The Freedom of Information Request (FOIA) seeks clarification on the potential impact of the draft guidance on a number of topics, including economic, business, and public health, the costs of testing and costs of actual notifications, safety issues, and probiotics.
In addition, the FOIA asks the Food and Drug Administration (FDA) for all documents pertaining to the comment period and FDA’s process toward a final guidance, and legal definitions.
Commenting independently on the FOIA from Jarrow Formulas (JFI), Virginia-based attorney Jonathan Emord told NutraIngredients-USA: “The questions raised in the FOIA are important ones that should be answered”.
JFI recently submitted a request to extend the comment period from 90 days to one year, following a similar request by law firm Hyman, Phelps & McNamara, P.C. on July 26, 2011.
As reported by NutraIngredients-USA , FDA granted a 60-day extension to the comment period for the NDI draft guidance last week. The announcement pushes the comment due date to December 2, 2011.
In its FOIA letter to FDA, signed by attorneys P. Scott Polisky and Susan Brienza, Jarrow Formulas (JFI) again makes the request to extend to one year.
“Please note that production of this information [requested in the FOIA] is vital to any comments JFI and other parties may seek to file in response to the Draft Guidance.
“Per our 16-point August 29, 2011 letter to the Dockets Management Branch, we requested that FDA extend the comment period from 90 days to one year, a fair and reasonable request given the complexity of the issues and requirements involved.
“As of [September 8, 2011] the FDA has extended the Comment period by 60 days, which is still inadequate given the enormous potential impact on industry and the public health. “
The letter finishes by noting that a response should be issued within 20 working days, as required by 5 U.S.C. § 552. “[However,] we certainly understand that complete responses to this request may take longer.”