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NDI Draft Guidance Comments in brief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The FDA’s NDI draft guidance sets up a ‘substantial and unprecedented premarket regulatory process’ that is ‘tantamount to obtaining FDA approval for dietary supplement products’, says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AHPA to FDA: Tear up NDI draft guidance and start again

NDI draft guidance comments

AHPA to FDA: Tear up NDI draft guidance and start again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The Food and Drug Administration should tear up its “hugely flawed” draft guidance on new dietary ingredient (NDI) notifications and go back to the drawing board, according to the American Herbal Products Association (AHPA).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NDI draft guidance comments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

Trade to FDA: Don’t leave us in limbo on NDI guidance

Trade to FDA: Don’t leave us in limbo on NDI guidance

By Elaine Watson

While the Food and Drug Administration (FDA) will need time to process the expected tidal wave of comments on its draft guidance on new dietary ingredients (NDIs), the supplements industry should not be left in regulatory “limbo” for long, trade associations...

Omega-3 again linked to lower inflammation: Study

Omega-3 again linked to lower inflammation: Study

By Stephen Daniells

Increased blood levels of omega-3s are associated with lower levels of compounds linked to inflammation and heart disease, says a new study that strengthens the heart health benefits of the fatty acids.

Vitamin C supplement sales edge up 2.8% in year to October 1

Vitamin C supplement sales edge up 2.8% in year to October 1

By Elaine Watson

Sales of vitamin C supplements – the biggest single category in the vitamins and minerals market - were up 2.8% to $221.27m in the year to October 1 across conventional and natural channels combined, according to new figures provided to NutraIngredients-USA...

Multivitamins may boost alertness and mood for men: RCT data

Multivitamins may boost alertness and mood for men: RCT data

By Stephen Daniells

A daily multivitamin and mineral supplement with added herbal ingredients may boost alertness and feelings of ‘general day-to-day well-being’, suggest data from a randomized controlled trial from Australia.

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