Ndi Notifications

NDI trespassers continue to plague market, attorney says

Dispatches from SupplySide West 2013

NDI trespassers continue to plague market, attorney says

By Hank Schultz

Follow on ingredients that rely on the safety halo provided by New Dietary Ingredient notifications filed by competitors continues to be a serious problem in the marketplace, according to a prominent attorney.

NDI guidance public comments: Don't revise it, ditch it

NDI guidance public comments: Don't revise it, ditch it

By Elaine Watson

The FDA should calculate how much complying with its guidance on new dietary ingredients (NDIs) will cost before forcing the supplements industry to embark on a “giant paperwork exercise” that will not make consumers any safer, according to the first...


Big interview: Daniel Fabricant, Food and Drug Administration (FDA)

FDA on NDI guidance: This is ‘not a doomsday scenario’ for supplements trade

By Elaine Watson

The trade can rail against the Food and Drug Administration's new dietary ingredient (NDI) guidance as much as it likes, but it cannot honestly pretend to be shocked or even surprised by it, according to the man in charge of the FDA’s dietary supplements...

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While many stakeholders seem to believe that the Food and Drug Administration’s (FDA’s) controversial draft guidance document on NDI (new dietary ingredient) notifications could spell Armageddon for the supplements trade, this is actually quite unlikely,...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


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