The first trade association to submit comments to the docket about the guidance ahead of tomorrow’s deadline, the NPA has drawn up a succinct 11-point action plan detailing what it believes the FDA needs to do to turn its July 5 draft into something the industry can work with.
FDA should make clear that it is not making enforcement decisions based on the draft guidance
In a 17-page submission signed by NPA chief executive John Gay and scientific and regulatory affairs chief Cara Welch, the NPA also urges the FDA to “make clear that it is not already following this draft guidance when making enforcement decisions”.
Ultimately, says the NPA, the industry asked for guidance on NDIs and welcomes the fact that the FDA has - 17 years later - finally provided it.
But the net result has been a document that “sets up inappropriate barriers to entry, imposes food additive criteria and requires multiple NDI notifications for dietary supplements beyond those required by law” – and will have a “chilling” effect on the trade if implemented in its current form, they conclude.
Guidance should be substantially rewritten
However, it could be salvaged if the FDA…
- Accepts industry grandfathered lists as a “rebuttable presumption of grandfathered status” – rather than requiring each firm to prove its products contain only pre-DSHEA dietary ingredients.
- Ditches its insistence on multiple end-product specific notifications.
- Scraps calls for food additive-style testing requirements.
- Opens up the definition of which processes do NOT constitute chemical alteration.
- Clarifies which bacterial micro-organisms are considered to be dietary ingredients and clarifies that probiotics are permitted dietary ingredients as long as they are not proven by the FDA to be unsafe.
- Revises its view that synthetic botanical constituents, even if they are chemically identical to their ‘natural’ counterparts - are not dietary ingredients and instead evaluates them on a case-by-case on safety grounds.
- Reconsiders its view that ingredients in an investigational new drug (IND) application cannot be dietary ingredients unless first marketed as dietary ingredients.
Click here to read the FDA's July 5 guidance document.
Click here to watch the FDA's Dan Fabricant defend the guidance at the SupplySide West show in Las Vegas.