Jarrow Formulas, a leading dietary supplement company, challenging the assumptions and interpretations in the “NDI” Draft Guidance, sent FDA a 128-item Freedom of Information Request (FOIA). These requests are material in every respect, and proportionate to the massive scope and scale of the NDI Guidance as drafted.
Over the last five years, Jarrow Formulas has submitted several FOIAs, which have yielded valuable information as to the internal workings of FDA–information that would have not otherwise been made public. For example, in 2009 Jarrow Formulas filed a FOIA in which it learned that FDA declined to accept most of the GAO’s recommendations for further oversight and regulation of dietary supplements.
This latest FOIA request seeks documents and asks for answers to a number of key questions, including these:
1. 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”?
2. What rationale supports FDA’s radical new positions on the status of probiotics?
3. What is FDA’s estimate for the cost of each individual test and study to be required under the NDI Draft Guidance?
4. Has FDA fully considered the enormous potential impact of the Guidance on public health?
Unfortunately, instead of FDA granting a one-year comment period, as Jarrow Formulas and Hyman, Phelps and McNamara requested, the due date for comments is now December 2, 2011.
“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be given sufficient time to receive, analyze and respond to this latest FOIA request before commenting on the ‘NDI’ Draft Guidance.”
ABOUT JARROW FORMULAS
Jarrow Formulas is based in Los Angeles, California, and is a formulator and supplier of superior nutritional supplements. The company was founded in 1977 and today markets its products in the United States and throughout the world. Jarrow Formulas' goal is to promote optimal health based on sound scientific research data. The company’s complete line of nutritional products includes vitamins, minerals, probiotics, standardized herbal concentrates, amino acids, enzymes and enteral nutrition products. www.jarrow.com