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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.

SIDI Working Group opens supplier qualification guidelines for comments

The Standardized Information on Dietary Ingredients (SIDI) working group is calling for comments from industry stakeholders on its new supplier qualification guideline.

News in brief

FDA’s Fabricant to headline NPA’s GMP webinars

The Food and Drug Administration’s Daniel Fabricant, PhD, will lead the Natural Products Association’s webinar two-parter on GMP complicance, and how to avoid an FDA warning letter.

News in brief

PGP International earns NSF GMP for Sport

California-based PGP International Inc., has been awarded  Good Manufacturing Practices (GMP) for Sport registration from NSF International.

"It’s unacceptable to be intimidated by cGMPs" - George Pontiakos

‘We’re gaining market share because of GMPs’: BI chief

GMP compliance and enforcement is good for the industry, but it is also good for business for suppliers that focus on quality, says George Pontiakos, president and CEO of BI...

Special edition: GMPs

From warning letters to dry labbing, the attention of many is firmly focused on compliance with, and enforcement of, current Good Manufacturing Practices (cGMPs). In this special edition we bring...

'It is incumbent upon any company that puts its name on a product to ensure that every part of its production program is tight' - Jim Kababick, Flora Research Laboratories

Expert: ‘Most of us know which labs are dry labs, or at least horrifically incompetent’

The analytical community knows which companies are involved in dry labbing, says a leading analytical expert, and the practices of a minority of labs are harming the whole industry.

FDA: We're taking Dateline NBC information seriously & will act appropriately

The Food and Drug Administration (FDA) is taking the information seriously from Dateline NBC’s exposé on dry labbing in the dietary supplements industry, NutraIngredients-USA has learnt.

Dateline exposé ‘not representative of the responsible supplement industry’: AHPA

The recent Dateline NBC investigative section on unsafe supplements and ‘dry labbing’ was “misleading” and “not representative of the responsible supplement industry”, says the American Herbal Products Association (AHPA).

Frank Jaksch talks to NutraIngredients-USA.com about dry labbing

Dateline NBC exposé provides opportunity to fix dry labbing issues

Yesterday's airing of a Dateline NBC exposé on dry labbing practices in dietary supplements represents an opportunity for industry to tackle the problem head on, says Frank Jaksch, CSO and...

US shuts down PA supplements company pending cGMP re-inspection

The United States has entered a consent decree against a Pennsylvania dietary supplement company to cease operations following numerous current good manufacturing practice (cGMP) violations.

pTeroPure is the flagship ingredient in ChromaDex's new BluScience branded supplement range

ChromaDex: pTeroPure poised to deliver in 2012

PTeroPure maker ChromaDex has posted a 7% rise in revenues to $8.1m in the fiscal year ending December 31, 2011, but notched up a net loss of $7.9m compared with...

Stover: 'We want to show industry that we are back and we are listening'

Twinlab prepares for June launch of new Clean Series range

Twinlab is preparing to unveil a new range of sports nutrition products under the Clean Series brand to tap into growing demand for products with ‘cleaner’ labels.

News in brief

NSF International Shanghai Testing Lab earns ISO/IEC 17025 accreditation

NSF International has achieved ISO/IEC 17025 accreditation from the China National Accreditation Service (CNAS) for its laboratory in Shanghai, China.

"Many companies are just not prepared when the FDA shows up at their door" - Steve Mister, CRN

CRN welcomes FDA ‘wake-up’ call for GMP compliance

Many dietary supplement companies are not fully compliant with GMP regulations, putting them at risk of warning letters and more, but resources are available to help companies prepare for an...

Picture: Steven Foster, Scutellaria lateriflora, 2012

ABC: Why is skullcap still being adulterated with germander?

Germander is still being used as a substitute for skullcap in dietary supplements, despite ongoing attempts to raise awareness about the problem, according to a new paper published by the...

Most major food manufacturers require a no objections letter from the FDA on a GRAS notification before they will add a new ingredient to their products

AHA GRAS attack reaction: Why self-affirmed GRAS is not ‘GRAS lite’

Experts in helping firms navigate the GRAS (generally recognized as safe) process say the American Heart Association (AHA) made some valid points in its recent attack on GRAS, but argue...

2011 saw a sharp rise in cGMP-related FDA warning letters
Guest article

2011 FDA Warning Letter Review: The Rise of GMPs

GMP violations dominated dietary supplement warning letters issued by the Food and Drug Administration in 2011, from failure to establish product specifications to poor record keeping, reveal FDA legal specialists...

Holly Bayne: 'FDA has all the legal authority it needs to protect public health and safety and remove unsafe or mislabeled products from the marketplace'

ABC paper promises to dispel ‘myth’ of unregulated supplements

A new paper published by the American Botanical Council (ABC) attempts to dispel the ‘puzzling’ and pervasive ‘myth’ that the US dietary supplements trade is unregulated.

January in pictures: Dr Oz, spiking, cGMPs, krill oil and kiwi fruit

So much for easing gently into the New Year. Just days into 2012, the supplements trade was wrestling with a big spiking story on Dr Oz, more difficult questions about...

Neal-Kababick: 'If an FDA inspector asks you how you know for certain that the lead level in the finished product is within specifications, answering ‘because it was never out of spec before’ is not going to cut it.'

cGMP compliance, time bombs and the ‘ten-ton elephant in the room’

An analysis of recent Food and Drug Administration (FDA) warning letters has exposed several ‘ten ton elephants in the room’ and ‘time bombs waiting to go off’ when it comes...

DCD LLC and subsidiary Advanced Muscle Science were fined $125,000 and told to implement testing protocols to ensure future products sold as dietary supplements do not contain synthetic steroids.

Idaho judge fines firms selling ‘synthetic steroids masquerading as dietary supplements’

Two firms found guilty of selling muscle building supplements laced with unapproved drugs have been fined by a federal court in Idaho.

AHP releases monograph for 'one of the most widely adulterated herbs on the market'

A monograph for American Ginseng – claimed to be one of the most widely adulterated herbs on the market - has been released by the American Herbal Pharmacopoeia (AHP).

Several US states have banned 'bath salts' laced with a class of compounds called substituted cathinones that behave like methamphetamine or cocaine

Be on your guard for ‘bath salt’ stimulants in supplements, warns expert

Dangerous stimulants in so-called ‘bath salts’ and plant food could make their way into the supplements trade this year if firms do not maintain their vigilance, according to one expert...

News in brief

GMP Labs gets NSF Certified for Sport

Anaheim-based GMP Laboratories of America Inc has been Certified for Sport by NSF International, as the company met stringent certification requirements, including testing for more than 150 banned substances.

FDA warning letters: Social media, website claims & GMP violations

The FDA published a handful of warning letters in late December, with cGMP violations and claims on websites and social media sites continuing to catch the FDA’s eye.