All news articles for December 2011

NDI Draft Guidance Comments in brief

Atrium Innovations on NDIs: The system isn’t broken, so why fix it?

By Stephen Daniells

The FDA’s NDI draft guidance sets up a ‘substantial and unprecedented premarket regulatory process’ that is ‘tantamount to obtaining FDA approval for dietary supplement products’, says Atrium Innovations.

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...

AHPA to FDA: Tear up NDI draft guidance and start again

NDI draft guidance comments

AHPA to FDA: Tear up NDI draft guidance and start again

By Elaine Watson

The Food and Drug Administration should tear up its “hugely flawed” draft guidance on new dietary ingredient (NDI) notifications and go back to the drawing board, according to the American Herbal Products Association (AHPA).

ABC: Expert panel should clarify list of grandfathered dietary ingredients

NDI draft guidance comments

ABC: Expert panel should clarify list of grandfathered dietary ingredients

By Elaine Watson

The Food and Drug Administration (FDA) should recognize the existing industry list of ‘grandfathered’ or ‘old’ dietary ingredients (ODIs) sold in the US pre-1994 – but work with an expert panel to clarify its contents, according to the American Botanical...

Krill oil specialist Neptune predicts 17-22% rise in Q3 revenues

Krill oil specialist Neptune predicts 17-22% rise in Q3 revenues

By Elaine Watson

Bosses at Canadian krill oil firm Neptune Technologies & Bioressources are confident that third quarter revenues (three months to Nov 30) will be in the $5m to $5.25m range compared with $4.29m in the same period last year, representing a 17-22% rise.

Quercetin heart benefits may be linked to genes: Study

Quercetin heart benefits may be linked to genes: Study

By Stephen Daniells

Daily supplements of the polyphenol quercetin may boost levels of good cholesterol and decrease blood pressure, but benefits for waist size may be linked to our genetics, says a new study from Germany.

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