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Trends > GMPs, QA & QC

GMPs, QA & QC

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.

Warning letter lawsuit highlights shared responsibility for bringing compliant products to market

A recent lawsuit filed in California points out some of the issues concerning who’s responsible for product claims as a product makes it way to market.  Everyone in the chain...

News in brief

FDA sends warning letter for DMAA-containing product, GMP violations

The US Food and Drug Administration (FDA) has issued a warning letter to Oklahoma City-based Pure Energy Products, Inc. for products containing controversial compound DMAA.

CRN Annual Conference

CRN's Mister challenges companies to 'decide where they stand…who they stand with…and then take a stand'

The decisions the US dietary supplements industry makes over the next three years will determine the long-term direction of the industry, said CRN's Steve Mister, and then challenged companies to ...

Experts outline 7 seven basic tips for selecting a contract laboratory: HerbalGram article

‘Qualifying more than one analytical lab’ and ‘using reference materials to evaluate lab proficiency’ are just two of the seven tips for companies when selecting a contract lab, according to...

AHPA's new guidance helps supplement manufacturers parse organic labeling requirements

The American Herbal Products Association has released a guidance for industry to help supplement manufacturers better understand how to comply with organic labeling requirements.

Website claims, cGMP violations, and label claims: FDA warning letter round-up

A new raft of warning letters for dietary supplement companies from the US Food and Drug Administration (FDA) shows that current Good Manufacturing Practice (cGMP) and label claims continue to...

Software maintenance solution can help boost manufacturers' GMP compliance

AssetPoint, a provider of maintenance software solutions, helps dietary supplement manufacturers bolster their equipment maintenance record keeping, somethat that can be a weak spot in their Good Manufacturing Practice compliance...

Durbin reaches for premarket approval with reintroduction of labeling bill, trade groups say

A bill reintroduced by Senators Dick Durbin, D-Il and Richard Blumenthal, D-CT to require registration of all dietary supplements with FDA is a solution in search of a problem, according...

Ginkgo adulteration ‘very widespread’, say industry experts, so why is awareness low?

Adulteration of Ginkgo biloba is ‘very widespread’, according to industry sources, but as the adulteration becomes more sophisticated new methods are emerging to help industry ensure the quality of this...

News in brief

Sabinsa gets NSF GMP certification on Utah facility

Sabinsa Corporation’s manufacturing facility in Payson, UT has been certified as GMP compliant by NSF International, the company announced yesterday.

FDA's GMP expert Brad Williams joins NSF staff

Brad Williams, a 30-year Food and Drug Administration veteran, has joined Ann Arbor, MI-based NSF International as technical manager of the global health organization’s dietary supplement GMP compliance program.

Alkemists Labs launches R&D Division for finished product testing

Leading analytical lab Alkemists Laboratories has expanded its service offerings to include a new R&D division focusing on finished product method development, verification & validation.

AHP 's botanical ID webinar series aims to help boost GMP compliance

Identity testing of botanical ingredients continues to be a hot button issue for the Food and Drug Administration.  To help companies comply with this aspect of GMP regulations, the American...

Complexity of supplements hampers adverse events reporting, experts say

The reporting of adverse events in connection with dietary supplements is woefully inadequate, according to experts who spoke Monday at a gathering of toxicologists in Aspen, CO. There are many...

Appetite-suppressing C. fimbriata extract (Slimaluma) gets ‘comprehensive’ safety support

The safety of appetite suppressing Caralluma fimbriata extracts are further supported with the publication of data from ‘comprehensive safety assessments’, say scientists.

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...

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