GMPs, QA & QC

Founded in 2005 by former Bayer executives Edward Yeh and Joseph Wang, privately-owned Syntec makes granulated supplements which it claims “combine the absorption advantages of a liquid based supplement with the convenience of individually packaged servings”.

Syntec hopes for 'swift resolution' with FDA post supplement seizure

By Elaine Watson

Syntec Inc (Syntec Nutraceuticals) says it is “fully co-operating” with the Food & Drug Administration (FDA) after supplements made at its facility in Wisconsin were seized following allegations of serious cGMP violations and unauthorized disease...

Imminent ‘seed event’ set to expose dry labbing issues?

Dispatches from SupplySide West

Imminent ‘seed event’ set to expose dry labbing issues?

By Stephen Daniells

The industry may be on the verge of facing up to potential ‘dry labbing’ issues, which could bring the issue to the forefront and ‘hopefully get this problem fixed’, says ChromaDex’s Frank Jaksch.

Curcumin is a powerful anti-inflammatory found in turmeric

EuroPharma to launch probe into synthetic vs natural curcumin

By Elaine Watson

EuroPharma is planning to launch a probe into commercially available curcumin supplements to establish whether products purporting to contain exclusively natural extracts in fact contain cheaper, synthetic raw materials.

ChromaDex seals African botanical standards deal

ChromaDex seals African botanical standards deal

By Elaine Watson

ChromaDex has signed a deal with the Association for African Medicinal Plants Standards (AAMPS) to sell and market its botanical standards and the African Herbal Pharmacopoeia.

NDI guidance public comments: Don't revise it, ditch it

NDI guidance public comments: Don't revise it, ditch it

By Elaine Watson

The FDA should calculate how much complying with its guidance on new dietary ingredients (NDIs) will cost before forcing the supplements industry to embark on a “giant paperwork exercise” that will not make consumers any safer, according to the first...

Kruger: Think about this from a consumer confidence perspective

Toxicologist: FDA’s NDI guidance is entirely reasonable

By Elaine Watson

Many dietary ingredients used in supplements today bear little resemblance to ingredients that were assumed to be ‘grandfathered in’ post the 1994 Dietary Supplements Health and Education Act, making a fresh safety analysis eminently reasonable if extraction...

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.

SuperBad? SuperPump is popular with gymgoers but the FDA is paying more attention to dietary supplements manufacturers and wants to know why manufacturer Gaspari Nutrition has not done more about AERs

FDA: Beware of Fraudulent ‘Dietary Supplements’

By Shane Starling

The Food and Drug Administration (FDA) today issued a statement warning consumers to “beware of fraudulent dietary supplements” as its labelling, GMP and AER crackdown continues.

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.

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