On January 3, the Food and Drug Administration (FDA) published an interim final rule to codify an April 22, 2004 proposal requiring certain drug labels to include a toll-free number for reporting drug side effects. The rule is effective January 1, 2008, as mandated by the Food and Drug Administration Amendments Act of 2007. The FDA notes, however, that since affected entities will need time to update labeling and systems to comply with the new requirements, the agency will exercise its enforcement discretion and not take enforcement actions with regard to these regulations until January 1, 2009.