Los Angeles, CA—Supplement maker Jarrow Formulas met with regulators at the CFSAN headquarters in September.
Jarrow L. Rogovin, president/founder of Jarrow Formulas, Inc., and chair of the board/founder, Jarrow Industries, Inc. (JII), raised several issues, the first regarding an FDA Safety Alert from Dec. 9, 2014. Following the death of a preterm infant that had been given a probiotic, FDA alerted healthcare providers that it believes there are risks associated with giving supplements with live bacteria or yeast to people with compromised immune systems. JFI speakers countered that an investigation found “the hospital environment itself appeared to be the source of contamination, likely the ventilation system,” and therefore the Safety Alert should be removed from the Agency’s website.
JFI and the International Probiotics Association (IPA) also voiced the opinion that when the revised NDI Guidance is released, it should “address probiotics in harmony with both DSHEA and the high level of evidence of safety.” The regulators implied that when FDA moves forward with this document, it is planning to release a draft guidance, not a final version, followed by a comment period.
The group also raised some concerns that California’s Prop 65 newly proposed thresholds for heavy metals are “drastically lower than those of the FDA or that state’s own previous levels” and that “the new standards will seriously disrupt interstate commerce and international trade.”
Rogovin also expressed the opinion that FDA should not remain silent when misinformation is circulating about the industry.
The meeting’s attendees included Mohammad Khalid, Ph.D., JII president; Silvano Arnoldo, JFI probiotic consultant; George Paraskevakos, IPA executive director; regulatory attorneys P. Scott Polisky, Susan D. Brienza, Ph.D., and Carol R. Brophy; FDA’s former acting director Stephen Ostroff, M.D.; Ted Elkin, deputy director for regulatory affairs at CFSAN; Robert Durkin, Esq., acting director in the division of dietary supplement programs (DDSP); Cara Welch, Ph.D., acting deputy director DDSP; David Shapinsky, deputy director for communications and public engagement; and Kari Barrett, advisor for strategic communications and public engagement.
Published in Wholefoods Magazine December 2015 (online 11/09/15)