Jarrow Formulas, Los Angeles, CA, sent a strongly critical letter to FDA’s (Food and Drug Administration) then-Acting Director Stephen Ostroff, MD, regarding the misrepresentations about safety of probiotics for use with infants. The FDA’s Deputy Director of CFSAN then invited the company to meet with the agency. A delegation affiliated with Jarrow Formulas, Inc. (JFI), and led by Jarrow L. Rogovin had a meeting with five officials from the FDA at CFSAN headquarters in September.
According to the company, “the meeting concerned issues of importance to the dietary supplement industry: probiotics, and in particular how this category will be handled by the Revised NDA Draft Guidance (now in progress), the recent revisions to California’s Proposition 65 and its impact on supplements, and the need for the FDA to be more forceful in publicizing enforcement actions against bad players who misrepresent their illegal products as dietary supplements.”
The company stated that at the culmination of the meeting, Ted Elkin, deputy director for regulatory affairs at CFSAN, had agreed in principle to the value of future public stakeholder meetings on these, and other issues affecting the industry.
The JFI delegation also included: Mohammad Khalid, Ph.D., President, JII; Silvano Arnoldo, Probiotic Consultant, JFI; George Paraskevakos, Executive Director, International Probiotics Association (IPA); and JFI's three regulatory attorneys, P. Scott Polisky, Susan D. Brienza, Ph.D., and Carol R. Brophy.
For more information, visit http://www.jarrow.com/eMarketing/Jarrow-Letter-to-FDA-Ted-Elkin-et-al-follow-up-to-Sept-21-2015-meeting.DOC.