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FDA Admits To Having Limited Source Documents For NDI Draft Guidance Creation

LOS ANGELES — March 14, 2012 — On September 8, 2011 Jarrow Formulas, Inc. (JFI) sent FDA a 128-item Freedom of Information Act (FOIA) Request in connection with the New Dietary Ingredient (NDI) Draft Guidance, published on July 5, 2011.

The requests, in essence, asked FDA to:

  • Explain the factual and legal basis for the Guidance

  • Identify the safety issues that could possibly justify the intended measures, and how the Guidance solved any safety issues

  • Provide its scientific basis for radical changes in policy as to product specific notifications, “chemical alterationprobiotics, and synthetic botanicals

  • Disclose if and how the Agency has assessed the potential economic impact of the 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,” a clear indication that the Agency lacks the substantiation to support the need and scientific basis for the Guidance.

“In sum, FDA acknowledged that they had no documents or information for over 70% 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

In this regard, FDA’s response to Request 101 is particularly enlightening and damning:

Request 101: “All FDA documents reflecting communications, discussions, and considerations as to the safety problem(s) of concern with dietary supplements and the precise endpoint(s)–reported deaths, serious adverse events, birth defects, etc.–intended to be remedied or corrected by the Draft Guidance; and all the documents reflecting estimates and mechanisms as to precisely how and to what extent the Draft Guidance would correct those safety problems of concern above.”

FDA’s answer, shockingly, is:  “We searched our files and found no responsive information

In an added rebuff, for a number of the remaining requests, FDA asserted a “privilege” for internal deliberations, even though the Agency is required by law to segregate and produce factual material. This withholding of information is at odds with well-established case law regarding FOIAs and with past policy.  FDA had in fact released several inter- and intra-agency communications in response to a 2009 FOIA Request by JFI showing that the Agency had soundly rejected GAO recommendations for stricter oversight and regulation for supplements in many key areas.  Apparently, this time around, the Agency deliberately wants to deny the industry and the public any clues as to the how and why of FDA’s NDI policy.

Susan Brienza, JFI co-counsel on regulatory matters, reports:  “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.”

Jarrow Formulas’ Food and Drug attorneys Susan Brienza and Scott Polisky have now submitted a formal appeal to FDA objecting to the Agency’s incomplete response to the original FOIA request.  As of this date, no reply to the Appeal has been received.

“We are insisting that FDA prove the NDI policy is needed and well thought out,” said Jarrow Rogovin, President and founder of JFI. “Based on the Agency’s own admissions, most of the NDI Draft Guidance lacks any basis in fact or science. Furthermore, the Agency has even admitted that is has failed to undertake any economic or health analysis whatsoever because they have no documents pertaining to these critical issues.”

ABOUT JARROW FORMULAS
Jarrow Formulas is based in Los Angeles, California, and is a formulator and supplier of superior nutritional supplements.  The company was founded in 1977, and today markets its products in the United States and throughout the world.  Jarrow Formulas' goal is to promote optimal health based on sound scientific research data.  The company’s complete line of nutritional products includes vitamins, minerals, probiotics, standardized herbal concentrates, amino acids, enzymes and enteral nutrition products. www.jarrow.com

MEDIA CONTACT:
Rory Lipsky
Marketing Director, Jarrow Formulas, Inc.
(310) 204-6936
rory@jarrow.com
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*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
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