Good Manufacturing Practice

FDA shuts down NY supplement firm

27-Oct-2017 By Hank Schultz

A dietary supplement manufacturer in Long Island, NY has been shut down by the Food and Drug Administration after numerous and repeated violations of GMP standards and labeling laws.

AHPA's botanical GMP document will help industry adapt to new requirements such as FSMA

06-Oct-2017 By Hank Schultz

Increasing scrutiny on the supply end of the dietary supplement business put the American Herbal Products Association in a position to contribute to the further legitimization of the dietary supplement industry, said the organization’s founder.

AHPA's botanical GMPs document ready for field testing

03-Apr-2017 By Hank Schultz

The American Herbal Products Association has issued a version of its ‘botanical GMPs’ document.  Several member companies have stepped forward to field test the recommendations, AHPA president Michael McGuffin said.

GRMA launches website ahead of releasing consensus-based GMP standard for dietary supplements

29-Mar-2017 By Stephen Daniells

The Global Retailer and Manufacturer Alliance (GRMA) has launched www.GRMAlliance.org to encourage participation in the ANSI standards development process, with its GMP standard for supplements expected soon.

FDA's move to seize products from foreign firms failing GMPs seen as important first step

14-Jan-2016 By Hank Schultz

A recent move by the Food and Drug Administration to detain products without examination from  foreign firms that have failed GMP inspections is welcome step toward "draining the swamp," said United Natural Products Alliance president Loren...

Steve Mister’s 10 year anniversary as president and CEO of the CRN

GMPs, AERs, and the NY AG’s action: CRN’s Mister on the big issues of the last decade

21-Apr-2015 By Stephen Daniells

The two most positive things to happen to the dietary supplements industry over the last ten years have been GMPs and AERs, says Steve Mister, CEO of the Council for Responsible Nutrition. And what is the most significant negative thing? The NY AG’s action.

GNC responds to industry questions about its NY AG deal with open letter from CEO

09-Apr-2015 By Stephen Daniells

Mike Archbold, CEO of GNC, has issued an open letter to the industry explaining its position in the wake of industry questions and criticism following the announcement that it had reached an agreement with the NY Attorney General.

GMPs, NDIs, and definitions for GMO and natural: NPA’s Fabricant on industry issues

17-Oct-2014 By Stephen Daniells

Despite ongoing vacancies in the main office of the Division of Dietary Supplements, companies must continue to build relationships with FDA’s district offices to ensure ongoing GMP compliance, says Dr Daniel Fabricant, CEO of the Natural Products Association.

Special edition: Outsourcing

Why do many brand owners in the market interpret GMPs as stopping at the manufacturer’s door?

19-May-2014 By Stephen Daniells

Many brand owners, particularly first time entry brand owners, remain ignorant about their responsibilities under good manufacturing practice (GMPs) when using contract manufacturers, say industry experts.

Finished product testing requirements puts pressure on multiple ingredient products, expert says

16-Dec-2013 By Hank Schultz

Setting specifications for products and testing to make sure the lots going out the door meet those specs is a key facet of meeting GMP requirements.  But if a company has a product that might include many ingredients, how does it formulate a realistic...

Dispatches from SupplySide West 2013

UNPA chief agrees with FDA that GMP compliance far from uniform

26-Nov-2013 By Hank Schultz

Adverse event reporting, amphetamine-like substances showing up in products and NDI notifications are all prominent blips on FDA’s radar, said Loren Israelsen, president of the United Natural Products Alliance.

Fabricant on GMPs: ‘There is not a clear indication there will be a drop in non-compliance anytime soon, and that concerns us’

13-Nov-2012 By Stephen Daniells

Strong enforcement from FDA on cGMPs (current good manufacturing practices) will continue, says FDA’s Dr Daniel Fabricant, but given that many GMP basics are still not being met and the Agency's limited resources, many of the issues seen today may...

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...

GMPs: Lack of records starting to sound like broken record

17-Sep-2012 By Hank Schultz

Lack of good record keeping forms the lion’s share of mentions on the warning letters companies receive from FDA after a GMP inspection, a consultant said in an industry meeting recently.

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).

AHPA committed to GMP compliance, but learning curve was expected: McGuffin to Durbin staff

16-Jul-2012

The learning curve for GMP compliance is to be expected – just look at other FDA-regulated industries, Michael McGuffin, president The American Herbal Products Association (AHPA), told staff for Senator Dick Durbin in a meeting July 13.

Dispatches from AHPA's Botanical Congress

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue

10-May-2012 By Stephen Daniells

The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good manufacturing...

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.

SIDI Working Group opens supplier qualification guidelines for comments

18-Apr-2012 By Stephen Daniells

The Standardized Information on Dietary Ingredients (SIDI) working group is calling for comments from industry stakeholders on its new supplier qualification guideline.

‘We’re gaining market share because of GMPs’: BI chief

28-Mar-2012 By Stephen Daniells

GMP compliance and enforcement is good for the industry, but it is also good for business for suppliers that focus on quality, says George Pontiakos, president and CEO of BI Nutraceuticals.

GMP inspections show ‘consistent fundamental failures’: Israelsen, UNPA

29-Nov-2011 By Stephen Daniells

The ‘consistent fundamental failures’ of companies in the dietary ingredients and supplement segment for current good manufacturing practices (GMPs) is a ‘topic of disappointment’, says Loren Israelsen.

Robinson Pharma gets NSF cGMP certified for supplements

18-Nov-2011

Products manufactured by Robinson Pharma Inc can carry the respected NSF Mark following NSF cGMP certification for its dietary supplement manufacturing facilities.

FDA on warning letters: ‘We are going to do more than just hand out paper’

24-Oct-2011 By Stephen Daniells

The dietary supplements industry should keep an eye on GMP compliance, and not be distracted by discussions over NDIs, because enforcement may move beyond handing out paper if warning letters are ignored, said FDA’s Dr Daniel Fabricant.

Cerebral Health fails FDA GMP inspection

07-Jun-2011

The US Food and Drug Administration (FDA) has issued a warning letter to Florida-based Cerebral Health, LLC, for failing to comply with Current Good Manufacturing Practice (CGMP).

BSN gets NSF GMP certification

15-Apr-2011

Sports nutrition player BSN has received Good Manufacturing Practices (GMP) from NSF International following a distribution facility audit, the company has announced.

GMP veteran Carl Reynolds shares ‘483’ learnings

05-May-2010 By Shane Starling

The highly regarded good manufacturing practices (GMP) expert Carl Reynolds – recently re-hired by the FDA to help it manage GMP reporting – highlighted problems from stray rodent activity to lack of batch data to inappropriate identity testing.

Expo West reflections: post-recession buy-outs and GMP compliance

17-Mar-2010 By Shane Starling

Private equity firms came in droves to Expo West looking for post-recession bargains, with dietary supplements firm in their sights. A NutraIngredients-USA.com straw poll in the supplements aisles confirmed acquisition offers were as abundant as natural...

National Enzyme earns GMP thumbs up in Oz

18-Aug-2009 By staff reporter

Missouri-based National Enzyme Company (NEC) has passed an extensive Good Manufacturing Practices audit of its Australian operations by the regulator there and can continue to market its ingredients and dietary supplements.

Best Formulations gets GMP certification

06-Jul-2009

Softgel supplier Best Formulations has received GMP certification for its manufacturing plant, following an independent third party audit at its facility.

FDA aims for 200 GMP inspections this year

10-Jun-2009 By Lorraine Heller

With two weeks to go before mid-sized supplement firms need to comply with new GMPs, the US Food and Drug Administration (FDA) has said it aims to inspect 200 facilities this fiscal year.

RFI undergoes GMP audit in consumer confidence mission

29-Jan-2009 By Neil Merrett

A US-supplier of functional ingredients and supplements has successfully completed an audit of its manufacturing facilities as part of NSF International’s Good Manufacturing Practices (GMP) Registration program.

GMP inspections could focus on Utah, California

20-Jan-2009 By Lorraine Heller

The focus of FDA’s GMP inspections of dietary supplement manufacturing facilities will likely take a short-term focus on the Utah area and Southern California, according to inside sources.

The biggest challenges in making GMPs work

31-Oct-2008

Many medium and small dietary supplement companies are still not close to meeting new GMP requirements, despite the looming deadlines. Lorraine Heller speaks to industry members about the major challenges that remain, and the next steps that should be...

GMP inspection reports only accessed through FOI requests, confirms FDA

28-Oct-2008 By Lorraine Heller

The US Food and Drug Administration (FDA) has confirmed that GMP inspection reports are not, in fact, available online, and that the only way to access these is by filing a Freedom of Information request.

Dispatches from SupplySide West

GMP inspection reports available online, says FDA

24-Oct-2008 By Lorraine Heller in Las Vegas

An update to this article has been published here.The US Food and Drug Administration (FDA) has published the first round of GMP inspection reports on its website, according to the director of the agency’s Division of Dietary Supplement Programs, Dr Vasilios...

NSF grooms manufacturers for global commerce

12-May-2005

NSF International is introducing a new quality certification
program for manufacturers which is intended to help companies be
competitive on a global scale, reports Jess Halliday.