Fda

FDA files motion to dismiss suit, defends FSMA implementation record

12-Dec-2012 By Hank Schultz

FDA has filed a motion to dismiss a lawsuit that sought to prod the agency into faster implementation of the Food Safety Modernization Act (FSMA).  But regardless of whether full implementation is accelerated, FSMA has already significantly altered the...

Hershey antioxidant labeling claims under spotlight in US court

19-Nov-2012 By Oliver Nieburg

Hershey is to face a lawsuit over antioxidant labeling claims made on its Special Dark Cocoa and Special Dark Kisses.

Is finished product testing the next big wave in GMP warning letters?

14-Nov-2012 By Stephen DANIELLS

Once GMP inspectors from the FDA move beyond the first tier of GMP compliance, the next big wave of warning letters from the agency could be on the issue of finished product testing, says a leading quality and regulatory expert.

FDA develops rapid screening for adulterants in weight loss products

02-Nov-2012 By Stephen DANIELLS

Scientists from the US Food and Drug Administration (FDA) have developed a rapid procedure to screen for adulterants in weight-loss products, which could benefit the industry by impacting the ‘rate at which these adulterated products find their way to...

FDA enforcement: Consent decree for GMP violations and an injunction for disease claims

26-Oct-2012 By Stephen Daniells

An Oregon herb and supplement manufacturer has been slapped with a permanent injunction for disease claims on products, while a NY supplement manufacturer has agreed to stop activities following repeated cGMP violations, as the FDA continues to use the...

Good 483 responses can squelch warning letters

24-Sep-2012 By Hank Schultz

Good responses to 483 can avoid a warning letter.  Including in those responses key elements of organization and documentation can improve the chances for success, an experts say.

Top analyst predicts FDA wriggle room in supplement-beverage guidance

21-Sep-2012 By Ben Bouckley

With the US Food and Drug Administration (FDA) poised to publish guidance on distinguishing between beverages and liquid dietary supplements, one analyst tells BeverageDaily.com he doesn’t see the agency cracking down too hard on traditional energy drinks.

Have a game plan for GMP inspections, experts say

18-Sep-2012 By Hank Schultz

A company going into a GMP audit is like a football team on the eve of a pivotal contest.  It’s best to have a game plan, experts say.

Durbin, Blumenthal send second letter to FDA seeking action on energy drinks

13-Sep-2012 By Hank Schultz

Sens. Dick Durbin and Richard Blumenthal have sent another letter to FDA inquiring about the regulation of energy beverages.

GMPs forum to bring together industry, FDA

10-Sep-2012 By Hank Schultz

Good Manufacturing Practices inspections have been a fact of life in the dietary supplement industry for more than five years now, and still some companies struggle with compliance. An event to be held this week by a Colorado-based consultancy aims to...

Will the market or FDA deliver the final blow for DMAA?

10-Sep-2012 By Stephen Daniells

There is a moment at the end of the legendary computer game, Mortal Kombat, where you have just beaten seven shades of something out of your opponent and all that is left is one final blow. ‘Finish him!’ says the game, and you ready your thumbs for the coup...

Will the FDA revise its stance on synthetic botanical constituents? It’s not looking promising…

30-Jul-2012 By Elaine WATSON

Firms hoping the FDA might change its unpopular stance on synthetic copies of botanical constituents as it rewrites its draft guidance on new dietary ingredients (NDIs) could be disappointed.

AHPA responds to Sen. Durbin-Blumenthal cGMP questions

25-Jul-2012 By Stephen Daniells

The American Herbal Products Association has responded to Senators Durbin and Blumenthal to outline current and future initiatives to support its members’ efforts to comply with current good manufacturing practices (cGMPs).

Updated: Associations welcome Durbin-Blumenthal cGMP dialogue & FDA explains GMP violation stats

12-Jul-2012 By Stephen DANIELLS

The Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) have welcomed requests from Senators Durbin and Blumenthal to outline cGMP education initiatives, but questions have been raised as to the numbers cited by FDA officials...

Nutratech reports surge in interest in bitter orange as firms seek to replace DMAA

06-Jul-2012 By Elaine Watson

Nutratech - the firm behind patented bitter orange (Citrus aurantium) extract Advantra Z - has seen a surge in enquires from manufacturers looking for alternatives to DMAA in the wake of the FDA’s crackdown on the controversial stimulant.

Jarrow calls for Congressional hearings to address NDI guidance woes

19-Jun-2012 By Elaine Watson

Jarrow Formulas has raised its concerns about the FDA’s draft guidance on new dietary ingredients (NDIs) with House Speaker John Boehner as part of its campaign to alert members of Congress to the dangers the “fatally flawed” document presents to the...

Many ‘Grapefruit Seed Extracts’ adulterated with synthetic disinfectants, says nonprofit research consortium

06-Jun-2012 By Stephen Daniells

The majority of products containing 'grapefruit seed extracts' may be adulterated with synthetic additives, according to a new review from a nonprofit research consortium.

Attorney: Revised green tea health claim another ‘value laden subjective judgment’ from FDA

07-May-2012 By Elaine Watson

The Food and Drug Administration (FDA) has drafted revised wording for a qualified health claim about green tea and breast/prostate cancer after being taken to task by a judge in Connecticut over the wording of its previous efforts.

DMAA latest: 14 class action suits now filed by CA law firm - but speed may not be of the essence, predicts expert

04-May-2012 By Elaine Watson

The law firm responsible for the flurry of class action lawsuits against 10 firms named by the FDA in its DMAA crackdown last week has now targeted four other firms selling products containing the 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”.  

Dan Fabricant: FDA ‘somewhat aghast’ at degree of cGMP non-compliance

26-Apr-2012 By Elaine Watson

The level of non-compliance with dietary supplement cGMP (current good manufacturing practice) regulations has left Food and Drug Administration (FDA) officials “somewhat aghast”, according to the agency’s supplements division boss.

Green tea qualified health claim ruling: ‘Once again FDA is taken to task…’

15-Mar-2012 By Elaine Watson

A Food and Drug Administration (FDA) qualified health claim about green tea and the risk of breast and prostate cancer is so strongly worded that it “effectively negates” the claim it is designed to qualify and violates the first amendment, a judge has...

‘Inhalable’ caffeine shot maker agrees to amend marketing after FDA warning

07-Mar-2012 By Elaine Watson

The firm behind ‘breathable’ caffeine shot AeroShot Energy has promised to amend its marketing to make it clear that it should be ingested – and not inhaled – following a warning letter from the Food and Drug Administration (FDA).

Fuji gets green light from FDA for 12mg/day dosage for AstaREAL astaxanthin

24-Feb-2012 By Elaine Watson

Fuji Health Science has received a no objections letter from the US Food and Drug Administration (FDA) responding to its new dietary ingredient (NDI) notification to up the permitted daily dosage of its AstaREAL branded astaxanthin to 12mg/day.

FDA: Proposed rule on changes to Nutrition Facts panel due by end of 2012

24-Feb-2012 By Elaine Watson

The Food and Drug Administration (FDA) is aiming to publish a proposed rule to reform the Nutrition Facts panel and related rules by the end of this year, somewhat later than originally expected.

cGMP compliance, time bombs and the ‘ten-ton elephant in the room’

24-Jan-2012 By Elaine Watson

An analysis of recent Food and Drug Administration (FDA) warning letters has exposed several ‘ten ton elephants in the room’ and ‘time bombs waiting to go off’ when it comes to cGMP (current good manufacturing practice) compliance, according to one leading...

Ullman: NDI draft guidance withdrawal unlikely, but industry deserves timely response

20-Dec-2011 By Elaine Watson

While it is possible that the FDA could withdraw its draft guidance on new dietary ingredients (NDIs), such a move would be “highly unusual”, according to one leading food law attorney.

Jarrow: FDA's talk of spiked supplements in context of NDI debate is 'highly disingenuous'

14-Dec-2011 By Elaine Watson

Food and Drug Administration (FDA) references to safety concerns over supplements spiked with drugs in the context of the debate on new dietary ingredients (NDIs) are “highly disingenuous”, Jarrow Formulas has argued.

NDI comments review: Industry urges FDA back to the drawing board

09-Dec-2011 By Stephen Daniells & Claire Videau

One week on from the deadline for submission of comments on the FDA’s new dietary ingredients (NDI) draft guidance, we review the comments.

NDI draft guidance comments

CRN on NDI draft guidance: ‘A choir has many voices but we’re all singing the same song ‘

02-Dec-2011 By Elaine Watson

There will be differences in emphasis in comments submitted to the FDA on its draft guidance on new dietary ingredients (NDIs), but the overall message from the supplements industry is clear - and consistent - says the Council for Responsible Nutrition...

Jarrow Formulas FOIA request on NDIs: ‘In sum, FDA has told us to drop dead’

28-Nov-2011 By Elaine Watson

Jarrow Formulas is still waiting for a “substantive response” from the Food and Drug Administration (FDA) to a Freedom of Information Act (FOIA) request submitted more than two months ago about the FDA’s draft guidance on New Dietary Ingredients (NDIs).

Warning Letters continue as FDA maintains cGMP vigilance

23-Nov-2011 By Stephen Daniells

The US Food and Drug Administration (FDA) has issued two warning letters in November for alleged dietary supplement cGMP violations, as the agency maintains its vigilance.

ProCaps Laboratories: FDA is wrong about free phytosterols

08-Nov-2011 By Elaine Watson

Supplement maker ProCaps Laboratories has weighed into the row over whether dietary supplements containing ‘free’ non-esterified phytosterols should be allowed to make coronary heart disease risk reduction claims.

POLL results: We need a clearer definition of natural... and the FDA should come up with it

07-Nov-2011 By Elaine Watson

We need a formal definition of ‘natural’ to ensure it is used more consistently in food labeling and marketing– and the FDA should provide it - according to the results of the latest FoodNavigator-USA/NutraIngredients-USA poll.

Special Edition: SupplySide West

01-Nov-2011 By Stephen Daniells

NDI draft guidance, market opportunities, adulteration, a perceived lack of innovation, and the specter of ‘dry labbing’ all got people talking at this year’s SupplySide West show in Las Vegas.

Poll: Do we need a clearer definition of ‘natural’?

28-Oct-2011 By Elaine Watson

In the world of food marketing, perception is everything. Consumers want foods that sound wholesome, friendly, and above all “natural” – although they are rarely able to articulate what this means.

EAS to set ‘new standard’ in sports nutrition quality

26-Sep-2011

EAS Sports Nutrition is taking a step further in the manufacturing of drug- free dietary supplements by partnering with two leading sports testing laboratories.

Trade associations: 45-day NDI draft guidance extension request ‘reasonable’

07-Sep-2011 By Stephen Daniells

The request from the main trade associations to extend the period for comments on the NDI draft guidance is ‘reasonable’ and the result of ‘carefully weighing the matter at hand’.

Hatch NDI guidance meeting: File comments for now, then explore legal avenues …

18-Aug-2011 By Elaine Watson

A range of options – “judicial, administrative and Congressional” – is being explored by the dietary supplements industry should the FDA prove unwilling to make substantial changes to its controversial draft guidance on new dietary ingredients (NDIs).

CRN: Case-by-case enforcement approach is best for phytosterol claims

18-Aug-2011 By Elaine Watson

Supplement makers with products containing free phytosterols should not be prevented from making heart health claims if they can prove their formulations are effective, the Council for Responsible Nutrition (CRN) has argued.

FDA must abandon 'blanket approach' to phytosterol claims, argue firms

17-Aug-2011 By Elaine Watson

Three more firms have followed Cargill’s lead and submitted petitions to the FDA urging it to rethink plans to amend the criteria for making health claims about phytosterols and heart disease or risk causing “irreparable injury”.

Probiotics maker: There is a temptation to overstate the benefits

08-Aug-2011 By Elaine Watson

Regulatory uncertainty in Europe and a string of high-profile lawsuits in the US has made firms much more cautious about making health claims about probiotics, according to one California-based supplier.

Supplements trade: NDI guidance can be salvaged, but give us more time

04-Aug-2011 By Elaine Watson

If stakeholders are granted more time to respond to the FDA’s draft guidance on new dietary ingredients (NDIs), it should be possible to reach a compromise that will satisfy regulators without devastating the dietary supplements industry, trade associations...

NDI guidance public comments: Don't revise it, ditch it

03-Aug-2011 By Elaine Watson

The FDA should calculate how much complying with its guidance on new dietary ingredients (NDIs) will cost before forcing the supplements industry to embark on a “giant paperwork exercise” that will not make consumers any safer, according to the first...

Shaping Beauty: We are cooperating with the FDA

27-Jul-2011 By Elaine Watson

The attorney representing Shaping Beauty – the recipient of a recent FDA warning letter claiming multiple violations of the Federal Food, Drug and Cosmetic Act – says her client is cooperating fully with the FDA.

‘No logic’ to FDA view on product-specific NDI notifications, says lawyer

21-Jul-2011 By Elaine Watson

There is “no logic” to the FDA’s insistence that NDI (new dietary ingredient) notifications are applicable only to the specific manufacturer that submits them, according to one leading food law attorney.

FDA to publish new rules on how daily values are calculated

13-Jul-2011 By Elaine Watson

The Food and Drug Administration (FDA) is hoping to publish new rules on how daily values on food labels are calculated this year, something that could have broad ramifications for the dietary supplements trade.

Could the trade mount a legal challenge vs NDI guidance?

06-Jul-2011 By Elaine Watson

If the Food and Drug Administration (FDA) does not revise its draft guidance on new dietary ingredients (NDIs) for supplements to reflect industry concerns, the trade might be stuck between a rock and a hard place, admit lawyers.

FDA's enforcement deserves loud applause

13-Jun-2011 By Stephen Daniells

A flurry of seizures, criminal charges, and warning letters shows that FDA is increasing it enforcement of dietary supplement regulations. Good for FDA and good for industry!

Breaking news

UAS Labs defends safety, efficacy of probiotics following FDA seizure

09-Jun-2011 By Stephen Daniells

Minnesota-based UAS Laboratories, Inc., has defended the safety and efficacy of its products following a US Marshalls-led seizure, adding that it is working with FDA to ‘remove and/or modify the language’ of alleged disease claims on the labels of its...