Regulation & policy

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).

US Patent Office to re-examine second Neptune patent

US Patent Office to re-examine second Neptune patent

By Elaine Watson

The US Patent and Trademark Office (USPTO) has granted a request from Aker BioMarine to re-examine another US patent recently awarded to its arch rival Neptune Technologies & Bioressources.

Beta-alanine is the rate-limiting precursor of carnosine, which is claimed to decrease fatigue in athletes.

DNP hits back at NAI in beta-alanine patent infringement row

By Elaine Watson

DNP International – the latest in a string of firms to be sued by Natural Alternatives International (NAI) for patent infringement over beta-alanine - insists the patent at issue is invalid and predicts it will “ultimately be vindicated” by the courts.

GNC: 'There is also no scientific/medical evidence that demonstrates any causal link between DMAA and any adverse medical condition, let alone a death'

GNC, Cellucor and Woodbolt targeted in new DMAA lawsuit

By Elaine Watson

GNC, Cellucor Sports Nutrition and others have been accused of misleading consumers over the source, regulatory status and safety of the controversial stimulant DMAA (1,3 Dimethylamylamine) in a new class action lawsuit filed in California.

Dr Cohen: 'In my opinion, the current regulatory framework creates a facade of safety for all supplements. This creates perverse incentives to introduce poor quality and even illegal products.'

Harvard professor: ‘NDI draft guidance doesn’t go far enough’

By Elaine Watson

It might have been roundly slammed by the trade as draconian and unworkable, but according to one academic, the Food and Drug Administration’s (FDA’s) controversial draft guidance on new dietary ingredients (NDIs) does not go far enough.

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...

Probiotics and stevia extracts among new FCC proposed standards

Probiotics and stevia extracts among new FCC proposed standards

By Caroline Scott-Thomas

US Pharmacopeia has drafted new ingredient quality standards for inclusion in the Food Chemicals Codex (FCC), for probiotics, steviol glycosides, benzoates, infant formula and flavoring ingredients, and is seeking industry comments.

IPA co-founder: EU probiotic approach is “dirty pool”

Disptaches from Microbiota 2011

IPA co-founder: EU probiotic approach is “dirty pool”

By Shane Starling

Jarrow Rogovin, never a man to mince his words, says it is high time the IPA and other trade groups stepped up to the plate to defend a sector that has been under regulatory siege on both sides of the Atlantic for several years.

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