GMPs, QA & QC

FDA warns against Viagra coffee

FDA warns against Viagra coffee

By Shane Starling

A coffee product claiming to assist erectile dysfunction has been deemed an unapproved drug by the Food and Drug Administration (FDA) due to the presence of hydroxythiohomosildenafil, an analogue of sildenafil, used in the sexual aid Viagra.

AHPA president: nothing to fear from AER

AHPA president: nothing to fear from AER

By Shane Starling

Michael McGuffin, the president of the American Herbal Products Association (AHPA), tells Shane Starling why recently implemented adverse event reporting (AER) is delivering on its promise some three years down the line.

Expo West reflections: post-recession buy-outs and GMP compliance

Expo West reflections: post-recession buy-outs and GMP compliance

By Shane Starling

Private equity firms came in droves to Expo West looking for post-recession bargains, with dietary supplements firm in their sights. A NutraIngredients-USA.com straw poll in the supplements aisles confirmed acquisition offers were as abundant as natural...

NPA chief: Industry must remain vigilant after McCain Bill victory

NPA chief: Industry must remain vigilant after McCain Bill victory

By Shane Starling

John Gay, the executive director and CEO of the Washington DC-based Natural Product Association (NPA), commends industry for the lobbying effort that has led to Republican Senator John McCain agreeing to alter his highly unpopular Bill.

McCain ‘flip-flops’ on supplements reform Bill

McCain ‘flip-flops’ on supplements reform Bill

By Shane Starling

In this US regulatory round-up, New York-based food and drug attorney, Marc Ullman unpicks the reformed position of Republican Senator John McCain on the regulations governing dietary supplements.

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.

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