NDI draft guidance

Doing nothing and hoping it will all go away is not a good plan ...

Big Interview: Vasilios Frankos, Herbalife

Frankos on NDI guidance (part two): This really isn’t a big surprise

While many stakeholders warn that the FDA’s controversial NDI draft guidance will stifle innovation and bury the supplements trade (and the FDA itself) under a hellish mountain of paperwork, they cannot pretend they didn’t see it coming, Herbalife’s Vasilios...

Frankos: You don't have to go out and spend millions on new tox studies...

Big interview: Vasilios Frankos, Herbalife

Frankos on NDI guidance (part one): Take a deep breath and don’t panic

While many stakeholders seem to believe that the Food and Drug Administration’s (FDA’s) controversial draft guidance document on NDI (new dietary ingredient) notifications could spell Armageddon for the supplements trade, this is actually quite unlikely,...

CRN: NDI guidance will stifle innovation

Mister on NDI guidance: ‘We are terribly disappointed.’

By Elaine Watson

The amount of safety data the FDA now says it requires to prove new ingredients in supplements are safe goes well beyond what Congress envisaged when it ratified DSHEA and establishes a process “ominously like the one for new food additives”, the Council...

Could the trade mount a legal challenge vs NDI guidance?

Could the trade mount a legal challenge vs NDI guidance?

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If the Food and Drug Administration (FDA) does not revise its draft guidance on new dietary ingredients (NDIs) for supplements to reflect industry concerns, the trade might be stuck between a rock and a hard place, admit lawyers.

The wait is over: FDA releases NDI draft guidance

Special edition: NDI draft guidance reaction

The wait is over: FDA releases NDI draft guidance

By Stephen Daniells

The Food and Drug Administration (FDA) has released the much anticipated New Dietary Ingredient (NDI) draft guidance, meeting its statutory deadline for the release of the document.

Ullman & Mackay: Not happy

Dispatches from SupplySide East

NDI guidance could be 'gamechanger' for supplements trade

By Elaine Watson, Secaucus, New Jersey

Fears are mounting that the Food and Drug Administration’s (FDA’s) long-awaited guidance on new dietary ingredients (NDIs) could prove a “game changer” for the industry, and not in a good way.

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