NDI guidance poll verdict: It’s catastrophic ...

By Elaine Watson

- Last updated on GMT

Related tags: Dietary supplements, New product development

It might not be legally binding, but ignore the FDA's draft guidance at your peril...
It might not be legally binding, but ignore the FDA's draft guidance at your peril...
A seemingly innocuous draft guidance document outlining the FDA's views on new dietary ingredient (NDI) notifications has provoked almost as much hysteria as Campbell Soup's move to put some salt back into its soups. But with good reason, according to many in the dietary supplements trade.

While the FDA's dietary supplements chief Dan Fabricant insists there are no surprises in this document, many of you beg to differ, according to the results of our latest NutraIngredients-USA poll.

Almost two thirds (63 percent) of respondents felt the guidance - if implemented - could prove "catastrophic​" or at least "very worrying".

However, a significant minority (19.3 percent) appeared to agree with Mr Fabricant, and believe the industry has overreacted to the document.

Readers were given four options to select from in response to the question: What impact will this draft guidance ​have on the dietary supplements trade?

  • It's catastrophic: It will stifle new product development and threaten scores of products already on the market.
  • It's very worrying:It will create significant hurdles for firms planning new products and does not match Congress’s intent that products made from ingredients on sale pre-DSHEA should remain on the market.
  • It's a mixed bag: It clarifies what FDA is looking for but goes beyond the intent of Congress in some areas.
  • The industry has over-reacted: It answers all the questions stakeholders wanted answered and will help the FDA pursue firms not playing by the rules.

Here's what you thought:

Click here ​to read the guidance document.

Related topics: Regulation, NDI draft guidance

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