When do the labeling requirements in section 403(y) become effective?
Under section 3(d)(2) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the labeling requirements of section 403(y) of the FD&C Act apply to all dietary supplements labeled on or after December 22, 2007. Therefore, these labeling requirements are already in effect. However, FDA intends to exercise enforcement discretion for the new labeling requirements until September 30, 2010. Congress provided one year after the Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law on December 22, 2006, for affected firms to comply with its new requirements. However, due to competing priorities, FDA was not able to consider, develop and finalize guidance on the labeling requirements of Section 403(y) until now. As a result, firms did not have the benefit of FDA’s guidance on how to comply with the new labeling requirements when the requirements went into effect. Although the December 2008 revised draft guidance notified industry that the ag
