Jarrow Formulas Sends Extensive Freedom of Information Request to FDA over NDI Draft Guidance

September 19, 2011

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comprehensive Freedom of Information Act (FOIA) request relating to FDA’s recently issued new dietary ingredient (NDI) draft guidance.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comprehensive Freedom of Information Act (FOIA) request relating to FDA’s recently issued new dietary ingredient (NDI) draft guidance.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:

  • Why has FDA ignored the stellar record of supplement safety vis-à-vis drugs and other FDA-regulated products (as FDA acknowledged in response to an earlier Jarrow FOIA)?

  • Given the relative safety of supplements, what could possibly justify the enormous financial costs and regulatory burdens FDA seeks to impose? 

  • Why has FDA failed to factor in, or for that matter, accurately calculate the economic consequences of the policy on industry, and its impact on the health of the American people?

  • What communications have taken place, regarding this Guidance, between CFSAN and GAO, USDA, CSPI, AMA, and CDER, and other agencies, departments or third parties?

  • Has FDA not changed the very definition of a “new dietary ingredient”?

  • 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”?

  • And should every post-DSHEA formulation require a NDI Notification as well?

  • What are the actual costs of every individual test and study required under the Draft Guidance?

  • What rationale supports FDA’s concerns and radical new positions on the status of probiotics and certain other dietary ingredients?  If probiotics (especially with “new” species and strains) will not be allowed in supplements, how can FDA explain why they have been allowed in cheeses and other conventional foods for the past 40 years?

  • Is the Draft Guidance not in essence an attempt by FDA to rewrite DSHEA (especially Section 4 and Section 8), and thus the Food, Drug & Cosmetic Act?

The company also expressed disappointment that FDA failed to extend the draft guidance’s comment period by a year, as Jarrow had requested.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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