Dietary Ingredient

NPA withdraws FDA lawsuit following final NAC guidance, marketplace stabilization

02-Nov-2022 By Stephen Daniells

The Natural Products Association has dismissed its case against the US Food & Drug Administration following the Agency’s issuance of a final guidance for N-Acetyl Cysteine (NAC).

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.

NAC supplements back on Amazon

25-Aug-2022 By Stephen Daniells

After a hiatus of over a year, Amazon is again selling NAC-containing dietary supplement products. The development was described as exciting by one industry trade association.

NAC: New FDA guidance confirms Agency exploring potential of rulemaking

01-Aug-2022 By Stephen Daniells

The FDA appears to be moving ahead with a proposed rule to allow NAC (N-acetyl cysteine) as a dietary ingredient for use in supplements, according to a newly published guidance.

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.

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.

NPA sues FDA over NAC: ‘We’ve been left with no choice,’ says Fabricant

07-Dec-2021 By Stephen Daniells

The Natural Products Association (NPA) has filed a lawsuit in the US District Court for the District of Maryland requesting the Food and Drug Administration cease its “unlawful retroactive application of the Food, Drug, and Cosmetic Act” against N-acetyl-L-cysteine...

‘FDA kicked the can’: NPA & CRN slam Agency’s ‘tentative’ responses to NAC Citizen Petitions

24-Nov-2021 By Stephen Daniells

The Council for Responsible Nutrition and the Natural Products Association have slammed the Food and Drug Administration (FDA) for delaying a decision on the regulatory status of NAC (N-acetyl-L-cysteine) in dietary supplements, as the Agency issues ‘tentative...

NutraIngredients-USA Awards: Meet the Ingredients of the Year!

21-Jul-2021 By Stephen Daniells

The Ingredient of the Year categories honored the best and the brightest across a range of health endpoints, including beauty-from-within, cognition, healthy aging, prebiotic, sports nutrition, and weight management.

CRN: ‘This is not the final word on NAC’

11-May-2021 By Stephen Daniells

While Amazon moves ahead with removing NAC-containing dietary supplements from its website, the FDA’s Office of Dietary Supplement Programs (ODSP) acknowledges that it is still reviewing the information around the ingredient.

Representatives Schrader and Griffith re-introduce bipartisan CBD bill

05-Feb-2021 By Stephen Daniells

The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act has been re-introduced in the US House of Representatives with the aim of making hemp and hemp-derived CBD a dietary ingredient in dietary supplements.

Researchers zero in on supplement use among college athletes

08-Oct-2020 By Danielle Masterson

The high prevalence of dietary supplementation use in the athletic population means there is a risk of inadvertent doping for those users who don’t do their research or get their information from reliable sources.

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.

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.

Experts recommend kratom & CBD players file NDIs first, before asking for new product category

12-Dec-2016 By Hank Schultz

Some proponents of botanicals such as kratom or CBDs have chafed under regulatory restrictions that have forestalled wider acceptance and availability. But the full market is potentially available for those companies willing to go through accepted channels,...

Linnea requests FDA to withdrawal vinpocetine notice

15-Nov-2016 By Stephen Daniells

Ingredient supplier Linnea has added its voice to the vinpocetine issue, submitting comments requesting the FDA to withdraw the tentative conclusion that vinpocetine cannot be used as a dietary ingredient.

Trade groups urge FDA to reconsider stance on vinpocetine

08-Nov-2016 By Hank Schultz

Trade organizations representing the dietary supplement industry urged the Food and Drug Administration to reverse its tentative conclusion that vinpocetine, despite several successful NDI filings, is no longer a legal dietary ingredient.

Senator Hatch urges withdrawal of vinpocetine notice

04-Nov-2016 By Stephen Daniells

Dietary supplement champion Sen Orrin Hatch (R-UT) is calling for the withdrawal of a Federal Register Notice that questioned the regulatory status of vinpocetine as a new dietary ingredient.

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.  

FDA rules vinpocetine not a legal dietary ingredient despite successful NDI filings

08-Sep-2016 By Hank Schultz

In what has been called an ‘unprecedented’ move, the Food and Drug Administration has initiated a proceeding to take vinpocetine off the market despite a number of successful NDI notifications filed on the ingredient.

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...

Self-affirmed GRAS omitted from new NDI draft guidance

18-Aug-2016 By Stephen Daniells

The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.

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.

FDA warns 7 companies over methylsynephrine

04-Apr-2016 By Stephen Daniells

The US Food and Drug Administration has issued warning letters to 7 companies regarding a total of 8 products marketed as dietary supplements and containing methylsynephrine as a dietary ingredient.

FDA sends five warning letters over supplements containing picamilon

02-Dec-2015 By Stephen Daniells

The US Food and Drug Administration has sent warning letters to five companies marketing dietary supplements containing picamilon, a controversial substance that has risen to prominence in recent months.

‘An interesting interpretation’: Does a concentrate of an ODI need an NDI?

24-Nov-2015 By Stephen Daniells

A concentrate of an old dietary ingredient may need to file a new dietary ingredient notification, according to a new warning letter from the US Food and Drug Administration about bitter orange. 

Oregon AG suit raises risk for ingredients with fuzzy legal standing, experts say

26-Oct-2015 By Hank Schultz

The lawsuit filed by the Oregon Attorney General raises overall risk for the supplements industry and could mean that a number of niche ingredients could disappear from the market, experts said.

FDA: Picamilon is not a dietary ingredient

05-Oct-2015 By Stephen Daniells

Dietary supplements containing picamilon are considered adulterated by the US Food and Drug Administration, because picamilon is not a legal dietary ingredient, the Agency has told NutraIngredients-USA.

NDI draft guidance continues to inform FDA's enforcement thinking, latest DMBA warning letter shows

20-Aug-2015 By Hank Schultz

The Food and Drug Administration is continuing enforcement actions based on the precepts laid out in the draft guidance on New Dietary Ingredients with a warning letter sent to a company marketing a product that contains the stimulant-like ingredient...

FDA says BMPEA not a legal ingredient, sends warning letters to 5 companies listing stimulant on labels

23-Apr-2015 By Hank Schultz

The Food and Drug Administration announced Wednesday that it has banned the use of the stimulant BMPEA in dietary supplements and foods. The agency also sent five warning letters to companies that have used the variant of amphetamine in weight loss supplements. ...

Warning letters to CBD companies hinge on disease claims, sidestep issue of ingredient's legality

04-Mar-2015 By Hank Schultz

Four companies marketing dietary supplement products containing cannabidiol (CBD), a non-narcotic fraction of Cannabis sativa, received warning letters recently from the Food and Drug Administration.  But the letters said nothing about the status of CBD...

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...

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.

CRN submits comments to FDA on ‘chemically altered’ definition for NDIs

08-May-2013

The Council for Responsible Nutrition (CRN) has submitted comments to the FDA via international law firm Steptoe & Johnson, LLP, to address when an ingredient is chemically altered such that it would require a separate NDI notification.

Updated: AHPA: 'If the ingredient is not lawful, the agency has full authority to remove it from the market'

UNPA: 'DMAA shows DSHEA process has worked'. AHPA, ABC, CRN, NPA, USADA also respond to FDA stance

15-Apr-2013 By Stephen DANIELLS

The FDA’s stance that DMAA is not a dietary ingredient and its urging to consumers to avoid supplements containing the ingredient have been welcomed by key industry stakeholders, including USADA, ABC, UNPA, NPA, and CRN.

Is the game up for DMAA? Why the FDA crackdown raises more questions than answers…

03-May-2012 By Elaine Watson

They’ve had the sword of Damocles hanging over their heads for months. So when 10 firms selling DMAA supplements were finally told to put up or shut up by the FDA last week, it looked like the game might finally be up for the controversial stimulant.

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”.  

Mister on NDI guidance: ‘We are terribly disappointed.’

06-Jul-2011 By Elaine Watson

The amount of safety data the FDA now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified DSHEA and establishes a process “ominously like the one for new food additives”, the Council...