FDA Extends Compliance Period for Change in Enforcement Discretion Policy Concerning Phytosterol Health Claims

February 20, 2011

By Riëtte van Laack

As previously reported, on Dec. 8, 2010, FDA published a proposal to amend the interim final rule ("IFR") governing health claims concerning the risk of cardiovascular heart disease and consumption of phytosterols (see 21 C.F.R. § 101.83).  FDA stated that, as of February 22, 2011, it intended to discontinue its policy of enforcement discretion that had been in effect since 2003 concerning certain health claims that go beyond the IFR.  Based on comments and petitions by industry contending that more than 75 days were needed to relabel and reformulate products (see our prior post here), FDA decided to extend the 2003 enforcement discretion policy until February 21, 2012.  FDA’s decision does not constitute a response to the petitions it received in response to the proposed rule.