NDI draft guidance comments

Citizens for Health NDI guidance withdrawal petition signatures approach 15,000

By Elaine Watson

- Last updated on GMT

Gormley: In the days ahead, we will be following up with 11 legislators whose offices we visited in order to ask for their support in calling on the FDA to withdraw the guidance and to hold a public hearing if it is not immediately withdrawn.”
Gormley: In the days ahead, we will be following up with 11 legislators whose offices we visited in order to ask for their support in calling on the FDA to withdraw the guidance and to hold a public hearing if it is not immediately withdrawn.”
Health advocacy group Citizens for Health (CFH) has delivered a petition to the House of Representatives, the Senate and the Food and Food and Drug Administration (FDA) signed by more than 12,000 Americans, calling on the FDA to withdraw its draft guidance on new dietary ingredients (NDIs).

This petition was delivered on Friday to coincide with the deadline for submitting comments to the FDA, said vice president and senior policy advisor James Gormley.

Signatures now approaching 15,000

He added: “We have been calling for the withdrawal of this guidance since September 13, and are pleased that the health-food industry associations are now calling for the guidance withdrawal, as well.

With signatures now approaching 15,000 even though the official comment period is over, we are going to continue to collect petition signatures and pass them along (in batches) to Congress and the FDA.

“In the days ahead, we will be following up with 11 legislators whose offices we visited in order to ask for their support in calling on the FDA to withdraw the Guidance and to hold a public hearing if it is not immediately withdrawn.”

Mystifying and baffling…

In formal comments submitted to the FDA in October, CFH said the guidance contravened the spirit and the letter of the Dietary Supplement Health and Education Act of 1994.

“It is mystifying to us, and to many others, why your agency would endeavor, 17 years after the passage of DSHEA, to re-interpret the laws governing dietary supplements as evident in this draft guidance”.

It added: “The American people would be harmed by the market and access implications within this document.

“The harm would come from whole swaths of products and categories (such as probiotics) being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, or even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already known to be safe.”

Related topics: Regulation, NDI draft guidance

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