Monday, April 30, 2007

FDA Draft Guidance Is Not A Concern

From the Natural Products Association, a supplement industry trade group:

"Association to Comment on FDA Guidance…The association has recently heard from members concerned about a draft “guidance” document from the Food and Drug Administration (FDA) on complementary and alternative medicine (CAM) that some are claiming will, among other things, classify all dietary supplements as drugs and curtail certain practices. As we stated in the April 16 edition of The Supplement, this is untrue. While the Natural Products Association recognizes that the guidance document itself does not affect the practices or products used in CAM, it does represent the FDA’s viewpoints about CAM, and in that regard, could be clearer. The association intends to file formal comments by the new submission deadline, May 29, 2007. Meanwhile, to assist members and others who have questions about the guidance, a new area is being created on the Natural Products Association’s Web site at

To reiterate what was previously communicated, a “guidance” document is by definition not legally binding and does not change or create laws or regulations. Guidances, like the one in question, are usually issued to help explain how a law or laws are applied. In this case, the guidance clarifies how products and practices used in CAM are regulated under different provisions or statutes depending on their intended use and claims. The deadline for sending comments to the FDA on the draft guidance document has been extended to May 29, and comments can be sent to the FDA’s comment area, or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Ln, Room 1061, Rockville, MD 20853. Refer to Docket No. 2006D-0480. Whether finalized or not, the draft guidance will not change current laws and regulations, such as the Food Drug and Cosmetic Act, which the Dietary Supplement Health and Education Act amended. The Natural Products Association is preparing comments to the FDA and is monitoring this and any other drafts, and will keep you up to date on any relevant developments that may affect our industry."