GMPs, QA & QC

Industry attacks McCain Bill for “regulatory overkill”

Industry attacks McCain Bill for “regulatory overkill”

By Shane Starling

Industry groups and legal experts have condemned the Dietary Supplement Safety Act of 2010 as an unnecessary threat to existing legislation that is already empowered to ensure dietary supplements in the United States are safe.

GAO investigating NDI herbs status

GAO investigating NDI herbs status

By Shane Starling

Several American Herbal Products Association (AHPA) and American Botanical Council (ABC) members have been contacted by the Government Accountability Office (GAO) seeking information about the marketing of herbal products with an emphasis on new dietary...

FDA highlights GMP no-no’s

FDA highlights GMP no-no’s

By Shane Starling

The Food and Drug Administration’s commitment to greater transparency is bearing fruit in the dietary supplements area, with the availability of GMP 483 reports providing valuable insights into potential GMP pitfalls.

The devil in GMP details

DSHEA turns 15

The devil in GMP details

By Shane Starling

In the fifth and final installment of this DSHEA special, Frank Jaksch, the president and chief executive officer of Californian-based botanicals reference provider, Chromadex, outlines why he thinks current GMP inspection methodologies are unlikely to...

Blumenthal: On supplements regulations and outrunners

Special edition: DSHEA turns 15

Blumenthal: On supplements regulations and outrunners

By Shane Starling

In part two of this DSHEA special, Mark Blumenthal, founder and executive director of the American Botanical Council, outlines why he believes DSHEA is a victim of the “erroneous negative view” that it limits the power of the FDA and can’t control rogue...

DSHEA turns 15 and growing up fast

Special edition: DSHEA turns 15

DSHEA turns 15 and growing up fast

By Shane Starling

The Dietary Supplements and Health Education Act (DSHEA) celebrated its fifteenth birthday in October – a birthday some thought would not be achieved.

FDA cops (more) GMP criticism

FDA cops (more) GMP criticism

By Shane Starling

Insufficient inspection numbers, unclear ingredient identity testing and supplier audit requirements to meet Good Manufacturing Processes (GMPs), are some of the problems blighting the recently introduced regulation, says a Californian-based supplier.

Reformulated Hydroxycut back on shelves

Reformulated Hydroxycut back on shelves

By Lorraine Heller

The market-leading weight loss supplement Hydroxycut has been reformulated and re-launched in the United States, just months after being recalled for potentially causing liver damage.

Court rules against FTC in supplement ad case

Court rules against FTC in supplement ad case

By Lorraine Heller

A US District Court has ruled against the Federal Trade Commission (FTC) and in favor of a supplements firm, in a landmark case that found FTC’s criticism of the company’s advertising was simply a “difference of opinion”.

FDA sued over ‘unclear’ GMP rules

FDA sued over ‘unclear’ GMP rules

By Shane Starling

The Food and Drug Administration is being sued over its controversial and much-amended GMP regulations on the grounds the 1000-page rule is “ambiguous where it should be clear”, according to the attorney mounting the action.

House passes landmark food safety bill

House passes landmark food safety bill

By Caroline Scott-Thomas

The US House of Representatives passed a food safety bill on Thursday that promises far-reaching reform of how food is processed and grown, intended to boost food safety and consumer confidence.

FDA gets tough on GMP failures

FDA gets tough on GMP failures

By Lorraine Heller

The US Food and Drug Administration (FDA) has clamped down on a number of dietary supplement firms that have repeatedly failed to meet new Good Manufacturing Practices.

In defense of DSHEA: a call for calm

In defense of DSHEA: a call for calm

By Ivan J. Wasserman and Svetlana N. Walker

The recent Hydroxycut recall has caused a stir and the knives are out once again for the Dietary Supplement Health and Education Act (DSHEA). But food lawyers Ivan Wasserman and Svetlana Walker argue those that would carve the regulation up are turning...

Supplements and DSHEA under mass attack

Supplements and DSHEA under mass attack

By Lorraine Heller

The US dietary supplement industry is facing a massive media onslaught after recent recalls of harmful products have placed the sector and the law that regulates it under the spotlight.

Developing solutions to fight food fraud

Developing solutions to fight food fraud

By Caroline Scott-Thomas

Adulteration of food proteins - as seen in the recent melamine scandal - is becoming a greater threat to industry as the food supply has become more globalized and economic crisis drives manufacturers to seek cheaper ingredients, says Jim Griffiths of...

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