GMPs, QA & QC

If the pricetag looks too good to be true, it probably is ...

GOED/Neptune: Krill monograph will help firms detect genuine article

By Elaine Watson

Another leading supplier has weighed into the debate over unscrupulous firms peddling ‘krill oil’ that contains “next to no phospholipids” but says the development of a monograph and better testing protocols might go some way to tackling the problem.

Pure krill oil has a minimum of 40% phospholipids

Fake krill undermines whole market, warns Aker Biomarine

By Elaine Watson

Unscrupulous firms peddling ‘krill oil’ that contains “next to no phospholipids” risk denting confidence in the efficacy of krill and the broader omega-3 market, a leading supplier has warned.

NBTY has a significant presence in branded and private label supplements

NBTY: FDA probe ‘embarrassing’, but we’ve addressed issues

By Elaine Watson

Supplements giant NBTY has admitted that being the subject of a Food and Drug Administration (FDA) warning letter this spring was “embarrassing”, but insists it has since addressed all of the outstanding issues raised by the regulator.

FDA data supports bitter orange safety

FDA data supports bitter orange safety

By Stephen Daniells

High doses of bitter orange (Citrus aurantium) are not toxic to mothers or their babies, according to a new toxicology study with rats from FDA that adds to the ingredient’s safety profile.

Credit where credit is due: FDA activity is a good thing

FDA's enforcement deserves loud applause

By Stephen Daniells

A flurry of seizures, criminal charges, and warning letters shows that FDA is increasing it enforcement of dietary supplement regulations. Good for FDA and good for industry!

Cerebral Health fails FDA GMP inspection

Cerebral Health fails FDA GMP inspection

The US Food and Drug Administration (FDA) has issued a warning letter to Florida-based Cerebral Health, LLC, for failing to comply with Current Good Manufacturing Practice (CGMP).

Purveyors of substandard raw materials will be

China tightens raw materials laws for supplements makers

By Shane Starling

Dietary supplement manufacturers operating in China will have to do more to guarantee the quality of their supply chains, after Chinese authorities imposed new quality control regulations last week.

Kava may not be toxic after all, a researcher has found

AHPA publishes report questioning kava-liver toxicity links

By Shane Starling

A veteran kava researcher says liver toxicity cases that have been reported in recent years may be down to isolated quality control issues, rather than inherent toxicity issues with the herb and its extracts.

Garden of Life recalls Raw Vitamin C

Garden of Life recalls Raw Vitamin C

Floridian dietary supplements manufacturer Garden of Life has issued a voluntary recall for a vitamin C product after detecting the product was contaminated with soy extracts.

'13-Dimethylamylamine' is listed on Jack3d's Supplement Facts panel

Synthetic geranium still raising industry red flags

By Shane Starling

An unauthorized synthetic form of geranium oil – known as 1.3-dimethylpentylamine – remains on-market in major-label dietary supplements, although a retailer crackdown has some “fringe” supplement manufacturers looking for other stimulants to illegally...

FDA is working with Customs officials to stop the flow of unauthorized herbals into the country

FDA and Customs cracking down on fake herbal Viagra

By Shane Starling

US Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) are employing “Predictive Risk-based Evaluation” to target economically motivated adulteration of erectile dysfunction and other unauthorized supplements at US borders.

The acquisition will help deliver of a wider range of health science services for dietary supplements

NSF International acquires biotech & pharma lab company

By Mike Stones

NSF International’s acquisition of Connecticut-based contract laboratory Pharmalytica Services will allow the company to deliver of a wider range of health science services to the dietary supplements, biotech, pharmaceutical and medical device industries,...

Montana firm warned over GMP transgressions

Montana firm warned over GMP transgressions

By Shane Starling

Failing to follow manufacturing records, inappropriate batch production records and poor packaging and label control have been cited by the FDA in a recent post GMP inspection warning letter to a Montana manufacturer.

GMPs boosting need for contract analytical prowess

Special edition: Outsourcing

GMPs boosting need for contract analytical prowess

By Stephen Daniells

The introduction of good manufacturing practices (GMPs) is a boon for contract analytical services, and those with special services to offer are standing out from the crowd.

Dr Shao: GMP guidance is useful in parts but lacks detail

FDA GMP guidance “won’t provide all the answers”, says CRN

By Shane Starling

Freshly issued FDA GMP guidance for small-to-medium sized dietary supplement manufacturers regurgitates a lot of what has already been published in the regulation, but does bring fresh focus to matters such as expiration dates and ingredient supplier...

RockHard Weekend? Unlikely, after sildenafil detection and voluntary recall

Dietary supplements firm Hain gets FDA 483 warning

By Mike Stones

Long Island-based dietary supplement firm, Hain North America has received a warning letter outlining infringements of Good Management Practice (GMP) from the Food and Drug Administration (FDA).

Eye to eye: Industry and ConsumerLab rarely see things that way

NPA raises concerns about ConsumerLab analytical methods

By Shane Starling

The Natural Products Association (NPA) has entered the debate about the analytical methods employed by product tester, ConsumerLab, by calling on the product tester to make its standards and methods more transparent.

Signergy: Found to be contaminated in New Zealand

FDA takes hard line on erectile dysfunction supplement

By Shane Starling

In the same week the US Food and Drug Administration (FDA) announced an industry-backed crackdown on spiked weight loss, body building and sexual enhancement products, the agency issued an alert against a sulfoaildenafil-contaminated product called Man...

FDA: Ready to use

Industry welcomes FDA clampdown

By Shane Starling

The dietary supplements industry has backed the Food and Drug Administration in cracking down on products tainted with sibutramine, steroids and other substances.

How much valerenic acid is enough?

AHPA calls for dialogue with ConsumerLab over testing methods

By Shane Starling

In the midst of a dispute over valerian product testing standards that has escalated into something far more rancorous, the American Herbal Products Association (AHPA) has called on ConsumerLab.com to seek industry counsel over those very same standards.

Duro has been pulled from the market by its maker

Contaminated herbal Viagra withdrawn

By Shane Starling

A herbal erectile dysfunction (ED) dietary supplement has been voluntary withdrawn from the US market by its Floridian manufacturer after it was alerted to a contamination problem with the unauthorized substance, sildenafil.

Coffee extract achieves GRAS status

Coffee extract achieves GRAS status

Illinois-based FutureCeuticals has self-affirmed GRAS status in the US for its line of patented coffee extracts after an assessment by a three-strong independent panel.

Pontakios: Irradiation problems despite GMP crackdown

Dispatches from SupplySide West

Price drives ongoing illegal irradiation practices

By Shane Starling

Irradiation has risen in importance as it has become specifically outlawed in new Good Manufacturing Practice (GMP) regulations. But the practice continues due to its ability to cheaply remove contaminants from raw materials.

USADA's Tygart says dietary supplements are still dogged by quality 'confidence killers'

Dispatches from SupplySide West

USADA chief explains dietary supplement ‘confidence killers’

By Shane Starling

NutraIngredients-USA.com caught up with United States Anti-Doping Agency chief executive officer, Travis Tygart, at the recent SupplySide West trade show in Las Vegas to get an update on USADA’s position on dietary supplements.

GMPs are working, but industry must keep working at them

Dispatches from SupplySide West

Three chiefs, GMPs, AERs and industry's ‘pretty choir’

By Shane Starling

In part two of this special interview with the heads of the major US dietary supplement trade groups, the three chiefs unpack the state of play for Good Manufacturing Practices (GMPs) along with adverse event reporting (AERs).

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