Jarrow Formulas has submitted a formal appeal to the Food & Drug Administration objecting to its “incomplete response” to a Freedom of Information Act (FOIA) request about its controversial draft guidance on New Dietary Ingredients (NDIs).
The California-based supplement maker says it is still waiting for what it calls a “substantive response” from the FDA to most of the key questions in its FOIA request, which was sent more than six months ago.
128-item FOIA request
Jarrow is seeking “access to and copies of all documents and evidence related to decision making, interpretations, and cost estimates in connection with” the draft guidance, published last July.
Jarrow has specifically asked the FDA to explain the scientific basis for its proposed policy on chemical alteration and synthetic botanicals and to give a detailed explanation of its thinking about probiotics within the context of new dietary ingredients.
It has also asked the FDA to provide documentation about its safety concerns about dietary supplements and the deaths and serious adverse events intended to be remedied or corrected by the guidance.
Jarrow Formulas: ‘We are insisting that FDA prove the NDI policy is needed and well thought out.’
However, for 90 of Jarrow’s 128 FOIA requests, FDA officials had informed the supplement maker that they had “searched our files and found no responsive information”, said Jarrow’s attorneys Scott Polisky and Dr Susan Brienza.
This is a “clear indication that the Agency lacks the substantiation to support the need and scientific basis for the Guidance”, they claimed.
“In sum, FDA acknowledged that they had no documents or information for over 70% of the FOIA requests,” said Polisky.
The firm’s president and founder Jarrow Rogovin added: “We are insisting that FDA prove the NDI policy is needed and well thought out. Based on the agency’s own admissions, most of the NDI Draft Guidance lacks any basis in fact or science.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.”