Federal Food Drug And Cosmetic Act

Self-affirmed GRAS omitted from new NDI draft guidance

18-Aug-2016 By Stephen Daniells

The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.

Syntec supplements seized over unauthorized disease claims and serious cGMP violations

05-Dec-2011 By Elaine Watson

The Food and Drug Administration (FDA) says it had no choice but to seize supplements manufactured by Syntec Inc (Syntec Nutraceuticals) after the firm committed serious cGMP violations and ignored warning letters accusing it of making unauthorized disease...

Could the trade mount a legal challenge vs NDI guidance?

06-Jul-2011 By Elaine Watson

If the Food and Drug Administration (FDA) does not revise its draft guidance on new dietary ingredients (NDIs) for supplements to reflect industry concerns, the trade might be stuck between a rock and a hard place, admit lawyers.

TSI bolsters self-affirmed GRAS status of joint health suite

03-Jun-2010 By Shane Starling

Montana-based TSI Health Sciences confirmed self-affirmed GRAS status for its chondroitin sulfate sodium offerings, as proposed regulatory changes increase demand for GRAS status for certain ingredients.

Astaxanthin wins full GRAS status

19-Jan-2010

Fuji Health Science, the American subsidiary of Japanese supplier, Fuji Chemical Industry, has won a GRAS (generally recognized as safe) thumb’s up from the FDA for its astaxanthin form – AstaREAL.