GOED - Request for Extension of Comment Due Date

Document ID: FDA-2007-0601-0005
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: January 17 2008, at 05:07 PM Eastern Standard Time
Date Posted: January 18 2008, at 12:00 AM Eastern Standard Time
Comment Start Date: November 27 2007, at 12:00 AM Eastern Standard Time
Comment Due Date: February 11 2008, at 11:59 PM Eastern Standard Time
Tracking Number: 8039d2c1
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Dear Sir or Madam: The Global Organization for EPA and DHA Omega-3s (GOED) respectfully requests a 90-day extension of time in which to file comments with respect to the above-noted rule. GOED is a relatively new association comprised of approximately 50 members representing a broad range of companies from small ingredient manufacturers to multinational food companies. We will be filing comments on this important rulemaking and anticipate that many of our members may do so as well. The additional time is needed to enable us to sort through and provide meaningful comment on the series of complex issues raised by the FDA proposed rule. We believe the proposed ruling relies on rationale that requires legal, scientific, and process-oriented responses. The issues raised by the FDA proposed rule are complex, and it is essential to our membership and industry that we have sufficient time to file complete, comprehensive comments on each issue. GOED feels strongly that EPA and DHA are vital nutrients to the general population and have a significant role in public health. Recent reports size the market for foods fortified with EPA and DHA in the US at $600 million in 2006 (Packaged Facts) and dietary supplements at an additional $489 million (Nutrition Business Journal). More than 180 million Americans use omega-3 products at least weekly. The essential link between consumption of omega-3 products and health place a premium on FDA allowing all stakeholders the opportunity to provide comprehensive, thoughtful comments that is only possible if the comment period is extended. In addition, the proposed rule has implications for other nutrients that fall in the ?authoritative statement? gray area. Therefore, the precedent this rule would set could potentially reach far beyond the EPA and DHA industry and should be carefully considered. We recognize the desire of the agency to proceed with rule-making as quickly as possible; however, in view of the complexity of the underlying issues associated with this proposed rule, we believe it is in the best interest of the agency, industry, and consumers to assure that FDA allows for an extended comment period that is necessary for GOED and many others to furnish to the agency information and analysis we believe is critical to the rulemaking process. Sincerely, Adam Ismail Executive Director Adam Ismail, Executive Director, GOED - The Global Organization for EPA and DHA Omega-3s (GOED) respectfully requests a 90-day extension of time in which to file comments with respect to the above-noted rule.

Attachments:

GOED - Request for Extension of Comment Due Date

Title:
GOED - Request for Extension of Comment Due Date

Abstract:
Adam Ismail, Executive Director, GOED - The Global Organization for EPA and DHA Omega-3s (GOED) respectfully requests a 90-day extension of time in which to file comments with respect to the above-noted rule.

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