Thursday, September 27, 2007

Does FDA really want public comments?

When FDA extended the comment period for the GMP identity testing exemption for dietary supplements, the agency addressed how to submit comments in the Federal Register announcement:

"Follow the instructions for submitting comments on the agency Web site.

"Written Submissions: Submit written submissions in the following ways:

"FAX: 301-827-6870.

"Mail/Hand delivery/Courier [For paper, disk, or CD-ROM> submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

"To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site...

"Instructions: All submissions received must include the agency name and Docket No(s). and/or RIN for this rulemaking. All comments received may be posted without change to> , including any personal information provided...

"For access to the docket to read background documents or comments> received, go to and insert the docket number(s), found in brackets in the heading of this document, into the "Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852..."

Does the FDA really want public comments? The easiest way for the public to comment is by email -- this route has now be cut off.

Dr. Laibow commented to me: "When Natural Solutions Foundation was encouraging over 200,000 people to comment to FDA on its anti-CAM guidane, the Supervisor of theReceiver of Dockets Office told me that the FDA does NOT tally written comments so this is yet another abuse of FDA authority to stifle public input..."

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