AHPA had issued comments to FDA's draft "Guidance for industry on complementary and alternative medicine products and their regulation by the food and drug administration", denouncing the document as unclear and likely to engender further confusion for manufacturers of products falling under the CAM (complementary and alternative medicine) umbrella.

"The effect that the guidance has had on industry to date is to cause significant confusion," AHPA president Michael McGuffin told NutraIngredients-USA. "Unless FDA either withdraws it or corrects it and identifies the failure that it is attempting to address, it will continue to have that effect."

The FDA asserts that the guidance is just a point of reference and not in fact regulation.

"This draft guidance, when finalized, will represent the FDA's current thinking on this topic," said FDA in the draft. "It does not create or confer any rights for or on any person and does not operate to bind FDA or the public."

However, AHPA finds the potential confusion surrounding what exactly the document is for, and who it pertains to, as a case of federal resources badly spent.

"FDA complains about its lack of resources on a regular basis, and this is not crying wolf," said McGuffin. "FDA has a continuing and worsening problem with reduced budgets - it would do better to invest its limited resources on issues of greater concern."

In the draft guidance, FDA uses the NCCAM (National Center for Complementary and Alternative Medicine) definition for CAM: "a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine."

AHPA has called for a complete eradication of the FDA guidance initiative.

"It is AHPA's view, as expressed below, that the draft guidance should be withdrawn through an announcement in the Federal Register," expressed AHPA in its comments. "No further effort should be made by FDA to develop any final guidance on this subject matter."