Dietary supplements manufacturer Jarrow Formulas says that it has sent FDA a comprehensive Freedom of Information Act (FOIA) request relating to FDA’s recently issued new dietary ingredient (NDI) draft guidance.
Dietary supplements manufacturer Jarrow Formulas says that it has sent FDA a comprehensive Freedom of Information Act (FOIA) request relating to FDA’s recently issued new dietary ingredient (NDI) draft guidance.
Specifically, the company says it is seeking clarity on the following points:
The company also expressed disappointment that FDA failed to extend the draft guidance’s comment period by a year, as Jarrow had requested. (Based on other requests, FDA has extended the comment period, but only to December 2, 2011, as opposed to the originally stated deadline of October 3.)
“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be given sufficient time to receive, analyze, and respond to this latest FOIA request before commenting on the NDI Draft Guidance.”
The company also recently sent a letter to FDA Commissioner Margaret Hamburg regarding the hiring of Daniel Fabricant, PhD.
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