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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.

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.

Bodybuilding.com steroid spiking case shows retailers also responsible for dietary supplements: US Attorney

The $8.1 million in total fines for Bodybuilding.com and the DeLuca brothers should serve as a reminder for retailers as well as manufacturers of their responsibility to ensure dietary supplements really...

NPA: Consumer Reports supplements probe is insulting to consumers

A probe into dietary supplements published in the September 2012 edition of Consumer Reports misleads and insults consumers and smears the industry, claims the Natural Products Association (NPA).

Jarrow: Tribune article was ‘designed to encourage Congress into imposing Draconian new regime’ on supplement trade

A recent article in the Chicago Tribune that prompted a wave of negative publicity for the dietary supplements trade unfairly “maligned an industry” according to California-based supplement maker Jarrow Formulas.

New bill would ensure anabolic steroids are not misrepresented as legitimate dietary supplements, say backers

New legislation proposed in the Senate this week would help to ensure anabolic steroids are not misrepresented as legitimate dietary supplements by broadening the definition and imposing tougher penalties on...

News in brief

AHPA: Mojo Nights warning letter ‘clear signal’ that FDA intent on tackling drugs masquerading as supplements

A Food and Drug Administration (FDA) warning letter sent to a sexual enhancement supplements maker should serve as a “clear signal that FDA continues its enforcement efforts against illegal drugs or...

AHPA responds to Sen. Durbin-Blumenthal cGMP questions

The American Herbal Products Association has responded to Senators Durbin and Blumenthal to outline current and future initiatives to support its members’ efforts to comply with current good manufacturing practices...

FDA files injunction against NY supplements company for GMP violations

The US Food and Drug Administration (FDA) has again shown that it will go beyond just sending warning letters for GMP violations after filing an injunction against a NY supplement...

AHPA committed to GMP compliance, but learning curve was expected: McGuffin to Durbin staff

The learning curve for GMP compliance is to be expected – just look at other FDA-regulated industries, Michael McGuffin, president The American Herbal Products Association (AHPA), told staff for Senator...

Updated: Associations welcome Durbin-Blumenthal cGMP dialogue & FDA explains GMP violation stats

The Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) have welcomed requests from Senators Durbin and Blumenthal to outline cGMP education initiatives, but questions have been raised...

Industry hopes Olympics will torch supplement contamination concerns

The Olympic Games have in the past brought the food supplements industry to the edge of its collective seat – but not necessarily in fevered anticipation of the world-class sporting...

Florida firm accused of serious cGMP violations and unauthorized disease claims

Private label supplement distributor Caribe Natural has been warned by the FDA that it is still responsible for violations of current Good Manufacturing Practice (cGMP) regulations and making drug claims...

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