Fda

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,...

DolCas gets ‘good day letter’ from FDA for GRAS status of BCM- 95 curcumin

28-Jul-2017

The US Food and Drug Administration has issued a ‘No Questions’ response letter to DolCas BioTech, LLC, for its BCM-95 turmeric extract.

NPA petitions FDA to shelve new nutrition, supplement facts labeling rule

20-Jun-2017 By Adi Menayang

Citing the Trump Administration’s policy to severely cut new and pending regulations, the National Products Association (NPA) petitioned the FDA to shelve the Obama-era proposed Nutrition and Supplement Facts labeling, calling it ‘poorly-written, rushed,...

Soup-To-Nuts Podcast: FDA & FTC move forward with enforcement even with some regulations in limbo

02-Jun-2017 By Elizabeth Crawford

New regulations and draft guidances may be on hold at many federal agencies until the Trump administration can find its footing, but enforcement by FDA, FTC and USDA is not – and neither is litigation related to how food and beverages are made and marketed...

ABA: Fiber suppliers are stuck in a 'holding pattern'

Nutrition Facts overhaul proves double-edged sword for inulin

30-May-2017 By Elaine Watson

The arrival of the new-look Nutrition Facts panel (which will require manufacturers to list added sugar), is generating renewed interest in inulin: a widely-used ingredient from chicory root that also serves as a sugar replacer. But this enthusiasm is...

FDA moves to organize inspectors along lines of expertise

17-May-2017 By Hank Schultz

A move by newly confirmed FDA commissioner Scott Gottlieb to reapportion FDA inspectors along lines of expertise has been welcomed as potentially improving the effectiveness of the inspection process.

Does FDA underestimate the time, resources spent on regulatory compliance?

21-Apr-2017 By Stephen Daniells

The Food and Drug Administration is underestimating the amount of time and resources the supplement industry spends annually complying with government regulations, including current good manufacturing practices (cGMPs). 

Enforcement likely to continue under Trump, with state AGs waiting in wings if it falters

24-Feb-2017 By Hank Schultz

The pace of FDA enforcement is unlikely to change under the Trump administration, at least in the near term, a former staffer has told NutraIngredients-USA.

Louisiana manufacturer hit with permanent injunction to stop distribution of adulterated supplements

17-Feb-2017

The US Department of Justice has filed a proposed consent decree that permanently instructs Louisiana-based Pick and Pay, Inc./ Cili Minerals LLC to stop distributing misbranded and unapproved new drugs and misbranded and adulterated dietary supplements.

Groups call for deep revision or outright rejection of FDA fiber guidance

15-Feb-2017 By Hank Schultz

FDA’s draft guidance on dietary fiber should be significantly amended or tossed out altogether, according to industry trade groups. But at least one company that has been affected by the process believes it adds value to the marketplace.

Hiring freeze at FDA dims view of industry as adequately regulated, experts say

02-Feb-2017 By Hank Schultz

A hiring freeze put into place by Pres. Trump could damage efforts to make the case that the dietary supplement industry is effectively regulated, experts say.

FDA offers to help industry draft guidance following Trump’s regulatory freeze

01-Feb-2017 By Elizabeth Crawford

Days after President Trump signed an executive order that freezes some regulations and draft guidance documents, FDA offers to help food industry associations draft their own guidance documents to help “capture the best practices” and boost industry compliance...

Hi-Tech founder claims his devotion to DMAA is part of crusade against regulatory overreach

27-Jan-2017 By Hank Schultz

Amid reports that new products containing the banned stimulant ingredient DMAA continue to find their way onto the market one company has persisted in marketing them openly.

Sen McCaskill calls on FDA to quickly finalize NDI guidance

16-Dec-2016 By Stephen Daniells

Senator Claire McCaskill (D-MO) is frustrated with bureaucratic delays to the New Dietary Ingredient (NDI) draft guidance, and is calling on the FDA to quickly finalize the document.

First take on NDI comments: Guidance will stifle innovation without increase in safety

13-Dec-2016 By Hank Schultz

Comments on FDA’s NDI guidance have flooded in, and several themes have emerged. Commenters observed that the guidance will stifle competition, is overburdensome and will contribute little to the overall safety of dietary supplements.

FDA releases adverse events data for supplements, foods, and cosmetics

07-Dec-2016 By Stephen Daniells

Motivated by transparency, the US Food and Drug Administration has released tens of thousands of adverse event reports for dietary supplements, but does the data actually allow for any conclusions to be drawn?

Bodybuilding.com urges FDA to reinstate GRAS self affirmation exemption in NDI guidance

23-Nov-2016 By Hank Schultz

Dietary supplement retailer bodybuilding.com has asked the FDA to reaffirm the exemption that self-affirmed GRAS ingredients have from the NDI notification provision. The company has also suggested changes to the NDI master file idea and has asked the...

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.

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.

Comments in FDA docket reveals consumers’ shifting perceptions of ‘healthy’

01-Nov-2016 By Elaine Watson

If the FDA’s decision to wade into the ‘natural’ debate seemed like an act of sadomasochism, its decision to re-examine the criteria underpinning ‘healthy’ claims on food labels looks set to be equally painful, judging by the first wave of public comments...

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.

FDA hints at how conventional foods can make structure/function claims

21-Sep-2016 By Elizabeth Crawford

For the first time, FDA weighs in on what marketers must have on hand to support claims about conventional foods’ direct impact on consumers’ bodies. 

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 investigating supplements with unsafe lead levels

31-Aug-2016 By Joseph James Whitworth

The US Food and Drug Administration (FDA) is investigating a dietary supplement found to contain dangerous lead levels.

Embracing the future: The dietary supplement industry comes of age

25-Aug-2016 By Duffy MacKay, senior vice president, scientific and regulatory affairs, CRN

Duffy MacKay of CRN argues that there is much in FDA's newly released New Dietary Ingredients draft guidance that represents a step forward for the industry.

Updated FDA marijuana Q&A hems in use of CBD still further

15-Aug-2016 By Hank Schultz

Marketers of CBD-containing dietary supplements have long held out the hope that the status of hemp as a food in the US could provide some regulatory cover. A newly-released clarification by the Food and Drug Administration seems to cast further doubt...

Senator slams FDA final rule on GRAS: ‘a self-graded take home exam that industry doesn’t even have to hand in’

15-Aug-2016 By Elaine Watson

New FDA rules clarifying the process by which ingredients are deemed generally recognized as safe (GRAS) have been welcomed by some stakeholders, but harshly criticized by others, who say any system allowing firms to self-determine the safety of their...

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.

AstaReal claims Algae Life overstating case on astaxanthin claims

23-Jun-2016 By Hank Schultz

A claim by Algae Life Sciences that it now has 239 health claims on its algal astaxanthin that have been ‘allowed’ by FDA provoked a sharp reaction from competitor AstaReal.

FDA takes company to task over medical food for macular degeneration

16-Jun-2016 By Hank Schultz

A warning letter from FDA emphasizes again that medical foods must meet very specific requirements in order to qualify for that status.

NutraIngredients-USA’s Top 5 most-read articles of 2016… so far

02-Jun-2016

CBD warning letters, Capstone’s lawsuit against MusclePharm, multivitamin science, and negative media dominate the most-read list of 2016 to date.

ProbioTech’s citizen petition calls for probiotic suppository to be included in supplement definition

28-Apr-2016 By Adi Menayang

The FDA defines supplements as something ingested. ProbioTech is petitioning an amendment to the Dietary Supplement Health and Education Act 1994 (DSHEA) to ensure that suppositories are included in the definition as well.

GRAS process for evaluating ingredient safety threatens FDA’s mission, Sen. Markey argues

27-Apr-2016 By Elizabeth Crawford

The “loose structure” and voluntary process for companies to self-determine if new ingredients are “generally recognized as safe” without required input from FDA undermines the agency’s ability to ensure the US food supply is safe and should be strengthened,...

DNA barcoding is a critical part of improving the industry’s quality program, says NY AG’s office

18-Apr-2016 By Stephen Daniells

The New York Attorney General’s Office believes DNA barcoding is still critical for testing herbal supplements, despite new studies showing the inadequacies of the technology.

FDA ‘appreciates’ CRN’s product registry efforts

15-Apr-2016 By Stephen Daniells

The US Food and Drug Administration tells NutraIngredients-USA that it looks forward to learning more about the Council for Responsible Nutrition’s proposed industry-wide dietary supplement product registry.

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.

A relative formality? Trades request elevation of DDSP to ‘Office’ within FDA

04-Dec-2015 By Stephen DANIELLS

The five main trade associations have signed a letter to members of Congress requesting that the FDA’s Division of Dietary Supplement Programs be elevated to an ‘Office’.

‘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. 

Jarrow Rogovin: ‘This is a period of opportunity for the industry’

11-Nov-2015 By Stephen DANIELLS

Following a recent meeting with high ranking FDA officials, Jarrow Rogovin, President/Founder, Jarrow Formulas, Inc, says that the dietary supplements industry has an historic opportunity to negotiate with the agency.

What is 'natural'? FDA finally weighs into the debate

FDA seeks comments on use of the term ‘natural’ on food labels

10-Nov-2015 By Elaine Watson

Having studiously avoided this food labeling minefield for years, the Food and Drug Administration (FDA) has surprised many in the trade by seeking comments on the definition of a word that has launched a thousand class action lawsuits (well almost):...

Dr Cohen, CSPI & CRN join Attorneys General to discuss herbal supplements

05-Nov-2015 By Stephen Daniells

Attention from State Attorneys General is expected to continue and even increase, with a recent meeting of the National Association of Attorneys General’s in St Louis hosting a public session on herbal supplements.

Special edition: Regulatory Focus

Sharfstein floats new regulatory framework dialing in on safety and backing off on claims

03-Nov-2015 By Hank Schultz

Former FDA official Dr Joshua Sharfstein, MD, has proposed a new paradigm for the regulation of dietary supplements. The underlying shift would be a move from an attitude of “benefit versus risk” to one of “access with safety.”

General Mills blasts ‘unprecedented’ FDA added sugars proposal: ‘We respectfully ask FDA to pause’

30-Oct-2015 By Elaine Watson

Food manufacturers remain sharply divided over FDA proposals to crack down on added sugar, with General Mills and other big names such as Kellogg and Unilever strongly opposed; and Nestlé, Mars, and KIND LLC in favor, according to the latest wave of comments...

Special edition: Regulatory Focus

FSMA addresses a gap between dietary supplements and dietary ingredients

22-Oct-2015

Attorney Jason Sapsin shows how new FSMA rules apply directly to dietary ingredient firms that were exempted from GMP requirements that apply to supplement companies.

Sen McCaskill calls for vinpocetine and picamilon supplements to be pulled from shelves

06-Oct-2015 By Stephen Daniells

Senator Claire McCaskill, the ranking member of the US Senate Special Committee on Aging, has called for the FDA to suspend sales of supplements containing vinpocetine and picamilon pending an investigation.

McCaskill opens inquiry into brain health supplements targeting seniors

17-Jun-2015 By Stephen Daniells

US Senator Claire McCaskill (D-MO) has sent letters to the Food and Drug Administration and 15 major retailers after launching an inquiry into products, regulations, and retailers in the dietary supplement industry that specifically market to seniors...

FDA's decision on CBD likely to be overturned after more info comes in, exec says

26-May-2015 By Hank Schultz

An executive with one of the companies promoting cannabidiol for dietary supplements believes that FDA’s recent determination that the compound is not a legal dietary ingredient is premature and will be overturned.

‘A valuable addition to QC’: FDA GutProbe may help verify accurate labelling in commercial probiotics

19-May-2015 By Stephen Daniells

A custom DNA microarray may provide a ‘quick, more accurate, and inexpensive’ method for identifying microbials and probiotics in dietary supplements, say the FDA researchers who developed the technique.

Extending GMPs to ingredient suppliers would fix gap in original rule, stakeholders say

18-May-2015 By Hank Schultz

A recently filed citizen's petition asking FDA to extend GMP requirements to ingredient manufacturers met with a cautious but generally positive reception among industry stakeholders. Having ingredient suppliers stand outside this aspect of the law...

Organic and non-gmo trends

Congress should strengthen FDA’s oversight of GMOs, CSPI leader says

23-Apr-2015 By Elizabeth Crawford

Congress needs to strengthen FDA’s oversight of genetically modified organisms before foreign countries, with potentially lower safety standards, begin genetically engineering crops used in finished products that are imported to the U.S., argues an executive...