Jarrow Formulas is still waiting for a “substantive response” from the Food and Drug Administration (FDA) to a Freedom of Information Act (FOIA) request submitted more than two months ago about the FDA’s draft guidance on New Dietary Ingredients (NDIs).
Given that the official deadline for comment on the controversial FDA document is December 2, the FDA’s failure to respond in a timely manner “jeopardizes Jarrow Formulas' ability to submit comprehensive comments”, claimed Jarrow’s attorney Scott Polisky.
In a letter to the FDA dated November 8, Polisky said the FDA’s response to Jarrow’s 128-item FOIA request sent on September 8, had been “woefully inadequate”.
FDA response ‘woefully inadequate’
He added: "Your delay in providing answers to our key questions about the Agency’s assumptions and policies in formulating the guidance only serves to justify our original position that anything less than a one-year comment period was insufficient.
“To date… FDA has proffered only two items, neither of which provides any illumination on the elemental questions raised in Jarrow Formula’s FOIA request, i.e., FDA’s assumptions, interpretations and rationale for a policy that in essence seeks to rewrite the Dietary Supplement Health and Education Act (DSHEA), a part and parcel of the federal Food, Drug & Cosmetic Act.”
While the FDA – which is required to respond to FOIA requests within 20 working days - has sent four responses to Jarrow’s request, the first and third “ were simply comments in the form of letters from the public in reaction to the Draft Guidance”, while the second “was correspondence to the FDA from senators Hatch and Harkin”, he added.
FDA has only sent information already in the public domain
In its fourth response, claimed Polisky, “FDA states that it has no information on 11 of JFI’s FOIA requests, including the unbelievable claim that FDA has no earlier drafts of the NDI Draft Guidance.
“The Agency also stated it had no information whatsoever on its DSHEA-denigrating decision to regard any new formulation, or even a minor change in an existing formulation, as an NDI.
“The agency has only sent us information that was already in the public domain. In sum, FDA has told us to drop dead.”
Meanwhile, time was running out, said the firm’s president Jarrow L. Rogovin, who has repeatedly called on the FDA to extend the comment period until next July.
“FDA has a legal obligation to respond to these FOIA Requests in a timely manner. We are simply not going to allow FDA to sidestep answering these crucial questions.”
128-item FOIA request
In its FOIA request, Jarrow sought “access to and copies of all documents and evidence related to decision making, interpretations, and cost estimates in connection with” the FDA’s NDI draft guidance, published this July.
Among the documents specifically requested were for copies of all drafts of NDI guidelines and guidance documents drawn up between October 2004 and July 2011, plus all drafts—complete and partial—of the current July 5 draft guidance.
It also asked for documents “indicating the projected or expected cost to FDA of enforcing the NDI notifications pursuant to the draft guidance if implemented as drafted” plus a detailed explanation of the FDA’s thinking about probiotics within the context of new dietary ingredients.
New trade association: Founding members to be announced ‘soon’
Jarrow hit the headlines in September by proposing a new trade association - the Dietary Supplements Manufacturers and Marketers Association (DSMMA) – with the express purpose of challenging the NDI guidance.
Asked whether the firm had received any firm commitments from companies wishing to join – and pay the $20,000 fee – marketing director Rory Lipsky said: “We are just finalizing our by laws and will be announcing the founding of the association soon, along with the founding members.”
The industry’s existing trade associations have not responded favorably to the proposal, arguing that the last thing the trade needs is another association.
However, while AHPA president Michael McGuffin shared this sentiment, he added: “I’m not going to discourage any company in the supplement business to do whatever it needs to do to protect its business, and so would not discourage any company from organizing in whatever way it need if its executives disagree with my first point (that the current associations can and already do serve their needs).”