FDA Releases New Guidance Regarding Qualified Health Claims

Yesterday, FDA posted new guidance regarding qualified health claims. This action stems from FDA's "Consumer Health Information for Better Nutrition Initiative" issued in July 2003 (see http://www.cfsan.fda.gov/~dms/nuttftoc.html).

This report noted the prevailing industry position that consumers benefit from more information on food labels concerning diet and health. Yesterday's guidance notes that "as part of this initiative, the agency established interim procedures whereby 'qualified' health claims can be made not only for dietary supplements, but for conventional foods as well" (see http://www.cfsan.fda.gov/~dms/hclmgui3.html).

"Moreover, past court decisions have clarified the need to provide for health claims based on less science evidence rather than just on the standard of significant scientific agreement (SSA), as long as the claims do not mislead the consumers," continues the guidance document. FDA has been considering qualified health claims under these interim procedures since Sept. 2003.

"FDA is currently considering various options regarding the development of proposed regulations related to qualified health claims," reports the document. "In the meantime, the agency plans to review qualified health claim petitions on a case-by-case basis to determine whether to issue a letter concerning the use of enforcement discretion for a qualified health claim or to deny the qualified health claim."

To view the complete guidance document, see http://www.cfsan.fda.gov/~dms/qhcqagui.html.