Food And Drug Administration

FDA seizes DMAA-containing supplements from GNC warehouse

21-Jun-2013 By Hank Schultz

The Food and Drug Administration moved today to seize more than 1,500 cases of supplements that contain DMAA from a Pennsylvania warehouse belonging to GNC Holdings, Inc.

House committee admonishes FDA to pick up pace on NDI issue

20-Jun-2013 By Hank Schultz

The US House of Representatives Appropriations Committee has sent a stern message to the Food and Drug Administration on the subject of the draft New Dietary Ingredients guidance. The message in a nutshell: Get a move on.

‘Vast majority’ of collegiate athletes taking energy drinks & supplements to boost performance: Survey

31-May-2013 By Stephen DANIELLS

Over 80% of US collegiate athletes are consuming energy drinks, supplements or prescription medications to enhance their athletic performance, says a new survey.

More FDA warning letters for website claims and cGMP violations

16-May-2013 By Stephen DANIELLS

The US Food and Drug Administration has issued warning letters to two dietary supplement companies, as the agency maintains its vigilance of website claims and cGMP compliance.

Special focus: Recent FDA warning letters offer important lessons for companies

15-May-2013

The US Food and Drug Administration has issued some important warning letters in recent weeks. In this special focus, we revisit the lessons for all companies, from website claims, to the obligations of private label distributors.

Warning letters show companies still vague on nature of website language

01-May-2013 By Hank Schultz

Now, almost 20 years after DSHEA became law, some companies seem to be just starting to get the message that the regulations governing health claims language don’t apply just to product labels. Websites are fair game, too, and can form easy pickings for...

Drug-tainted weight loss, bodybuilding, and sexual enhancement products top DS recall lists

18-Apr-2013 By Stephen Daniells

Weight loss, bodybuilding and sexual enhancement products tainted with unapproved drug ingredients are responsible for 98% of recalls for ‘dietary supplements’, says a new analysis.

New management team to reinvigorate UAS Labs brands, R&D as part of acquisition

15-Apr-2013 By Hank Schultz

Lakeview Equity Partners, a Milwaukee-based investment firm, has taken its first dip into the human nutrition pool with the acquisition of probiotics supplier and finished goods manufacturer UAS Labs.

Strapped by FSMA, FDA seeks authority for new user fees in budget request

11-Apr-2013 By Hank Schultz

The US Food and Drug Administration has requested a $4.7 million dollar budget for fiscal year 2014, an increase of $821 million, or 21%, over FY 2012. The biggest chunk of that increase is due to the Food Safety Modernization Act and almost all of that...

Supplement maker Kabco shut down over GMP violations

10-Apr-2013 By Hank Schultz

After a history of GMP compliance failures, dietary supplement manaufacturer Kabco Pharmaceuticals has been shut down by FDA until such time that it can meet the stipulations of a consent decree.

Bitter orange and caffeine combo may be unsafe, says BfR

09-Apr-2013 By Nathan Gray

Sports supplements and weight loss products that contain a combination of caffeine and synephrine from bitter orange may not comply with current regulations and could be classified as unsafe, warns the BfR.

FSMA guidance document serves as reminder to make sure facilities are registered

05-Apr-2013 By Hank Schultz

A new guidance document made public by the Food and Drug Administration serves as a reminder to industry to review their FSMA registration status, experts say.

Carnitine researcher recognized with award

26-Mar-2013

Supplement industry pioneer Dr Stephen L. DeFelice has been honored with the 2013 Marconi Science award by UNICO, the largest Italian-American service organization at a recent meeting of the organization in Las Vegas.

Peanut indictments show there's a new sheriff in town, lawyer says

25-Feb-2013 By Hank Schultz

Former officials of a peanut company have been indicted in criminal court on charges of food violations, mail fraud and conspiracy. The indictments are not a surprise, said a prominent lawyer, but should serve to put the food and dietary supplement industries...

FDA is regulating red yeast rice manufacturers, say ABC & NPA, as scientists question safety and labels

21-Feb-2013 By Stephen DANIELLS

Oregon State University researchers claim that the US Food and Drug Administration is not regulating manufacturers of supplements containing red yeast rice, claims that have been flatly rejected by the Natural Products Association (NPA) and the American...

NX Generation Ltd. warned for alleged GMP violations

06-Feb-2013 By Stephen DANIELLS

The Food and Drug Administration (FDA) has sent a warning letter to New York based NX Generation Ltd for ‘serious violations’ of the current Good Manufacturing Practice (cGMP) regulation for dietary supplements.

Food for Health International ‘much stronger’ following FDA audit and warning letter

25-Jan-2013 By Stephen Daniells

Utah-based Food for Health International, LLC, says it is ‘much stronger’ following a recent FDA audit and the changes necessitated by a subsequent warning letter.

Food for Health International hit with FDA warning letter for alleged disease claims, GMP violations

22-Jan-2013 By Stephen Daniells

Utah-based Food for Health International, LLC, has received a warning letter from the Food and Drug Administration (FDA) for alleged disease claims and GMP violations.

NDIs, GMPs, FSMA: The regulation scene in 2013

07-Jan-2013 By Hank Schultz

GMPs, NDIs and FSMA will top the list of most-frequently mentioned acronyms in the regulatory sphere for dietary supplements and functional food ingredient companies in the coming year, industry experts agree.

FDA creates new NDIN and structure function docket formats

04-Jan-2013

The Food and Drug Administration has created new dockets for new dietary ingredient notifications (NDINs) and structure-function claim notification letters.

Could ‘controversial’ pharma court ruling provide ‘wiggle room’ for off-label dietary supplement marketing?

03-Jan-2013 By Stephen DANIELLS

A recent ruling by the US appeals court protecting free-speech relating to off-label use of pharmaceuticals may have ‘far reaching effects’ for the nutritional supplement business, says a leading industry figure.

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...

Foreign facilities falling behind on FSMA, consultant says

04-Dec-2012 By Hank Schultz

A large number of foreign food facilities likely will not be in compliance with the Food Safety Modernization Act re-registration guidelines when the deadline passes at the end of the year, a consultant has said.

Steroids, an injunction and more warning letters: FDA enforcement round-up

26-Nov-2012 By Stephen Daniells

It has been a busy couple of weeks for the Food and Drug Administration, with the Agency filing another injunction, and sending warning letters for GMP violations and product claims.

Equateq, Cognis and Pronova: “Each are complementary”, says BASF

26-Nov-2012 By Shane Starling

BASF’s ever-expanding nutrition unit says its €644m bid last week bid for Norwegian omega-3 firm, Pronova Biopharma, is as important for its food supplements business as its pharmaceutical operations.

Durbin seeks meeting with FDA following 5-Hour adverse events news

19-Nov-2012 By Hank Schultz

Sen. Dick Durbin (D-IL) read a statement on the Senate floor late Thursday calling for FDA action on the safety of energy drinks in apparent reaction to the news that 92 adverse event reports have been received by FDA in the past four years citing 5-Hour...

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...

CRN asks FDA to reverse stance on synthetic botanicals

25-Oct-2012 By Hank Schultz

The Council for Responsible Nutrition (CRN) has called upon the Food and Drug Administration to reverse its position concerning so-called “synthetic botanicals.”

FDA seizes N.Y. company's products over disease claims

24-Oct-2012

The Food and Drug Administration has seized products marketed by Port Washington, N.Y.-based Confidence Inc., the agency announced Tuesday.

Breaking news

FSMA registration process opens today

20-Oct-2012 By Hank Schultz

The Food Safety Modernization Act (FSMA) registration process will be open for business on Monday, Oct. 22, it was announced Friday.

New consultancy to help companies comply with FSMA

17-Oct-2012 By Hank Schultz

A new regulatory consultancy has launched to ride the wave of work sure to come out of compliance issues surrounding the Food Safety and Modernization Act (FSMA).

FDA: Inflammation and diabetes raising red flags for tainted products

05-Oct-2012 By Stephen Daniells in Laguna Beach

Concerns over tainted dietary supplements are extending to products promoted for pain/inflammation and diabetes, beyond the ‘classic’ sectors of erectile dysfunction, weight loss and bodybuilding, said the new head of CFSAN at FDA.

Breaking news

FDA not ready to start FSMA registration process

29-Sep-2012 By Hank Schultz

The Food and Drug administration announced via e-mail alert late Friday that the procedure for food facility registrations will not be ready to be implemented by Monday, Oct. 1, the day the biennial registration procedure was supposed to begin as mandated...

Letter to FDA seeks guidance on FSMA food facility registrations

25-Sep-2012 By Hank Schultz

A group of industry trade associations has sent a letter to FDA asking for clarification for the process of registering their facilities under the Food Safety Modernization Act. The deadline approaches, and FDA has yet to release the guidance for how...

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.

FDA issues new DMAA warning letter

12-Sep-2012 By Stephen Daniells

The US Food and Drug Administration (FDA) has issued another warning letter for DMAA, with Irvine, CA-based Regeneca receiving the letter for its RegeneSlim product.

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...

Slate magazine tells athletes: “Stop taking supplements”

02-Aug-2012 By Shane Starling

Athletes should avoid taking food supplements because they are overpriced, don’t boost performance and could provoke doping violations, an article in online daily news site, Slate, has said.

AHPA: Mojo Nights warning letter ‘clear signal’ that FDA intent on tackling drugs masquerading as supplements

26-Jul-2012 By Elaine WATSON

A Food and Drug Administration (FDA) warning letter sent to a sexual enhancement supplements maker should serve as a “clear signal that FDA continues its enforcement efforts against illegal drugs or drug alternatives masquerading as dietary supplements”...

FDA files injunction against NY supplements company for GMP violations

16-Jul-2012 By Stephen DANIELLS

The US Food and Drug Administration (FDA) has again shown that it will go beyond just sending warning letters for GMP violations after filing an injunction against a NY supplement manufacturer.

'Decocainized' coca leaf extract debuts for weight management sector

11-Jul-2012 By Stephen Daniells

Florida-based MB Innovations has launched a blend of botanicals, including a decocainized coca leaf extract, to suppress appetite and offer weight management solutions to the dietary supplements, food and beverage industries.

DMAA in the dock

Ireland: DMAA products are “illegal medicines”

09-Jul-2012 By Shane Starling

Ireland has joined the UK, Sweden, Denmark, Finland, Australia, New Zealand, Canada and the US in warning against the pre-workout stimulant DMAA (methylhexaneamine/1,3-dimethylamylamine).

Breaking news

Who says the FDA doesn't listen? Industry welcomes plan to issue revised draft NDI guidance

20-Jun-2012 By Elaine Watson

The FDA might have spent the past year vigorously defending its much-maligned draft guidance on new dietary ingredients (NDIs), but it appears it has been listening to industry concerns as well.

FDA: All-natural dietary supplement Reumofan Plus contains prescription drugs

12-Jun-2012 By Elaine Watson

Lab tests on Reumofan Plus, a dietary supplement made in Mexico and marketed as a natural pain reliever, show that it contains at least two prescription painkillers, the Food and Drug Administration (FDA) has warned.

Safety & efficacy – The industry’s mission statement in two small words

30-May-2012 By Stephen Daniells

Company mottos and mission statements are marvelous – they talk about lofty goals, commitments to people and the environment, and leaving the planet a better place than how they found it. But boil it all down and there are only two words that companies...

FDA warns of sexual enhancement products and sends yet more letters for GMP violations

18-May-2012 By Stephen Daniells

Another week, another batch of warning letters from the Food and Drug Administration (FDA): Warning letters for current good manufacturing practice (cGMP) violations continue, and the agency has warned consumers against three sexual enhancement products...