Jarrow Formulas Says FDA “Stonewalled” NDI Guidance Freedom of Information Request

With the deadline for submitting comments on FDA’s New Dietary Ingredient (NDI) draft guidance just a few days away, Jarrow Formulas is calling out FDA for failing to adequately respond to a Freedom of Information Act (FOIA) request the supplements brand sent the agency in September, it says.

Jarrow’s FOIA request sought information clarifying FDA’s reasoning behind its NDI guidance. For more on the information Jarrow is specifically seeking, click here.

Jarrow says that it has not received a “substantive response” from FDA since the FOIA request was sent. “To date, FDA has offered no meaningful response to Jarrow Formulas’ September 8, 2011, FOIA request,” said the company’s food and drug attorney Scott Polisky, in a press release.

“The Agency has only sent us information that was already in the public domain. In sum, FDA has told us to ‘drop dead,’” Polisky continued.

In terms of responses Jarrow has received, the company said it received four responses: two that were comments in the form of letters from the public in response to the draft guidance, one that was correspondence to FDA from U.S. Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT), and an agency response stating it has no earlier draft of the NDI guidance, Jarrow says.

In light of what it says has been a lack of response, the company has sent FDA another letter stating that the agency’s lack of response has jeopardized the company’s ability to submit comments before the December 2 deadline.

“FDA has a legal obligation to responds to these FOIA requests in a timely manner,” stated Jarrow’s founder and president Jarrow Rogovin, in the press release. “We are simply not going to allow FDA to sidestep answering these crucial questions.”