Jarrow Dissatisfied with FDA's FOIA Response

LOS ANGELESJarrow Formulas Inc. said it has not received a "substantive response" from FDA regarding a 128-item Freedom of Information Act (FOIA) request the company sent on Sept. 8, 2011. The FOIA request asked FDA to provide certain documents relating to the agencys New Dietary Ingredient (NDI) Draft Guidance, which was released in July 2011.

Jarrow reported the agency sent four responses. The first and third were comments in the form of letters from the public in reaction to the Draft Guidance. "These form letters were entirely non-responsive to Jarrow Formulas FOIA Request," according to a press release from Jarrow.  The second FDA response was correspondence to FDA from U.S. Senators Hatch and Harkin. In its fourth response, Jarrow said FDA stated it has no information on 11 of the FOIA requests, including no earlier drafts of the NDI Draft Guidance.

To date, FDA has offered no meaningful response to Jarrow Formulas Sept. 8, 2011, FOIA request," said food and drug attorney Scott Polisky, who represents Jarrow.  The Agency has only sent us information that was already in the public domain. In sum, FDA has told us to drop dead."

Jarrow Formulas said it recently sent FDA a letter objecting to the non-responsive documents sent. Jarrow believes FDA's lack of response jeopardizes Jarrow Formulas' ability to submit comprehensive comments before the Dec. 2, 2011, NDI Draft Guidance comment period deadline. Jarrow sent a letter to FDA on Aug. 29, 2011, requesting an extension of one year for the comment period. FDA extended the comment period by 60 days, which was 15 days longer than requested by several industry trade organizations.

FDA has a legal obligation to respond to these FOIA requests in a timely manner," said Jarrow L. Rogovin, founder and president, Jarrow Formulas Inc. We are simply not going to allow FDA to sidestep answering these crucial questions."