LOS ANGELES—Jarrow Formulas on Sept. 8 filed a Freedom of Information Act (FOIA) request with FDA, challenging certain assumptions and interpretations in the agency’s New Dietary Ingredient (NDI) Draft Guidance. The request is seeking certain documents as well as answers to a number of key questions, including:
- Why has FDA made a sudden "about-face" in considering most dietary ingredients and supplements (including new formulations) sold after October 1994 to be "new dietary ingredients"?
- What rationale supports FDA’s radical new positions on the status of probiotics?
- What is FDA’s estimate for the cost of each individual test and study to be required under the NDI Draft Guidance?
- Has FDA fully considered the enormous potential impact of the Guidance on public health?
The NDI Draft Guidance was originally published July 5, with a 90 day comment period. FDA recently extended the comment period by 45 days, to Dec. 2; however, Jarrow Formulas had requested a one-year comment period. “FDA’s time squeeze is illogical, unreasonable and patently unjust," said Jarrow L. Rogovin, founder, president and chairman of the board of Jarrow Formulas. “Considering the extensive Guidance requirements that are so dramatically different from prior policy, and the potential for a significant economic impact on the dietary supplement industry, it is vital that industry be given sufficient time to receive, analyze and respond to this latest FOIA request before commenting on the NDI Draft Guidance."
