URGENT UPDATE: Deadline for Comments on CAM Guidance Switched by FDA: Agency’s Own 90-Day Period Not Being Honored

Citizens for Health Urges FDA to Accept Public Comments Through May 28^th

May 8, 2007 - FOR IMMEDIATE RELEASE

Washington - Citizens for Health has discovered that the U.S. Food and Drug Administration (FDA) has retroactively changed the comment period for accepting comments on "Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration" from May 29th to April 30th. This latest switch by the agency is another mistake on the part of the FDA regarding this Guidance. For example, April 30th was originally posted as the deadline but sometime sincethen the deadline was extended to May 29th, which was posted on the FDA website and still listed as late as May 1.

Frank Herd, Jr, Executive Director of Citizens for Health, contacted the FDA’s Philip Chao directly himself for clarification, who explained that the "extension" was the result of a mistake by one of the agency’s employees. He went on to say that it had been discovered in mid-April and was in the “process” of being corrected.

Mr. Chao stated that the FDA had received more than 125,000 comments on the Guidance, the vast majority of which expressed everything from concern to fear regarding the implications the Guidance could have for consumers’ access to supplements and the health practitioners they choose. Given this overwhelming public response, anything short of the full 90-day comment period is unacceptable.

We at Citizens for Health believe that, in light of the thousands of negative comments submitted by angry consumers, it is hard to view this “mistake” as anything but an effort on the part of the FDA to cut short the public’s right to be heard once the agency realized the degree of concern the Guidance had stimulated among consumers, industry and the natural health community.

A Curious Turn of Events

The Guidance states: “Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.” (Underlining is ours. See http://www.fda.gov/cber/gdlns/altmed.pdf).

The notice announcing the availability of the draft guidance was stamped with a publication date of 2/27/07. (See the attachment at the end of this article). Simple math: this means that – according to the Guidance itself, and before any “extension” was announced – the public should have been able to submit comments through 5/28/07.

It appears as if the FDA never had any intention of allowing the public (including consumers and industry) the time to which it was entitled to make its voice heard.

Time to Take Action!

We at Citizens for Health are reviewing all options for responding to this abrogation of the public’s right to be heard.

Meanwhile, click here to send a fax or email to the FDA urging them to honor the deadline for comments suggested by the guidance itself.