Jarrow Says FDA Unresponsive to Many Questions in Brand’s Freedom of Information Act Request over NDI Guidance

Supplements marketer Jarrow Formulas (Los Angeles) says FDA has failed to adequately respond to a number of questions the brand asked in a Freedom of Information Act (FOIA) request sent to FDA. The FOIA request asked the agency to provide evidence supporting several points in FDA’s new dietary ingredient (NDI) draft guidance.

According to Jarrow Formulas, for 90 of its 128 FOIA requests, FDA replied, “We searched our files and found no responsive information,” which the brand called “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, in a press statement. “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.”

Read more of what Jarrow Formulas said on the matter here.