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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.
FDA warning letter gives important lessons for finished product testing, labeling and adverse event reporting
A new warning letter from FDA for a company manufacturing products that contained only 5% of declared nutrient levels shows that the agency is stepping up its testing of finished...
AREDS2, FDA warning letters, and GMO labeling: May 2013 in pictures
There wasn’t a dull moment in May for the US dietary supplements industry, with the highly anticipated AREDS2 data being published, FDA enforcement, and the GMO issue all making headlines....
AERs – A unique opportunity to build confidence in supplements: SafetyCall
Establishing robust systems for safety surveillance and the reporting of adverse events presents the dietary supplements industry with an opportunity to instill confidence in the products, says Rick Kingston, PharmD,...
More FDA warning letters for website claims and cGMP violations
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
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...
FDA warning letter highlights obligations of private label distributors
A new warning letter illustrates FDA’s stance on the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary...
UNPA's Israelsen proposes new carrot to go with FDA's GMP stick
The dietary supplement industry is falling behind on GMP compliance, says Loren Israelsen, executive director of the United Natural Products Alliance. Fixing that is a matter of coming up with...
Drug-tainted weight loss, bodybuilding, and sexual enhancement products top DS recall lists
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.
‘The industry is recognizing that spending good dollars gets you good products’: BI Chief on GMPs, adulteration, and the Dr Oz effect
The dietary supplements industry is making ‘heartening’ progress on taking a hard look at raw material sourcing, but GMP issues and adulteration issues continue to cause concern, says the CEO...
Strapped by FSMA, FDA seeks authority for new user fees in budget request
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...
FSMA guidance document serves as reminder to make sure facilities are registered
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.
NPA's GMO labeling stance headlines annual lobbying day
The Natural Products Association’s newly announced stance on GMO labeling was the biggest attention getter as members spoke with members of Congress during the organization’s annual lobbying event Tuesday....
AHPA expands staff with program development position
To go with an expanding membership, the American Herbal Products Association has expanded its staff with the addition of Jane Wilson in the newly created role of director of program...
GMP compliance is a 'huge opportunity' for dietary supplements market: Chromadex CEO
FDA enforcement of the current good manufacturing practices (cGMP) regulations is ‘a huge opportunity for the dietary supplements market’, says Frank Jaksch, CEO of Chromadex.
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...
News in brief
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...
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