The September 21, 2015 meeting covered a variety of topics, including spiked and adulterated products, the NDI draft guidance, Prop 65, negative media, and probiotics. Rogovin was accompanied by Mohammad Khalid, PhD, President of Jarrow Industries, Inc., Silvano Arnoldo, probiotic consultant with Jarrow Formulas, George Paraskevakos, Executive Director of the International Probiotics Association (IPA), and JFI’s three regulatory attorneys, P. Scott Polisky, Susan Brienza, PhD, and Carol Brophy.
“The meeting was characterized by a spirit of welcoming and fostering dialogue between the Agency and the supplement industry; and both sides hope to keep the momentum of this open conversation going,” said Rogovin. “This is also a period of opportunity for the industry. The Agency would be gratified by the industry supporting the elevation of the Division to an Office.
“This is an historic opportunity for the industry to negotiate with the agency. My company has accomplished a great deal, but other elements in the industry sector need to get creative, energized and involved.”
Present from the Agency were Ted Elkin, deputy director for regulatory affairs at CFSAN, Robert Durkin, Esq., acting director, Division of Dietary Supplement Programs (DDSP), Cara Welch, PhD, acting deputy director DDSP, David Shapinsky, deputy director for communications and public engagement at OFVM, and Kari Barrett, advisor for strategic communications and public engagement, OFVM.
The company applauded recent FDA enforcements against marketers promoting and selling adulterated and/or chemically spiked products including otherwise illegal drugs masquerading as dietary supplements that have resulted in jail sentences. However, more could be done to better publicize these enforcement actions and particularly the outcomes of criminal cases, said the company. “Failure to do so gives the misimpression that the industry is unregulated,” said a release from the company.
Rogovin also noted that the FDA too often has remained silent in the face of the relentless drumbeat of misinformation and misconceptions about supplements and their regulation and that this silence needlessly damages the image of the industry as well.
The Jarrow delegation raised concerns with the Agency over its December 9, 2014 Safety Alert linking a preterm baby’s death to a probiotic supplement. The Agency also cautioned health practitioners about use of probiotic supplements in all infants. Evidence was presented by the JFI speakers to show that an incomplete investigation led to an inaccurate Safety Alert, which should be removed from the Agency’s website.
“The facts and peer-reviewed science show that it was not the probiotic supplement, but rather the hospital environment itself which appeared to be the source of contamination, likely the ventilation system,” said JFI in a release.
The wider probiotic category was also addressed by JFI and IPA with a focus on the forthcoming revised NDI draft guidance. The guidance should address probiotics in harmony with both DSHEA and the high level of evidence of safety, said JFI.
The FDA was supposed to have issued a revised draft guidance by the end of 2014, but that did not happen. According to the Jarrow Formula personnel, the FDA’s representatives indicated that there were hundreds of comments on the first draft, including FOIA Requests, that were all being carefully considered, and that the process was taking a substantial amount of time.
FDA’s Dr Welch spoke with NutraIngredients-USA at the recent SupplySide West show in Las Vegas on the topic of the re-issue of the NDI draft guidance, and a number of key industry issues. To watch that interview please click HERE.
The third issue raised with the FDA representative concerned Prop 65 (California's Safe Drinking Water and Toxic Enforcement Act). Recently proposed lower thresholds for lead and other heavy metals will more dramatically affect both the supplement and food industries nationally and even worldwide, said the Jarrow Formulas delegation. Carol Brophy, Esq., noted that Prop 65 poses a very real threat to the FDA’s legal authority, especially as to the regulation of supplement quality.
“The new standards will seriously disrupt interstate commerce and international trade,” said the company. “The new state regulations conflict irreconcilably with federal law and policy and erodes FDA’s congressional mandate. The delegation stated a stakeholder meeting on the matter is urgently needed and should include the California Chamber of Commerce.”