GMPs, QA & QC

With the Olympic Games approaching, NAI is predicting growing interest in its patented beta-alanine ingredient CarnoSyn

NAI posts 30% surge in sales in Q3, 2012

By Elaine Watson

California-based nutritional supplement contract manufacturer Natural Alternatives International (NAI) has posted a 30.3% rise in net sales to $17.4m in the three months to March 31, 2012.

FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue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FDA: We’re not enforcing NDI draft guidance; GMPs are the biggest issue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The Food & Drug Administration is not preparing to enforce its controversial draft guidance on new dietary ingredients (NDIs), but companies can expect more inspections, more injunctions, and more product seizures related to current good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...

Special edition: GMPs

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 together all the news, views and developments in GMPs from...

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).

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

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 Ivan Wasserman and La Toya Sutton.

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...

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