NDI Notification Draft Guidance In Brief

Outspoken NDI notification draft guidance opponent Jarrow Rogovin continues his criticism in comments that attorneys submitted for Jarrow Formulas. If adopted in its current form, the draft guidance would have “catastrophic effects” on the supplement industry, consumers and the economy, according to the comments attorneys Susan Brienza and Scott Polisky wrote. They estimate that each notification would cost a firm between $845,000 and $6.6 million and, because FDA likely would reject many notifications, $7.84 billion to $14.7 billion in supplement sales would be lost annually, they say. Brienza and Polisky also recommend that if FDA imposes the compliance standards stated in the draft guidance, the agency should withdraw the document and resubmit it as a proposed rule because the draft would establish regulatory requirements outside those created by DSHEA.

The comments also reflect common industry concerns about FDA’s thinking in the draft on chemical alteration, synthetics, amino acids, probiotics,...