GMPs, QA & QC

KGK Synergize to launch GMP auditing firm

KGK Synergize to launch GMP auditing firm

By Hank Schultz

Contract research organization KGK Synergize Inc. is broadening the scope of its expertise with the formation of a new company called GMP Auditing Partners and has named industry veteran Ed Wyszumiala as CEO.

Summit session to focus on 'freshness' of omega-3s

Summit session to focus on 'freshness' of omega-3s

By Hank Schultz

Marketers of omega-3s talk a lot about freshness, but it’s not what the consumer understands with the term.  It’s really about controlling oxidation and it can have a big impact on the sensory experience, experts say.

Keeping it clean: 3 botanical chiefs pull adulteration weeds

Dispatches from Vitafoods Europe 2014

Keeping it clean: 3 botanical chiefs pull adulteration weeds

By Shane STARLING

Botanical adulteration, like doping in sports, is a problem that can be controlled but never totally resolved, but what is being done about it? Here the world’s biggest botanical players debate their attacks on the problem.

Fabricant leaves FDA, replaces Shaw as head of NPA

Fabricant leaves FDA, replaces Shaw as head of NPA

By Hank Schultz in Washington, DC

The Natural Products Association (NPA) announced this morning that Daniel Fabricant, PhD, will succeed John Shaw as chief executive officer of the organization effective immediately.  Shaw had tendered his resignation several days ago, the organization...

FDA agrees to new deadlines on FSMA final rules

FDA agrees to new deadlines on FSMA final rules

By Hank Schultz

The Food and Drug Administration has agreed to new deadlines for final rules detailing the implementaiton of the Food Safety Modernization Act (FSMA). The agreement comes as part of a settlement in a lawsuit brought by advocacy groups claiming that FDA...

2013’s top regulatory, policy & enforcement news

2013’s top regulatory, policy & enforcement news

By Stephen DANIELLS

From warning letters to GMO labeling and FSMA, it’s been a busy year for the regulatory people. In this special gallery we review the top regulatory, policy & enforcement headlines from 2013. 

Hiring an attorney early is cheaper than hiring one late, expert says

Dispatches from SupplySide West 2013

Hiring an attorney early is cheaper than hiring one late, expert says

By Hank Schultz

As dietary supplement firms prepare for their initial (or follow up) GMP compliance inspections, it pays to have the advice of a consultant and/or a lawyer up front. Fixing problems on the back end is inevitably more expensive, said attorney Ivan Wasserman.

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