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GMPs, QA & QC

The implementation of new safety measures and current good manufacturing practices (cGMPs) are having a huge impact on business. We bring you the latest developments in this increasingly important sector.

NSF had ample opportunity to find Beehive's GMP problems, but didn't, attorney says

A breakdown in communication between Beehive Botanicals and its GMP certifier NSF International created the situation in which Beehive received an FDA Warning Letter over GMP violations.  And, from Beehive’s...

NSF responds to Beehive Botanicals warning letter situation

NSF International has responded to an article in NutraIngredients-USA on the FDA Warning Letter received by Beehive Botanicals after having GMP audits conducted by NSF.  A Beehive Botanical company official...

Beehive Botanicals gets GMP warning letter despite clean bill of health from NSF

Beehive Botanicals Inc. has received an FDA Warning Letter even though the company had received a successful GMP audit by NSF International and had NSF review the changes it made...

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

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...

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ABC honors Chinese professor with Farnsworth award

The American Botanical Council has given its annual ABC Norman R. Farnsworth Excellence in Botanical Research Award  to professor De-an Guo, PhD, of Shanghai, China.

USPlabs slapped with warning letter over drug claims, GMP failures

USPlabs, the maker of the DMAA-containing sports supplement Jack3d, has received a warning letter over drug claim violations and GMP deficiencies, the Food and Drug Administration confirmed Friday.

FDA sends more GMP-related warning letters to four dietary supplement manufacturers

Four dietary supplements have received independent warning letters from the Food and Drug Administration for alleged GMP violations, as the agency maintains its focus on compliance.

News in brief

NX Generation Ltd. warned for alleged GMP violations

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...

NSF expands in Latin America with Peruvian acquisition

NSF International announced a significant expansion of its footprint in Latin America with the acquisition of INASSA Group of Lima, Peru.  INASSA provides technical analysis, laboratory and sanitation services. In...

News in brief

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

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.

ChromaDex adds Dutch isotope-labeled markers to line of testing standards

ChromaDex has announced a partnership with a Dutch company to distribute a line of isotope-labeled plant products and phytochemicals, taking a step forward in the company’s aggressive program of expanding...

News in brief

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

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

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...

Outsourcing manufacturing doesn't lift burden of GMP compliance, experts say

A recent teleseminar put on by the American Herbal Products Association on GMP compliance made it clear that there is still a significant portion of the dietary supplement industry that...

2012’s regulations in pictures: GMPs, NDIs, and energy drinks

As 2012 comes to a close, NutraIngredients-USA looks back on an action packed year. In the second of our series of galleries capturing the year’s main events, we take a...

2012’s predictions: How did we do?

In January, NutraIngredients-USA raised its head above the parapet and made some predictions for 2012. As the year draws to a close, we look back on what did and didn’t...

Pomegranate and black cohosh adulteration: Botanical collaboration lines up next focus topics

The American Botanical Council’s Mark Blumenthal has called for more self-regulating from industry and regulating from FDA to combat adulteration, as the ABC-AHP-NCNPR Botanical Adulterants Program lines up black cohosh...

News in brief

Health Technology gets FDA warning letter for GMP and alleged label violations

Health Technology, Inc., from Dawson, Georgia, has received a warning letter from the Food and Drug Administration for alleged GMP violations, and failing to include contact details on the labels...

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

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.

GMPs, Prop 37, and market opportunities: The best of SupplySide West

GMP compliance, Prop 37, market opportunities, hot ingredients and many more dominated this year’s discussions at SupplySide West. In this special newsletter, NutraIngredients-USA round-ups its exclusive coverage of the event.

Low barriers of entry have enabled ‘grifters, cobblers, and vermin’ to give industry bad GMP compliance press: BI chief

The industry’s big names have been complying with GMP regulations for years, but low barriers to entry have made it easy for less serious companies to do business with low...

GMP compliance levels are ‘all over the place’: Alkemists CEO

Current compliance levels to good manufacturing practice (cGMP) are ‘all over the place’, but ‘for the most part there is an increase in compliance’, says the CEO of Alkemists Laboratories.

FSMA facility registration: ‘It’s an easy one for industry,’ says CRN’s Mister, ‘so remember to register!’

Dietary supplement companies have six weeks to ensure they have registered their facilities with FDA to comply with FSMA, an issue that is easy to fix for the industry, says...

Dietary supplement industry needs ‘cultural shift’ to deal with GMPs

Supplement manufacturers – particularly smaller companies – need a ‘cultural shift’ to cope with the demands of good manufacturing practices (GMPs), says a former associate chief counsel with FDA.

Dry labbing practices ‘mushrooming’ and ‘metamorphosing’: Chromadex CEO

The practice of dry labbing in the industry is continuing, and the practice is becoming more sophisticated, increasing the need for continued vigilance, says Frank Jaksch, CEO of Chromadex.

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