary Ingredient Notification process (NDIN) for its Superba Krill Oil ingredient.

Vegetarian chitin-glucan gains global deal

11-Feb-2010 By Shane Starling

Missouri-based Novus International offshoot, Stratum Nutrition, has signed a global deal with biotech firm, KitoZyme, to exclusively distribute the Belgian company’s vegetarian, chitin-glucan ingredient in the nutra space.

Brain health ingredient switches from drug to supplement route

28-Jul-2009 By Lorraine Heller

A Canadian pharmaceutical firm is asking the US Food and Drug Administration (FDA) to approve a new supplement ingredient, which has demonstrated brain health benefits – one year after the firm withdrew its application for it to be approved as a drug.