Jarrow Gets 'No Responsive Information' for FDA FOIA Requests

LOS ANGELESFDA said it found "no responsive information" to 90 of the 128 Freedom of Information Act (FOIA) requests submitted by Jarrow Formulas Inc. (JFI) regarding the New Dietary Ingredient (NDI) Draft Guidance, released by FDA on July 5, 2011.

In the FOIA requests, submitted on Sept. 8, 2011, JFI asked FDA to: explain the factual and legal basis for the Draft Guidance;  identify the safety issues to justify FDA's thinking, and how the Draft Guidance solved those safety issues; provide a scientific basis for its thinking on product-specific notifications, chemical alteration, probiotics and synthetic botanicals; and disclose if and how the agency assessed the potential economic impact of the Draft Guidance and its effect on public health.

For 90 of the 128 FOIA requests, FDA replied,  We searched our files and found no responsive information."  JFI said this is an indication that the agency lacks the substantiation to support the need and scientific basis for the Draft Guidance.

In sum, FDA acknowledged that they had no documents or information for over 70 percent of the FOIA requests," said Jarrow Formulas food and drug attorney Scott Polisky.  Ignoring the stellar safety record of supplements vis-à-vis other FDA regulated products, FDA officials, in numerous NDI-related seminars since July, have repeatedly stated that the agency is in the public safety business and have stressed the need for preventive controls for the sake of ensuring supplement safety. Yet, no FDA records show such a need."

JFI said FDA asserted a privilege for internal deliberations, but the company said withholding information is at odds with established case law for FOIA requests as well as past policy.

Significantly, for the 35 detailed questions on probiotics (e.g., how can species and strains on the market for decades be considered unsafe or NDIs?), the vast majority of these FOIA requests were again answered with:  'We searched our files and found no responsive information,'" said Susan Brienza, JFI co-counsel on regulatory matters.

Brienza and Polisky have submitted a formal appeal to FDA objecting to the agencys response to the original FOIA request. 

In November, JFI said FDA has did not respond to its FOIA request with enough substance to provide an adequate comment to the NDI Draft Guidance during the comment period, which ran from July to December 2011. JFI requested FDA extend the comment period to one full year, but that request was denied.

Find out more about the NDI probiotic issue at the SupplySide MarketPlace education session, "Probiotics, NDIs and Species Identification" with speakers Christine Farrance, Ph.D., senior application scientist, Accugenix; and Anthony L. Young, Esq., partner, Kleinfeld, Kaplan and Becker LLP, on Thursday, May 10, 2 p.m. to 4 p.m, Javits Center, New York.