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.
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.
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.
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.
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
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.
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.
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.
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.
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...
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.
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...
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...
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.
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).
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.
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...
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.
The Standardized Information on Dietary Ingredients (SIDI) working group is calling for comments from industry stakeholders on its new supplier qualification guideline.
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.
From warning letters to dry labbing, the attention of many is firmly focused on compliance with, and enforcement of, current Good Manufacturing Practices (cGMPs). In this special edition we bring together all the news, views and developments in GMPs from...
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.
Products manufactured by Robinson Pharma Inc can carry the respected NSF Mark following NSF cGMP certification for its dietary supplement manufacturing facilities.
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.
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).
Sports nutrition player BSN has received Good Manufacturing Practices (GMP) from NSF International following a distribution facility audit, the company has announced.
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.
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...
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.
Softgel supplier Best Formulations has received GMP certification for its manufacturing plant, following an independent third party audit at its facility.
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.
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.
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.
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...
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.
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 International is seeing demand from the dietary supplement
industry for its Good Manufacturing Practices (GMP) registration
system and announced it has completed the process for 11 new
facilities for the first quarter of 2007.
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.
