GMPs, QA & QC

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue

Dispatches from AHPA's Botanical Congress

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue

By Stephen Daniells

The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good manufacturing...

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

ChromaDex: pTeroPure poised to deliver in 2012

By Elaine Watson

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 a net loss of $2.1m in 2010.

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

By Stephen Daniells

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 FDA inspection, says the Council for Responsible Nutrition (CRN).

Picture: Steven Foster, Scutellaria lateriflora, 2012

ABC: Why is skullcap still being adulterated with germander?

By Elaine Watson

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 American Botanical Council (ABC).

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’

By Elaine Watson

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 to cGMP (current good manufacturing practice) compliance, according to one leading...

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...

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