Gmp Compliance

NutraCast: Safety considerations for dietary supplement manufacturers

16-Feb-2024 By Danielle Masterson

A new paper is out titled “Safety Considerations for Dietary Supplement Manufacturers in the United States", co-authored by Jay Sirois, PhD, VP of regulatory and scientific affairs, Consumer Healthcare Products Association, alongside several CHPA...

NOW unveils new method for finding pesticide residues in complex botanicals

31-Aug-2021 By Hank Schultz

Scientists at supplement manufacturer NOW have validated a new test method for finding pesticide residues in difficult-to-analyze botanicals, such as Hawthorn extract.

InstantGMP updates service with additional SOPs

26-Aug-2021 By Hank Schultz

Document services firm InstantGMP says it has added 115 Standard Operating Procedure (SOP) templates to its flagship software suite.

NAI becomes first company to step up to SSCI plate

13-May-2021 By Hank Schultz

In the first of what is slated to be many such audits, Natural Alternatives International has become the first company to officially complete the SSCI certification process.

Surging sales, more transparency pressure driving contract manufacturing transformation

16-Apr-2021 By Hank Schultz

Rising demand in the contract manufacturing realm is driving both consolidation and pressure to make more transparent this sometimes closed section of the dietary supplement industry, observers say.

Confidence USA ordered to close after decade of inspection failures

09-Mar-2021 By Hank Schultz

Confidence USA Inc, a dietary supplement manufacturer, has been ordered to close after a history of alleged non-compliance with cGMP regulations that extends over a decade.

New quality advocacy group brings medical, pharmaceutical groups to table with supplement industry stakeholders

27-May-2020 By Hank Schultz

A new stakeholder group has come together to push for quality and transparency in the dietary supplement industry. Called the Dietary Supplement Quality Collaborative (DSQC), the group published a policy paper recently as part of its public debut.

Lief Labs launches GMP starter kit initiative

07-May-2020 By Danielle Masterson

The GMP Starter Kit aims to help guide brands through current Good Manufacturing Practices (cGMP) regulations and FDA compliance for nutritional and dietary supplement brands.

ABH recall debacle holds stern lessons for industry, experts say

06-Apr-2020 By Hank Schultz

A wide ranging recall of products made by a New York-based contract manufacturer holds lessons supplement firms can use to avoid similar problems in the future, experts say.

From the Editor's Desk

FDA’s inspection hiatus provides opportunity for industry to prove self regulation is real

20-Mar-2020 By Hank Schultz

With FDA receding into the inspection background, now is the time for the dietary supplement industry to step up and show if there are any real teeth in the notion of self regulation.

From the editor's desk

The 'other' side of the industry creates most of the problems, but has most of the new blood, too

21-Feb-2020 By Hank Schultz

There has been a lot of talk over the years about there being ‘two’ dietary supplement industries. One that plays by the rules, one that doesn’t. But it’s wise not to forget in that discussion the entrepreneurial drive that made this a thriving industry...

Contract manufacturer recalls products under more than 1,200 brand names

21-Jan-2020 By Hank Schultz

A New York-based contract manufacturer has recalled hundreds of lines of products manufactured over a period of almost seven years in a consent decree it publicized recently.

Trade group advocates to keep skip lot testing option in dietary supplements GMPs

19-Jul-2018 By Adi Menayang

The Food and Drug Administration (FDA) is soliciting comments for a GMP code in which ingredient companies can petition for skip lot testing, but one trade group found discrepancies in the Federal Registrar notice.

FDA's Welch: Industry continuing to fail on basic GMP compliance

14-Oct-2016 By Hank Schultz

The dietary supplement industry has not shown steady improvement on GMP compliance.  The same fundamental issues seem to crop up over and over, FDA official Cara Welch PhD said.

Fine print of GMP compliance still a mystery to many small manufacturers, expert says

14-Oct-2014 By Hank Schultz

The smallest tier of dietary supplement manufacturers still, as a class, lack comprehensive understanding of GMP requirements, according a digital solutions provider.

Emerson Ecologics says new quality program will boost GMP compliance of brands it carries

02-Apr-2014 By Hank Schultz

Emerson Ecologics, which distributes a wide range of dietary supplements in the practictioner channel, has altered its quality program in a way that the company hopes will up the GMP compliance ante for its participating suppliers.

Dispatches from SupplySide West 2013

UNPA chief agrees with FDA that GMP compliance far from uniform

26-Nov-2013 By Hank Schultz

Adverse event reporting, amphetamine-like substances showing up in products and NDI notifications are all prominent blips on FDA’s radar, said Loren Israelsen, president of the United Natural Products Alliance.

FDA's GMP expert Brad Williams joins NSF staff

23-Jul-2013 By Hank Schultz

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.

UNPA's Israelsen proposes new carrot to go with FDA's GMP stick

29-Apr-2013 By Hank Schultz

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 a new carrot to go with the stick wielded by the Food and...

Supplement maker Kabco shut down over GMP violations

10-Apr-2013 By Hank Schultz

After a history of GMP compliance failures, dietary supplement manaufacturer Kabco Pharmaceuticals has been shut down by FDA until such time that it can meet the stipulations of a consent decree.

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

16-Jul-2012

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 Dick Durbin in a meeting July 13.