Such statements - which Jarrow claims the FDA has made in webinars and other events since July - reinforce the erroneous impression that the FDA's draft NDI guidance is critical to ensuring safety, despite the fact that supplements with undeclared active ingredients are in fact GMP enforcement issues, claims Jarrow, a Californian supplement maker.
FDA is blurring the issue
Jarrow, which is still waiting for a “substantive response” from the FDA to its recent Freedom of Information Act (FOIA) request about the guidance, has submitted a 45-page comment to the FDA on the offending document via attorneys Scott Polisky and Susan Brienza.
This points out that dietary supplements have an “extraordinary safety record when compared to every other FDA-regulated category”.
And where there are legitimate safety concerns – notably over supplements spiked with steroids, hormones or drugs – these are nothing to do with NDIs, argue Polisky and Brienza.
Spiked supplements are a GMP issue, not an NDI issue
They add: “Steroids and hormones are not NDIs; they are not even dietary ingredients… Steroids and drugs in supplements are a GMP enforcement issue, along with other federal statutes, and not an NDI issue.
“Apparently in its arguments in support of its guidance, FDA has lost track of the various purposes of applicable statutes and of the Agency’s own regulations.”
Meanwhile, if the FDA really believed that producing NDI guidance was critical to ensuring supplement safety, it would not have waited 17 years to produce it, they suggest.
“If the NDI guidance is so necessary to protect public health and as preventive controls for supplements, then why was it not issued in any of the years since 1994… and why did it take a Congressional mandate for the FDA to complete it?”
Catastrophic for the industry
If the guidance is finalized in its current form, it will be catastrophic for the trade, claims Jarrow, which has called on the FDA to ditch the “fatally flawed” document immediately.
Founder Jarrow Rogovin added: “The guidance… is truly an escort to the guillotine for the supplement industry.”
128-item Freedom of Information Act (FOIA) request
In its recent FOIA request, Jarrow asked 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documents drawn up between October 2004 and July 2011, plus all drafts—complete and partial—of the current July 5 draft guidance.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 has 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 NDIs.
Click here to see all of NutraIngredients-USA’s coverage of the NDI draft guidance.