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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.

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.

Is finished product testing the next big wave in GMP warning letters?

Once GMP inspectors from the FDA move beyond the first tier of GMP compliance, the next big wave of warning letters from the agency could be on the issue of...

Fabricant on GMPs: ‘There is not a clear indication there will be a drop in non-compliance anytime soon, and that concerns us’

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...

FDA develops rapid screening for adulterants in weight loss products

Scientists from the US Food and Drug Administration (FDA) have developed a rapid procedure to screen for adulterants in weight-loss products, which could benefit the industry by impacting the ‘rate at...

FDA enforcement: Consent decree for GMP violations and an injunction for disease claims

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...

FDA: Inflammation and diabetes raising red flags for tainted products

Concerns over tainted dietary supplements are extending to products promoted for pain/inflammation and diabetes, beyond the ‘classic’ sectors of erectile dysfunction, weight loss and bodybuilding, said the new head of...

News in brief

Marlyn Nutraceuticals earns NSF GMP for Sport certification

Marlyn Nutraceuticals Inc., a Phoenix-based contract manufacturer, has successfully completed an NSF GMP for Sport certification program, the company announced recently.

Good 483 responses can squelch warning letters

Good responses to 483 can avoid a warning letter.  Including in those responses key elements of organization and documentation can improve the chances for success, an experts say.

Have a game plan for GMP inspections, experts say

A company going into a GMP audit is like a football team on the eve of a pivotal contest.  It’s best to have a game plan, experts say.

Keep CEOs on short leash during GMP inspections, experts say

When FDA comes for a GMP inspection, it’s best for your CEO to be mostly seen and not heard, an industry panel agreed recently.

GMPs: Lack of records starting to sound like broken record

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...

GMPs forum to bring together industry, FDA

Good Manufacturing Practices inspections have been a fact of life in the dietary supplement industry for more than five years now, and still some companies struggle with compliance. An event...

Parrillo Performance receives FDA warning letter for cGMP violations

Bodybuilding supplement manufacturer Parrillo Performance has received a warning letter from the FDA for an ‘inadequate response’ to an FDA 483 for alleged cGMP violations.